Systematic data capture reduces the need for source data verification: exploratory analysis from a phase 2 multicenter randomized controlled platform trial
Extensive SDV does not change any results or conclusions of the I-SPY COVID trial, which was designed with a systematic strategy for data capture, monitoring, and safety. This strategy could improve the efficiency of clinical trials and eliminate the need for manual SDV.
Authors
- Christian Sandrock
- Alexis Serra (ORCID: https://orcid.org/0000-0001-7366-1350)
- Abhishek Methukupally
- John Schicchi
- Alejandra Jáuregui (ORCID: https://orcid.org/0000-0001-9158-2007)
- Sara C. Auld (ORCID: https://orcid.org/0000-0002-8972-3736)
- Ivan Garcia (ORCID: https://orcid.org/0009-0003-6508-2115)
- Robert C. Hyzy (ORCID: https://orcid.org/0000-0003-1890-4932)
- D. Clark Files (ORCID: https://orcid.org/0000-0002-1595-4080)
- Romina Wahab
- Christopher Jordan (ORCID: https://orcid.org/0009-0002-1987-2047)
- Siddharth Patel (ORCID: https://orcid.org/0000-0002-9543-3233)
- Richard A. Lee
- Siddharth Nair
- Amy Dzierba (ORCID: https://orcid.org/0000-0002-1527-6830)
- Ali Zarrinpar (ORCID: https://orcid.org/0000-0002-6812-1816)
- Angela Haczku (ORCID: https://orcid.org/0000-0002-1301-4941)
- C.A.G. Ittner
- Imogene Dunn
- Adam L. Asare (ORCID: https://orcid.org/0000-0002-9299-3518)
- Anita Darmanian
- G. R. Scott Budinger (ORCID: https://orcid.org/0000-0002-3114-5208)
- Michael J. Bernstein (ORCID: https://orcid.org/0000-0001-7980-0489)
- Jessica García Suárez (ORCID: https://orcid.org/0000-0003-0287-2809)
- Joseph L. Nates (ORCID: https://orcid.org/0000-0002-3190-3670)
- Sheetal Gandotra (ORCID: https://orcid.org/0000-0002-5475-9704)
- Lamorna Brown Swigart (ORCID: https://orcid.org/0000-0003-2076-5177)
- Benjamin David Singer (ORCID: https://orcid.org/0000-0001-5775-8427)
- Mark M. Wurfel
- S. B. Samavedam
- Mary LaRose
- Philip A. Robinson (ORCID: https://orcid.org/0000-0002-0577-3147)
- A.M. Hamed (ORCID: https://orcid.org/0000-0002-8428-1385)
- Fady Youssef (ORCID: https://orcid.org/0000-0001-6123-970X)
- Maged Tanios (ORCID: https://orcid.org/0000-0002-4103-6099)
- Jeremy R. Beitler (ORCID: https://orcid.org/0000-0003-0797-2374)
- Ali B. Abbasi (ORCID: https://orcid.org/0000-0002-1039-2832)
- Richart W. Harper (ORCID: https://orcid.org/0000-0001-8097-6465)
- Farjad Sarafian
- Neil R. Aggarwal (ORCID: https://orcid.org/0000-0002-0922-8824)
- Kashif Khan
- Richard G. Wunderink (ORCID: https://orcid.org/0000-0002-8527-4195)
- Kevin W. Gibbs (ORCID: https://orcid.org/0000-0002-5272-2289)
- Nuala J. Meyer (ORCID: https://orcid.org/0000-0003-4597-5584)
- Rajiv Sonti (ORCID: https://orcid.org/0000-0002-3564-6720)
- Gavin Harris (ORCID: https://orcid.org/0009-0007-6988-1204)
- Albert F. Yen
- Kristine Nelson
- Christina Creel-Bulos (ORCID: https://orcid.org/0000-0003-1984-4150)
- Trung Dong Huynh (ORCID: https://orcid.org/0000-0003-4937-2473)
- Adina Wynn (ORCID: https://orcid.org/0000-0002-7256-5815)
- Michael A. Matthay (ORCID: https://orcid.org/0000-0003-3039-8155)
- Max W. Adelman (ORCID: https://orcid.org/0000-0002-9277-6046)
- Noha Lim (ORCID: https://orcid.org/0000-0001-8330-4701)
- Joshua F. Detelich (ORCID: https://orcid.org/0000-0002-8585-0594)
- Timothy E. Albertson (ORCID: https://orcid.org/0000-0001-5724-3300)
- Nilam S. Mangalmurti (ORCID: https://orcid.org/0000-0002-9146-1608)
- Lindsie Boerger (ORCID: https://orcid.org/0000-0001-7150-7157)
- Ruixiao Lu (ORCID: https://orcid.org/0000-0003-1330-1972)
- Caroline M. Quill
- Alejandro Botello Barragan
- Justin Muir (ORCID: https://orcid.org/0000-0002-8444-5028)
- Philip Yang (ORCID: https://orcid.org/0000-0001-5142-1137)
- Carolyn S. Calfee (ORCID: https://orcid.org/0000-0001-9208-6865)
- Purnema Madahar (ORCID: https://orcid.org/0000-0002-1417-2060)
- Derek W. Russell (ORCID: https://orcid.org/0000-0002-2716-1344)
- Brian Morrissey (ORCID: https://orcid.org/0000-0002-0137-7817)
- Ana Monteiro (ORCID: https://orcid.org/0000-0002-7839-2556)
