CBI Scene Blog

The EMA Disclosure Mandate – A Shift for Clinical Trial Data Sharing

Posted by Amanda Batstone on Apr 30, 2013 1:56:00 PM

clinical trial data checklist

The EMA recently announced one of the biggest developments around public disclosure and sharing of clinical trials data; the regulatory body set a mandate that companies must publish their clinical trials raw data for public access starting January 1, 2014. Journals will no longer publish the results of clinical trials unless drug companies agree to provide raw study data (not just summary data) on request to third party researchers/investigators.

GSK and The BMJ (British Medical Journal) are taking the lead in this space. GSK started the disclosure of individual patient-level data in October of 2012 and The BMJ was the first to announce that they will only accept manuscripts on clinical trials if the authors agree to release patient-level trial data to researchers who make a “reasonable request”. They already started enforcing this rule in January of 2013, even though the regulation doesn’t officially go into effect until 2014.

What does this new mandate mean for registries and results posting, as well as the subsequent publication of data? We’ve outlined below the 5 things to look for over the course of this year so that you are fully prepared for the January 1, 2014 sharing date. Learn more about greater transparency of clinical trial results, data privacy concerns, patient confidentiality and the potential for misinterpretation of the data by third parties. 

Top 5 Things to Watch For:

1) Potential for Publication of Misleading Results – How Do We Combat This?

Researchers can use the raw data from multiple trials to conduct their own analyses and subsequently publish their findings. While this may lead to some research breakthroughs, there are also looming concerns around the potential for misinterpretation of the data by third parties. Of course, this leads to questions around: 

  • Accuracy of publications
  • Training those who are allowed access to the data

How can pharmaceutical companies combat this potential concern? Some companies are creating teams devoted to ensuring the external requests for data are coordinated. But, do all organizations have the time and resources needed to set up something like this? Companies may need to come up with new plans to contend with the publication of misleading data results. 

2) Global Competitiveness – A Growing Concern?

As companies are now required to disclose the raw data from a clinical trial, is there potential for the re-analysis of data to be misused for competitive purposes? Both U.S.-based and global pharmaceutical companies are sweating the implications of having their raw data publically accessible, including legal constraints and intellectual property concerns about disclosing data.

3) The Disclosure of Individual Patient-Level Data coupled with Data Privacy – Is that Even Possible?

The mandate has also led to concerns for patient confidentiality, especially in very small trials. Patients have expectations of data privacy based on signed consent forms, so what will this disclosure mandate mean for those patients whose data will be readily accessible? Are there legal concerns around patient confidentiality based on this idea of “ultimate transparency” of patient-level data?

4) Publishing Data in Scientific Journals – What Do the Timelines Look Like?

Once a trial is completed, the results are often posted in scientific journals. The publication of data in a peer-reviewed journal is critical to showcase the sound scientific processes of the company conducting the trial. Publications put the results data into context to clarify outcomes and meanings. Publication and medical writing teams must work closely with their disclosure counterparts to ensure the data is reported consistently and published in a timely manner. 

5) Hefty Fines – How Do We Stay Compliant?

As of October 2012, the FDA began policing compliance with clinical trial submission requirements for ClinicalTrials.gov. The FDA is now identifying incorrect or fraudulent submissions and the penalties for noncompliance can be severe. For instance,

  • Any person who fails to properly disclose trial information will be subject to a civil monetary penalty up to $10,000, and this number could multiply based on the number of days until the violation is corrected.
  • Agency can also withhold funding grants for current trials until disclosure requirements are met.

Will similar fines be enacted for incorrect posting on the EudraCT database? Another issue to keep an eye on.

Keep a Look Out for Future Developments:

1) The EMA Pilot Study for Results Posting on the EudraCT Database

While the EudraCT database has been in effect for several years, the infrastructure for results posting is still not finalized. Results disclosure on the EudraCT database will soon be required, and regulators have started conducting pilot studies to test how this will work. We are still seeking guidance on:

  • When the results posting feature will go live
  • Development of the IT system
  • Efforts to make posting and upload of data more user friendly
  • Posting results for unapproved drugs and the impact on department workload

If the system to post data on the EudraCT database is drastically different than that of CT.gov, it will require extensive training and adaptation to follow the rules correctly.

2) The European Commission’s Clinical Trial Regulation – Centralized Submission of CTAs

The proposed Clinical Trial Regulation, released on July 17, 2012 calls for all clinical trial applications (CTAs) for an EU clinical trial to go through one central portal, rather than each country having to approve each application. While this streamlined process sounds efficient and perhaps ‘easier’ than navigating multiple portals, there are looming political and procedural hurdles, which leaves the question of when this central portal will likely become reality.

Learn More and Discuss with Peers at CBI’s Upcoming Events

We’ll be discussing the best ways to coordinate data sharing and ensure transparency at the following events:

CBI’s 8th Global Forum on Clinical Trial Registries

April 29-30, 2013, Philadelphia, Pennsylvania

CBI’s 2nd Annual Forum on Global Publication Planning and Clinical Trial Registries

June 11-12, 2013, Dublin, Ireland

Pharma Medical Publications

Topics: Medical Affairs, Clinical