Pursuant to the terms of the agreement, YODA will serve as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, the pharmaceutical companies of Johnson & Johnson, and make final decisions on data sharing.
As per the clinical trial data sharing agreement, YODA will independently review and make final decisions regarding all requests for the company’s clinical trial data including clinical study reports (CSRs) and de-identified patient-level data.
An independent external panel of non-Janssen experts will be selected and appointed by the members of the YODA team to help in some cases to assess requests.
Johnson & Johnson is also committed to the sharing of data from clinical trials of the medical device and consumer products of the Johnson & Johnson family of companies in addition to Janssen’s sharing of data from pharmaceutical product clinical trials through the agreement with YODA.
The company has created a new web-based mechanism to assist researchers in requesting access to data from the company’s clinical trials.
Janssen R&D global head Dr Bill Hait noted the company already have well established policies for registration and disclosure of clinical trial results in external registries as well as publication of results in peer reviewed journals, and worked with external researchers to address other types of data requests.
"We are delighted that through agreement with YODA, we will now be able to share data from our clinical trials in the form of Clinical Study Reports (CSRs) and participant level data in a systematic and objective way that advances medicine and scientific knowledge while protecting patient privacy and confidentiality," Dr Hait added.