- Ellen Lyda Burnham (ORCID: https://orcid.org/0000-0002-9945-0284)
- John Kazianis
- Thomas R. Martin (ORCID: https://orcid.org/0000-0002-8193-909X)
- Emilio Mazza
- Leigha Landreth
- Alexis Suarez (ORCID: https://orcid.org/0000-0001-9759-8720)
- Laura J. Esserman (ORCID: https://orcid.org/0000-0001-9202-4568)
- Martin Eklund (ORCID: https://orcid.org/0000-0001-5032-5266)
- Joseph E. Levitt (ORCID: https://orcid.org/0000-0001-5316-4971)
- Erin Hardy
- Helen K. Donnelly (ORCID: https://orcid.org/0000-0001-8827-8581)
- Scott A. Fields (ORCID: https://orcid.org/0000-0002-6218-5579)
- Katarzyna Gosek (ORCID: https://orcid.org/0000-0003-2549-6615)
- Paul Berger
- James Hurst‐Hopf
- Eliot Friedman
- Amanda Rosen (ORCID: https://orcid.org/0000-0002-2358-3128)
- J.W. Awori Hayanga (ORCID: https://orcid.org/0000-0001-5091-7069)
- Daniel H. Kett
- Nathan Cobb (ORCID: https://orcid.org/0000-0003-4210-226X)
- Kenneth E. Remy (ORCID: https://orcid.org/0000-0001-5222-9884)
- Santhi Kumar (ORCID: https://orcid.org/0000-0003-0981-4222)
- Timothy Obermiller
- Christina Spainhour
- Aaron Mittel (ORCID: https://orcid.org/0000-0003-0852-9876)
- Jonathan L. Koff (ORCID: https://orcid.org/0000-0003-3240-3173)
- Katherine L. Nugent
- Jeff McKeehan
- Ari Moskowitz (ORCID: https://orcid.org/0000-0002-0194-990X)
- Alessio Crippa (ORCID: https://orcid.org/0000-0002-2254-2420)
- John P. Reilly (ORCID: https://orcid.org/0000-0003-3937-5320)
- Paul T. Henderson (ORCID: https://orcid.org/0000-0003-4238-0446)
- Catherine Nguyen
- K. Wei (ORCID: https://orcid.org/0009-0008-0661-0180)
- Praveen Vijhani
- Andrea Discacciati
- Lisa Parks
- Carrie Higgins
- Donna Harris
- Se Fum Wong
- Karl W. Thomas
- Usman Shah
- Melissa H. Coleman
- Brian M. Daniel
- Adrienne M. Casciato
- Vaney Capetillo
- Anna Rodriguez-Vasquez
- Karla Leon Escalona
- Kristin Broderick
- Fady Yousef
- Daniel Belvins
Institutions
- Northwestern University (US)
- University of Southern California (US)
- West Virginia University (US)
- University of Maryland, Baltimore (US)
- University of Colorado Hospital (US)
- Sanford Health (US)
- Hoag Memorial Hospital Presbyterian (US)
- Main Line Health (US)
- University of Maryland Medical Center (US)
- Montefiore Medical Center (US)
- Kaiser Permanente (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of Miami (US)
- Emory University (US)
- University of California, Los Angeles (US)
- University of California, San Francisco (US)
- Georgetown University (US)
- University of Washington (US)
- University of California, Irvine (US)
- University of Michigan (US)
- Kalispell Regional Medical Center (US)
- MemorialCare Long Beach Medical Center (US)
- Our Lady of Lourdes Medical Center (US)
- Stamford Hospital (US)
- West Virginia University Hospitals (US)
- University of California System (US)
- Karolinska Institutet (SE)
- University of Alabama at Birmingham (US)
- Yale University (US)
- University of Florida (US)
- Los Angeles Medical Center (US)
- Mercy Hospital Springfield (US)
- Doctors Hospital at Renaissance (US)
- Quantum Leap Healthcare Collaborative (US)
- Long Beach Medical Center (US)
- Michigan Medicine (US)
- University of Minnesota Rochester (US)
- Irvine University (US)
- Pulmonary and Critical Care Associates (US)
- Wake Forest University (US)
- University of Colorado Anschutz Medical Campus (US)
- Columbia University (US)
- University of Pennsylvania (US)
- University of California, Davis (US)
- University of Colorado Denver (US)
- Stanford University (US)
Publication Details
- Journal
- Communications Medicine
- Published
- 2025-10-29
- DOI
- https://doi.org/10.1038/s43856-025-01126-9
- Primary Topic
- Meta-analysis and systematic reviews
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- U.S. Department of Health and Human Services
- Amgen
- Pfizer
- George Mason University
- National Institutes of Health
- Defense Threat Reduction Agency
- Genentech
- Allergan
- Biomedical Advanced Research and Development Authority