Clinical Research and Clinical Care: Carving a New Approach
Bridging the gap between clinical care and clinical research may not be that far away.
The future of clinical trials will mean carving a new approach to how patients and doctors view clinical research, which will be a much more central part of everyone’s lives, even healthy people, says Ken Getz, director of the Tufts Center for the Study of Drug Development.
“We need an open innovation model, where you can draw from data and analytics to find patients wherever they might be anywhere in the world, and to be able to engage external parties to support a clinical trial within clinical care,” said Getz.
“Ultimately, where this is leading is all of us, healthy patients too, will always be in a clinical trial,” he told CenterWatch. Getz was the keynote speaker at last week’s Metrics Champions Consortium conference in Philadelphia.
“It might be primarily collecting data on a healthy individual, everything you ingest, a drug, food, your body’s ability to digest that, it will all be on your Apple watch. When you start taking medication, it will track that. Your clinical care doctor will then know about it.”
“It’s just moving into an environment where the patient data sits at the core,” he said. “It’s taking longer to get there because companies are very risk averse. They are concerned that if they engage a practicing physician with no prior experience, is it going to take them longer to start up a study, are they going to make mistakes, in a non-compliant practice.”
“We need increasing flexibility to support complex trial designs. Trials have so many procedures, endpoints, investigator sites. So being able to find investigators that have the appropriate and intelligible patients, especially in a rare disease or personalized medicine-based study are major challenges,” he said.
According to a CISCRP study, 68 percent of patients rate their healthcare provider as the top preferred source for information about their clinical research; 88 percent of patients feel it would be valuable for clinical research options to be presented during regular office visits; 71 percent say they would speak to their physician or nurse prior to deciding to participate; 83 percent consider their physicians’ recommendations a top factor influencing their decision to participate and 93 percent report feeling comfortable having their medical health records routinely used to identify appropriate studies.
Sponsors are already using patient advisory boards, professional advisory panels, home nursing networks, wearable devices and concierge services to better recruit and maintain patients in trials.
In three years, smart phones are projected to go from being used 45 percent of the time as a source of clinical research data to 92 percent. Electronic health and medical records are expected to triple, from 20 percent to 67 percent, according to a CSDD study.
“Using patient input to design protocols and get patient feedback, that can tell us factors that challenge their convenience participating in a study is important, as well getting patients to define what are the most meaningful endpoints to be measured, supporting models where clinical trials can be conducted wherever the patient can most easily get to them can help,” Getz said.