Happy Holidays from CTC

We will be taking some much needed time off for the holidays. We'd like to thank you for your readership and we encourage you to check back with us next year for more innovative thought, perspective and news surrounding the world of clinical trials.

We wish you a joyous holiday season!

Hard times leads to more patients for clinical trials

A recent news report from ABC 15 in Phoenix, Arizona reports that the current recession is leading more people to enroll as patients in clinical trials. Patients see this not only as a way to supplement their income, but also as a way to help perfect drugs that could be vital in future of their children.

CTC Best of 2008

As 2008 draws to a close, we'd like to share with you some of the most popular articles from the Clinical Trials Congress in 2008!

Web 2.0 ... Health 2.0 ... Research 2.0?
India Times: Recession not to hit clinical trials: CROs
Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit
Zagats for Clinical Trial Sponsors and CROs
AHA Meeting 2008

Site Activation is Key for Successful Clinical Trials

PharmaExec.com has a informative article on its site that explains in full detail how site activation can improve and make way for successful clinical trials. Take a couple of minutes to read it, it’s worth it!

Consortia -- Pre-Competitive Is In the Eye of the Beholder

It is hardly news that drug development is high-cost and high-risk. What is relatively new is for pharma to lower their guard and begin to share information that action together that may potentially reduce cost and risk. Enter the era of the pharma industry consortia.

Perhaps the grandparents of this space are groups such as the Biomarkers Consortium and the SAE Consortium. The C-Path Institute was created, in-part, to create consortia to act upon the FDA's Critical Path Initiative. Where there has been a lack of sound business models for creating new tools for drug development, consortia have been a good solution.

The ability for otherwise competitors to suddenly collaborate is based upon what some have called the “pre-competitive space”. At least one group has defined this as “technologies that aren’t really the basis on which they are competing but helps them do their jobs.”

But there is an inherent conflict. By their very design, consortia are meant to be inclusive and bring representatives from various related areas around the table. But what is pre-competitive to one stakeholder is likely a key revenue source, business opportunity, or competitive differentiator to another stakeholder. In most cases, “pre-competitive” is in the eye of the beholder.

Today it seems not a week goes by without another new industry-wide initiative being launched. Each requires an investment of resources and a commitment to see value ultimately generated.

Impact on drug development? Consortia have emerged as important mechanism for improving the clinical development toolbox (biomarkers may be a good example). But each initiative must start with an honest discussion among stakeholders around the table about what is truly pre-competitive, and whether everyone sees the same opportunity in the same light.


Co-posted from www.pharmasherpa.com

Dude Where’s My Bailout: US- and UK-biotech edition

This was going to be a posting a few weeks back when the US automakers were heading (back) to Washington in search of billions. Unlike the Wall Street package, most believed the financial struggles from Detroit were based only in-part on current economic turmoil and largely based on a flawed and unsustainable business model.

And so I penciled a what-if posting about pharma heading to Washington. Sure the largest players in the industry are sitting on billions in cash, but the coming struggles are well-known as some will lose over 40% of their revenue over the next 2 years with key products coming off-patent. Could they get in line for a bailout?

But before I could get back on-line and move from pencil to keyboard, BIO beat me to it.

Despite the headlines, the BIO request is perhaps more a cash-advance than a bail-out. Currently companies can use today’s operating losses to offset future taxes when they are profitable. The request in Washington is to let companies receive money from the government today in exchange for giving up those future tax deductions.

And BIO cites a direct linkage to the financial crisis – lack of access to capital coupled with roughly 25% of publicly-traded biotechs having less than 6 months of cash equals an inability to fund expensive clinical trials (or even stay afloat altogether). As the NY Times article notes, “the change, if Washington approved of it, could enable the industry to receive potentially hundreds of millions or even billions of dollars, on the condition that the money would be used for research and development.”

Meanwhile, a similar story from the UK -- although here perhaps more of a bail-out compared with a tax reshuffle. As proposed, first there would be a £500 million ($740M USD) government fund set-up to support consolidation among smaller biotechs. Then there would be a £100 million ($146M USD) VC-backed fund to enable larger biotechs to pursue acquisitions and fund clinical trials.

Impact on drug development – Increasing the potential for companies and trials to survive the economic chaos...especially as proposals in the US and UK stipulate applying funds toward R&D.

Co-posted from www.pharmasherpa.com

Setting up Successful Meetings for Clinical Trials Investigators

According to this article on ClinicalTrialsToday, participation from investors in global clinical trials conducted in the Central and Eastern European region was up 25% over the prior year’s. A reason why this is happening is because there has been a slight change in setting up investigator meetings.

One aspect is that meetings should be set in “nice” locations outside of Eastern Europe. Investigators from Eastern Europe like to travel and so that would produce higher numbers. Also, give the investigators some time for sightseeing as they rarely step foot outside of the office. This will take away the bitter feelings of having to sit within four walls and then return home immediately. Take a look at the article to see the rest of the aspects highlighted.

Free Webinar: Project Management in the Life Sciences

Don’t miss your chance to view the free webinar Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade with presenter Jann Nielsen on Wednesday January 22nd from 2:00 PM – 3:00 PM Est. Here’s a brief description of the webinar:

The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted.

- How project management occurs in large pharma, small pharma, and biotech
- Differences in how project management is performed in the US, EU and Canada
- Contrasts between virtual and defined project management group’s practices
- Comparisons between single and multiple function project management practices

Register here:
https://www1.gotomeeting.com/register/403770168
Mention priority code: G1M2140W1BLOG

Clinical Trials and Unfavorable Results

This post on Chilmark Research discusses how the pharmaceutical industry has an uncharacteristic practice of sequestering less than favorable results. According to the post, approximately 75 percent of research never sees the light of day due to unfavorable results. Read the full article here.

Ex-Lilly executives open 'trials' clinic

From Applied Clinical Trials Online:

A new clinic that is on the cusp of conducting human trials in Indianapolis could distinguish itself as a key player in drug development, not only within the state, but nationally as well.Centurion Clinical Research LLC serves pharmaceutical companies and medical-device makers that need to test their products before they can be approved for widespread use. That first phase, in which healthy people are paid to participate in the overnight studies, is critical in determining the safety and success of a treatment.

"Without people volunteering, there won't be cures for these diseases," Centurion CEO William McGinnis said.
McGinnis and company President Michael Smiricky, both former Eli Lilly and Co. executives, are part of a group of 10 investors who raised more than $2 million to launch Centurion. It is the only commercial clinic in the city and just the second in the state that hosts Phase I trials.

For the rest of the article, click here.

People in the Move in the Clinical Trials Industry

This latest article one outsourcing-pharma.com reports some very important changes in personnel within the clinical trials industry. Some changes include GVK Biosciences appointing Dr. Shoibal Mukherjee to the post of senior vice president, clinical development, and The appointment of Joerg Reinhardt as chief operating officer of Novartis. There are plenty more changes, you can read the full article here.

Chinese CRO Cuts Manufacturing Positions in US

Clinical Trials Today reports that WuXi Pharma Tech, which is a Chinese contract research organization, is discontiunuing its U.S. biologics manufacturing operations as of December 31st, and as a result of this the company will be cutting nearly 100 manufacturing positions across its Philadelphia facility.

The restructuring of the CRO will cost the company between $2.5 million and $3.5 million within the next couple of months. WuXi CFO Benson Tsang recently mentioned:

“Given the depressed demand and the high cost structure of our biologics manufacturing services, we will focus on expanding our biologics testing, cell banking and cell therapy services in our Philadelphia site instead.”

Open Source for Clinical Trials

Matt Asay recently posted on cnet that the clinical trial open source project OpenClinica has finally broken through. TMCnet gives a great profile of the open source project:

“Since its debut in 2005, OpenClinica [developed by Akaza Research] has quickly become the most popular open source clinical trials software in the world. Akaza Research previously announced that it had experienced 2,000 OpenClinica downloads as of August 2006. Today's announcement represents a growth of 700 percent since that time....Akaza Research takes the position that its professional open source approach is key to helping to facilitate widespread adoption.”

This is a very interesting concept for the clinical trials industry, but I’m eager to see if this concept will catch on with big pharma execs.

Pushing past the placebo: Legislating for a new kind of clinical trials

From amednews.com:

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

For the rest of this article, please click here.

Zagats for Clinical Trial Sponsors and CROs

Living in Manhattan years ago, Zagats defined how we found restaurants. This was Web 2.0 before the Internet -- relying on feedback from other diners to find the "best" restaurant.

Today the spirit of user ranking and feedback defines Web 2.0 -- TripAdvisor tells us which hotel is best, Epinions which product is best, etc.

We are also seeing the Zagat spirit in healthcare. Enter your doctor's name in Google and the first matches are likely all physician and hospital rating sites -- HealthGrades, Vitals, RateMDs. Even Zagats has entered the fray of rating doctors.

So how far could we be from sites where investigators and patients can post reviews and rankings for clinical trial sponsors?

Some groups such as CenterWatch have a history of surveying sites to identify top rated CROs and sponsors. But moving from a controlled survey to the "wild west" of Internet reviews and postings will be a different world. Same too for inviting feedback from patients.

If this seems unrealistic, that is probably what the venture capital community used to believe. No entrepreneur would ever dare to post ratings and reviews of interactions with VCs while seeking funding? And then came TheFunded.com, disrupting and nudging a long-standing power balance.

Today many are addressing the shortfall in number of investigators by looking for sites around the world, and addressing the challenges in patient recruitment by increasing trial-related advertising spend. Perhaps such a review website would be good for drug development -- a site where investigators and patients were posting their feedback and ratings may force the industry to identify and address the roots behind the problems.

