COVID-19 Has Lessons for Oncology Clinical Trials

The coronavirus disease 2019 (COVID-19) pandemic required that investigators, sponsors, and regulators adapt clinical trials to prioritize the safety of patients. Now momentum is gathering to make permanent the flexibilities introduced in regulations and procedures to improve access to clinical trials for patients with cancer.

“Things that had been suggested prior to the pandemic to make trials less bureaucratic and easier for patients were seen as not possible. What we learned [during the] pandemic is that a lot of these [changes were] incredibly possible and, in fact, happened almost overnight,” said Nathan A. Pennell, MD, PhD, an associate professor in the Department of Medicine and director of the Lung Cancer Medical Oncology Program at the Taussig Cancer Institute of Cleveland Clinic in Ohio.

For example, Pennell said patients in clinical trials could be seen in their homes through telemedicine and have their medications shipped to them. Patients could have scans and blood work performed at local centers instead of at the trial sites. “The majority of what was done to add flexibility to research during the pandemic should essentially continue,” he said in an interview. “We were focusing on changes to the protocols or issues that were most important to the safety of the patients or whether it actually would affect the outcome of the trials.”

The speed that the regulatory agencies showed during the COVID-19 pandemic was unprecedented, and this kind of acceleration is what the medical oncology community is asking for, said Cristina Oliva, vice president of Oncology and head of the Oncology Centre of Excellence at IQVIA in London, England.

She said some changes that COVID-19 triggered are likely here to stay, including simplifying clinical trials, streamlining procedures, reducing the patient and site burden, and improving the institutional review board approval process.

“During the pandemic, investigators had to prioritize which studies to keep open,” Oliva said in an interview. “Their thought process was to prioritize the innovative therapies that could provide real benefit to patients.”

Oliva said oncology drug development can be streamlined through close collaboration, cross-functional approaches, and innovative trials designs. “Additionally, innovative technologies created virtual solutions. They’ve been used perhaps for the very first time in such magnitude during the COVID-19 vaccine development.”

The American Society of Clinical Oncology’s (ASCO) Road to Recovery Task Force, which Pennell chaired, recommended in January 2021 that permanent changes be made to processes to make oncology trials more accessible, efficient, and less costly.1 The recommendations center on 5 goals that focus on the efficiency of clinical trials and reducing the burdens on patients and trial sites. (Box.)

“Clinical trials should be designed specifically so that patients can enroll from wherever they are, they should be able to have assessments of patient-reported outcomes and quality of life done virtually, and they should be able to sign consent forms virtually,” Pennell said. “We can do financial transactions and buy a house using electronic signatures, but in order to sign consent for a clinical trial, patients have to get back in a car and drive to the site to sign on paper.”

Pennell said ASCO’s recommendations are the first step in the process of making trials less bureaucratic and more accessible to everyone. Over the next year, he said more concrete proposals will likely be put forward.

Box. ASCO’s Goals for Oncology Research Post–COVID-19

1. Ensure that clinical research is accessible, affordable, and equitable. Research procedures during the pandemic have become more patient-centric, with remote or virtual consent with e-signatures, patient assessments, laboratory testing, and imaging at local centers, and collection of research-only biospecimens.
2. Design more pragmatic and efficient clinical trials. Adaptive trial designs can improve study efficiency. Master protocols can be written to allow participants to potentially qualify for several arms. Common control groups can decrease the number of participants assigned to control treatments across studies. Minimizing data collection on patients with long-term follow-up decreases the burden on research sites.
3. Minimize administrative and regulatory burdens on research sites. Allow virtual and flexible options for site selection, and study start-up and implementation, documentation and signatures, and study monitoring. Widespread adoption of common, centralized, and interoperable technology platforms would streamline research administration.
4. Recruit, retain, and support a well-trained clinical research workforce. Enhanced cross-training of research teams would facilitate staff coverage during such disruption, as well as increase the efficiency of research, protect the quality of study conduct, and allow clinical investigators and research staff to move between studies.
5. Promote appropriate oversight and review of clinical trial conduct and results. Reviews by central institutional review boards would improve the efficiency of study oversight and reduce costs by eliminating the review of the same study by multiple institutions.

Reference

Pennell NA, Dillmon M, Levit LA, et al. American Society of Clinical Oncology Road to Recovery Report: learning from the COVID-19 experience to improve clinical research and cancer care. J Clin Oncol. 2021;39(2):155-169. doi:10.1200/JCO.20.02953