Many authors (Bassi & Hwenda, 2020; Bauchner & Fontanarosa, 2020; Dean et al., 2020; Eichler et al., 2020; Gates, 2020; Glasziou, 2020; London & Kimmelman, 2020; Norrie, 2020) have emphasized the need for data-sharing, collaboration, and the use of core protocols in order to develop reliable evidence about benefits and harms of potential treatments for COVID-19 through randomized clinical trials (RCTs). Coordination across RCTs is crucial to ensure that evidence for the treatment and prevention of COVID-19 is adjudicated and disseminated as quickly and reliably as possible. In the absence of coordination, false positives from underpowered and uncoordinated collections of redundant trials could fuel the proliferation of ineffective and potentially dangerous treatments.
The COVID-19 Collaboration Platform (CovidCP; https://covidcp.org) is a joint venture initiated by researchers across North American institutions, leadership of NIH’s Trial Innovation Network and SMART IRB, and collaborators in Europe to facilitate global collaboration among COVID-19 RCTs. CovidCP is a repository for RCT protocols whose principal investigators are open to various levels of collaboration. Principal investigators who submit their draft or completed protocols are encouraged and, importantly, provided support to:
Initiate new multi-site trials;
Work with other research teams to create a collaborative protocol that can be used at multiple sites but as independent studies;
Admit new research sites under the existing trial and IRB;
Share anonymized interim and/or final data with other sites that choose to conduct a trial under a similar but not identical protocol; and
Collaborate on data collection tools, data standards, and case report forms.
In the US, the Trial Innovation Network and SMART IRB will prioritize and expedite requests to initiate multi-site studies received through this platform. Volunteer statisticians with expertise in adaptive and multi-site clinical trials will work with study- and domain-specific Data Monitoring Committees to ensure that any interim analyses meet standards for best statistical practice, ethics, and maximal informativeness outlined in Dean et al. (2020).
Organizing multi-site RCTs and, where that is not possible, combining data from separate but similar trials, will produce answers faster and more precisely than conducting each trial independently. We believe that every patient participating in an RCT has the right to have their data used as efficiently and meaningfully as possible, and CovidCP can help researchers make full use of data even from trials that are stopped early due to a change in standard of care or local epidemic waning, trials that are small and possibly underpowered, and single-arm trials.
We trust that CovidCP will help the clinical research community to share their work and knowledge in the service of developing all possible tools for fighting this pandemic. Furthermore, we hope that a cooperative platform such as CovidCP will remain in place for future global health emergencies.
Contributor Information
Elizabeth L. Ogburn, Department of Biostatistics, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA 21205
Barbara E. Bierer, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA 02115-6195
Ron Brookmeyer, Dean, UCLA Fielding School of Public Health, Professor, Biostatistics, University of California Los Angeles, Biostatistics, Los Angeles, CA, USA 90095
Christine Choirat, Swiss Data Science Center, INN Building, Station 14,1015, Lausanne, Switzerland
Natalie E. Dean, University of Florida, Department of Biostatistics, PO Box 117450, Gainesville, FL, USA 32611-7011
Victor De Gruttola, Harvard School of Public Health, Department of Biostatistics, 665 Huntington Ave., Boston, MA, USA 02115
Susan S. Ellenberg, Professor of Biostatistics and Interim Chair, Department of Biostatistics, Epidemiology and Informatics, Professor of Medical Ethics and Health Policy (secondary), Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Blockley 611, Philadelphia PA 19104
Elizabeth Halloran, Fred Hutchinson Cancer Research Center, Seattle, WA, USA 98109-9024
Daniel F. Hanley, Jr., Johns Hopkins Institute of Clinical and Translational Research, 750 E. Pratt Street, 16th Floor, Baltimore, MD 21202
Joseph K. Lee, Covid-19 Collaboration Platform, Boston, MA, USA 02118.
Rui Wang, Harvard Medical School and Harvard Pilgrim Health Care Institute, Population Medicine, 401 Park Drive, Boston, MA, USA 02215
Daniel O. Scharfstein, Johns Hopkins University Bloomberg School of Public Health, METRC Coordinating Center, 415 N. Washington Street, 3rd Floor, Baltimore, MD, USA 21205-2103
References
- Bassi LL, & Hwenda L (2020). COVID-19: time to plan for prompt universal access to diagnostics and treatments. The Lancet Global Health. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bauchner H, & Fontanarosa PB (2020). Randomized Clinical Trials and COVID-19: Managing Expectations. JAMA. [DOI] [PubMed] [Google Scholar]
- Brodwin E and Robbins R (2020, April 23). ‘It’s noisy’: Competing Covid-19 efforts could hamper progress, experts warn. Stat News. [Google Scholar]
- Christley RM (2010). Power and error: increased risk of false positive results in underpowered studies. The Open Epidemiology Journal, 3(1). [Google Scholar]
- Dean NE, Gsell PS, Brookmeyer R, Crawford FW, Donnelly CA, Ellenberg SS, … & Krause PR (2020). Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks. The New England Journal of Medicine, 382 (14), 1366. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Eichler H, Cavaleri M, Enzmann H, Scotti F, Sepodes B, Sweeney F, Vamvakas S, and Rasi G (2020). Clinical trials for Covid-19: can we better use the short window of opportunity? Clinical Pharmacology and Therapeutics. 10.1002/cpt.1891 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Gates B (2020). Responding to covid-19—a once-in-a-century pandemic. The New England Journal of Medicine. 10.1056/NEJMp2003762. [DOI] [PubMed] [Google Scholar]
- Glasziou P (2020). Waste in covid-19 research. The BMJ, 369:m1847. [DOI] [PubMed] [Google Scholar]
- London AJ and Kimmelman J (2020). Against pandemic research exceptionalism. Science, DOI: 10.1126/science.abc1731. [DOI] [PubMed] [Google Scholar]
- Norrie JD (2020). Remdesivir for COVID-19: challenges of underpowered studies. The Lancet. 395(10236), pp. 1525–1527. [DOI] [PMC free article] [PubMed] [Google Scholar]