Co-posted from www.pharmasherpa.com

Freakonomics of Drug Development

In their best-selling book Freakonomics, Levitt and Dubner look at the world through the lens of economics and demonstrate how incentives (how people get what they want or need) are the root of most everything around us.

So what are the Freakonomics of drug development? Where are the incentives?

Here is a good starting question -- If you work at a "sponsor" is the goal of your company to make medicine or to sell medicine?

I would argue that if you are at a start-up biotech, you are there to make medicines. Your company likely aspires to get a drug into clinical trials, but it is unlikely they would still own the drug by the time of registration and equally unlikely the company would transform into sales & marketing.

If you are at a large pharma, I would argue your company is there to sell medicine. To confirm this, look no further than the revenue cliff ahead for most pharma as patents expire. The anticipated drop in sales is what drives most current decision-making.

So where are the incentives for those in development? Does your company reward for new project starts (regardless of ultimate project value)? Does it reward for killing a project early? Does it reward for innovation and risk-taking?

If your company is ultimately seeking to bring new approved medicines to patients and the marketplace as quickly and safely as possible, it would seem most of these incentives are misaligned.

Co-posted from www.pharmasherpa.com

Continued Growth in India's Clinical Trials

We've been frequently updating you on the rise in Clinical Trials in India, another news story on this growth has come up today that we wanted you to be aware of.

From Press Trust of India:

Clinical trials in India to test the safety and efficacy of newly invented drugs or medical devices have shown a huge growth and registered nearly a five-fold increase in the last four years, a top official said today."In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," Joint Drugs Controller of India, A B Ramteke, told reporters on the sidelines of a conference here today.

What do you make of this rise in Indian Clinical Trials? We'd love to hear your thoughts.

SuperGen Receives Clearance to Begin Clinical Trials With SGI-1776, a PIM Inhibitor

From International Business Times:

SuperGen, Inc. a pharmaceutical company dedicated to the discovery anddevelopment of novel cancer therapies, today announced that it has receivedclearance to initiate clinical trials with SGI-1776, an inhibitor of Pimkinases. The clearance of its Original Investigational New Drug Application("IND") triggers a $5.2 million milestone payment to the former stockholdersof Montigen Pharmaceuticals, Inc. The milestone payment will consist of $2.8million in cash payments and the issuance of approximately $2.4 million inequity, representing approximately 1.5 million shares of SuperGen commonstock.
SuperGen will initiate a Phase I clinical trial to evaluate the safety,tolerability and pharmacokinetic profile of SGI-1776, a novel, orallyadministered, small molecule anticancer compound. The first in human clinicaltrial program will enroll patients with solid tumors with specific emphasis onhormone refractory prostate cancer and refractory non-Hodgkin's lymphomas.These solid tumor types have been reported to overexpress the Pim kinasefamily of proteins at a high frequency. Overexpression of Pim-1 kinase hasbeen shown to be a marker of poor prognosis in these tumors. A second PhaseI/II study is being planned in patients with refractory leukemias in which Pimkinases are also overexpressed, and correlated with poor prognosis and drugresistance.

Web 2.0 ... Health 2.0 ... Research 2.0?

Web 2.0 showed us how social networking, communities, and collaboration could make the Internet a more engaging and interactive experience – think Facebook, Flickr, and YouTube.

Health 2.0 takes a page from the Web 2.0 playbook to enable the health consumer (formerly known as "patient") to also become engaged in their health and wellness. Here we have on-line support groups and condition-specific forums. We have our health information becoming accessible with tools to make it actionable (via personal health record offerings from Google Health, Microsoft HealthVault, and others). We even have on-line forums for medical professionals, enabling physicians to have peer-to-peer social networking (Sermo).

Health 2.0 brings great potential for improving individual wellness as well as public health, but what are the implications for clinical research? Should we anticipate “Research 2.0”?

In its most primal form, Research 2.0 could mean new ways to find patients that may be interested and eligible for clinical trials. Inspire builds strong on-line communities of patients around specific conditions and diseases, then makes clinical trial matching available to these communities.

At another level, PatientsLikeMe.com has demonstrated the willingness of patients to share personal health information and experiences for the benefit of their patient communities. Registered users (and there are several thousand) share functional status, medication and supplement use, and other interventions. As a result of this information sharing, PatientsLikeMe has found a novel Research 2.0 tool – patient-initiated research.

The patients in this community wanted better data to understand if Lithium is of benefit to patients with ALS. In the spirit of “Research 2.0”, these patients are now sharing their experience – via structured, quantitative data – and creating a dataset including the clinical experience of several thousand ALS patients.

A future with Research 2.0 brings opportunity and risk. Patients may be recruited for trials through communities, but patients may also freely create a discussion forum within a community to discuss experience within a particular trial. Imagine a significant percent of the subjects in your randomized and blinded trial virtually “talking” with one another and exchanging experiences and observations. This is a reality one needs to anticipate.

