New questions and considerations
In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.
He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.
To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.
In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
Looking to the future
For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.
Dr. Alan P. Lyss
When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.
Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.
He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.