Making effective use of decentralized clinical trials (DCTs) could help diversify patient populations, create new study opportunities for sites, and improve the quality of surgeries, says Dr. Pamela Tenaerts, who has just joined Medable as Chief Scientific Officer. Thought leader Tenaerts is based on more than 30 years of clinical research experience, most recently as Executive Director of the Clinical Trials Transformation Initiative (CTTI) at Duke University.
The relative lack of diversity in the patient population in clinical trials has “been a problem for years,” notes Tenaerts. “There was a greater awareness of it [since] 2020, but something has to be done, ”she says.
She believes that increased use of DCT technology and associated best practices would help meet the diversity challenge, also because it would make participation in studies less stressful for patients.
“More than 70% of the [American] The population lives more than two hours away from a research location, ”says Tenaerts. Participating in studies takes time, especially when frequent visits to a study site are required, she adds.
The stress is a major obstacle for many rural groups and minorities as it can be more difficult for them to take time off work to devote sufficient time to a process. “Reducing this burden should help [close] the inequality, ”she says.
Tenaerts firmly believes that physical locations will always play an important role in studies, but encourages the industry to use DCTs when they make sense. “I see an opportunity for sites that are not close to hospitals to do more research,” if they can find ways to use elements of DCTs, says Tenaerts. “It’s not all or nothing,” she insists. Sites should “consider what they will need to be achieved in the study and be open to giving patients more flexibility” if DCT is appropriate.
Tenaerts is a leading advocate for innovation in clinical trials with a unique personal background as a clinical trial investigator, hospital research administrator, and academic in the US and Europe. Prior to joining Medable, Tenaerts led CTTI’s efforts to develop and advance practices that improve the quality and efficiency of clinical trials.
CTTI is a public-private partnership co-founded in 2007 by Duke and the US Food and Drug Administration. It includes more than 80 member organizations including government agencies, industry representatives, patient advocacy groups, professional societies, research groups and academic institutions.
In her new role, Tenaerts says she is excited to “roll up her sleeves and do something to improve the exams beyond that [just] Make recommendations. “At Medable, she will lead the evidence collection focusing on patient centricity, efficiency, and quality in DCTs, and will work with Medable’s existing science leaders, including Dr. Ingrid Oakley-Girvan, to expand the company’s digital biomarker work with the National Institutes of Health and other partners.
Author: Michael Causey