Given that drug development is increasingly global, disclosure of clinical trial data submitted to EMA will impact all manufacturers. Data shared anywhere is data shared everywhere.
On Jan. 1, 2015, EMA will begin publishing clinical reports for a product after a decision is made (irrespective of whether that decision is an approval, rejection or the application is withdrawn). The policy only applies prospectively. Existing data for applications filed prior to Jan. 1, 2015 (or for line extensions and extensions of indications of already approved medicines, July 1, 2015) are not subject to the policy. The policy outlines that the public “can either browse or search the data on screen, or download, print and save the information” for non-commercial purposes. The Agency will decide whether the clinical reports contain commercially confidential information that should be redacted (ultimately decided by EMA). At some point in the future, EMA will also publish individual patient data. EMA explained that it will continue to discuss with stakeholders how to implement the policy, in particular with regards to individual patient data to identify “the most appropriate balance between protecting patient privacy and retaining scientific value of the data.”
As explored in a recent Avalere analysis entitled, “In the Patient’s Interest: Improving Access to Clinical Trial Data,” ensuring that patients benefit from this enhanced clinical trial data transparency involves addressing:
1. “Respective promises made by trial investigators to study participants, including individuals’ informed consent, as well as contracts and agreements with institutions and research facilities;
2. Safeguarding study participant privacy; and
3. Ensuring the quality of the data, including the appropriateness of the availability, use and reliability of the data such that conclusions from subsequent research are valid, and will not undermine current and future therapies and their appropriate use.”
Increased transparency is anticipated to benefit the public by accelerating research, enhancing patient outcomes, and increasing public trust in the research enterprise. Without consideration given to the complexities and consequences of such disclosure, along with stakeholder involvement, these benefits are not guaranteed.
For more questions about the EMA announcement, contact Brenda Huneycutt at BHuneycutt@Avalere.com.