The Wellcome Trust has appointed a new independent review panel to assess applications from researchers for access to clinical trial data through the website clinicalstudydatareque
The website clinicalstudydatareque
The five-member panel will be chaired by Professor Jeffrey P Koplan, President for Global Health at Emory University. The new appointments mean that the panel and review process are completely independent of the trial sponsors offering to make data available.
In a mutually transparent process, researchers are asked to submit research proposals when they request anonymised patient-level data from studies listed on the site. The independent review panel then evaluates the scientific rationale and robustness of these research proposals, before deciding whether to grant access to the clinical trial data. To date, data have been made available to over 80 research teams.
GSK now lists over 1700 clinical trials on clinicalstudydatarequest.com, fulfilling their commitment to list their global trials conducted since the formation of the company in 2000. Trials are listed for data request after the regulators have approved the medicine or GSK terminates development. Researchers are also able to enquire about access to non-listed studies.
Nicola Perrin, Head of Policy at the Wellcome Trust, said:
“The Wellcome Trust, acting as secretariat, and the new independent review panel are now completely separate from the companies who sponsor the clinical trials that are listed on the website. We hope this change will encourage researchers to request access to the data while also highlighting to trial sponsors the benefits of listing more studies on the website.”
Dr Murray Stewart, Chief Medical Officer at GSK, said:
“Providing researchers with access to data from clinical trials is scientifically essential and helps ensure that the contribution made by volunteers who participate in our clinical trials is used to maximum effect in furthering knowledge. We’re encouraged by the continued growth of support for greater transparency and we hope that the Wellcome Trust’s involvement will encourage further participation from the broader scientific community.”