Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) Initiative

Background

The 21st Century Cures Act highlights the opportunity to modernize trial design and expand evidence generation, including the use of real-world data for potential regulatory purposes. Use of RWD is increasing in regulatory submissions, with the majority supporting oncology indications.

Purpose

The Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) initiative was designed to facilitate effective communication between Sponsors and FDA Oncology reviewers to improve review efficiency for early RWD study proposals. The QCARD initiative was a collaboration between the OCE and the Reagan-Udall Foundation to evaluate essential data elements that could provide a basis for characterizing the data source(s) and design of a RWD study. Importantly, the Oncology QCARD is intended to improve the quality of initial study proposals and is not an evaluation of the quality of real-world data submitted within a regulatory review.

The Oncology QCARD initiative created a set of key design and data source elements that helped to inform information requests from oncology review teams to facilitate meaningful feedback on proposed RWD studies. FDA is making the common data elements from those information requests available for sponsor awareness in Figure 1. Sponsors should follow recommendations consistent with published FDA RWE guidance and scientific best practices throughout protocol development. Formal protocol and statistical analysis plans should be finalized and submitted to FDA prior to study initiation and conduct of any analyses.

When submitting early proposals that contain RWD for review in oncology, sponsors should include sufficient information to support study characterization. Considering the inclusion of commonly requested data elements reflected in Figure 1 may be helpful. While an initial foundation, the elements in Figure 1 are  non- exhaustive as there may be additional important design or data source information not listed or elements listed that may not be relevant to the particular study proposal. Please include any relevant references where appropriate. If you are planning to submit an early proposal containing RWD for review in oncology, please contact the appropriate review division to discuss your specific drug development program.
 

Figure 1:

Common Data Elements for Early Proposals of Oncology Studies Using RWD

Overall Study and RWD Source Information	Study Design Parameters	Statistical Plan	Data
Study Sponsor Real World Data Source Provider  Data Analyst(s)  Regulatory history of RWD proposal Study Status (Planned, Ongoing) Regulatory or Related Purpose(s)  Study Question(s)/ Objective(s) RWD Source(s) Including any Linked Data  Care Setting (as applicable) Brief RWD Source Description Rationale for RWD Source Selection	Data Temporality • Complete Original Source Data Years Available • Study Period • Data of Data Extraction (Analytic Dataset)  • Initial Design Diagram (Graphical depiction of study design) Population • Disease or Condition for Intended Use • Indication Statement • Relevant Biomarkers  • Study Eligibility Criteria • Expected Study Sample Size • External Validity: Representativeness of the source data to the intended use population (as applicable). Exposure • Type of Medical Product Exposure • Medical Product Exposure of Interest • Description of Exposure Ascertainment Method • Index Date Definition for Exposure Group Comparator • Comparator(s) of Interest • Description of the Comparator Ascertainment Method • Index Date  • Definition for Comparator Group Endpoints • Primary Clinical Endpoint(s) Definition • Secondary Clinical Endpoint(s) Definition Key Covariates • Include any key covariates	Brief summary of the planned main statistical analyses of the primary endpoint(s)	• Source Data Availability and Auditing Plan • Data Provenance Documentation Plan  • Data Quality Plan • Missing Data

Questions

Please contact OCERWE@fda.hhs.gov for any questions on Oncology QCARD or Oncology RWD regulatory questions.

Further Information

• Oncology Real World Evidence Program
• FDA Voices: Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative