Mounting evidence is pointing to a likely scenario, at least in the short-term, for the evolution of clinical research and how virtual trials will fit in. After reviewing pilot test results, patient feedback, and research coordinators’ input, several industry experts have recently voiced their opinions that hybrid trials, which include a combination of virtual visits and in-person visits, will have the greatest chance for success as the future of clinical trials.
Pfizer’s study called REMOTE, was one of the earliest entirely virtual trials. It helped pave the way forward by providing lessons learned for the industry. Results led many to consider a more gradual approach to virtual trials to support a smoother patient transition.
In addition to the increased focus on patient acceptance, only a very small percentage of studies can be designed to be 100% virtual in their protocol. Given these facts, and patients’ differing comfort levels with technology, many experts believe a hybrid model will emerge as the future of clinical trials.
Industry Leaders’ Thoughts on the Future of Clinical Trials
Craig Lipset, former Head of Clinical Innovation at Pfizer Global Product Development said, “I don’t expect to see entirely siteless trials flourishing but I do expect to see far more hybrid studies. Companies will look at a particular indication and say, let’s try one virtual site in this multicenter trial and see how it performs, or they will spare patients certain visits. As these experiences grow and the impact is realized, more opportunities to go remote will emerge.”
Lipset continued, “Not all patients are happy to ‘go it alone’ emphasizing the importance of offering patients greater choice in how they participate in a trial. We need to make sure participation is fit for the patient rather than fit for the protocol; that convenience for the participant is put before convenience for the study team,” he said. “Patients who happen to be local to a site or are happy to attend appointments should be able to continue to do so, while those who prefer not to travel or are comfortable with enabling technology can take part remotely.” 1
SCRS President, Casey Orvin said, “Unless the day comes when technology can address a patient’s social and emotional needs, the quality of clinical trials will not be improved by eliminating sites and severing the human connection that research has proven to be essential to the patient.” 2
“What the data shows us is that patients value, more than anything else, the relationship that they establish with the study coordinator and with the investigator,” 3 said Ken Getz a research associate professor at Tufts University School of Medicine and founder of the Center for Information & Study on Clinical Research Participation (CISCRP) in Boston, a non-profit that educates the public about clinical research participation.
“Faced with a desire to unlock the benefits of virtual trials and a need to perform some procedures at sites, sponsors have hit upon hybrid designs as the best of both worlds.” 4 ~ Marken: Global Life Science Supply Chain Solutions
VirTrial Works with Sites to Facilitate the Future of Clinical Trials
VirTrial’s stance has always been that a hybrid approach is the answer. Led by a management team with a long history in the clinical trial industry and first-hand experience with more than 10,000 trials, VirTrial strongly believes in the intrinsic value of direct human interaction and advocates that in-person visits are necessary in certain cases. The company’s vision is to replace only 25 – 50 percent of in-person visits with virtual visits. VirTrial enables patients to continue seeing and interacting with their familiar study coordinator and investigator during remote visits.
VirTrial’s Patient Management Program works in conjunction with any research site to augment their existing processes and works on any device (Apple, Android, smartphone, tablet, laptop.)
Contact us to schedule a free demo and talk with an experienced clinical research professional about how your organization can benefit from using VirTrial’s platform to prepare for the future of clinical trials.
- Eyeforpharma – “Siteless: The Future of Clinical Trials?” February 2017
- SCRS InSight Journal – “The Changing Face of Clinical Research” March 2019
- Fast Company – “The search for new drugs is coming to your house” August 2018
- Outsourcing-Pharma – “ How companies are realizing the potential of virtual and hybrid clinical trials” October 2018