Bristol-Myers Squibb: Disclosure Commitment
 

Disclosure Commitment

Updated 31 December 2013

Bristol-Myers Squibb is widely recognized for excellence in providing some of the world’s most important medicines for patients. At the same time, we strive to be transparent by providing information about treatments we are studying, whether they are investigational compounds, or new indications for existing marketed products.

It is our policy to provide patients, physicians and others with information about Bristol-Myers Squibb sponsored clinical trials that are conducted on investigational compounds and marketed products. We publicly disclose study information on Bristol-Myers Squibb sponsored interventional trials, as well as certain non-interventional clinical trials, to help the public understand when we have trials that are open and recruiting patients, or trials which are no longer enrolling patients.

Registration of clinical trials
Bristol-Myers Squibb sponsored trials are those studies in which our company is ultimately responsible for all aspects of the study, even if some or all of these activities are transferred to another party. Bristol-Myers Squibb will register all Phase I, II, III and IV interventional trials when it has responsibility for all aspects of the trial on the National Institutes of Health website called www.ClinicalTrials.gov and other applicable websites as required. For specific trials where Bristol-Myers Squibb is not the sponsor, but has agreed to carry out the disclosure responsibility of the sponsor, Bristol-Myers Squibb will register the trials.

Disclosure of clinical trial results
Our policy also calls for the open and timely reporting of results from Bristol-Myers Squibb sponsored clinical trials involving Bristol-Myers Squibb marketed products. Bristol-Myers Squibb shares clinical trials results data through scientific congresses or publication in peer-reviewed journals. In addition, trial results are available on the National Institutes of Health website at www.ClinicalTrials.gov. Our goal is to present these clinical trial results in an accurate, balanced and complete manner regardless of development phase or outcome. Results will not be posted for new formulations of marketed products until the new formulation is approved by a regulatory agency (i.e., Food and Drug Administration (FDA)), unless the trial data is clinically relevant to the use of the marketed product. In general, results from non-sponsored Bristol-Myers Squibb trials will not be reported by Bristol-Myers Squibb. However, for certain trials where Bristol-Myers Squibb is not the sponsor but has agreed to carry out the disclosure responsibility of the sponsor, Bristol-Myers Squibb will post the results as required.

Clinical Trial Data Sharing
Bristol-Myers Squibb fully supports enhanced transparency and sharing of clinical trial data with researchers, clinical trial participants, regulators and patient advocates. We believe that enhanced transparency will contribute to public confidence in medicines while improving public health. Our policy on data sharing is aligned with the Principles released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA, entitled Principles for Responsible Clinical Trial Data Sharing. In the Principles, biopharmaceutical companies pledge their commitment to enhancing public health through responsible sharing of clinical trial data consistent with safeguarding patient privacy and informed consent, respecting the integrity of national regulatory systems and maintaining incentives for investment in biomedical research.

How can qualified researchers access data from Bristol-Myers Squibb trials?
We will share clinical trial data from Bristol-Myers Squibb sponsored Phase I- IV interventional trials in patients which completed after January 2008, in response to legitimate, verified scientific requests from qualified researchers and regulators. This includes 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 EU. Requests are subject to terms necessary to protect patient privacy and respect the patient’s informed consent.

The submission of a research proposal can be made to request data on the trials described above on any approved medicines or from study programs that have been terminated. All requests will be reviewed internally by a qualified panel of Bristol-Myers Squibb experts and then passed to an Independent Review Committee (IRC) of external experts for review and final decision.

All research proposals will be evaluated on the basis of the scientific rationale and methodology of the proposed research, among other criteria. The proposal must include:

  • Title of proposed research
  • Proposal summary
  • Study design
  • Description of studies selected and patient populations
  • Primary and Secondary endpoints for the proposed study
  • Statistical analysis plan
  • Publication plan
  • Qualifications and experience of the research team (include Curricula Vitae)
  • Source of research funding
  • Any potential conflicts of interest
  • Other supporting documents

To submit your research proposal, please follow this link to our online request system:
Submit a Data Request

Frequently Asked Questions on accessing Bristol-Myers Squibb clinical trial data results

I participated in a Bristol-Myers Squibb trial – how can I see the results of this trial?
We are working to provide a factual, easy to read, lay-language summary of clinical trial results for those who participated in clinical trials and wish to receive a summary of the results. We will continue to collaborate with other biopharmaceutical companies, academic institutions, industry groups and regulators to establish standards for creating these lay summaries to ensure they are as useful and informative to patients and healthcare providers as possible.

How can I see the synopsis of the Clinical Study Report (CSR) for Bristol-Myers Squibb trials?
At their outset, clinical trials conducted on investigational compounds and marketed products are registered to www.ClinicalTrials.gov and other registries, as required, globally. Once a trial completes, results from those trials conducted on U.S. marketed products are posted to the www.ClinicalTrials.gov site. In additional, trial results may be posted to other registries outside the U.S. in accordance with local regulations. Synopses of clinical study reports for clinical trials in patients that were submitted to the FDA, European Medicines Agency (EMA), or national authorities of EU member states as of January 1, 2014, will be publicly available on www.bms.com shortly after approval of a new medicine or new indication.

Does Bristol-Myers Squibb publish trials in peer-reviewed journals?
We fully commit to considering all company‐sponsored clinical trials for submission for publication in scientific literature regardless of outcome. At a minimum, results from all Phase III clinical trials and clinical trial results of significant medical importance will be submitted for publication. 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.

 
 
 
 


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