Modernizing Clinical Trials

Clinical Trials and Translational Research Committee (CTAC) Ad Hoc Working Groups

NCI CTAC Working Groups report on strategies for achieving NCI’s strategic vision for its clinical trials system for 2030 and beyond.

2019 CTAC Strategic Planning Working Group (SPWG) 

In October 2019, the NCI CTAC established the SPWG to assess NCI’s strategic vision for its clinical trials system for 2030 and beyond and make recommendations to achieve that vision.

The SPWG articulated a bold vision for flexible, faster, simpler, less expensive, and high-impact trials that seamlessly integrate with clinical practice. They emphasized modernizing clinical trials through:

• Streamlining processes for clinical trial design and execution
• Focusing on essential endpoints
• Decreasing regulatory hurdles
• Broadening trial access
• Increasing efficiency of data collection

2022 CTAC Streamlining Clinical Trials Working Group (SCTWG)

In July 2022, NCI convened the SCTWG to advise on the implementation of the SPWG recommendations related to data collection and electronic health records. The SCTWG recommended ways to limit trial data collection in late phase trials to data elements essential for the primary and secondary objectives of the trial. A set of standard practices was developed for data collected in NCI phase 3 and phase 2/3 Investigational New Drug-exempt treatment trials. These standard practices are anticipated to reduce the operational burden of participating in NCI National Clinical Trials Network trials, which is critical to sustaining a publicly supported late-phase cancer clinical trial enterprise.

While the initial focus of the standard practices for data collection is on IND-exempt trials (Prindiville, 2025), many of the principles could be extended, in certain clinical and regulatory contexts, to studies being conducted under an IND. 

Implementing Criteria to Expand Clinical Trial Eligibility

NCI is working to implement criteria to expand clinical trial eligibility; maximizing opportunities for diverse populations to participate in trials is a priority for NCI. Eligibility criteria must be as broad as safely possible to achieve diverse and representative populations in future clinical trials.

Centralized Coordination and Standardization of Electronic Health Record (EHR) Pilot

EHR treatment plans are essential components of NCI-supported clinical trials, but their configuration is complex, inefficient, and can be a barrier to trial activation and participation. NCI is working to standardize and improve the implementation of EHRs in clinical trials.

NCI Virtual Clinical Trials Office (VCTO) Pilot Program

The VCTO Pilot Program is designed to address the trend of decreased patient participation in NCI-sponsored clinical trials by supporting clinical sites that were experiencing workload challenges. The goal of the program is to develop best practices for implementing clinical trials and improving patient recruitment and retention to ultimately expand patient access to innovative cancer therapies and advance cancer treatment outcomes.

Pragmatica-Lung Cancer Treatment Trial

Pragmatica-Lung was a phase 3 clinical trial for people with non-small cell lung cancer that had spread beyond the lungs (stage 4 cancer). The goal of this simplified trial was to be less burdensome to patients and investigators and serve as a model for future cancer clinical trials. The trial enrolled more than 800 patients in just 21 months.

Clinical Trials Innovation Unit (CTIU)

The CTIU was launched in February 2023 to advance innovative science, trial designs, and operational efficiencies for high-priority clinical research needs. The CTIU was created in recognition of the need to accelerate clinical testing of new cancer prevention, diagnostic, treatment, and survivorship approaches.