Global position statement on representative clinical trials

Clinical trials are an integral step in the development of new, potentially life-saving drugs and therapies. In these studies, important information on safety, dosing, and efficacy is collected. Because clinical trials provide insight into how patients will respond to the therapy being tested, it is important that participants are representative of those who may be prescribed the trial product after regulatory approval.

Historically, clinical trial enrollment has not always reflected the full range of patient populations affected by the diseases under study. When trial populations do not adequately reflect the disease epidemiology and the clinical populations for whom therapies are intended, the resulting safety and efficacy data may be less generalizable. This can affect the strength and applicability of clinical evidence supporting new treatments.

BMS is committed to designing and conducting clinical trials that produce scientifically rigorous evidence applicable to the patient populations our medicines are intended to treat. This includes thoughtful protocol design, broadening site placement to reach communities affected by the diseases under study, and engaging investigators, healthcare providers, and patient advocacy organizations to support informed clinical trial participation. Strengthening the scientific representativeness of clinical research requires sustained collaboration across the healthcare ecosystem, and we are committed to continuing this work in alignment with regulatory expectations and scientific best practices.