The patients and health care professionals who rely on our medicines place their trust in our clinical research and development. At Janssen, we believe making clinical trial data available furthers understanding of diseases, expands the base of knowledge needed to develop new treatments, and provides relevant information to help health care providers and patients make better health care decisions. Sharing information about clinical trials also helps patients identify clinical studies that may be appropriate for them.
We are proud of our history of transparency when it comes to clinical trial data. Here is a summary of how Janssen discloses information about our clinical trials:
- Registration and Disclosure of Clinical Trial Results: Janssen provides information about our clinical trials in the largest U.S. public registry, ClinicalTrials.gov. Our disclosures, which comply with U.S., European Union and other global laws, include listing our controlled interventional studies conducted in patients — which are used to test the efficacy and safety of medicines — and, after the studies are completed and the medicine is approved for sale, revealing the results of the studies.
- Publication of Clinical Trial Results in Peer-Reviewed Journals: We seek to publish the results of all company-sponsored interventional pharmaceutical clinical trials in humans in peer-reviewed journals. This includes those studies that are positive as well as those that are negative, those that end early, and those from discontinued research programs. We also seek to publish health economic studies and other forms of our research that may be useful in advancing public health. The quality and rigor of our R&D efforts is reflected in the publication of many of our studies in top-tier peer-reviewed medical journals.
- Sharing of Participant-Level Data and Clinical Study Reports: In January 2014, Janssen R&D entered into a first-of-its-kind agreement with Yale University School of Medicine to establish a pioneering clinical data-sharing initiative. Under the agreement, the Yale Open Data Access (YODA) Project serves as an independent review panel to evaluate and make decisions regarding requests from researchers to access summary and participant-level data from Janssen’s clinical trials. These data, which are not available through registries and scientific literature, include clinical study reports (CSRs) and participant-level data. Participant-level data provides de-identified data at the individual or study participant level, while CSRs are extensive reports summarizing the aggregate results of a trial. YODA enables researchers to access and review such additional data from clinical trials for approved Janssen medicines for purposes of conducting their own scientific or medical research — with the goal of increasing medical knowledge and improving public health.
We believe granting an independent, academic group ultimate authority to determine how we respond to requests for access to participant-level data or CSRs from Janssen’s clinical trials is a fair and unbiased approach.
YODA Update
In 2015, we expanded our agreement with YODA to include not only pharmaceutical but also medical device clinical trial data. Just recently, in February 2017, we expanded our agreement again to include clinical trial data for consumer products.
To date, the YODA Project has approved more than 60 research proposals for Janssen data as well as one request for medical device data. In 2016, the YODA program received 36 requests for data from researchers and physicians at institutions and academic centers in the U.S. and worldwide, including the Mayo Clinic, Mount Sinai Medical Center, the Harvard School of Public Health, Johns Hopkins University, McGill University, University College London and the Princess Margaret Cancer Centre, among others. All of these requests were approved. In addition, two papers were published this past year as a result of data we have shared via the YODA Project.
Researchers interested in requesting access to data from Janssen’s clinical trials can do so via the YODA Project portal.OUR LEADERS DISCUSS
Joanne Waldstreicher, MD, |
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