Although the future of COVID-19 remains unknown, it is clear that the pandemic’s effects will linger in many aspects of cancer care and research, including oncology clinical trials. In a recent JAMA publication, Dr Daniel V. Araujo et al shared their perspectives on the evolving landscape of oncology research.
Just as patient visits for treatments and monitoring have been disrupted, participation in clinical trials has also decreased. Clinical trials, particularly those evaluating novel agents, mandate frequent tests and physician visits for assessment without a guaranteed return of therapeutic benefit. In the midst of a pandemic, standard risk-benefit ratios have shifted, as physicians and patients must now also consider the potential increase in risk of contagion associated with the hospital and lab visits needed for assessments. Without a guaranteed return of therapeutic benefit, this risk may outweigh the benefits for some prospective clinical trial participants.
Despite the risks of COVID-19, there remains a general consensus among multidisciplinary teams that life-saving and value-proven interventions should still be offered to patients with cancer. Clinical trials are essential, but may need to be adapted and adjusted to help mitigate risk. Trial protocol writers and investigators may need to rethink and revise some practices, such as converting to digital signatures vs paper/ink and implementing telehealth visits when feasible. Although physical examinations remain a crucial assessment tool, in-person visits may increase the potential exposure risk both for patients and providers. Investigators should reevaluate which in-person physical examinations are necessary and consider whether some could be conducted as telehealth visits without compromising vigilance. Investigators might also consider whether having tests performed in local certified labs would suffice, rather than requiring patients to go to certain trial locations.
On the positive side, we have learned from this experience that there may be some processes that can be adapted to make it easier and safer for more patients to participate in clinical trials. The future of oncology research may look very different, with the use of locally performed staging and diagnoses, as well as increased use of virtual tumor boards and discussions among local and academic physicians. Centralized artificial intelligence models may also play a role in helping to identify suitable clinical trials for a particular patient. Initial screenings with principal investigators could be conducted virtually before enrolling in the trial. Ultimately, it is possible that these measures could mean more patients would be able to participate in clinical trials in the future.
As the future course of the pandemic remains uncertain, resources must be prudently allocated so that current trials can remain on track. Many research laboratories were forced to close during the period of widespread COVID-19, which resulted in some clinical trials being paused or even terminated. Adapting trial designs and increasing use of technologies may be necessary in order to save time and resources. For new trials, enrollment might be increased by expanding eligibility criteria and eliminating those of unproven value. Remote practices such as telehealth visits and virtual tumor boards, as well as permitting administration of treatment in local satellite centers, may also help to broaden the scope of upcoming clinical trials. By embracing new technologies to supplement old practices, oncology researchers will be able to continue on the course toward better patient outcomes.
As we navigate this devastating virus with adaptive measures, we may be learning lessons that could reshape processes for the better. Now more than ever, the scientific community must come together to share its collective wisdom to ensure that clinical trials have the greatest potential for success. Community practices should continue to enroll patients in clinical trials when appropriate and encourage them to adhere to protocol-driven treatment recommendations. Consider alternate ways to provide greater support to patients, for instance the use of virtual visits, phone check-ins, and localized practices such as home-based blood draw and infusion services.