Published: Feb 1, 2014
By David Pittman, Washington Correspondent, MedPage Today
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.
"FDA should actively encourage the conduct of at least one trial in a broad population that closely resembles the people who will use the drug if it is approved, and should discourage unnecessary exclusions," stated the memo, which was released last month.
While that sounds like something the FDA should already be doing, a study the agency commissioned in 2011 found some troublesome trends in trial exclusions.
The study from Digital Infuzion looked at trial data submitted in 2011, which included 147 studies in 42 conditions. Two-thirds excluded patients with a heart disorder, 71% excluded patients with a psychiatric disorder, and 38% excluded diabetics.
Temple said the widespread exclusion of those with hints of psychiatric disorders troubled him because so many drugs are found to cause increased rates of depression.
The change in FDA's thinking in this area was only very recent, and Temple had trouble saying what the impact has been and what it would have done to the drug review process in the past.
"We don't know how many oddities are going to turn up," Temple said. "I think in most cases we would modify the labeling."
The FDA's change in policy is part of a broader effort from the Department of Health and Human Services to pay attention to and account for patients with multiple chronic conditions.