Fact sheet
Representative clinical trials strengthen the science behind our medicines

Representative clinical trials strengthen the science behind our medicines

Understanding how a disease affects the full range of patient populations is essential to the drug development process and to creating the most effective treatments and interventions. By designing clinical trials that enroll patients representative of the disease epidemiology and the clinical populations for which an investigational product is intended, we strengthen the scientific rigor, safety, and efficacy of our medicines.
 


We seek to enroll patient populations in our clinical trials that are representative of the disease epidemiology and the clinical populations for which each investigational product is intended. In doing so, we strengthen the scientific validity of our research and deepen understanding of the safety and efficacy of our medicines across the populations they are designed to serve.
 

Recognition of the need for more diverse representation has prompted an industry-wide effort for inclusive medical research

Regulatory and scientific expectations for representative clinical trial enrollment have prompted an industry-wide effort to improve the rigor and generalizability of clinical research
 

How is Bristol Myers Squibb strengthening the scientific representativeness of its clinical trials?


As we continue designing trials with the right patient population in mind, we have taken a comprehensive approach focused on:
 

Protocol design

Protocol design considerations
Designing clinical trials to reflect disease epidemiology and the needs of the intended patient populations

Communication and engagement

Communications and engagement
Engaging with a broad range of stakeholders — including advocacy organizations, industry collaboratives, principal investigators, and community groups — to foster access to and trust in clinical trials

Metrics and measures

Metrics and measures
Monitoring enrollment representativeness relative to disease epidemiology as an indicator of data quality and the generalizability of clinical findings

Site and investigator

Site and investigator selection
Recruiting and retaining participants representative of the disease burden and ensuring research centers are accessible to the communities most affected by the diseases under study

Patient Support

Patient support
Providing tailored support services to understand and reduce barriers to clinical trial participation

Training

Training
Investing in staff training on representative study design, effective patient engagement and communication, and regulatory expectations for representative enrollment

Our work to-date


BMS has expanded clinical trial site placement to include locations in communities with high disease burden, improving geographic accessibility for the patients most affected by the diseases under study

 

In 2023, 58% of BMS clinical trial sites in the U.S. were located in metropolitan areas with significant disease burden, broadening patient access to participation in clinical research.

Stethoscope
Larger hands heart

Evolving our approach to ensure that enrollment in our clinical trials across key indications — including lupus, multiple myeloma, pulmonary fibrosis, and Alzheimer's disease — where disease prevalence or burden supports such representation.

We are committed to scientific excellence and continued investment in our R&D capabilities to develop more effective medicines for more patients. Our approach to clinical trial enrollment is grounded in scientific rigor, regulatory expectations, and the goal of producing data that is generalizable to the patient populations our medicines are intended to serve.

Download Representative Clinical Trials Fact Sheet