Updated 29 November 2012
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 have completed.
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 (IND) application or non-U.S. equivalent) on the National Institutes of Health website called www.ClinicalTrials.gov and other applicable websites as required. Additionally, Bristol-Myers Squibb will register company sponsored Phase I trials which are conducted in patients, and certain non-interventional clinical trials 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. Currently, 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. FDA), unless the trial data is clinically relevant to the use of the marketed product. In general, data from non-sponsored Bristol-Myers Squibb trials will not routinely be provided. 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.