With clinical trials costing an average of $22,000 a patient, lasting up to five years and involving hundreds of patients at a time, the need for efficiency and efficacy is critical in testing new drugs and treatments. And a College of Medicine volunteer faculty member has been selected to play a key role in making those improvements.
Dr. Jason Connor, who teaches research methodology and statistics at the medical school, was recently appointed to a 10-person national board established to improve the lengthy clinical research process. The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization of healthcare professionals, scientists and caregivers.
Dr. Connor brings to the group experience in “adaptive” clinical trials – which are more flexible and can focus on adjusting areas like drug dosages and the sample group as trials progress rather than waiting until the study’s end to view results. His involvement in such trials ranges from Alzheimer’s to cancer treatments, and he designed the trial for a brain aneurysm pipeline device in 2011, which received FDA approval.
Although researchers first began using adaptive clinical trials in the 1980s, it was not until around 2000 that the new methodology became more widely accepted. Dr. Connor likened the process of a conventional clinical trial to sending out a ballistic missile compared to an adaptive trial that is more focused and targeted, like a smart missile. For example, most trials select inclusion/exclusion criteria at the start, and remain unchanged throughout the course of the trial. In an adaptive trial, if only patients of a certain genetic profile or illness type are responding well to the treatment, the trial changes according to predetermined rules and the emphasis can shift to studying just those patients most likely to respond to treatment.
“We’re moving from a one-size fits all healthcare system to more individualized care. We really tailor a clinical trial design to the specific clinical question,” Dr. Connor said.
Dr. Connor started his career in biomedical engineering before switching to statistics, combining his interest in mathematics of medicine. Now instead of being on the front end of medical device or drug development, he’s more in the middle – helping companies or individuals determine if their treatments are really safe and effective and helping doctors decide what therapies work best for which patients.
He hopes the adaptive approach will help trails run faster and provide more pertinent information to patients in a timely manner. The first meeting with the new advisory board takes place in Washington D.C. in May.
Dr. Connor, who serves as an assistant professor at UCF, is a student advisor for the medical school’s Focused Inquiry and Research Experience (FIRE) program, which requires students to conduct a two-year research project on a topic of interest. He is also a visiting professor for Johns Hopkins University Bloomberg School of Public Health.
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