Regulatory Focus™ > News Articles > Trials Fail to Represent Actual Population, Say Researchers

Trials Fail to Represent Actual Population, Say Researchers

Posted 29 December 2011 | By Alexander Gaffney, RAC 

Placebo-controlled, double-blind, randomized clinical trials are supposed to be the gold standard in medical science.  But some researchers are suggesting that contemporary clinical trials are failing to examine patients who have multiple chronic health conditions-an oversight that means that efficacy data generated in clinical trials isn't generalizable to the population at large.

The researchers, led by Alejandro Jadad, MD of the Centre for Health, Wellness and Cancer Survivorship at the University Health Network in Toronto, published their research letter in the Dec. 28 issue of the Journal of the American Medical Association. 

Their research examined 284 studies looking at long-lasting chronic disease and chronic conditions, and found that only 6 of the studies sought out and included patients with multiple chronic conditions or diseases.  The study did not find any improvement in trial participation from this group over the course of the 15-year data set (1995-2010).

The authors go on to suggest that the US Food and Drug Administration (FDA) mandate that companies conducting clinical trials have subgroups of patients who have common chronic disease combinations, and to closely monitor these strata of the population in post-marketing studies.


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