The U.S. Department of Health and Human Services’ Initiative on Multiple Chronic Conditions (MCC) is an effort to improve the health and quality of life of Americans living with two or more chronic diseases. Part of FDA’s role in this initiative is to encourage drug developers to include a diverse, “real world” patient population in the clinical trials used to study the effects of a drug in development.
Drug developers sometimes exclude older patients and patients with chronic illnesses in their studies because of concerns that these individuals might eventually drop out of the study, use other medicines that could alter the effects of the drug being studied, or have complications related to their other disease. This approach, however, does not show how a drug affects those people who have other diseases or who are using other medications who may one day take the drug in question.
FDA internal policy (PDF - 46KB) now instructs that a closer examination of the populations to be included in clinical trials should be a regular part of FDA’s assessment of clinical trials and FDA expects the development plans proposed by drug developers to include patients with multiple chronic conditions. FDA’s goal is to ensure that products coming to market will be as safe and effective as possible for all members of the public, and clinical trials that closely mirror the current patient population are an important part of achieving this goal.