SOURCE: Xtalks

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November 30, 2015 15:00 ET

Transparency in Clinical Trials: Why the Industry Isn't Measuring Up

TORONTO, ON--(Marketwired - November 30, 2015) - A recent study conducted by Bioethics International -- a not-for-profit organization that keeps tabs on the way pharmaceutical companies develop and market drugs in order to determine the ethics behind these practices -- found that many large pharmaceutical companies failed to achieve transparency in their clinical trial results. The main take-home result of the study, was that only two out of every three clinical trials in 2012 -- the results of which were used to support new drug approval applications -- were ever disclosed to the proper authorities. Even more alarming is the statistic that nearly 50 percent of all drugs had at least one Phase II or Phase III clinical trial that was never reported. Despite the fact that some of these unreported trails may have had negative results, the investigators are still required to disclose the data.

Not only does this result indicate that many pharmaceutical developers are failing to meet ethical standards by sharing the results of clinical trials, but they are also failing to achieve legal standards; since the establishment of the Food and Drug Administration Modernization Act (FDAMA) in 1997, companies conducting clinical trials have been required to register them on the US government-maintained website, clinicaltrials.gov. The agency updated their requirements in 2007 after Congress passed the FDA Amendments Act (FDAAA), requiring that more types of clinical trial proceedings be registered with the agency, along with additional data from existing trials.

The study has caused many in the industry to ask why transparency in the clinical trials process has not been forthcoming by most pharmaceutical companies, and whether true transparency will ever be attained. "A critical issue facing the biopharmaceutical industry today is the loss of public trust," said Dr. Jennifer E. Miller, assistant professor of medical ethics in the Department of Population Health at NYU Langone Medical Center, and president of Bioethics International. "Clinical trial transparency is important for advancing evidence-based medicine, and respecting the rights and wellbeing of research participants."

In addition to publication of their transparency study, Bioethics International also designed the Good Pharma Scorecard -- a ranking system for biopharmaceutical companies based on a number of measures -- which was designed to hold the industry accountable. Pharmaceutical developers -- along with the new drugs they produce -- are independently ranked based on public health criteria, human rights and company ethics, spanning from R&D all the way through to the release of clinical trial data. The not-for-profit plans to release the rankings on an annual basis in an effort to improve pharmaceutical companies' adherence to legal and ethical standards.

"Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12 percent of Americans believe that pharmaceutical companies are honest and ethical, said Miller. "The Good Pharma Scorecard enables the biopharmaceutical industry to evaluate its performance across key areas of ethical and legal concern, and offers companies the ability to publicly demonstrate meaningful improvement in trustworthiness over time."

While increasing regulatory compliance at the level of the individual pharmaceutical company is a start, some say there are other industry-wide practices that are standing in the way of complete clinical trial transparency. Dr. Brad Thompson, CEO of biotech firm Oncolytics, says that clinical investigators' goals of publishing positive trial results may be impeding the industry's path towards transparency.

"I think a lot of people, patients especially, believe that companies are the roadblock in keeping the results of clinical studies from becoming public," said Thompson. "But personally, I believe it is a much wider issue than that, especially when it comes to finding out the results of unsuccessful trials."

According to Thompson, clinical investigators are most interested in publishing positive results from clinical trials, in order to advance their careers. Since reporting neutral or negative results has no benefit on their career goals, clinical investigators can delay reporting of these results in order to put their energy into more professionally lucrative pursuits.

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