In addition to the lockdowns that halted ongoing cancer care and treatments, the coronavirus disease-19 (COVID-19) pandemic also had its impact on cancer clinical trials. For future pandemic preparedness, an international panel of oncology experts discussed possible solutions to keep clinical trials going.
The article by Prof. Cristiana Sessa and colleagues describes three different strategies to secure cancer clinical trials, as the recruitment of new patients for oncology trials decreased during the pandemic, however to a lesser extent than for non-oncology trials.
The most common responses to COVID-19 were changing protocols, switching to virtual visits, extending time windows for patient visits, and sending study drugs to patients. Planning was complicated by the reduced availability of health care personnel, who were in high demand in some regions due to the pandemic. Overall, the authors conclude, there has been a shift in the way clinical trials are conducted during the pandemic toward decentralized models.
Now that vaccination strategies have been implemented, the situation in health care has rapidly improved. However, successful new approaches to patient management and remote studies have paved the way for new ways to practice oncology and conduct clinical trials. This encourages researchers, sponsors, regulators, and others to discuss ways to optimize the conduct of clinical trials.
Oncological trials can be very demanding for patients and their families. During the pandemic, institutions sought to reduce the time patients spent on their sites by minimizing and streamlining procedures and replacing in-person visits with remote options.
While these procedures were intended to reduce the risk of COVID infection, it also reduced the burden of care and of clinical trials for patients. Optimizing both the trial design and study conduct from an operational perspective, with more streamlined clinical visits and some visits and treatments taking place in patients’ homes, may make participation in clinical trials less of a strain, while extending the reach of the trial to a broader population.
The pandemic has highlighted the need for new trial designs that accelerate research and reduce risks and burden to patients, while optimizing clinical trial objectives and endpoints and minimizing testing. The COVID-19 pandemic has also driven real-world evidence uptake in clinical trials in several ways.
At the same time, the pandemic is driving optimization of clinical trial objectives and endpoints, which are being re-assessed, while testing is being minimized. This approach is aimed at making trials more closely aligned to clinical practice in oncology. Eligibility criteria are being relaxed to facilitate recruitment of patients with unmet need and to enable enrollment completion.
Furthermore, the COVID-19 pandemic highlighted the underrepresentation of minority groups in clinical trials.
Lastly, a new problem-oriented collaborative framework among oncology trial stakeholders could shorten the timelines for patient access to new treatments by addressing the cultural and technological barriers to the adoption of the above mentioned new operational approaches and innovative clinical trials.
The pandemic has driven improved collaboration among clinical trial stakeholders, leading to faster approval of protocols by institutional review boards and regulators and even to faster regulatory approvals (e.g. for vaccines), by simplifying and optimizing processes to facilitate innovative research.
Pharmaceutical companies, ideally with the support of medical societies, investigators, clinical research organizations, payers, providers and patients, should consider working with political, administrative and health authorities to build on the positive impacts of COVID-19 on oncology clinical trials.