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Disclosure Commitment
Registration of clinical trials:
It is our policy to provide patients, physicians and others with information
about new or ongoing Bristol-Myers Squibb sponsored interventional clinical
trials that are open and recruiting patients. Bristol-Myers Squibb sponsored
trials are those studies in which Bristol-Myers Squibb 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, i.e., Bristol-Myers Squibb holds the Investigational New Drug (IND)
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 co-development
partner, the agreement with the co-development 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
to 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 (PhRMA) 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 (i.e., Bristol-Myers
Squibb held the Investigational New Drug (IND) 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-sponsored Bristol-Myers Squibb 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 PhRMA sponsored website www.ClinicalStudyResults.org.
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