It’s no secret that digital is shaping what clinical trials will look like in the future. A recently published position paper published in Nature discusses the potentials and challenges of digital clinical trials. The paper builds on a workshop held by the U.S. National Institutes of Health and the National Science Foundation in April of 2019.
One of the big opportunities that the paper outlines is remote data collection. Authors point out that today wearables and apps are able to gain insights about a user’s physical activity, sleep, heart rate, medication adherence and respiratory rate.
However, the researchers note that much of this data is collected on consumer-grade products, and in order to be used in a clinical trial they would need to be upgraded to medical grade.
Being able to collect this kind of data could mean cutting down on the input burden for researchers and participants, and a more inclusive participant pool, particularly in regard to rural participants.
“A fully digital trial will enable access for potential participants regardless of where they live or work,” authors wrote. “For investigators, this means more efficient and real-time remote monitoring and multiple opportunities for interactive patient management and assessment (passive and active), which means that more intensive work can be done with budgets that may not require greater resources.”
Another major avenue the paper explores is tapping into digital for clinical trial recruitment. Authors argued for a balance of oversight and flexibility when it comes to these communications. For example, the writers noted social media communications could be reviewed by an institutional review board, but the investigators should be able to react and respond in real time without having to go back to the board.
Real-world data, where metrics collected outside of the walls of a clinic could be incorporated into an EHR, was another area researcher saw opportunity. In particular the paper pointed out the potential for SMART (substitutable Medical Applications, Reusable Technologies) on FHIR APIs.
While there was a big focus on what is currently available, researchers stressed that a new strategy needs to be put in place in order for future success.
“The current methods for conducting clinical trials are not sustainable, and will leave a chasm between the need for evidence to inform health and healthcare and the availability of that evidence. New strategies for the future of clinical trials are needed,” authors wrote.
WHY IT MATTERS
Pharma companies and research institution are looking to digital as a way to modernize the traditional clinical trial. However, guidelines and best practices are still emerging in this relatively new field.
“[T]raditional clinical trials pose challenges that can hinder the efficient conduct of research to develop a knowledge base supporting products for patient communities. Current operational inefficiencies relating to the identification, recruitment, data acquisition, and follow-up of participants inflate costs, increase participant burden, and extend the already long clinical trial timelines, all of which contribute to low clinical trial participation: for example, only about 8% of cancer patients enroll in cancer trials,” authors of the paper wrote. “Enter the concept of digital clinical trial, which holds promise as a way to overcome current clinical trial challenges. A digital trial is one that uses technology to improve recruitment and retention, data collection, and analytics.”
THE LARGER TREND
Some of the biggest names in pharma are teaming up with big tech. For example, last year Novartis teamed up with Microsoft on a new artificial intelligence initiative focused on drug discovery and development.
Academic has also been turning towards big tech. Stanford University, Apple, Amwell and BioTelemetry have teamed up on the Apple Heart study, which uses the Apple smartwatch to detect AFib.
