An expert panel has released new guidelines for modern clinical trials, examining the importance of utilizing telehealth technologies in clinical studies.
The guidelines, published in Clinical Therapeutics, are the results of a roundtable discussion hosted by CRO Center Point Clinical Trials, and included clinical specialists in metabolic and neurodegenerative diseases, health information technology and the pharmaceutical industry.
To the panelists, the clinical research industry has some catching-up to do. As the number of devices connected to the internet is projected to exceed 20 billion by 2020, and with many mobile health technologies already available and being developed and improved every day, clinical researches haven’t fully taken advantage of those advancements.
“Until recently, most clinical trials relied on paper-based processes and technology,” reads the study put together by the panelists. “This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development.”
Besides, lack of proximity to trial sites, the inability or unwillingness of participants to stay in a trial that usually includes multiple visits, plus the demand for more diverse sample sizes over wider geographic areas in clinical trials, are potential hurdles that hurt patient recruitment and retention, notes the study.
“The way to reverse these trends is to modernize the clinical trial process, where appropriate, is to consider the siteless CRO model, and to adopt a set of industry accepted guidelines to regulate the process,” said Irl Hirsch, M.D., the lead author of the recommendations, during a Center Point-sponsored webinar announcing the guidelines. Hirsch is a professor and a regular clinical researcher at the University of Washington School of Medicine with a focus on diabetes.
The guidelines suggest that videoconferencing and other telehealth technologies could play an important role in many aspects of trial activities such as recruitment and informed consent, screening and data collection. Although technology is the base, the study also stresses that “(d)irect communication and relationships between participants and a trusted study health professional are key features.”
The guidelines list suggestions on how remote technologies could be incorporated into clinical trials and the need for further regulatory clarification to keep up with the new development. Some of the “low-hanging fruits” the guidelines have identified include using electronic informed consent, direct-to-patient clinical supply shipments and real-time notification of adverse events.
The panelists also call on more public-private collaborations to work on innovative R&D paradigms and regulation that guide the process.
A shift to digitally managing clinical trial process and participants has been an apparent trend. Last November, Center Point launched the industry’s first siteless CRO that could go through the entire trial process virtually by using digital tools and electronic communication between research pharmacists and participants. Earlier this month, Parexel started to offer services that allow study subject data collection remotely using wearables and sensors. Clinical cloud technology firm Medidata is also extending its reach to the CRO industry and just recently bought clinical trial e-consent pioneer Mytrus.