Contributed Commentary by Thomas Wicks

January 6, 2016 | I recently had the opportunity to host TrialScope’s Leadership Forum on Clinical Trial Transparency. The attendees, representing organizations that conduct global clinical trials, had come together to discuss pending changes to global transparency requirements, which will increase the scope of disclosure and shorten timelines.

A recent study published in BMJ Open by Bioethics International highlighted some of the challenges of transparency. We invited the lead author of the study to join the meeting as the featured speaker and to participate in a round-table discussion of the issues raised in the article. The participants considered compliance with clinical transparency requirements both from a legal perspective as mandated by FDAAA, and from the broader perspective of groups like WMA, WHO, and AllTrials.

I believe that any transparency efforts must confront two major challenges:

There is a need for timely disclosure of clinical trial data, but the publicly available information must be consistent to communicate clearly about trials, to avoid confusion, and to provide data that can more readily be used for analysis. Beyond the laws that mandate trial disclosure, there are many relevant organizations that require or promote transparency across the industry. The World Medical Association and World Health Organization both require the registration of protocols related to any study in humans before recruitment of the first participant. Journals that are members of the International Committee of Medical Journal Editors (ICMJE) require the registration of protocols at or before the time of first patient enrollment as a condition for publication. And AllTrials calls for all past and present clinical trials to be registered and their full methods and summary results reported.

The industry has also continued to see growing expectations from patient advocacy groups, doctors, researchers, regulators and individual patients to make more clinical trial information publicly available. 

Adding to the urgency, in July 2015, AllTrials announced a collection of 85 different asset managers and pension funds from the US, EU and Australia that urged clinical trial sponsors to be more transparent with clinical trial data. This announcement represented the first time that clinical trial transparency began to be directly tied to the valuation of clinical trial sponsors by investors.

In short, we are heading toward a perfect storm that could catch trials sponsors off guard. This will pose the greatest challenge to sponsor organizations whose transparency efforts must encompass global clinical trial projects. However, I think that many small or mid-size organizations, even those with an international outlook, may not be considering the impact of these changes yet. These companies have developed resourcing plans around current requirements and may assume they can use current processes and tools—yet the new requirements will require significant automation, as well as a “content management” approach to global disclosure that tracks and manages disclosable data that can be reused across various regions and countries.

The posting of clinical trial protocols, and the subsequent disclosure of results, are intended to promote public understanding of clinical research in humans. Transparency, as advocates note, may help avoid duplicative studies that put patients at risk unnecessarily, guard against publication bias, and shore up the brand integrity of life sciences organizations. 

Today, it is more important than ever for sponsors to look at their current processes and identify gaps. Cross-functional processes, information sources, data management practices, tools and organizational knowledge may all be lacking or out of date. Information changes constantly as a clinical trial progresses, and compliance is becoming more complex. As I learned from my peers at the forum, it is not too early to plan, because disclosure and transparency touch so many different functions across the organization.

Thomas Wicks is Chief Strategy Officer at TrialScope. Thomas has more than 17 years of experience with performance and content management solutions, specializing in applications for life sciences such as clinical trial disclosure, structured product labeling and submissions management. Prior to TrialScope's acquisition of PharmaCM, Thomas served as the General Manager of PharmaCM at Deloitte and as the Director of PharmaCM Product Management at Intrasphere Technologies. Before joining Intrasphere, Thomas worked in leadership, client-facing positions for Revelwood Inc. and Shepherd Systems, focused on performance management solutions.