Physicians have long been concerned about Web 2.0, with patients seeking health information on-line and the risks of user-generated content. But there is more to worry about than whether Google can get a diagnosis correct.

Pharma has its own fear of patients in a world of Web 2.0, with concerns over inappropriate identification of safety signals (FYI, any known adverse experience linked to a specific drug that can be traced to an identifiable patient with an identifiable reporter must be reported to FDA).

The dialogue can not be stopped, and so risks (and potential benefits) must be understood. Some (see BMS and Novartis unrestricted grants for social networking) are already seeing this potential . Our patients are talking and the waiting room chatter is now global – are we ready to listen?

Co-posted from www.pharmasherpa.com

Images: Flickr

Access to Clinical Trials Under Fire

From News4Jax.com

Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.

For the rest of this article, please click here.

What do you think should be the process of getting access for individuals to particpate in clinical trials or for the approval rates for new medications from the FDA?

We'd love to hear your thoughts.

Will Change in Washington Bring Change in Clinical Research?

On January 20, 2009 change will come to Washington. Will a new resident in the White House have implications for drug development? Here are a few areas of possible impact:

Investments in Health Information Technology
Both Obama and McCain featured increasing investments in Health Information Technology as part of their healthcare reform proposals, and the recent Max Baucus reform proposal continues the trend. While the intent from the politicians is to decrease medical costs, reduce errors, and improve quality, there is great potential for clinical research as a by-product. The proliferation of electronic medical records and personal health records can bring transformation in the conduct of clinical research -- new opportunities to find patients, integration of EMRs and electronic data capture (EDC), running virtual trials, identifying biomarkers, the list goes on.

Personalized Medicine
Obama demonstrated awareness of the potential for personalized medicine back in 2006 when he introduced the Genomics and Personalized Medicine Act. And while the act never became law, the passage of GINA earlier this year did bring some protection around the use of genetic information. Outgoing HHS secretary Michael Leavitt has left a note to Obama emphasizing personalized medicine as a potent tool for repairing the healthcare system, which should be a good reminder to the new president that there is still work left undone. Increased investment in personalized medicine will bring more companion diagnostics into clinical development with each new drug, affecting everything from sample size to study logistics.

Continuing Focus on Drug Safety
Most feel the pendulum has swung and the FDA is focusing on safety over accelerating drugs for efficacy. With the media focusing on everything from safety of drug imports (including ingredients used to manufacture drugs) to what seems like every anecdotal report, there is no sign of this trend changing. For clinical development, sponsors will continue to aspire to accelerated approvals -- but will plan for the realities of studies large enough to demonstrate safety (to prove that every needle has been found in the haystack).

Beyond Safety and Efficacy -- Comparative Effectiveness
Once upon a time it was sufficient to run a development program to demonstrate safety and efficacy. Lessons learned from the UK's National Institute for Health and Clinical Excellence (NICE) have taught us the future adds a third endpoint -- comparative effectiveness. In fact, recent healthcare plans in Washington suggest creating an independent "Comparative Effectiveness Institute" for the United States, tasked with head-to-head comparisons of quality and cost for one drug vs. another. Be sure to have a few more voices at the table when writing that next registration study protocol (outcomes research, evidence-based medicine, etc).

Autism and Vaccine Safety Research
Obama and McCain were both enjoying the response of crowds on the campaign trial when raising the potential link between autism and vaccines. Assuming this campaign themes travel from Chicago to Washington in January, there is certainly the suggestion of additional research for vaccines new and old.

Stem Cell Reversal
Most seem to be anticipating an Obama reversal of the Bush restrictions on stem cell research. If this happens and if this research is successful, it would still be several years before one would see any heightened impact of stem cells in clinical research. But clinical trials of stem cells would certainly bring heightened planning -- from dose setting to safety monitoring.

New FDA Leadership
Other far more qualified political sources have taken educated guesses at naming the next FDA commissioner (including Scientific American's proposal of Stephen Colbert). We will need to wait and see in a few weeks, but the new leadership will certainly be expected to bring change within the agency -- which in turn will bring it's impact on clinical research.

Doing More with Less (and less and less...)
We have heard it time and time again. Big pharma are being hit by loss of patent protection to generics coupled with a weak pipelines and the growing risk of reimportation. And now small biotechs are expected to see challenges in raising capital to maintain their development work due to the credit crisis. This conspires to mean a familiar message for clinical development -- the need to do more (more products, more trials) with less. Except the "more" seems to keep growing and the "less" keeps shrinking.


What will come to fruition? Time will tell. But at last check we still have an aging population in this country, and plenty of unmet medical need to go around. (Personally, I am going to make sure I know what HIT, EMR, and PHR all stand for...)

