WASHINGTON -- The FDA is taking steps to include more patients with multiple chronic conditions in clinical trials of new drugs, believing such patients are too frequently excluded from new drug studies.
Pharmaceutical companies routinely exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates, but, as a result, the studies don't provide a glimpse of the treatment's "real world" effect.
To counter this, the FDA recently issued a memo to its new drug reviewers asking them to work with drug manufacturers to include a broader population in trials more regularly.
"The whole point of this is that if there really are differences in response -- either favorable or unfavorable -- among subsets of the population, what clinicians need is to know about it, so they can either watch for them or use a different drug," Bob Temple, MD, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, told reporters Friday. "This adds to the information available."
The internal memo, which effectively changes FDA policy, will force those conducting trials to focus more on their inclusion criteria and avoid unnecessary exclusions.
