The Oncology <scp>QCARD</scp> Initiative: Fostering efficient evaluation of initial real‐world data proposals
Evaluation of studies including RWD requires understanding the data source, study design, and potential biases to preliminarily evaluate whether selected RWD are fit-for-use for the research question. The Oncology QCARD-IPC provides a structured, transparent approach to facilitate early review and enhanced communication between study sponsors and scientific reviewers of initial study proposals including RWD.
Authors
- Rebecca A. Hubbard (ORCID: https://orcid.org/0000-0003-0879-0994)
- Cristeen Okafor
- William A. Wood (ORCID: https://orcid.org/0000-0001-7439-2543)
- Monica M. Bertagnolli (ORCID: https://orcid.org/0000-0002-0248-3849)
- Joy C. Eckert
- Jennifer L. Lund (ORCID: https://orcid.org/0000-0002-1108-0689)
- Lawrence H. Kushi (ORCID: https://orcid.org/0000-0001-9136-1175)
- Shirley Wang (ORCID: https://orcid.org/0000-0001-7761-7090)
- Carla Rodriguez‐Watson (ORCID: https://orcid.org/0000-0003-4898-1613)
- Susan C. Winckler
- Paul G. Kluetz (ORCID: https://orcid.org/0000-0002-9796-4791)
- Donna R. Rivera (ORCID: https://orcid.org/0000-0002-4565-4556)
- Jennifer J. Lee (ORCID: https://orcid.org/0000-0002-4358-6393)
- Kanwal Ghauri
- Deborah Schrag (ORCID: https://orcid.org/0000-0002-4334-5717)
- Catherine C. Lerro
Institutions
- University of North Carolina at Chapel Hill (US)
- Brigham and Women's Hospital (US)
- United States Food and Drug Administration (US)
- Memorial Sloan Kettering Cancer Center (US)
- Kaiser Permanente (US)
- Harvard University (US)
- Alliance for Clinical Trials in Oncology (US)
- Reagan-Udall Foundation (US)
- Women's Hospital (US)
- University of Pennsylvania (US)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2024-10-27
- DOI
- https://doi.org/10.1002/pds.5818
- Citations
- 5
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 3.55
Funders
- U.S. Food and Drug Administration