Bristol-Myers Squibb is a global BioPharma company focused on Our Mission to discover, develop and deliver innovative medicines to patients with serious diseases. By adhering to local, regional, and national requirements for clinical trial disclosure, 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. Our internal disclosure procedures are routinely audited to ensure adherence to this commitment.
Registration of Clinical Trials
In 2003, Bristol-Myers Squibb implemented a policy for registering clinical trials on public databases. Bristol-Myers Squibb is committed to registering all Phase I-IV interventional trials, conducted in any geographic location, on applicable registries including ClinicalTrials.gov and EU Clinical Trials Register prior to the first patient being enrolled We also voluntarily register 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 of interventional clinical trials that are conducted on our marketed products within 12 months of trial completion, regardless of the outcome of the trial, on all applicable registries. 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 in the EU, involving both investigational and marketed Bristol-Myers Squibb products, within 12 months of trial completion 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 within 24 months of trial completion. 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. Prior to posting, personal identifiers and commercially confidential information will be redacted in accordance with Bristol-Myers Squibb redaction guidance, which adheres to industry best practices.
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
In alignment with the PhRMA and EFPIA Principles for Responsible Clinical Trial Data Sharing, Bristol-Myers Squibb reaffirms our commitment to consider all company-sponsored clinical trials for publication in the scientific literature irrespective of whether the results of the trials are positive or negative. At a minimum, we expect results from all Phase III clinical trials and any clinical trial results of significant medical importance to be submitted for publication. This commitment also pertains to investigational medicines whose development programs have been discontinued. 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 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 in-scope Phase I-IV interventional trials in patients that have completed on or after January 1, 2008. 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.