U.S. Clinical Trial Investigators
Bristol-Myers Squibb considers requests for clinical research trials from all clinical and therapeutic areas, and gives priority to proposals that support our medical plans in the following therapeutic areas: cardiovascular/metabolics, neuroscience, cancer, immunology and virology.
Bristol-Myers Squibb has updated its process to receive web applications for investigator-sponsored trials. Specific time periods for submissions are now offered. Bristol-Myers Squibb has completed the January 2010 IST application window which was open from November 1, 2009 through midnight January 2, 2010. An internal Scientific Research committee will be assessing all submitted applications with the intent of conveying the committee’s decision by February 15, 2010.
Please note that select products are still accepting applications at this time. The next official application submission window will be April 1, 2010 through June 30, 2010. Please review the information below and proceed with the application process to view which products are currently accepting applications.
Objectives
The Bristol-Myers Squibb IST application process provides a framework and allows investigators to work from a common set of criteria, requirements and schedule of events. The process is designed to ensure scientific rigor and patient safety while supporting unique research ideas and providing insights into areas of unmet medical need.
Disclaimer
Requests for Research Proposals are not to be interpreted as suggesting that any product is safe or effective for an investigational use or recommended for any use outside of its FDA approved labeling. Bristol-Myers Squibb does not guarantee support. Please note that studies may be submitted for “drug-only” support as well as drug & funding support. Support is solely recognized at the time of full execution of the clinical trial agreement.
Term & Conditions
- Rationale. The trial must address a legitimate medical or scientific question affecting the use of a Bristol-Myers Squibb drug and not duplicate other planned or conducted research unless justified on a scientific or medical basis.
- Sponsor. The applicant (investigator, cooperative group, institution, network) must be qualified and capable of conducting the proposed study in compliance with the U.S. Food & Drug Administrations Good Clinical Practices. The sponsor must comply with all applicable legal and regulatory requirements and must not be the subject of any legal or regulatory restrictions or sanctions.
- Medical appropriateness of proposed research. The proposed research must be reasonably likely to produce results that could beneficially impact medical therapy for the condition being investigated.
- Scientific validity. The proposed study procedures must fulfill the stated objectives of the study.
- Ethical considerations. The study must be designed to meet ethical guidelines concerning human subjects in research (for interventional trials).
- Financial support. Funding requests must reasonably reflect the cost and effort involved and should not be used to defray normal operating expenses of the sponsor-investigator or institution that are not directly related to the supported research. An executed research agreement must be in place prior to any study commencing.
- All applicable regulatory requirements, including but not limited to study registration and results disclosure, must be observed.
- Publication of study results. The results of the research will be collected and analyzed and a report of the study will be prepared and planned for potential publication in a peer-reviewed journal.
- Priority. We consider requests for clinical research trials in all clinical and therapeutic areas, and give priority to proposals in the cardiovascular/metabolics, neuroscience, cancer, immunology and virology therapeutic areas.
All support for investigator-sponsored trials is awarded at the sole discretion of Bristol-Myers Squibb based on the criteria set forth above.
Before starting the submission process, please be sure to have the following information available.
- Contact information (valid e-mail address required)
- Curriculum vitae
- Budget
- Hypothesis/Rationale
- Objective/Endpoint
- Treatment
- Sample size
- Eligibility
- Statistical plan
- References
Click here to agree and review the application process.
Please click here to agree and return to a saved application.
Please contact us at ist.help@bms.com for any questions.