In the Popular Press: What Your Patients are Reading:

A new report on the clinical trial process in the US revealed that trials often exclude or underrepresent certain segments of the population, such as women, minorities, disabled individuals, the elderly, and people who live in rural areas. This underrepresentation weakens the quality of the data collected in clinical trials. Roughly 80,000 clinical trials are conducted annually in the US, with about 2.3 million Americans participating in trials—less than 1% of the US population. The report includes criticisms of the lack of training for review board members and duplicated trials conducted by government institutions and private industry companies, but the exclusions of certain constituencies drew the most criticism from analysts. In studies on arthritis, Alzheimer’s disease, and incontinence, all issues that primarily affect older people, individuals over the age of 65 were routinely excluded from clinical trials. In cancer trials looked at by researchers, only 25% participants were over the age of 65. By underrepresenting key demographics, such as women and the elderly, clinical trial results are undermined by their lack of consideration of factors relating to gender, age, race, and culture. Such factors can impact how drugs will perform across the entire population once approved for use. Further research indicates that women are so underrepresented in clinical cardiology trials that it is questionable whether the research being conducted can even be applied to women, since it is based primarily on male patients.

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