This week in transparency news: June 13 – June 26, 2020

by Donald McLean, MBA,
Posted on 6/26/2020

clinical trial transparency landscape clinical trial disclosure data sharing transparency news insights alerts fda ema brexit health canada trialassure events software services vendor consultant partner help guidance eudract italian medicines agency italy europe

Clinical trial transparency in the pharmaceutical industry is continually evolving, and to stay on top of the news, TrialAssure brings a bi-weekly round-up of some of the key stories. Select recent and relevant stories are as follows:

FDA Piloting Website to Share Patient-Reported Outcomes – Healthcare Innovation

The U.S. Food and Drug Administration has launched a pilot project to make patient-reported outcome (PRO) data from cancer trials publicly available. The goal of Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE), is to create a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments.

Learn more about Project Patient Voice

Vivli members commit to sharing data from COVID-19 trials

Members who have committed to sharing their data on the COVID-19 portal, a dedicated search function within Vivli for COVID-19 include Eli Lilly & Company, Regeneron, Roche, Takeda. Additionally, Cochrane, Covid Collaboration Platform, UCB, and the Wellcome Trust expressed their support of these efforts. “Vivli will continue to waive the fees for sharing for any interventional trial related to COVID-19 and to make the process as easy as possible,” said Rebecca Li, Vivli Executive Director.

Read the full release from Vivli

J&J Advancing Clinical Trial Data Sharing Through the Yale University Open Data Access Project J&J

In this article, a video with Joanne Waldstreicher, M.D. is featured, discussing clinical data sharing. The company has been involved with the Yale University Open Data Access (YODA) Project since 2014, and they grant the YODA Project full decision rights regarding the release of their clinical trial data.

View the video

Webinar: Understanding EMA Policy 0070 and Health Canada PRCI Transparency RequirementsMMS Holdings & TrialAssure

Kelly Vaillant, Kavita Verma, and Megan Niner present this Expert Insights webinar on key elements of current transparency regulations, including the background and history of the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) requirements for the publication of clinical trial data. Key requirements of both health authorities were discussed in-depth, including similarities and differences. Additionally, attendees learned about the future of document sharing and what will be required to disclose publicly in the years to come.

View the EMA Policy 0070 and Health Canada PRCI Transparency Requirements webinar on Youtube

New Research Platform Seeks to Rapidly Share Parkinson’s Patient Data in Canada – Parkinson’s News Today

Parkinson Canada is inviting patients to join the Canadian Open Parkinson Network (C-OPN) to help advance Parkinson’s disease care and research. The hope is to facilitate rapid sharing of data and blood samples for large-scale and multidisciplinary research projects.

Read more on data sharing in Parkinson’s Disease