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Unique safety considerations in oncology trials
Medelis: Until now we’ve been discussing general patient safety issues. What about oncology trials – are there unique considerations for sponsors and CROs?
Dr. Gourzis: Yes, oncology trials have more complex patient safety issues. First, patients in a phase I or II oncology trial almost always have the disease and have usually exhausted other treatment alternatives. The disease may not be stable, so there are issues with disease progression -- increased symptoms and/or adverse events not related to the drug.
In addition, you’re often dealing with patients who don’t have much more than six months to live, and these patients are often willing to take greater risk for a potentially positive therapeutic effect.
These factors create additional complications for maintaining patients on study, which makes enrollment, schedule/timing compliance, budgets and data all more complex.
Medelis: Given that oncology trials usually involve smaller numbers of patients, is the monitoring burden lower than trials for other indications?
Dr. Gourzis: Oncology trials don’t require as many patients; however, given the nature of oncology disease, those patients must be monitored more intensively. In addition, medical records are often extensive, requiring time for proper scrutiny.
Unless the FDA changes their criteria for efficacy, a lot of oncology compounds will be approved even though they have been tested in relatively few patients, which can lead to serious patient issues after the drug has gone to market.
Medelis: What’s a medical officer’s worst safety monitoring nightmare?
Dr. Gourzis: Promising results from at the end of an oncology phase II are can be exciting even though the drug has been tested on very few patients. Word may reach Wall Street; people start salivating.
The nightmare is a severe toxicity occurring in phase II or III — either that or a lack of sufficient efficacy.
A severe toxicity in phase II usually kills the compound unless it has tremendous lifesaving potential in a disease that is uniformly lethal. If the compound moves into phase III involving a larger number of patients, there is greater probability for an adverse event, especially one of low frequency. Sites and monitors have to be extremely alert for such an occurrence in a single site or the entire patient population. If a toxicity or adverse event is properly documented and analyzed, the compound may still be viable as a targeted therapeutic.
The nightmare can be magnified when an event isn’t properly documented and analyzed. With poor analysis, a highly targeted therapeutic may never make it to market. Or the drug may make it to market, only to be pulled later because of major safety concerns with substantial costs to the sponsor.
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