The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|April 9, 2014
Gap May Exist for Therapies for Age-related Diseases
Author(s)Philip Ward
The elderly is the fastest-growing segment of the global population, but only a few of their treatments have been clinically tested in age-appropriate patients
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The elderly is the fastest-growing segment of the global population, but only a few of their treatments have been clinically tested in age-appropriate patients, and many therapies are still not available in suitable formulations and dosages, according to a report by GBI Research.
Many older people suffer from comorbid conditions and one in three takes at least five drugs or more on a daily basis, which significantly increases the risk of adverse drug events and hospitalization, with up to one third of elderly emergency admissions being drug-related, note the report (Geriatric Medicine Development - Carving Out New Opportunities to Treat Age-Related Diseases).
Pre-marketing drug trials often exclude geriatric patients and approved doses are not likely to be appropriate for the elderly, making off-label prescriptions relatively common for older patients. Antipsychotic medications, for example, are regularly prescribed off-label in up to 80% of care-home patients, to manage delirium, agitation and psychosis resulting from Alzheimer’s disease and schizophrenia, and these drugs have been associated with an increased risk of diabetes, cerebrovascular events and death, according to the authors.
The development of age-appropriate formulations and doses could allow for smarter prescriptions of approved drugs, such as anti-coagulants, anti-diabetic agents, antipsychotics and analgesics in older people, they note. Additionally, opportunities exist for companies to develop medicines for age-related diseases, including cognitive impairment, sarcopenia and neurodegenerative diseases.
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