UCB Increases Clinical Study Transparency Through New Data Portal
By Lori Clapper
UCB announced it will now be the first midcap biopharma company to allow responsible sharing of clinical study data.
The company’s new data sharing online environment will provide access to anonymous patient-level data and associated documents from clinical studies, enabling researchers to conduct further research. In a company announcement, UCB said this decision will help “uncover new scientific knowledge or insights, advance medicine, and ultimately benefit patients and other stakeholders.”
Professor Dr. Iris Loew-Friedrich, CMO and EVP, UCB, added that because data transparency “will lead to better solutions for patients, we have committed to sharing data from our clinical studies in a responsible way. We hope this will enhance disease understanding, generate new insights, and help develop new treatments.”
UCB is now accepting requests relating to all clinical studies that were considered ‘pivotal studies’ for purposes of regulatory approval of the core UCB medicines. All other requests for clinical study data will be considered on a case-by-case basis.
Big Pharma companies like Eli Lilly and Co. have already jumped at the chance to increase transparency in clinical trials. In June, the company unveiled its new data access portal. Tim Garnett, M.D., Lilly’s SVP and CMO, said the collaboration of global research is vital to significantly improve patient care, citing the company’s early partnership with academic researchers that resulted in the first commercial insulin.
“By joining others in our industry to share clinical trial data with qualified researchers, we can quicken the pace of scientific advances needed to make life better," Garnett said.
But despite the growing trend towards transparency, the U.S. Food and Drug Administration (FDA) questions whether there is a time to share and a time to keep things private. The agency is afraid that offering access to data too early in clinical studies could bias the final result, Nature reported. To further discussion on situations in which preliminary results from clinical trials should be kept confidential, the FDA is holding a public hearing in Maryland on August 11th.
The European Medicines Agency (EMA) has had its qualms, as well, postponing the adoption of clinical data sharing policies until October 2, 2014. The agency has kept fairly quiet as to the reasons why, except for saying that “its board was unable to reach agreement on final wording, although board members have confirmed their general support to the overall aims and objectives of the policy,” according to the Wall Street Journal. This is the second time that the EMA has put off the approval in two months.