Clinical Investigators Financial Information

Released this month, The Food And Drug Administration’s Oversight Of Clinical Investigators’ Financial Information is now available. Read the document here.

New clinical trial at Johns Hopkins

MEMOTEXT will be tested for its effects on people with glaucoma. There will be 500 people recruited using telephone calls and text messages.

Amos Adler, president of MEMOTEXT, finds it to be an honor to collaborate on this special grant and believes this new interface will significantly improve medication adherence in patients with glaucoma. The company is confident this trial will demonstrate that their technology-driven adherence solutions help patients managing various conditions.

For more information on the trial, click here.

University of Kentucky starts new clinical trial

The University of Kentucky will start a clinical trial for an anti-seizure injection. They will be testing an auto-injector that will allow medicine to enter into the bloodstream of a a seizing patient before the medicine of an IV begin to work. They will be testing both methods.

The UK research team was selected along with 16 other prominent research institutions across the nation to conduct the emergency medicine trial known as RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) within the Neurological Emergencies Treatment Trials (NETT) Network. The network, formed by the National Institutes of Health, conducts large, simple clinical trials to reduce the burden of very acute injuries and illnesses affecting the brain, spinal cord, and peripheral nervous system.

For more on the story, read here.

Covance Names Three New Senior Executives

According to this article in Clinical Trials Today, Covance has added three new senior executive positions to its services team. Covance has appointed Glynis Neagle, M.D., vice president for medical affairs; Robert Bader, director for product safety services; and Thomas Noto, vice president for regulatory affairs.

All three have over 15 years of experience in the clinical trials industry. It will be exciting to see what changes that they will bring to the table.

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.

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.

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.

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?

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."