Feasibility assessments (FA) for clinical trials are conducted to establish that prospective trial sites can safely and effectively meet study goals and protocol requirements, however, a new research statement by the American Society of Clinical Oncology (ASCO) asserts that current standards are “costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.” These deficiencies ultimately result in fewer patients with timely access to clinical trials and delays in advancing novel safe and effective treatments.
The research statement, which was published today in JCO Oncology Practice, provides concrete recommendations to improve the effectiveness and efficiency of the FA process to ensure that more trial sites and patients can participate in oncology clinical trials. These recommendations also help address a goal established in ASCO’s Road to Recovery report to simplify, streamline, and standardize clinical trials.
The following recommendations were developed through an ASCO task force and incorporate feedback from stakeholders including trial sites, biotech-pharma sponsors, and contract research organizations (CROs). The recommendations were approved by ASCO’s Board of Directors.
Streamline and standardize the FA process –
During the typical FA process, sponsors and CROs assess the ability of a site to conduct clinical trials and implement specific trial protocols. The FA process typically includes completion of a comprehensive and lengthy site feasibility questionnaire (FQ) and an in-person pre-study site visit (PSSV) prior to selecting the site for a trial.
“Stakeholders who participated in this initiative described existing site feasibility methods as burdensome, inefficient, time-consuming, redundant, and resource intensive. They also reported that the process causes delays in time to enrollment and affects the capacity for sites to participate in clinical trials, particularly smaller research programs with limited resources and infrastructure,” the authors write.
ASCO recommends the implementation of a streamlined and uniform FA process for use by all trial sponsors and CROs. FAs should be conducted in one of the three ways: (1) a short FQ and a PSSV, (2) a long FQ only (no PSSV), or (3) a PSSV or teleconference only (no FQ).
All stakeholders identified benefits with the recommended process changes, including time savings, expedited start-up, reduction in personnel resources, and cost savings.
In addition to recommended process changes, the research statement also outlines best practices for sponsors, CROs, and trials sites to adopt to improve efficiencies throughout the FA process. For example, each organization should consider establishing standard operating procedures (SOPs), designating a single point of contact, and conducting as much of the process as possible remotely (as has been happening with many sponsors during the COVID-19 pandemic). Trial sites should also consider maintaining a standardized site capabilities document to share with sponsors and CROs.
Minimize and standardize FA questions –
Questions asked through FQs and PSSVs are often redundant and highly variable across sponsors and CROs. ASCO recommends sponsors and CROs standardize FA questions with common nomenclature, questions, and response options. FA questions should also be kept to the minimum necessary (i.e. need-to-know) and focus on two factors: (1) site capability to conduct clinical trials and (2) specific protocol feasibility.
Minimizing and standardizing FA questions would save sites a significant amount of time and effort and would help them respond with accurate and consistent information.
Leverage technology to centralize information exchange –
ASCO recommends all sites, trial sponsors, and CROs use a universally accessible and accepted database and portal to centralize FAs, improve efficiencies, and expedite clinical trial start-up. The database should be a web-based portal that can integrate as seamlessly as possible into clinical and research staff workflows.
The research statement acknowledges existing portals have limitations and/or are not widely used, and competition among sponsors, CROs, and vendors might make agreement on a single portal unlikely in the near future. In the absence of a portal, sites, sponsors, and CROs should use a universal and standardized site profile and capabilities form to more efficiently share information.
“All stakeholders stand to benefit from implementing these recommendations," the authors write. “To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.”
Read “Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement” for more details on ASCO’s recommendations.