Co-posted from www.pharmasherpa.com
Image: Flickr

India Times: Recession not to hit clinical trials: CROs

The Economic Times

The $200-million Indian clinical research outsourcing market will reach up to $600 million by 2010, according to a joint study done by research firm KPMG and the Confederation of Indian Industry (CII) in September this year. “Credit restrictions will prompt global biotech companies to see greater favour in outsourcing clinical trials to India,” Partner- Healthsciences Practice, Ernst & Young India, Ajit Mahadevan said. While the cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial—involving imaging systems—may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. India scores high due to faster enrollments, speed of completion, large and diverse patient pool as well as increasing private healthcare network.

For the rest of the article, please click here.
We'd love to hear your thoughts on this!

From CNNMONEY

The Independent Data Monitoring Committee (IDMC) constituted to oversee the conduct of the Phase III OVArian TUmor REsponse (OVATURE) Trial, yesterday recommended continuation of the study.
The OVATURE trial is a major multi-center international Phase III clinical trial of orally-administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin.
Read more here.

AHA Meeting 2008

According to MedPage today, the American Heart Association said that lipid studies have caused a surge in discussion about clinical trial bias.

Large multinational clinical trials require a "global set of standards of conduct and behavior" to ensure that outcomes reflect objective, unbiased evidence, a prominent cardiology researcher said here.

Because pragmatic clinical trials provide the foundation for clinical practice, a global imperative exists to develop internationally recognized and accepted "rules of conduct," Robert Califf, M.D., of Duke in Durham, N.C., said during a plenary session at the American Heart Association meeting.

The first step in developing those standards should be to bolster the independence of data monitoring committees, he said.

Read more here.

Science Daily: National Call For Cancer Clinical Trial System To Be More Responsive To Community Needs

The United States has seen poor performance in recruiting individuals for cancer clinical trials--especially individuals of lower socioeconomic status. According to this article in Science Daily, new efforts are going to be made in the marketing, design and overall outreach approach to particpation by this population in the cancer clinical trials. A landmark report just released yesterday by the Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy will aid and map out this effort.

Read more here.

Medtronic reveals results of clinical study done in the United States

Results from 66 patients from across the country participating on a study in transcatheter pulmonary valve for congenital heart disease resulted in:

... a high acute procedural success rate of 98 percent. At six-months follow up, maintenance of excellent valve competence was demonstrated as was a corresponding, clinically-significant, reduction of more than 18 percent in right ventricular volume. Valve competence was assessed by median pulmonary regurgitation fraction, which was down to 0 percent from a baseline of 30 percent.

Read more here.

Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit

Health Minister Mary Harney has officially opened the Oncology Clinical Trials Unit in Cork University Hospital (CUH). The unit provides access to research studies designed to test new treatments in cancer care. A clinical trial is set up at the end of a long and careful clinical research process in order to test a newly developed drug or procedure which shows promise. Patients who participate in clinical trials may be the first to benefit from the latest cancer treatments.

Their care is closely monitored during and after the trial. Clinical trials also offers patients an opportunity to make a contribution to cancer research.

Read more here.

Medical News Today: Researchers Find Relationship Between Brain Fluid And Adult Seizures

According to a new study published early online and in the December issue of Lancet Neurology, researchers better understand the disease mechanisms behind brain seizures that are due to the tapeworm-derived parasitic infection called neurocysticercosis. Their finding that the seizures are frequently associated with fluid or perlesional oedema (PO) around dead calcified cysticercal granulomas (immune cells) may lead to better possible treatment targets.

For more information on this study please visit: Medical News Today

New clinical trial for eye device

Doheny has partnered with Second Sight Medical Inc to develop a device that could help people suffering from night blindness and blindness caused by old age.

Rajat Agrawal, an assistant professor at Doheny commented, “We are creating an artificial retina. We are creating an artificial device where that function (is) to be superseded so that you are able to simulate the impluses to go on to the optical nerve and to the brain.” For more information, read here.

Sanofi-Aventis SA halts clinical trial

Sanofi-Aventis SA halted all clinical trials involving Acomplia, an obesity medicine after authorities in several countries requested them to stop the trials. According to Bloomberg, this comes after European regulators stated last month that the drug was too dangerous for sale. The trials were global, including 500 patients in France. According to FierceBiotech, patients who were taking the medicine experienced a doubled risk of psychiatric disorders.

E-governance for Indian clinical trials

The Economic Times recently announced that the Indian government could be using e-governance for clinical trials in India as soon as 2013. This would allow companies to file online applications for approval of their clinical trials. They would be the first country to approve clinical trials electronically. Read more here.

Study Optimizer gets an upgrade

DecisionView has upgraded its software that increases the efficiency of clinical trials. It's designed to help improve the patient recruitment process during clinical trials. The new version of the software has features that included improved user experience, performance, scalability and reliability. Find out more here.

Do you use this software in your clinical trials? How has it improved your performance?

