Disclosure Commitment
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 are an acknowledged leader based on environmental, social and governance criteria.
As a responsible corporate citizen, Bristol-Myers Squibb is committed to providing patients, physicians and others with information about new or ongoing Bristol-Myers Squibb sponsored interventional clinical trials that are open and recruiting patients, as well as information on all our marketed products.
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 II, III and IV interventional trials when it has responsibility for all aspects of the trial, (for example, when Bristol-Myers Squibb holds the Investigational New Drug application or non-U.S. equivalent). Additionally, Bristol-Myers Squibb will register company sponsored Phase I trials in patients, except for single dose trials. Where Bristol-Myers Squibb is not the sponsor but is a codevelopment partner, the agreement with the codevelopment partner will define the registration scope and responsibilities between Bristol-Myers Squibb and the partner. The ongoing clinical trials registered here are also registered on the government sponsored website www.ClinicalTrials.gov.
Disclosure of clinical trial results:
Our policy also calls for the open and timely reporting of clinical trial results of Bristol-Myers Squibb owned and marketed products. This will be accomplished by posting results to two websites, the new NIH results website www.ClinicalTrials.gov, and to the PhRMA sponsored website, www.ClinicalStudyResults.org in an accurate, balanced and complete manner, regardless of trial outcome. The posting of interventional clinical trial results or references to publications for company sponsored trials is in accordance with the Pharmaceutical Research and Manufacturers of America principles and other international association principles for medicines marketed outside the U.S. Bristol-Myers Squibb will disclose the results of any interventional clinical trial conducted in patients, for which Bristol-Myers Squibb was responsible for all aspects of the trial (for example, when Bristol-Myers Squibb held the Investigational New Drug application or non-U.S. equivalent), regardless of development phase or outcome, for medicines that have at least one indication approved for marketing in one country. Results will not be posted for new formulations for marketed products until the new formulation is approved, unless the trial data is clinically relevant to the use of the marketed product. Bristol-Myers Squibb will also post the results of long-term extension trials for its marketed products conducted in patients. In general, data for non-Bristol-Myers Squibb-sponsored trials will not routinely be provided. For certain trials where Bristol-Myers Squibb is not the sponsor but has agreed to carry out the disclosure responsibility of the sponsor, the results for such trials will be disclosed. Decisions on disclosing clinical trial results for medicines that are not exclusively marketed by Bristol-Myers Squibb will be made by agreement with our respective development/marketing partners with the intent to publish all results which meet the criteria for a given product. The clinical trials results disclosed here are also registered on the Pharmaceutical Research and Manufacturers of America website at www.ClinicalStudyResults.org.