Disclosure commitment
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 on ClinicalTrials.gov most of our non-interventional trials including post-authorization safety and efficacy studies.
Disclosure of clinical trial results
We are committed to disclosing the results of clinical trials on all applicable registries in accordance with applicable law.
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 interventional studies conducted on US and EU marketed products in approved indications on BMS.com within a reasonable amount of time. 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.
At a minimum, we will provide a factual summary of interventional clinical trials results, which is easily understood by the general public, for those studies required by the European Clinical Trial Regulation (EU CTR).
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. Scientific publications accurately disclose the Company’s financial and non-financial support, including publication assistance. All publication activities will continue to be conducted in alignment with industry and regulatory standards.
Click here to read a summary of Bristol Myers Squibb’s Policy on Scientific Publications.
Data sharing with researchers
Bristol Myers Squibb will honor legitimate requests for our clinical trial data from qualified researchers with a clearly defined scientific objective. We consider data sharing requests for Phase II-IV interventional clinical trials that completed on or after January 1, 2008. In addition, primary results from these trials must have been published in peer-reviewed journals and the medicines or indications approved in the U.S., EU, and other designated markets. Sharing is also subject to protection of patient privacy and respect for the patient’s informed consent.
Data considered for sharing may include non-identifiable patient-level and study-level clinical trial data, full clinical study reports and protocols. Bristol Myers Squibb reserves the right to update and change criteria at any time. Other criteria may apply, for details please visit Bristol Myers Squibb at www.vivli.org