Elusive Definitions Stymie Progress on Clinical Trial Quality

Nicholas Focil, Chief Executive Officer, FOMAT Medical Research

Nicholas Focil, Chief Executive Officer, FOMAT Medical Research

A former Supreme Court Justice, struggling to define the term pornography in a landmark case, famously hedged his bets by saying he knew it when he saw it.

Many research professionals feel a similar challenge when defining the term quality—especially when examining it in terms of the various stages of a clinical trial. “I’m a big believer that simple makes better quality,” says Nicholas Focil, CEO of FOMAT Medical Research. The more hurdles you put up in trials, the more headaches you create, he adds.

Unfortunately, hurdles and barriers abound in terms of disparate quality expectations among regulators, vendors, and other trial practitioners across the process spectrum. “Sometimes people interpret quality as more work, as more filters,” Focil says. “But quality can be done in a more robust way” with a focus on customer service.

Given his druthers, Focil might start the quest toward higher quality with software vendor management. “I’m not here to say, ‘Hey let’s disappear all the vendors,’ not at all. But let’s have them speak a similar language.”

While its definition remains elusive, the importance of quality is clear from the site standpoint, Focil says. “It’s important for you if you want to maintain clients and customers. Customers in this case could be the pharmaceutical company and, more importantly, the patient.”

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Join Nicholas Focil of FOMAT Medical Research, Steve Whitaker of PharmaPM Consulting, LLC, Donna Hellsten of PPD, and Doug Schantz of AstraZeneca at the ACRP 2019 Quality Congress next month for this engaging panel discussion.

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There are other important aspects of quality to consider, Focil says. “I don’t know if you want to call it ethical, or rather the altruistic standpoint, but it’s also the fact that drugs that are going to be approved down the line and you want them to be approved [based on] the highest quality possible data,” he notes. The reason: When people are using that drug, it is representative of what was actually studied.

ACRP 2019

Embracing quality should also mean less work in the end, Focil adds. “When you do something poorly, you end up having to do it twice, three times, four times,” he says. “But if you do something right, it may take a little longer, but it’s going to be done only once.”

Focil welcomes the opportunity to appear on an ACRP Quality Congress panel at ACRP 2019 in Nashville in April, representing various clinical trial constituencies. “We need to get together and agree on some definitions,” he says.

Author: Michael Causey