Bristol-Myers Squibb: Disclosure Commitment
 

Disclosure Commitment

Commitment to Responsible Clinical Trial Data Sharing

Updated June 2014

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.

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 Bristol-Myers Squibb sponsored Phase I, II, III and IV interventional trials 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 through scientific congresses or publication in peer-reviewed journals. In addition, results for clinical trials completed after 2008 on marketed products approved by the FDA 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 on www.ClinicalTrials.gov 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-Bristol-Myers Squibb sponsored 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 for Responsible Clinical Trial Data Sharing (Principles) released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA. 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?
In response to legitimate, verified scientific requests from qualified researchers, we will share clinical trial data from Bristol-Myers Squibb sponsored 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.

Clinical trials must meet the following criteria to qualify for requests:

  • Completed after January 2008
  • Be part of a program where BMS currently has the legal right to develop and commercialize the asset
  • Be part of a program approved for marketing  or a terminated program and two years have elapsed since study completion or termination of the program

All data requests/proposals will be reviewed internally by a qualified panel of Bristol-Myers Squibb experts that are familiar with the data in question. The Bristol-Myers Squibb team will ensure the proposal is complete, the scientific request is valid, and that the data are available, consistent with safeguarding patient privacy and informed consent. The qualifying proposals will then be passed to an Independent Review Committee (IRC) of external experts for further discussion and final decision.

What are the role and membership of the Independent Review Committee (IRC)?
Bristol-Myers Squibb has established a relationship with Duke University through the Duke Clinical Research Institute (DCRI) to ensure that qualifying requests for patient-level data have a complete, consistent and fair assessment. The DCRI will act as the IRC for Bristol-Myers Squibb and has agreed to review and make the final decision on all qualifying data requests for in-scope studies as described above. The IRC will also review the proposal with the research team and discuss any clarifying questions that would better support the decision on the proposal. The IRC membership will represent three broadly defined areas of expertise: clinical, statistical and bioethical/protection of human subjects. The IRC will also contract with additional experts depending on the request, therapeutic area, or other relevant factors.

The IRC will evaluate the proposal based on:

  • Scientific rationale and methodology
  • Experience and relevant qualifications of the research team
  • Presence of a robust statistical analysis plan
  • Publication plan
  • No potential conflicts of interest exist. If conflicts of interest are present, there is a plan to address them.

Duke Clinical Research Institute (DCRI) Independent Review Committee

  • IRC Chairs
    • Eric D. Peterson, MD, MPH, FAHA, FACC: Fred Cobb, M.D., Distinguished Professor of Medicine, Division of Cardiology at Duke University School of Medicine; DukeMed Scholar; and Director of Duke Clinical Research Institute
    • Michael Pencina, PhD: Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Biostatistics at DCRI
  • IRC Members
    • Lawrence H. Muhlbaier, PhD: Associate Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and nationally recognized expert in HIPAA, patient privacy and ethical standards for research
    • Nancy M. Allen LaPointe, PharmD, MHS: Associate Professor of Medicine at Duke University School of Medicine; Chair, Duke University Health System Institutional Review Board; and Director of the Duke Heart Center Distinguished Research Center Programs
    • Victor Hasselblad, PhD, MS: Professor of Biostatistics and Bioinformatics at Duke University School of Medicine

What is expected of the researcher(s) requesting data?
Prior to data being released, the researcher(s) will be expected to sign a Data Sharing Agreement, which among other things, will require the researcher(s) to obtain any necessary ethics board or regulatory approval for conduct of the research.

The Data Sharing Agreement will ensure that the team:

  • Use the data only for the agreed purpose
  • Ensure patient privacy and agree  not to attempt to identify the study participants
  • Inform regulatory authorities and Bristol-Myers Squibb of any potential safety concerns as soon as they are identified
  • Complete analyses within two years of access
  • Seek publication of all results
  • Provide Bristol-Myers Squibb/DCRI with a copy of the manuscript at the time of journal submission
  • Affirm that the analyses conducted will not be used for commercial purposes
  • Agree to other conditions outlined by the IRC

To submit a research proposal for use of patient-level clinical data, please follow this link to our online request system:
Submit a Data Request

For other investigator sponsored research proposals or requests, please visit the
 
Investigator Sponsored Research site.

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

I was a patient in a Bristol-Myers Squibb trial – how can I see the results of this trial?
If you participated in a clinical trial that contained a Bristol-Myers Squibb marketed product during 2009 or after, you should be able to view the aggregate results of the clinical trial at the study-level on www.ClinicalTrials.gov once the trial and all patients have completed. In addition, we are working to provide a factual, easy to read, lay-language summary of clinical trial results for those who participated in clinical trials. 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 useful and informative to patients and healthcare providers.

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 approved by the FDA 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 also be publicly available on www.bms.com  shortly after approval of a new medicine or new indication. For terminated programs, the CSR synopsis will be available on www.bms.com  two years after the program terminated.

Does Bristol-Myers Squibb publish all trials in peer-reviewed journals?
We commit to submitting all phase III and IV clinical trials regardless of outcome to peer reviewed journals for publication and any clinical trial results of significant medical importance. 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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