Bristol-Myers Squibb is a global BioPharma company focused on Our Mission to discover, develop and deliver innovative medicines to patients with serious diseases. We are committed to publicly sharing information on the clinical trials we conduct, regardless of the outcome, as described below. We also believe in providing access to clinical trial information to researchers who seek to advance science. We are committed to providing access that also protects patient privacy, respects the integrity of national regulatory systems and maintains incentives for those who invest in biomedical research.
Registration of Clinical Trials
Bristol-Myers Squibb is committed to registering all Phase I-IV interventional trials prior to the first patient in the study being enrolled. These trials are publicly registered to applicable registry databases including ClinicalTrials.gov and EU Clinical Trials Register. Bristol-Myers Squibb also voluntarily registers our non-interventional trials that are conducted to gather information on the safety and effectiveness of a product or class of drugs on ClinicalTrials.gov.
Disclosure of Clinical Trial Results
We are committed to disclosing the results from our registered clinical trials that are conducted on our marketed products approved by the FDA, regardless of the outcome of the trial. Results for our clinical trials completed after 2008 can be found on ClinicalTrials.gov. Results for new formulations of marketed products will be disclosed once the new formulation is approved by a regulatory agency (FDA). Bristol-Myers Squibb also discloses the results for trials, conducted on both investigational and marketed BMS products on EU Clinical Trials Register.
Compliance with PhRMA-EFPIA Principles
We are aligned with the PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing and support enhanced transparency and sharing of clinical trial data with researchers, clinical trial participants, regulators and patient advocates.
Enhanced Public Access to Clinical Study Report Information
Bristol-Myers Squibb will post the clinical study report (CSR) synopses of completed studies conducted on marketed products on BMS.com. The CSR synopses will also be posted for any trial conducted on an investigational product whose development program has been discontinued, provided that investigational product has been given to at least one patient in the trial.
Sharing Results with Patients who Participate in Clinical Trials
We believe that the participants in our clinical trials should be made aware of and be able to understand the outcome of the trial they participated in. We are engaged in an industry-wide effort to provide summaries of the results of our clinical trials to participants in a user-friendly format that is easily understood.
Reaffirming Commitments to Publish Clinical Trial Results
Bristol-Myers Squibb will submit for publication all Phase III clinical trials and any clinical trial results of significant medical importance regardless of outcome. We commit to the timely sharing of this information with healthcare professionals and the public through scientific congresses and in peer-reviewed journals. We will also disclose any financial contributions made by Bristol-Myers Squibb in support of a clinical trial, including publication assistance. All publication activities will continue to be conducted in alignment with global industry and regulatory standards.
Enhanced Data Sharing with Researchers
Bristol-Myers Squibb will honor legitimate requests for our clinical trial data from qualified researchers.
We will share clinical trial data from our Phase I-IV interventional trials in patients. This includes de-identified patient-level and study-level clinical trial data, full clinical study reports and protocols from clinical trials conducted in patients for medicines and indications approved in the U.S. and/or EU. Sharing is subject to protection of patient privacy and respect for the patient’s informed consent.
Process for Submitting a Data Request
To submit a research proposal for use of patient-level clinical data, please visit our online request system.
For other investigator sponsored research proposals or requests, please visit Investigator Sponsored Research.