The stages of a clinical trial are reassuringly familiar to scientists but even when they know what to expect, the worst stage seems to be before the study even starts. Will the patients trust the company enough to take part? Will they be anxious? Will they understand what the objective is? Will they drop out? Will patients be placed in a placebo group? Most people eligible for a clinical trial don’t live near a center where it’s being done. Institutional review boards and contracting requirements are costly and time intensive.
Dr. Joshua Korzenik, director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, talked at the DIA conference in Philadelphia this week about what it learned from a pilot study that used digital health to collect data. The study centered on decentralized data collection for dietary intervention in patients with ulcerative colitis. His team had sought 50 patients. It got four. So much for digital health improving clinical trial recruitment.
“It was staggering to me. There was tremendously high interest among patients, but low uptake. Providers were not hooked in and there was low motivation to participate. Data was collected remotely from places that don’t routinely collect data….It became a more labored process than we had anticipated.”
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
He discussed how his team re-examined its approach. They had to get people comfortable with using tracking technology so they could get to a point where this happens more readily and is a relatively pleasant experience.
“Technology doesn’t replace patient-physician relationships,” Korzenik said, but it can help in certain areas like enhancing recruitment and improving education and data collection.
As part of a collaboration with PatientsLikeMe, Korzenik’s team worked on an app to enable patients to monitor their symptoms and provide information to help them prep for their visits to the study center. The goal was to improve the quality of patient partnerships with healthcare professionals and to increase patient responsibility.
There are plans to add a video conferencing component, using telemedicine to make follow-ups easier. It could also include patient reported outcome measures to screen for anxiety and depression.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
It’s also in the process of setting up a hub backed partly by insurance companies and pharmaceutical companies. The idea is to create hubs of information that would train patients in certain ways to improve adherence but which could also go beyond a clinical trial.
