The BMJ Audit That Will Make Sponsors Rethink Their Transparency Policies

Thomas Wicks

August 1, 2017

AUGUST 1, 2017

A recent article in the British Medical Journal on Pharmaceutical companies’ policies on access to trial data, results and methods, is an interesting next step in the evolution of publicly disclosing clinical trial information. These policies help communicate both internally and externally an organization’s commitments to sharing clinical trial information with patients, doctors, researchers, and the public.

In the article, the policies are scored and ranked based on their stated commitments across four dimensions of transparency; protocol postings, summary results disclosure, as well as the sharing of clinical study reports (CSRs) and individual patient data (IPD).

As with any ranking system, it is fair to question the scoring criteria, and review the individual assessments, but it is also true that this audit establishes a baseline of sorts, against which organizations can to measure their own policies, in terms of scope and clarity of their commitments.

For pharmaceutical companies, this audit provides an opportunity to review their approach to communicating their transparency commitments, since some may not be receiving the full credit for their actual disclosure practices, because these may have not been spelled out in their policy. Ultimately, it is the quality, scope, and timeliness of data that is publicly available which is of the greatest value – while the policies are a way to communicate, and receive credit for all the hard work.

In 2015, TrialScope ran the first Global Clinical Trial Disclosure Maturity Assessment, where sponsors reported the scope of their disclosure commitments and their approaches to tracking and managing global transparency. While the focus of the maturity assessment was more on the operational aspects of disclosure, we too saw a clear difference in the scope of transparency commitments between larger and smaller trial sponsors. Smaller Biopharmaceutical companies were more likely to focus their efforts on complying with disclosure regulations, while larger sponsors were taking a broader perspective and committing to transparency beyond regulatory requirements. We are currently running the Second Disclosure Maturity Assessment and look forward to seeing whether these trends have shifted in the past two years.

As companies continue to expand their transparency policies to cover a greater range of data, across broader geographies, and covering studies further back in time, the challenge becomes operationalizing these commitments. A comprehensive and clear policy is the bedrock of an effective transparency program and can help align internal processes, disclosure technology decisions, and executive management efforts to effectively deliver on data sharing commitments to benefit all.

About the author

Thomas is responsible for tracking regulatory and market trends that shape TrialScope’s clinical trial disclosure and transparency solutions. He has more than 23 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. Thomas has been focused on trial transparency since 2007.