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Advancing Oncology Decentralized Trials

Modernizing Evidence Generation

Background 

In 2020, the US Food and Drug Administration issued guidance for trial investigators on clinical trial conduct for the duration of the COVID-19 public health emergency. This guidance clarified that, where appropriate, FDA regulations can accommodate the adoption of methods to facilitate trial decentralization through the remote collection of trial data outside of a standard in-person clinical trial site. These methods include patient-centric trial flexibilities such as electronic informed consent, virtual clinic visits, delivery of investigational product to the home and obtaining laboratory or imaging assessments locally. 

The FDA Oncology Center of Excellence (OCE) supports efforts to modernize clinical trials and evidence generation. COVID-19 provided a proof of concept for several decentralized trial modifications, and OCE is engaging with stakeholders to evaluate the benefits and challenges seen with decentralized trials in order to prioritize streamlined procedures to deploy in future prospectively designed cancer clinical trials

Why is This Important?

  • Decentralized Clinical Trials (DCT) hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population, a key goal for OCE programs including Project Equity and Project Silver. 
  • Evaluating the COVID-19 experience with remote assessments is important to develop best practices when deploying DCT modifications in future prospective DCT designs.

Ongoing Initiatives

The Clinical Trials Transformation Initiative (CTTI) Collaboration  

  • There is a lack of data as to which DCT modifications were used in registrational trials conducted during the COVID-19 pandemic that subsequently were submitted and led to FDA approval of a new oncology indication. 
  • FDA OCE has partnered with the Clinical Trials Transformation Initiative (CTTI) to conduct sponsor surveys to understand the prevalence of remote trial modifications for trials that provided evidence supporting the approval of supplemental or new drug or biologic applications for oncology indications. 

ASCO - Friends of Cancer Research Protocol Adherence and Fidelity Project

  • Currently there isn’t a quantitative or qualitative analysis of the impact of COVID-era protocol deviations on clinical trial data from multiple sponsors. 
  • Using a mixed methods approach (sponsor survey, interviews, and data meta-analysis), the project aims to describe and evaluate the impact of the COVID-19 pandemic on the types, frequency, and risk of protocol deviations documented in cancer treatment trials.
  • FDA’s OCE is providing oncology regulatory perspective as a member of this working group.

FDA Guidance Document

Select Publications

For Further Information

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