With several exceptions, the FDA requires that studies of drugs and devices be registered, and their results reported, by their sponsors or principal investigators1. But there is often a tug-of-war, in the clinical research field, between researchers who value confidentiality in trial results and governments and advocacy groups who demand transparency2. The issue is complex, with various interests coming into play. Let’s take a look at these different interests, and at a recent attempt, in Europe, to reconcile them.
From the government’s perspective–as well as, arguably, the public’s–the demand for transparency is driven in part by safety concerns. An overzealous approach to confidentiality can result in safety-related information such as adverse reactions being underpublicized, potentially putting the public at risk. There is also the concern that confidentiality impedes the spread of useful knowledge about a treatment, undermining the research community’s efforts to strengthen medical progress by building upon previous findings2.
On the other side of the debate are the drug companies, whose resistance to full transparency is both ethical and economical in nature. Perhaps their most obvious reservation is that transparency could compromise patient privacy; some have extrapolated this concern with the argument that if patients believe their privacy won’t be protected, they will be disincentivized from enrolling in a trial in the first place, thereby endangering medical progress and exacerbating the already cumbersome process of patient recruitment3. On the economic side, companies see full transparency as a threat to the proprietary aspect of their products. The more data from a particular study is available, the less competitive the drug or device at the center of that study may become2.
In Europe, this debate recently culminated in a ruling by the European Medicines Agency (EMA) intended to strike a balance between the two sides. The ruling allows for information from a clinical trial to be withheld or redacted as long as the pharma company involved can justify the economic necessity of doing so. The reaction has so far been mixed, with some groups worried that the EMA has capitulated to the drug companies2. The controversy of the case highlights the difficulty in reconciling opposing sides in a debate involving such sensitive issues as patient privacy, public health, and commercial profit.
1 FDAAA 801 Requirements; ClinicalTrials.gov
2 Silverman, Ed; European regulators issue final guidelines for retracting clinical trial data; STAT; 3/14/2016
3 Binder, Daria; The Full Clinical Trial Data Transparency & Limited Disclosure Debate; CBI; 1/2/2014