title: Elderly patients' participation in clinical trials.
abstract: The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health conditions including cancer, cardiovascular disease, arthritis, and Parkinson's disease, among others in most parts of the world. Furthermore, elderly make up the majority of patients for many medications treating chronic conditions. Typically, clinical trials conducted in adult population include patients between the ages of 18 and 64 years. However, drugs should be studied in all age groups and trial participants should be representative of the patient population receiving the therapy in daily medical practice. Elderly patients are poorly represented in clinical trials. Hence, there is inadequate evidence and knowledge about responses of geriatric patients to medications. Regulatory authorities in developed countries urge to avoid arbitrary upper age limits and advise researchers and industry not to exclude elderly people from clinical trials without a valid reason. Since last few years Indian regulatory authority has been stipulating upper age limit for studies conducted in India. The Central Drugs Standard Control Organization (CDSCO) will be doing a great contribution to the researchers if it changes its view on stipulating upper age restrictions in clinical studies. This article describes the need for including elderly patients in the clinical trials in order to garner data from geriatric patients who form major medication users in most of the chronic diseases.
authors.affiliation: Regulatory Affairs and Patient Safety, AstraZeneca Pharma India Ltd., Bengaluru, Karnataka, India.
authors.forename: Premnath
authors.initials: P
authors.lastname: Shenoy
authors.affiliation: Regulatory Affairs and Patient Safety, AstraZeneca Pharma India Ltd., Bengaluru, Karnataka, India.
authors.forename: Anand
authors.initials: A
authors.lastname: Harugeri
keywords: Clinical trial; India; drug regulations; elderly