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"And it's probably inevitable that I'm going to put on my peddler's cape from Act IV of 'Winter's Tale' some night when I'm supposed to enter into Shylock's Act IV trial scene".
This was a prospective, randomized, open-label, parallel-group, phase IV trial to explore the efficacy of subacromial injection of HA as adjuvant treatment for supraspinatus tendinosis.
Levetiracetam (Keppra) was evaluated in a subset of patients aged ⩾65 years (n=78) enrolled in a large (n=1030) open-label, phase IV trial (the KEEPER trial).
For lisinopril, a large phase IV trial showed that a dose much higher than that widely used was necessary to reduce mortality in patients with congestive heart failure.
A Phase IV trial, otherwise called post-marketing surveillance, monitors the safety and efficacy profile of the drug or device once regulatory permission is granted for sale via prescription or over the counter.
This project called REMOTE is a phase IV trial under an Investigational New Drug (IND) application.
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The emphasis has been on post-marketing phase IV trials.
Post-marketing surveillance, also referred to as phase IV trials may be required to ensure patient safety and drug efficacy.
The Vioxx (rofecoxib) debacle, for instance, highlighted why phase IV trials matter.
Yet, the federal budget is now increasingly stretched, with newly authorized phase IV trials remaining unfunded by Congress and only the permission having been granted to charge companies for the costs.
Once it is clear that industry, the FDA and patients' advocacy organizations are supporting changes that make it possible for early phase IV studies to be conducted to support compassionate use, a much greater number of phase IV trials could be done later as well, and the resulting widespread studies will help make medicine safer and more effective for all.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com