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Trials Going Unpublished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"What if some of those unpublished trials shed important new light on existing cancer drugs?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"