Experts Predict COVID-19 Will Accelerate Modernization of Clinical Trials
Solving challenges of the current system is vital to spreading clinical trials into community clinics, which may be increasingly important.
The coronavirus disease 2019 (COVID-19) pandemic will lead to increasing adoption of artificial intelligence, automation, and virtual clinical trials, according to a prediction presented Thursday, during a virtual session of the Community Oncology Alliance 2020 Meeting.
“We really are in a place now to not lose momentum as we go through the pandemic, but in fact to accelerate it,” said presenter Howard Burris, III, MD, FACP, FASCO, president and chief medical officer of clinical operations at the Sarah Cannon Research Institute in Nashville, Tennessee.
The current systems of clinical trials have several challenges, including the sheer number of ongoing trials, handling rare mutations, limited patient access, and managing the amount of data. Solving these problems is vital to spreading clinical trials into community clinics, which Burris said is going to become increasingly important.
Before discussing these various challenges, Burris gave a brief overview of current trends in oncology clinical trials. Notably, Burris said the tumor agnostic approach, in which the biology of the tumor is more important than the site, has become more popular in recent years. There is also growing interest in plasma-based testing and increasing interest in FGFR inhibitors. While Burris said these FGFR inhibition was “troubling” a few years ago, he added that the FDA recently approved a second inhibitor, and that they are becoming increasingly understood, thanks to trials.
Additionally, Burris said physicians are ordering next generation sequencing-based gene panel testing for patients increasingly sooner to the time of diagnosis, which can have significant effects on patient participation in clinical trials. A large percentage of those tests are ordered for lung cancers and melanoma, according to data presented by Burris, but growing numbers are ordered for patients with head and neck, breast, and brain cancers.
In addition to the benefit for the patient, early testing can improve clinical research, drug development, and overall cancer research, Burris said.
“It is often the driving factor for participation in a clinical trial, knowing which drugs or which trials might be pertinent,” Burris said.
Earlier testing is one aspect of the effort to expand patient eligibility. Burris cited a recent analysis which found that expanding eligibility criteria enables more patients to participate, makes the trials more representative of the community and patients that physicians are seeing, and moves trials through the pipeline faster.
The data found that of 10,500 willing participants in a clinical trial, 5005 were excluded based on 1 or more of 3 traditional criteria. Instead of 5495 participants included based on traditional criteria, expanded criteria would have allowed 10346 participants to be included in the trial.
Finally, Burris said, there are infrastructure issues that must be addressed in order to expand clinical trials into community clinic environments. Facilities must invest in both necessary staff as well as systems in order to successfully handle clinical trials. Staff must include technical support, marketing support, regulatory experts, and safety experts, among others. Systems must also be implemented, including document management, molecular profiling, and clinical trial management.
E-consent form systems are also going to be increasingly important, Burris predicted, because they allow patients in more rural areas to consent without traveling to the facility.
“E-consent has been a huge satisfier for our many patients that are in outreach or rural sites, where we maybe have a physician visit once a week to provide care,” Burris said. “The need to travel and be in person will still happen, but that will be fewer and far between.”
All of these trends have been in effect for a while, Burris concluded, but he added that the COVID-19 pandemic will accelerate all of them.
“All in all, it’s just clear that this pandemic is paving the way, that we’re going to have the ability to, in fact, include more patients, include more practices, and include more physicians in participating in cancer research,” Burris said.
Burris, H. The Now & Future of Clinical Trials in the Community Oncology Setting. Presented at: COA (Community Oncology Alliance) 2020 Virtual Conference. April 23, 2020.