Dr Kimmelman also mentioned that the lower frequency of in-person visits might translate into issues with participant retention. While patients with advanced stages of disease may be more motivated to stay on in this scenario, others might not feel as inclined to do so. The potentially higher drop-out rates may in turn impair the overall quality of trials.
Finally, the pandemic might alter the make-up of trial populations in ways that could then complicate the interpretation of trial results in non-pandemic conditions. For example, Dr Kimmelman said, patients who are older or who have comorbidities that dramatically raise their risk of COVID-19 infection may be particularly reluctant to enroll in a new trial that they would otherwise join in a non-pandemic scenario. At the same time, some people who have lost health insurance due to the economic disruption may be more likely to enroll, perhaps in an attempt to get coverage. “To me, it’s an interesting question whether or not the kinds of people who are flowing into those trials during a pandemic are similar to the kinds of patients who flow into trials outside of a pandemic,” Dr Kimmelman said.
Moreover, the data collected by trial investigators during the pandemic may not be as complete as they would have been before the COVID-19 crisis began. Rebecca Pentz, PhD, professor of research ethics in the Winship Cancer Institute at Emory School of Medicine in Atlanta, Georgia, noted that the NCI is now allowing researchers to skip collecting quality of life (QoL) secondary objectives. “Those are included in trials now because we want the patient’s perspective,” she said. “But that’s one of the things that they’re kind of allowing to let go if it’s too hard to collect, and yet those are important pieces of data.”
For example, if an investigational agent helps patients live only a few months longer but the patients feel much better when they receive the drug, then there’s value in recording this information, Dr Pentz said.
The NCI is also allowing researchers to omit collecting secondary biospecimens — which can provide information for secondary objectives — if the tissue is difficult to obtain. “Obviously [researchers] are going to get the mandatory biospecimens, but getting that tissue is how we make advances against cancer,” Dr Pentz said. “Losing the opportunity to get that tissue is, I think, necessary given the situation we’re in, but unfortunate.”
Nonetheless, Dr Pentz thinks that other changes — using telehealth, signing consent forms via e-consent, allowing some follow-up appointments at a local provider, and shipping oral medications to the patient — are predominantly positive and should be retained once the pandemic is over. “[We should] find out what the differences are between telehealth and in-person [appointments], and then see if we can alleviate any issues that arise,” she said. “But in the long term, I think these kinds of changes that make it possible for underserved populations to participate are going to be a bonus to clinical trials. It will make them more generalizable.”
- National Cancer Institute. Responding to coronavirus, cancer researchers reimagine clinical trials. Published June 29, 2020. Accessed September 14, 2020.
- Borno HT, Zhang L, Siegel A, Chang E, Ryan CJ. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018;23(10):1242–1249.