Collecting Real-World Patient Drug Experience
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Collecting Real-World Patient Drug Experience
Stiffer post-marketing commitments highlight the need to optimize data
gathering
We can all hear the train coming. More post-marketing research, also known as
post-marketing studies/surveillance/safety monitoring, is going to be required
of all manufacturers in the wake of safety concerns around blockbusters
Celebrex, Vioxx and Avandia. From 1998-2003 the FDA required Post-Marketing
Commitments [PMCs] on 73% of new drug approvals, a number expected to
increase over the next few years. The issue has also become a political
football and calls for increased post-marketing surveillance have
It’s a long way from the
lab to the patient’s
medicine chest, and what
happens in the
uncontrolled real world,
is not always predictable
based on experience in
controlled clinical trials.
come from the halls of Congress. A sign of the times, many companies
are opting to do these studies on their own even without a PMC
required by the FDA.
It’s a long way from the lab to the patient’s medicine chest, and what
happens in the uncontrolled real world, is not always predictable
based on experience in controlled clinical trials. Efficacy and safety of
the drug in the real world are impacted by the constellation of realworld physician prescribing habits, patient non-compliance, side
effects, co-morbidities and drug interactions. For many products, their true
safety profiles are not well understood until they are on the market, and unless
monitored, often not until it’s too late.
While patient safety is of the greatest concern to industry, it’s not just the
patient who has a serious adverse event that we should be concerned about.
There is other collateral damage from such unfavorable real-world experience.
If the product is removed from the market, it would mean that many patients
who would safely benefit from the drug will be denied access. If the result is
revised labeling, the product may still be difficult to get for certain patients due
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