Posted on 9/28/2016 2:48 PM
Releasing the details and results of clinical trials to the public has long been a critical ethical issue facing the pharmaceutical industry. How much information should be disclosed? How do companies developing new products protect sensitive details? What is our obligation to trial participants, the scientific community, and the world in general? The position of the National Institutes of Health is clear; as NIH Director Francis S. Collins states, “Medical advances would not be possible without participants in clinical trials. We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.” This philosophy has been echoed by prominent organizations like the European Medicines Agency, World Health Organization, and International Committee of Medical Journal Editors over recent years, and drives new regulations today.
After years of waiting, the US Department of Health and Human Services announced a final ruling that provides clarity on the requirements of disclosure reporting. The pharmaceutical industry has been awaiting this for years, and while expected, the final ruling is surprising in its significance (expanding scope of what needs to be reported, requiring quicker reporting timelines, and requiring disclosure of data for non-approved drugs). A number of other new guidances in recent years have required more and more global transparency, including results reporting on the EU Clinical Trials Registry, as well as the EMA’s policy on the publication of clinical data (Policy 0070). Both new guidances have expanded and enhanced the requirements, mandating the pharmaceutical industry to share data in a more transparent fashion, and this new ruling follows that trend as well.
For US trials, perhaps the biggest divergence from previous regulations is that trial results for investigational drugs are now mandatory, and must be reported to ClinicalTrials.gov. This means any pharma company with a drug in development (Phase 2 and up) will be required to disclose results, including drugs not yet approved by the FDA. Many companies do not have any marketed products currently in their portfolio, and they will now have the daunting task of registering results for the first time. Another major impact is that trials involving products that have been abandoned by the sponsor must now be disclosed as well.
An important aspect of this ruling is that it takes effect in just a few short months (on January 18, 2017). Any study starting or completing after this date will be subject to new rules, and drug companies will have 90 days to meet compliance. The final rule also established consequences ranging from civil and criminal actions to financial penalties and grant withholding. Previous regulations established similar penalties, but enforcement on pharma companies has been largely nonexistent thus far, allowing many organizations to remain non-compliant. It will be interesting to see if that changes in the coming year.
The MMS Transparency and Disclosures experts are currently poring over the rules to understand all the implications, and are in the midst of advising MMS current clients of what will be needed. It is an exciting time for the transparency area, as pharma companies look to adjust to these new rules. This change will surely usher in a new era of data sharing for the good of the patients and the advancement of science, but may well come with its fair share of growing pains as everyone learns the new requirements!
Please contact me if you have any questions about the new rule and its impact on the pharma industry and practices. I can be reached at firstname.lastname@example.org.