In back-to-back announcements, Boehringer Ingelheim and Bayer HealthCare announced their pathway to allow access of clinical trial data to qualified researchers.
On May 12, BI released information on its results sharing and transparency policy, which is contained on its web site. BI has four routes of access—clinical study results synopses in ICH E3 summary format; a request site for clinical study reports and related clinical documents via a “Document Sharing Agreement” for scientific purposes only; a link to clinicaltrials.gov for its ongoing and completed studies; and a link to its patient level study data using an external platform—www.clinicalstudydatarequest.com.
On May 13, Bayer announced it would share its anonymized patient-level data from clinical studies, also through clinicalstudydatarequest.com. And, similar to BI, Bayer provides information about its trials dating back to 2005 through its Bayer Trial Finder at www.bayerpharma.com but the request to data mechanism is also ClinicalStudyDataRequest.com.
So what is ClinicalStudyDataRequest.com? According to the Bayer release, it is “a secure internet portal for researchers to request patient-level anonymized clinical trial data provided by sponsor organizations.” And it is that and more. ClinicalStudyDataRequest.com is a collaborative system—now with seven pharmaceutical companies—that theoretically can allow researchers access to datasets from Bayer, Boehringer Ingelheim, Novartis, GlaxoSmithKline, Roche, Sanofi and ViiV Healthcare in related mechanism of action studies for more robust safety and efficacy analysis. And the platform itself has a built-in secure discussion and workflow capabilities that allow for the external review of the requests.
ClinicalStudyDataRequest.com has its roots in this press release from GSK in October 2012, when the pharma announced its support for BMJs policy-change that it would only publish scientific papers from companies where there is a commitment to make the relevant anonymized patient level data available on reasonable request. The company went so far as to affirm “GSK’s ultimate goal is to see a broad system develop where the clinical research community can access data from trials conducted by different organizations.”
By spring 2013, GSK was well on its way past planning and closer to implementing its system for sharing anonymized, patient-level data from clinical trials. The front-end of the system would reside on the GSK site and was developed by ideaPoint, Inc., a provider of partnering and collaboration systems for global enterprises.
According to Scott Shaunessy, CEO of ideaPoint, GSK has been a client of theirs since 2009, and received a referral from another internal department about the clinical trial data requests project. And ideaPoint built it. Soon after GSK rolled out its site in April 2013, Roche and ViiV got wind of the platform, which led to talks of a multi-sponsor site, which is what was rolled out formally January 2, 2014. The platform also now includes Boehringer-Ingelheim, Sanofi, Novartis and Bayer and the company is in talks with still more sponsors.
“It’s moving really fast,” Shaunessy told Applied Clinical Trials. “If you would’ve told me a year ago that this is what we’d be doing, I’d definitely be surprised.” Shaunessy attributes this industry-unusual speed to adopt directly to the executive-level commitments the EFPIA and PhRMA member companies have made to its joint principles for data sharing.
ClinicalDataStudyRequest.com features a steering committee of the sponsoring pharma companies who have input into the functioning of the site. Shaunessy explained that this is evolving the way the system works, and in early July they will be launching the next version. Some features of the new version include updated information from the data requesters, and even results from the requesters. In discussions right now among committee members is the use of a truly neutral third-party review system.
Shaunessy explained that its Independent Review Panel, is just that, independent. However, it was inherited from the GSK development and Shaunessy explained that the sponsors believe, in the interest of transparency, the review process should be turned to a completely different third party. In fact, Shaunessy disclosed that with the sponsors have spoken to J&J about potentially joining together in the future. J&J’s Janssen unit uses YODA, Yale University’s Open Data Access Project, as its independent review panel. But the actual request portal is on its web site at http://www.clinicaltrialstudytransparency.com.
And there in lies the difference and the current discussions at ClinicalDataStudyRequest.com. Shaunessy says having the combination request and approval process is key to its function. Having more than one external review panel could become problematic and potentially against the goals of ClinicalDataStudyRequest.com. “Our system has a slightly different approach,” explained Shaunessy.
After the request and approval process of ClinicalDataStudyRequest.com, approved researchers then receive access to a secured environment, currently built and maintained by SAS, to the requested datasets. They then can run their analytics on the once disparate and now commonly loaded data sets in the environment.
Shaunessy sees a clear path for more sponsors to use this request, review and access system. But he also sees potential to address the Clinical Study Report (CSR) sharing principles, which also requires redaction after requester approval. And he sees potential to use the system in other industries, for example for chemists or automotive safety data sharing.