Patient Recruitment Technology

Patient Recruitment just got a little easier. Praxis has announced the release of their new Patient Recruitment Management System, PraxisDirect2.0. The aim of this latest technology, is to make patient recruitment easier as mentioned in this article. The benefits listed in the article are:

PraxisDirect 2.0 features customized homepage dashboard views -- for site staff and for sponsors. Site staff can download important study documents, request recruitment materials and access patient recruitment information in one central location. Real-time enrollment tracking, personalized messages from Praxis and the sponsor, and the ability to email their Patient Recruitment Coordinator from any page enable sites to manage the patient enrollment process from start to finish in the most efficient way possible.

Lack of Minorities in Clinical Trials

The first of eight town hall meetings was held in Harlem to discuss the disproportianate amount of minorities who enroll in testing for clinical trials. Recent studies have found that approximately half of Americans questioned are nervous about clinical trials, with that number being higher among African Americans, and Hispanic groups. The goals of the meetings are to find solutions to reduce the fear that these minority groups have of clinical trials and encourage patient recruitment as reported here.

Clinical Trials Labeled as “Negative”

Henry Miller writes in this latest article on Forbes.com that when unfavorable findings in clinical trials are deemed as “negative”, the term itself has a very different meaning from the common usage.

To anyone who is not familiar with clinical trials, it might seem as if a “negative” clinical trial went haywire and that the testing was detrimental to patients. Henry assures that clinical trials are very seldom negative in that sense. What negative really means is that the tested drug was not helpful for the applicable uses for which regulatory approval is being sought.

There can be several reasons why these drugs were labeled negative. Henry provides these: The reasons can include insufficient statistical power (number of patients) in the study; inappropriate choice of dose, frequency of administration, or stratification (grouping) of subjects; or simply the drug's failure to be effective for the purpose for which it was tried.

Synexus Plans to Double Clinical Trial Capacity

MarketWatch reports that Synexus, which is a leader in the recruitment and running of clinical trials, is planning to double its clinical trial capacity in South Africa through the expansion of its Pretoria facilities, and by opening two new sites in Mamelodi and Soshanguwe.

Michael Fort, the CEO of Synexus, mentions:

"South Africa has proven to be one of our most successful sites both in terms of achieving high numbers of patients and also in the quality of the trials carried out. We will continue to expand our presence in South Africa."

The site in South Africa is well equipped with state of the art x-ray and DXA scanners for bone scanning. Staff members are estimated to grow to about 25 instead of the current 10.

BioPharm Insight Announces New Clinical Trials Network

Market Watch reports in this article that BioPharm Insight, a leading provider of information in the life sciences industry has announced the availability of the Clinical Trials Network to its array of products.

Sean Power, President of BioPharm Insight mentions:

"Our Clinical Trials Network reveals previously unknown relationships between Biotech, Pharma, and the global network of physicians that work on their trials. We have once again leveraged our unique capabilities in uncovering new intelligence to generate profitable new business opportunities for our clients."

How to evolve your trials

At Pharma Exec, they recently looked at how companies can evolve their trials so that they can become more efficient. They need to start by looking at and solving the current problems to evolve their efficiency. Before a trial starts, the companies need to predict more of what will happen in the trial, such as: more clinical trials, adaptive trials, regulations, geographies in which to conduct trials, and outsourcing partners. However, the key to successfully evolving clinical trials lies within the clinical trials supply chain. Find out more here.

Rabies Trial returns positive results

A Phase II clinical trial testing a vaccine with a treatment for rabies has turned out positive results. Read more here at FDA News.

The U.S. trial was set up as a single-blind, controlled study in 140 healthy volunteers to test the antibody in association with Sanofi Pasteur human diploid cell rabies vaccine.

All subjects completed the study, only mild-to-moderate adverse events were reported and the overall systemic safety was comparable with that of the placebo. The neutralizing activity against the rabies virus was comparable with that of standard care.

Successful clinical trial reported by Abbott

Yesterday, Abbott reported that a two year study showed that:

a bioabsorbable stent successfully treated coronary artery disease and was absorbed within the walls of arteries.

It was proven by:
data from 30 patients showed the drug-eluting stent left behind blood vessels "that appeared to move and function similar to unstented arteries."

Eighty patients will be included in the next stage of the clinical trial and Abbott hopes to release this drug to the European market by 2012, followed by the United States.

Athersys, Inc completes first clinical trial

According to Cleveland.com, Athersys, Inc has successfully completed treating its first clinical trial patient at the Cleveland Clinic. They're using stem cell therapy to determine the maximum dosage of Multistem, a medicine that is used after a heart attack.

B.J. Lehmann, president and chief operating officer, at Athersys, had this to say about the success:

"We are excited about the potential of MultiStem to provide benefit in multiple diseases and conditions, and we look forward to providing additional information about this Phase I clinical trial and other studies as we move our programs ahead."

