Clinical trial transparency - The road ahead
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The seventh International Congress on Peer Review and Biomedical Publication is in full swing in Chicago this week, and judging from the program, it appears various aspects of clinical trial transparency are once again hot topics. "Various" is the key word here, because "clinical trial transparency" is often used to refer to three distinct issues - trial registration, results reporting, and open data access. Although these issues may appear tightly linked, they are in fact largely independent from one another in terms of their philosophical underpinnings and implementation challenges.
In addition, despite the efforts of some loud voices to reframe the debate mainly as a critique of the pharma industry, "clinical trial transparency" is important far beyond drug development. For example, academic investigators have the same ethical responsibilities to research subjects as companies, and yet it's becoming increasingly evident that awareness of and compliance with even basic, widely-accepted clinical trial transparency standards are often quite low in academia. Thus, the "variety" inherent in clinical trial transparency relates not just to the underlying issues, but also the stakeholders (including, but not limited to, pharma) who are critical to drive meaningful change.
I'm sure a lot of great research will be presented at the PRC this year, and although I'm not in Chicago, I plan to follow along via the #PRC7 Twitter hashtag. But the PRC is more than just a research conference - it's a once-every-four-years gathering of a "who's who" of top-tier editors, publishers, and academics who in many ways will drive the discussion and implementation of emerging ideas in biomedical publishing in the months and years to come. In that spirit, here are the issues related to clinical trial transparency I hope PRC attendees will take on when they return home after the close of the meeting:
Trial registration: Registration of clinical trials in public databases is critical to enable the research community to track the progress and outputs of clinical research, and it has widespread, international support. If trial registration is not yet at or near 100%, the broader community needs to wield some "sticks" to gain the attention of clinical investigators. For example, both medical journals and Institutional Review Boards (IRBs) could productively and actively encourage trial registration by requiring registration for publication or IRB approval, respectively. A recent report suggesting that journals are less-than-wholeheartedly enthusiastic for these sorts of activities is surprising and disconcerting, and hopefully this finding will engender some intense navel-gazing on the part of PRC attendees to understand whether as a community they can and should do more to move toward "zero tolerance" of unregistered trials.
Results dissemination: There is a compelling argument to be made that we have an ethical obligation to research subjects to disseminate clinical trial results in order to benefit the broader research community. Some prior attempts to quantify the current level of results dissemination (see one of my recent posts) have had methodologic challenges (see a post by Paul Ivsin at "Placebo Control"), and it's clear we need better data on results dissemination in journals, ClinicalTrials.gov, and other venues for a data-driven conversation. Hopefully PRC attendees will conduct and support more high-quality research in this area to help inform further policy and implementation discussions.
Data access: Recent announcements by Roche and GSK that they will make patient-level trial data publicly available raise the question of whether data access is a concern chiefly for pharma-sponsored clinical studies - a stance commonly taken by "pharmascolds" who believe that industry-sponsored trials are inherently and pervasively biased. Alternatively, data access may be equally critical for non-pharma trials - or even non-clinical studies as well, as promoted by many advocates of "reproducible research". These are important questions that bear further thoughtful debate on both philosophical and logistical grounds, and hopefully PRC attendees will continue to engage in and promote this discussion after the congress.
The PRC is a great opportunity to take a focused look at the challenges and opportunities in improving clinical trial transparency, and there appear to be many people from journals, academia and other organizations at the PRC who are fiercely committed to this goal. Let's hope they make good progress in Chicago this week, and return to their "day jobs" energized to explore the nuances of this complex area and work collaboratively toward solutions.
(Full disclosure: From 2008 to 2012, I consulted extensively for the Medical Publishing Insights and Practices (MPIP) initiative, a multi-pharma consortium that aims to "elevate trust, transparency and integrity in publishing industry-sponsored studies", and co-authored several papers with that group. In addition, I am currently employed by a global pharma company.)