title: FDA perspective: enrolment of elderly transplant recipients in clinical trials.
abstract: Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.
authors: Division of Transplant and Ophthalmology Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
authors: Joette M
authors: JM
authors: Meyer
authors: Patrick
authors: P
authors: Archdeacon
authors: Renata
authors: R
authors: Albrecht
mesh_terms: D000367:Age Factors; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016377:Organ Transplantation / Q000009:adverse effects; D061214:Patient Safety; D018579:Patient Selection; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D007166:Immunosuppressive Agents