AcelleRX Therapeutics Inc will finance clinical trial

AcelleRX Therapeutics Inc., a Cleveland, Ohio, based company, will finance it's first clinical trial on cardiovascular stem cell therapy. It received a $6.9 million investment. The company's main product is Stromal Derived Factor-1, which is given to patients immediately following a heart attack or heart failure. Read more here.

SNM Creates Molecular Imaging Clinical Trials Network to Streamline Regulatory Processes

EurekAlert! reports that SNM has announced the creation of the Molecular Imaging Clinical Trials Network, which is a model for the use of imaging biomarkers in clinical trials in order to reduce the burden of the time, complexity, and cost of the regulatory process.

This network is designed to provide centralized investigational drugs for biomarkers of interest to pharmaceutical and imaging communities, and then coordinate certain imaging protocols across many clinical trial sites. SNM President Robert W. Atcher mentions:

"The plan specifically includes creation of a Biomarker Use Pathway, which will provide SNM-sponsored centralized INDs that pharmaceutical manufacturers can cross-reference for their multicenter trials. Large trials of investigational therapeutics can often demonstrate safety and efficacy more efficiently if imaging biomarkers are included in the protocols. SNM is taking the lead to establish FDA-friendly imaging biomarker protocols via approved INDs."

It will be interesting to see how effective this network will be in streamlining the regulatory process once it becomes fully functional in the first quarter of 2009.

Patient Recruitment Incentives

Patient recruitment can be expensive in clinical trials, as this article states, it takes up approximately 23% of clinical trial resources and time lines. As such, companies are always looking for the right incentives to provide to patients, in order to get them to enroll in sometimes risky trials. According to a new study by Cutting Edge Information titled "Streamlining Clinical Trials", the number one incentive in patient recruitment was the possibility of receiving innovative treatment. This was followed by getting free medicine, and the number of "physicians visits that could be garnered from participation."

More than money drives clinical trials outside of the US

In a recent article at Bioresearch Online, they say that conducting clinical trials in India is 44% less expensive than conducting clinical trials in the US. Cutting Edge Information research states that a clinical trial in the US would cost$125 million while only $70 million in India. Other factors pushing researchers out of the US is better patient recruitment and retention outside of the US. Find out more here.

Who funded the clinical trial, anyway?

Last week, we told you that an alarming amount of clinical trials are never published in peer review journals. The Deseret News in Utah now reports that when articles are published in news papers and online, they often times fail to report who funded the clinical study. According to Harvard's research which included 306 articles from 45 sources, 42% of study sponsors are never mentioned in the articles. This is information is critical to consumers, because the results of the studies are often influenced by who pays for the study.

Publication Bias in Clinical Research

This post on Outsourcing-Pharma.com discusses how a team of researchers looked at 90 drug applications involving over 900 different clinical trials between the years of 1998 and 2000, and then identified whether or not the study had been published.

What researchers discovered is that when drugs performed relatively well the trial was more likely to be published in medical journals within the following five years. Drugs did not perform as well, were not as likely to be published in medical journals. Overall, 43 percent of all trials conducted were later published in medical journals. 66% of trials that had significant findings in support of the drug were published whereas the rate dropped down to 36% for trials that did not support the drug.

Trials Going Unpublished

In a paper recently published in The Oncologist by Dr. Scott Ramsey and Dr. John Scroggins, they found that an alarming number of clinical trials are not published, especially those relating to cancer studies. Reasons have included that there have not been enough applicants, or the trial was never concluded, as well as trial results came our negative. According to this news report, "Less than 1 in 5 clinical trials were published in peer-reviewed journals", as also stated "when it came to trials sponsored by industry, the rate was even lower: Just 1 in 20 is published." Some of the bigger problems that this article asked were:

"What if some of those unpublished trials shed important new light on existing cancer drugs? Perhaps a trial revealed that a drug caused previously unknown side effects. Or perhaps the drug didn't extend the life of cancer patients."

Market Research In Clinical Trials

Latest news in Clinical trials is that marketing efforts are happening in earlier phases than used to be the norm. In a study from Cutting Edge Information titled "Outcomes-Based Pharmaceutical Pricing: Meeting Stakeholder Needs" they found that 56% of companies surveyed start doing price focused market research prior to the start of product development in Phase III. As Haley Wynn, lead author of the study remarked:

"Market research campaigns that were once a thing of Phase III are now taking place during Phase II, and even earlier in some cases. These companies want to get to know their primary customers as well as possible, as soon as possible, in order to make informed pricing decisions."

As also found in the study, the reason for this shift is because third party payers have "amplified their requests." Has this proven to be true in your organization?

University of Michigan to start clinical trial for cancer-related pain

As reported by The BioTech Web, the University of Michigan will begin a clinical trial. This Phase I trial will be for gene therapy for untraceable pain for cancer patients. They're testing a vector created from herpes simplex virus (that which creates cold sores) to deliver for the gene enkephalin, which is a pain releiver produced by the body. They are looking for the trial to have twelve patients.

