In December 2020, the American Society of Clinical Oncology (ASCO) published the Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. The report created a roadmap for how to apply the lessons learned during the COVID-19 pandemic to create positive change in cancer care delivery and research. The effort was guided by the ASCO Steering Group on Cancer Care Delivery and Research in a Post-Pandemic Environment, which is comprised of two multidisciplinary tasks forces: the Cancer Care Delivery Task Force and the Research Task Force. The Road to Recovery Report makes specific recommendations for maintaining the adaptations made necessary to accommodate the disruptions caused by the pandemic. Where possible, the report recommends building on that momentum to spur much-needed change in cancer care and research.
The report’s recommendations for clinical research focus on five goals that aim to support the drive toward a “more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality.” These goals aim to:
Ensure clinical research is accessible, affordable, and equitable
Design more pragmatic and efficient clinical trials
Minimize administrative and regulatory burdens on research sites
Recruit, retain, and support a well-trained clinical research workforce
Promote appropriate oversight and review of clinical trial conduct and results.
Table 1 of the report provides more detail on each goal, along with action steps for achieving them.
In March 2020, the U.S. Food and Drug Administration issued Emergency Guidance to enable clinical trials to continue within the constraints made necessary by COVID-19. These flexibilities enabled aspects of the clinical research enterprise to carry on while also keeping patients and research teams safe. The flexibilities included:
Enabling patient participation in research through telehealth visits
Allowing research-related care to take place at clinical sites in the community rather than at research center, and closer to patients’ homes
Increasing flexibility in protocol requirement
Permitting remote visits between research sites and sponsors and CROs
Allowing the use of electronic signatures and documentation.
Although ASCO and other organizations have long advocated for these changes, overcoming systemic resistance to changing established procedures and processes has been difficult. ASCO’s Road to Recovery report is a call to continue the momentum for change stimulated by COVID-19 beyond the pandemic. It advocates for retaining the process modifications that have served patients, providers, regulators, and sponsors well by addressing inefficiencies, access barriers, costliness, and disparities in cancer clinical research.
ASCO complemented the Road to Recovery with a research statement, Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments (FAs). The statement critiques current clinical research standards as “costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.” In brief, ASCO believes that the current FA process impedes timely access to studies and delays advancements in safe and effective novel therapies. To address this, ASCO recommends that all trial sponsors and contract research organizations implement a streamlined, uniform feasibility assessment process. To do so, ASCO proposes that the FA process be completed in one of three ways:
A short feasibility questionnaire and an in-person pre-study site visit
A long feasibility questionnaire only
An in-person pre-study site visit or a teleconference only.
ASCO’s additional recommendations to streamline the FA process include:
Establishing standard operation procedures at each organization
Maintaining a standardized site capabilities document at trial sites for sharing with sponsors and CROs
Designating a single point of contact
Completing the process remotely as much as possible.
For the feasibility questionnaire, ASCO recommends reducing redundancy and variation across sponsors and CROs and, where possible, standardizing the assessment questions to include:
Standardized feasibility assessment questions with common nomenclature, questions, and response options
Feasibility assessment questions focused on site capability to conduct the trial and specific protocol feasibility.
These FA recommendations reflect the work of an ASCO task force that was informed by feedback from multiple stakeholders, including trials sites, biotech-pharma sponsors, and CROs. “All stakeholders stand to benefit from implementing these recommendations to improve site FAs for clinical trials,” the report’s authors summarize. “Standardizing and centralizing the FA process will expedite trial start-up, allow sites to devote more time and attention to trial implementation, and enable more sites and patients to have access to high-quality oncology clinical trials.”
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