Industry needs to get better at trial site assessment according to American Society of Clinical Oncology (ASCO), which says there is an urgent need to make the process more efficient.
ASCO outlined its concerns in a recent paper, arguing that current sponsor and CRO site feasibility assessment (FA) methods are too expensive, time consuming and a barrier to participation in cancer studies.
The authors wrote, “There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.”
Typically, FAs require potential trial sites to complete a comprehensive and lengthy feasibility questionnaire (FQ), in addition to the sponsor/CRO conducting an in-person pre-study site visit (PSSV), prior to selecting the site for the trial.
ASCO quizzed sponsors and CRO about FA processes and reported that those who participated “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 enrolment and affects the capacity for sites to participate in clinical trials, particularly smaller research programs with limited resources and infrastructure.”
Solutions
To address these problems, ASCO has developed a series of recommendations for CROs and sponsors and potential trial sites.
The authors suggested CROs and sponsors should do things like provide the potential site with detailed protocol information, ensure communications are efficient, effective and focused and minimize data collection using technology.
They also backed the development of a “universally accessible and accepted database and portal to centralize FAs, improve efficiencies, and expedite clinical trial start-up.”
The ASCO team said, “The database should be centralized and accessible to all sites, trial sponsors, and CROs.
“It should be a web-based portal that has the ability to enter and integrate data and interact with clinical trial management software to remove the need for sites to purchase additional software.”
“Site-specific data should be entered initially and kept current. The database and portal should be consistently referenced by sponsors and CROs and used to facilitate communications,” the authors said.
Advantages
The ASCO taskforce wrote that, “All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials.
“To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.”
Image: iStock/XtockImages