At Janssen, the Pharmaceutical Companies of Johnson & Johnson, we believe transparency of clinical trial data advances science and medicine and is in the best interest of the patients who use our pharmaceutical products and providers who prescribe them.
Janssen agreement on sharing of clinical trial data with Yale School of Medicine
Janssen Research and Development, LLC, has entered into an agreement with Yale School of Medicine’s Open Data Access (YODA) Project to extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine. Under the agreement, YODA will serve as an independent body to review requests from investigators and physicians seeking access to anonymised clinical trials data from Janssen and make final decisions on data sharing. This is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data. In addition to sharing data from Janssen’s pharmaceutical product clinical trials through the agreement with YODA, Johnson & Johnson is also committed to sharing data from clinical trials of its medical device and consumer products.
We support the overall principles of greater clinical trial data transparency, including registration and disclosure of clinical trial results in external registries, publication of results in peer-reviewed journals, and sharing of Clinical Study Reports (CSRs), as outlined below.
Registration and Disclosure of Clinical Trial Results
Janssen publicly discloses information about its clinical trials in external public registries, such as clinicaltrials.gov. Disclosure includes:
- Registering all pharmaceutical clinical trials conducted in patients (Phase 1b through phase 4) on external registries in accordance with specified requirements.
- Upon receiving regulatory approval, disclosing clinical trial results of investigational studies in accordance with specific format and timeframe of local laws and regulations.
- Disclosing company-sponsored pharmaceutical clinical trial results of approved products within one year of study completion, in accordance with and within the timeframe of applicable laws and regulations.
Publication of Clinical Trials Results in Peer-Reviewed Journals
- We seek to publish, in peer-reviewed journals, results from all company-sponsored pharmaceutical Phase 2 through 4 clinical trials and Phase 1 trials in patients. Studies that terminate early (prior to pre-specified study end date) are included in our commitment to publish, provided they yield scientifically or medically important results.
- We also seek to publish medically or scientifically important pharmaceutical research from discontinued clinical research programs, prospective observational studies including registries, analyses from subscribed databases, and health economics and outcomes research programs.
Sharing of Clinical Study Reports (CSRs)
CSRs are detailed study reports that provide additional details on design and results of clinical trials that form the basis for submissions to regulatory authorities. We consider requests for CSRs from investigators and physicians for scientific research and medical purposes, and are currently evaluating our processes and procedures for handling these requests.
- We appreciate and acknowledge that study participants (patients, investigators and sites) who agree to participate in our clinical trials are critical partners in advancing medical knowledge. We are dedicated to protecting the commitments we have made with them, including patient privacy.
- We also abide by agreements we have made with our co-development partners, which may set out different procedures, contractual agreements, and expectations.
- We also have an obligation to protect intellectual property rights and confidential company information.
We are fully engaged with experts and stakeholders, both internally and externally, across academia, government and industry, on a unified approach, including common processes and procedures, for handling CSR requests, and on a governance framework to protect patient privacy, intellectual property, and scientific integrity, while creating greater transparency to advance medical knowledge and science.
For more information about our clinical trials please visit:
ClinicalTrials.gov
ClinicalTrials.gov provides patients, their family members, and the public with easy and free access to information on clinical studies for a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study.