Clinical Trials: The Pandemic Has Brought Needed Changes

Clinical trials are a very important part of how we make progress against cancer. The more people participate in clinical trials the more quickly we can learn whether potential new treatments are safe and effective.

During the early months of the pandemic, enrollment in cancer clinical trials plummeted. But changes were made to increase flexibility and enrollment quickly came back up. The changes that were made, if they’re kept up, could mean that many more people are able to participate in clinical trials.

Why Don’t We Participate in Clinical Trials?

Low participation in cancer clinical trials has long been a problem. For a variety of reasons, less than 5 percent of adult cancer patients overall participate in clinical trials. And the rate for minority populations is even lower.

One reason for the low participation has to do with misperceptions about clinical trials and the way they’re conducted. But often cancer patients simply aren’t aware of trials that may be relevant for them and, unfortunately, they don’t learn about them from their doctors. I wrote about those issues in this post.

Another common barrier is living far from the cancer center where a trial is being conducted and not being able to travel there or afford the costs of the travel and time off work.

Increased Flexibility During the Pandemic

During the early months of the pandemic, it was found that cancer patients were at increased risk for severe illness from COVID-19. Clinical trials soon slowed down dramatically. One study found that during the first five months of the pandemic, there was a 60% decrease in launches of oncology clinical trials on a major clinical trial platform.

In response, changes were quickly made to the way clinical trials were being conducted so cancer patients could participate safely. At the heart of the changes was more flexibility in a number of areas.

Among the changes that were made were allowing in-person visits to be replaced with telehealth visits, having local health care providers handle in-person visits when necessary such as for physical exams and blood draws, and permitting oral medications to be sent directly to patients at their homes.

Clinical trial participation recovered very quickly with these changes. A study published recently found that, for the entire year, enrollment in clinical trials testing new treatments was just 9% below normal levels, although enrollment in prevention trials was down more (about 46%).

Clinical Trials Moving Forward

It’s not surprising to see that the new flexibility had such a big impact. Many of the changes that were made out of necessity in response to the pandemic were changes that researchers and advocates have called for for years to make trials easier for more people to access.

A group of thought leaders in cancer research recently reviewed the experience with trials during the pandemic so far and has made recommendations that many of the changes made should become permanent.

Here are some of the major changes they recommend keeping:

• Use of telemedicine visits in place of in-person visits.
• Delivery of medicines to the participant’s home or local clinic.
• Administration of intravenous drugs at the patient’s home or local clinic.
• Use of laboratories and imaging centers at alternative locations.

Lead author Keith Flaherty, MD, director of clinical research at Massachusetts General Hospital, told Medscape:

The ability to distribute oral investigational drugs by mail to patients at their home has probably been the single most impactful change to clinical trial conduct, linked with virtual visits with patients to assess side effects and symptoms.

Several other groups have published papers coming to similar conclusions. Among them are this article in the Journal of Clinical Oncology, this article in ESMO Open, and this article in the Annals of Surgical Oncology.

There is clearly consensus across expert groups internationally that many of the changes in the way cancer clinical trials are conducted that were made during the pandemic should become permanent. This much-needed and long called-for flexibility would be a major step forward and should allow many more individuals to participate and benefit.

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Cancer Clinical Trials: Why Don’t More of Us Participate?
Clinical Trials: How Can Patients Benefit More?
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