Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:
EMA updates access to documents policy – European Medicines Agency (EMA)
EMA revised Policy 0043 regarding access to documents. Policy updates include clarifying the publishing process, extending the scope to documents that are not related to medicines, and establishing a restriction on requests originating from outside the EU.
Review the updated EMA policy.
Boehringer Ingelheim describes experience with ClinicalStudyDataRequest.com – The New England Journal of Medicine (NEJM)
Authors from Boehringer Ingelheim (BI) and the University of Basel, Switzerland published correspondence to the editor of the NEJM of their experience with data sharing on ClinicalStudyDataRequest.com. In four years’ time, BI listed 350 clinical trials for potential data sharing opportunities. Research teams submitted 55 access request proposals for review, and 37 were approved. The vast majority of approvals were granted to address new scientific questions or conduct further confirmatory research under new hypotheses, and not to replicate analyses or affirm previous conclusions.
Read about their transparency experience.
Using blockchain for transparency in pharma – Clinical Trials Arena
A recent article on using blockchain in pharma summarizes discussion with TrialAssure CIO Mohamad Zahreddine by stating, “With study data… trial sponsors can use blockchain to store vital information, all while protecting the identities of patients. It is hoped for this reason patients and volunteers alike will be more encouraged to participate in clinical trials. By having access to study data at any given time, Zahreddine argues, will engender a greater sense of trust between trial sponsors and patients.”
Read more on blockchain and transparency.
Five years in with the Yale University Open Data Access (YODA) Project – Nature.com
It’s been five years since Yale University’s YODA project began facilitating access to clinical trial data, with the mission to “1) promote the sharing of clinical research data to advance science and improve public health and healthcare; 2) protect the rights of research participants; 3) promote the responsible conduct of research; and 4) ensure good stewardship of clinical research data by external investigators.” The article discusses the group’s partnership with Medtronic and Johnson & Johnson, key data sharing policy decisions, and learnings for future initiatives or other data sharing platforms.
Learn more on the YODA Project.