You can read Part 1 of this series here.
Much of the debate surrounding clinical trial transparency has focused on researchers. However, physicians are also impacted by whether or not they have access to all available clinical trial data—and not just a selective set of published articles culled from Clinical Study Reports.
Last April, the Cochrane Collaboration published evidence that unequivocally demonstrated the lack of transparency in clinical trial reporting, as well as the fact that a large portion of negative clinical trial data goes unreported and is therefore unavailable to researchers and physicians—not to mention patients.
The physician perspective on unpublished data
For Dr. Barry Mennen (pictured above), a Washington, D.C.-based practicing physician who also worked with the pharmaceutical industry for 30 years, the knowledge that many studies associated with FDA-approved drugs are unpublished is a matter of concern. "It makes my prescribing decisions more conservative," said Mennen in an interview with BioPharma Dive. "I usually wait for six months before prescribing any newly approved medication, just in case unreported side effects emerge. Perhaps I will now wait a year."
Despite the poor track record with respect to clinical trial transparency, the tide is turning as advocacy groups and respected organizations, such as the Institute of Medicine and the British Medical Journal, start demanding that pharmaceutical companies open the vaults and make all data available to anyone and everyone who wants to see it.
Dr. Mennen agrees. "I think the data should be available to anyone who wants to see it," he said. "The only stipulation would be a reasonable blackout on propriety data by the pharma company (that does not involve adverse reactions). For example, if a proprietary drug undergoing testing for condition A is also seen to have a positive effect on condition B, the pharma company should be able to mask that, anticipating future marketing potential."
The Declaration of Helsinki
In 2007, a revision to the “Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects” was updated to include a clause that mandates registration of all clinical trials and reporting of all clinical trial results. One of the main goals of the Declaration of Helsinki (which was originally drafted by the 18th World Medical Association in June 1964) was to decrease publication bias and also to ensure respect for the public purpose of medical research involving human beings. The WMA was also focused on preservation of human subjects’ dignity and respect for the sacrifice that they make by participating in clinical research
Admittedly, progress has been made since the Helsinki Convention adopted the transparency policy. According to information from clinicaltrials.gov, a service of the National Institutes of Health (NIH), published on January 7, the total number of registered clinical studies increased from 5,635 in 2000 to 181,801 in 2014. As of this month, 15,790 studies have posted results—representing roughly 11.5% of all registered clinical trials.
Multiple stakeholders, scientific integrity
Data transparency is important not just for physicians, researchers, patients, and clinical trial subjects, but for science itself. The overall integrity of the biopharmaceutical industry depends on the integrity of the data that comprises the medical literature.
So what does the future look like? Most likely, data will continue to become more readily and easily available to those who look for it.
"No question...the public will demand access to data that are produced by academics or pharmaceutical companies," predicted Mennen. "Please remember that cases of withholding data or outright fraud are not limited to the pharma industry: There are many cases of academic malpractice that have nothing to do with the pharma industry. Therefore, we need universal transparency in order for practitioners and patients to trust results. Perhaps legislatures will pass laws that will keep everyone involved more forthcoming."