Drug Industry in Developing Countries

One often overlooked drug market is for diseases that are common in developing countries. In these situations the cost of the trials for bringing these drugs to market is more than what could be made off of profits from sales after approval. Victoria Hale from OneWorld Health discusses the issue in this CNN video interview courtesy of YouTube.

Cleveland BioLabs Awarded Contracts for New Drugs

Buffalo Business First reports that Cleveland BioLabs Inc. is getting closer to FDA approval for its drug that treats the gastrointenstinal effects of acute radiation syndrome.

Cleveland BioLabs has been awarded several contracts, both with the Biomedical Advanced Research and Development Authority and from the Department of Defense. These contracts play a major role in paying for the company’s expenses. The total contract value for Cleveland is now at $13.3 million.

The current cost of drug prices

A while back, Mike Huckman at the CNBC Pharma’s Market blog wrote about the opinions of Dr. Roy Vagelos, the former CEO of Merick. His beliefs on the current state of drug prices were quite contradictory to what we usually hear coming out of the drug industry.

"There is a shocking disparity between value and price and it's not sustainable. The industry will bring about government price controls which will be devastating for the industry."

Do you find this to be true? What do you think?

Online Recruitment is Key to Patient Recruitment

Recently Healthcare IT News, reported on the evergreen problem of patient recruitment. The article stated that 90% of drug trials are delayed due to poor patient recruitment. This problem doesn't stop there; drug companies are pouring money into these trials only to earn little results.

The solution? Recruit online.

Like we've seen in countless other avenues, online can prove to be a fast and cheap way to drive traffic. In this case, drive traffic to the recruitment pool.

Exco InTouch & MMG Partner

This article from PharmaLive informs of a partnership between Exco InTouch, and MMG. This fledgling partnership was created to help improve the patient recruitment process for Clinical Trials, with an added benefit of helping sponsors with speeding up identification, and pre-screening of possible subjects. Specifically Exco InTouch will combining their REACT SMS technology with MMG’s existing services. In a statement regarding the benefits of this partnership, Tim Davs, Co-Founder of Exco InTouch said:

"The new combined services from Exco InTouch and MMG reflect our close collaboration, enabling sponsors to streamline clinical trials and offering significant productivity gains. In addition, SMS communication between sponsors and patients ensures that subjects feel supported throughout the trial, typically improving retention by 20%"

Massachusetts could take on more clinical trials

Although Massachusetts is the state that comes in ninth for conducting the most clinical trials, there is belief that more can be done.

Although the state is proportionately smaller population wise, the 1,900 clinical trials currently taking place in the state are keeping the state held up to it's reputation with cutting-edge technology. In particular, the state is well known for early stage trials, which helps it maintain the goal of being a center for life sciences.

This article at the Boston Globe, Robert Coughlin, president of the Massachusetts Biotechnology Council, said clinical trials not only help develop drugs for the population, but also help contribute to the economy, providing jobs and business where clinical trials are taking place. While some clinical trial leaders are hesitant on conducting more trials due to population limits, others insist things such as databases notifying willing participants could help bring more patients into the state.

Clinical Trials and Web 2.0

Web 2.0 is a buzz word for many organizations, and as I found out today, it is no stranger to the world of Clinical Trials. I was looking at some slideshare presentations and came across this one aptly titled "Web 2.0 in Clinical Research". It provides some key insights as well as examples that are currently out there. I suggest you go through the presentation, and let me know any of your feedback!

Web 2.0 In Clinical Research

View SlideShare presentation or Upload your own. (tags: informatics web2.0)

Getting Global: A Focus on China

Huebei Province, China
The Rise in HIV/Aids cases among Chinese Citizens dramatically decreased from 49% to 8% following an influx of standardized Rapid Antiretroviral Therapy.
Antiretroviral drugs are broadly classified by the phase of the retrovirus life-cycle that the drug inhibits. This sort of success in China can be repeated if patients are given access to proper medical care. In order to do so, one must look at the types of clinical research being done in China and the ways that clinical research can improve despite difficulties with cost, patient retention and properly equipped staff:

Sources:
Wikipedia,
Health Affairs.
Clinical Trials in China

Feasibility of Multi-Phase Trials

Mahesh Paramar, Ph.D., from the Medical Research Council Clinical Trials Unit in London, along with some colleagues have "modified standard clinical trial methodology so that multiple therapies or combinations can be compared in a single trial." What this means, is that Phase II and Phase III goals are combined into a single "multi-phase trial," that also would have the benefit of needing less patients. As stated in this article, from Science Daily, Parmar and his colleagues wrote an article for the Journal of the National Cancer Institute detailing their proposal. regarding the practicality of using the approach outlined by Paramer, the authors of the proposal wrote:

"With three real examples, we hope that we have shown that such trials are feasible and can lead to major improvements in speed and decision making"