Pharma Execs Prefer Hybrid Clinical Trials
Author: Darcy Forman, Chief Delivery Officer
Decentralized clinical trial methods are being adopted at a record pace, according to Science 37’s second annual Agile Clinical Trial Survey: How Decentralized and Hybrid Trials are Impacting Clinical Research. The data proves that this approach to research has become a permanent part of the trial landscape.
7-in-10 sponsors planning hybrid clinical trials
The data shows that almost 70% of sponsors plan to run hybrid or fully decentralized clinical trials in the next 12 months. The bulk of these trials are in oncology, rare disease, and infectious diseases. Many respondents are already using decentralized elements in current trials. The most popular tools include clinical trial technology such as electronic clinical outcome assessments (eCOA), telemedicine, and remote monitoring, all of which enable sites to interact with patients and capture data without a lot of site visits.
The growing adoption of hybrid clinical trial methodologies suggests that sponsors see the value these tools bring to their patients, sites, and business models. It also helps that many of the benefits of hybrid clinical trials are directly linked to obstacles that sponsors have long been trying to overcome.
Faster recruiting, better patient retention
The 2022 survey shows that study delays and patient recruiting continue to be the challenges that keep executives up at night. Respondents also believe faster enrollment is one of the top three benefits of decentralized clinical trials, reduced patient burden, and better patient experience. All of these perceived benefits can contribute to easier recruiting and faster start-up.
In the webinar, Jonathan Cotliar, Chief Medical Officer at Science 37 shared several examples of clinical trials supported by Science 37 in the past two years, that leveraged hybrid clinical trial models to engage remote patients and create better patient experiences through the use of home health visits and decentralized trial technology.
He shared the story of a stage 3 Breast Cancer Study to test a subcutaneous formulation. Twelve academic medical centers recruited 164 patients who needed 18 treatments over a 12-month period. Normally, that would require patients to travel to a site every few weeks for treatment and follow-up visits, which would have narrowed recruiting to minimal geography around the sites. Instead, 95% of the visits were conducted in patients’ homes by traveling healthcare staff.
Science 37 deployed a single platform for all data capture, ensured investigational drugs were shipped within 24 hours of each dosing and managed the team of visiting healthcare professionals to deliver the treatments. Enrollment wrapped up quickly, and the study has already completed nearly 2000 visits over the course of two years. One medical director involved in the trial said it was “above and beyond anything I have seen in my oncology career.”
Hybrid trials support diversity goals
The survey also proved that hybrid clinical trials are helping sponsors overcome another growing challenge – diversity. 84% of respondents said decentralized and hybrid clinical trials enable greater diversity in research.
This is helping them adapt to regulatory demands for proven diversity in future trials. Almost 45% of webinar participants said they have already begun implementing diversity initiatives, and most agreed that lack of awareness among these patients, limited access to study sites, and poor trust are among the biggest obstacles they face to meeting diversity goals.
Using decentralized trials can help address these challenges. Home healthcare and remote tools can reduce or eliminate travel burdens, which allows sponsors to bring trials to new communities with minimal disruption to patients’ lives. It also sends a message that sponsors are interested in accommodating patients’ needs, which may help bolster patients’ trust in the industry, and give them new avenues to access innovative treatments.
The future is agile
As an industry, we’ve known for a long time that the traditional clinical trial model is outdated. It's slow, it's costly, and it's inaccessible to most of the population. Hybrid trial designs are proving to be a solution that brings new value to patients, sites, and sponsors. Over the past two years, we’ve proven that with the right partner, technologies, and hybrid trial plans, sponsors can overcome many of the burdens of traditional clinical research to deliver a better experience for all stakeholders involved.