Friday, February 21, 2014
Exclusivity of clinical trials
I understand why pharmaceutical companies are insistent on their strict criteria. They want to make sure if they take a group of similar people they can monitor for effectiveness and adverse effects. If they have a very diverse group, it can be much harder to determine the results.
The FDA is interested in changing this policy and forcing companies to include patients with chronic conditions (possibly me?) in clinical trials.
"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.”"
I find it to be a shame that so few Americans participate in clinical trials but then so many are told that they are eligible. With my medical history, no one ever wants to include me. I for one am looking forward to this change.