The life science industry has been warming up to the use of health IT and digital health tools to improve clinical trials. Remote monitoring, adherence tools and ways to make clinical trial design easier are a few of the areas that have gotten attention. The goal is to cut the time it takes to set up clinical trials and make them easier to manage, which could have an impact on drug development costs and, ultimately, prices.
In a phone interview, Dr. Andreas Koester, head of clinical trial innovation at Janssen, a division of Johnson & Johnson (NYSE: JNJ), talked about its collaborations to develop health IT solutions.
eMeds: Janssen is developing a way to track adherence in clinical trials and provide dosing updates to patients through an integrated system using a smartphone. Currently, investigators have to fill out paper logs, which can be imperfect. Automating the process could reduce the burden on the investigator side. The eMeds system includes medication scanners and electronic labels. When patients take their medication, it’s noted automatically through a web portal. When they don’t, reminders are sent. A small pilot in Belgium was able to show that it’s technically feasible – elderly patients can handle, receive and understand the update and change medication intake based on the update. Koester said it’s generated some interest from other pharmaceutical companies.
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Electronic informed consent form: Another nagging problem clinical trials have had is that participants rarely read the documents that explain the trial. A new app for iPads focuses on informed consent. It introduces the patient to the study with a consumer-friendly animated video that provides easy-to-understand information. An interactive feature allows patients to look up word definitions and mark sections they don’t understand so they can get clarification from the site personnel.
Janssen is working with Mytrus on a Phase 3 clinical trial for electronic consent. Janssen is measuring whether patients understand the content of the clinical trial description.
Investigator database: A clinical trial database Jannsen started building last year with Lilly, Johnson & Johnson (Pfizer joined the group later) could help reduce the administrative burden of clinical trials. It would also whittle down the high turnover rate for principal investigators, in many cases due to a poor match between investigators and a trial. Koester said the investigator feedback has been “overwhelmingly positive,” with 90 percent of those contacted giving permission for inclusion in the database. To date, the database contains 120,000 principal investigators, 20,000 sites and 4,000 clinical studies in detail. It’s designed to be a reliable record and makes it easier for pharmaceutical companies to match up investigators with clinical trials appropriate for their training and experience. It’s expected to go live in the first quarter of 2014.
