Quantifying the impact of the COVID-19 pandemic on cancer center clinical trial operations.

Background: Oncology clinical trials are complex, and the COVID-19 pandemic caused major disruptions in 2020.

Methods: Using its networking and sharing of best practices, the Association of American Cancer Institutes, comprising 105 cancer centers, solicited a longitudinal series of voluntary surveys from members to assess how clinical trial office operations were affected. The surveys showed that centers were able to keep oncology trials available to patients while maintaining safety.

Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement.

Purpose: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.

Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers.

Purpose: Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation.

A Comprehensive Program for the Enhancement of Accrual to Clinical Trials.

Background: The Ohio State University Comprehensive Cancer Center (OSUCCC) embarked on a single institution campaign over 2 years to enhance the enrollment of cancer patients into therapeutic clinical trials. The goal of this campaign was to achieve a 40 % increase in accrual over a 2-year period.

Methods: The entire process of accruing patients to clinical trials at the OSUCCC was carefully evaluated and broken down into several interlocking components.