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COVID-19 Collaboration Platform
 * Home
 * Rationale
 * How It Works
 * Partners
 * Protocols
 * Submit Protocol
 * FAQ


WE CAN FIND EFFECTIVE TREATMENTS FOR COVID-19 MUCH FASTER BY SHARING PROTOCOLS
FOR RANDOMIZED CLINICAL TRIALS. THIS PLATFORM IS A HOME FOR RCT PROTOCOLS THAT
ARE AVAILABLE FOR COLLABORATION.

CONTACT@COVIDCP.ORG


RATIONALE

> “In the context of public health emergencies... study teams should be
> encouraged to collaborate on existing, ongoing protocols rather than starting
> new, independent trials.”
> 
> Dean et. al, The New England Journal of Medicine, April 10, 2020. Read the
> full text.


In the U.S. only a few COVID-19 randomized clinical trials (RCTs) have been
centrally organized, e.g. by NIAID, PCORI and individual PIs. Over 400 such
trials have been registered on clinicaltrials.gov with dozens being added each
day. Many of them are designed to answer similar questions and combining data or
aggregating evidence could dramatically increase their efficiency and precision,
getting answers to doctors faster and more reliably. Many of the studies getting
off the ground right now are being run outside of the research environment by
hospitals in need of decision-making information for their doctors. Like these
studies, our primary goal is to get high-quality evidence to doctors quickly.

Furthermore, local outbreaks may taper off before institutions are able to
enroll their target sample size. Notably, this has happened in China, where many
trials are effectively suspended with incomplete enrollment and inconclusive
results. If the US response to COVID-19 proves successful, hospitals will be
lucky to find themselves in a similar position with a sudden drop off in COVID
cases that could affect enrollment. If protocols are public and open for
collaboration, an RCT can be picked up in different regions as the outbreak
moves across the country. Unfortunately, no platform currently exists for such
collaboration on RCTs.

CovidCP fills this gap by publicizing protocols whose PIs are open to various
levels of collaboration: joining forces with other research teams to create a
core protocol; admitting new sites under the existing PI and IRB; sharing
anonymized interim and/or final data through our partner Vivli with other sites
that choose to independently operate a trial under a similar protocol.


HOW IT WORKS


SUBMITTING A PROTOCOL

Protocols can be in draft form, enrolling, or completed. To ensure that the
authors receive credit, anyone using a protocol will be required to include a
citation in any resulting research products. Submissions will be vetted for
legitimate scientific value and well-defined interventions and outcomes. Submit
a protocol here.

USING A PROTOCOL

To request to collaborate on a protocol, click here. In doing so you agree to
appropriately cite the authors of the original protocol in any resulting
research products. Requests will be vetted for legitimate scientific value.

COLLABORATING ON A PROTOCOL

We strongly encourage collaboration. If a protocol is not yet enrolling subjects
at the time of submission, we encourage the submitting study team to accept
input from other interested research groups in order to create a collaborative
multi-site protocol. The Trial Innovation Network and SMART IRB will prioritize
and expedite requests to initiate multi-site studies that come to them through
this platform. If a protocol is currently enrolling, it may be possible for
interested research groups to join the existing study as a second or additional
site under the submitting PI and IRB of record. If that is not possible we
encourage interested research groups to match eligibility criteria, intervention
definitions, and a subset of the six core outcomes (presumed COVID-19 diagnosis,
hospitalization, ICU admission, supplemental oxygen use, mechanical ventilation,
death) as closely as possible. In all cases, we encourage all researchers to
make their data available for aggregated analyses and to make every attempt to
include or reference an analysis that combines evidence from all collaborating
studies in any resulting reports.

CITING A PROTOCOL

Cite protocols as [Authors] (2020). Protocol for [Study Name]. Retrieved from
covidcp.org.

AGGREGATED DATA ANALYSIS

Statisticians from top (bio)statistics departments will volunteer time to run or
advise on aggregated analyses, including working with study-specific Data
Monitoring Committees to ensure that any interim analyses are grounded in best
statistical practice, ethical, and maximally informative. Resources to anonymize
and house interim and final data provided free of charge by Vivli.


For help, email us.


PARTNERS

PARTNERING INSTITUTIONS

 * Drexel University Dornsife School of Public Health
 * Duke Clinical and Translational Science Institute
 * Geisinger Health System
 * Harvard Data Science Institute
 * Harvard Pilgrim Health Care Institute
 * International Forum for Acute Care Trialists (INFACT)
 * Johns Hopkins Institute for Clinical and Translational Research
 * McGill Department of Epidemiology, Biostatistics and Occupational Health
 * Michigan Institute for Clinical Health Research
 * MRCT Center of Brigham and Women’s Hospital and Harvard
 * Swiss Data Science Center
 * Society for Clinical Trials
   
 * UNC Translational and Clinical Sciences Institute
 * University of Utah
 * Vivli Center for Global Clinical Research Data

EXECUTIVE COMMITTEE

 * Barbara Bierer, Harvard Medical School
 * Betsy Ogburn, Johns Hopkins University
 * Dan Scharfstein, Johns Hopkins University

WITH HELP FROM

 * WEB DEVELOPMENT

 * Noam Finkelstein
 * Adi Gherman
 * Courtney Gibbons
 * Jacob Hodes
 * Ryan Turner
 * Michael Weiss
   
   

 * OPERATIONS

 * Joseph Lee

ADVISORY BOARD

 * Nicole Basta, McGill
 * Ron Brookmeyer, UCLA
 * J. Brian Byrd, University of Michigan
 * Christine Choirat, Swiss Data Science Center
 * Elizabeth Colantuoni, Johns Hopkins University
 * Mercè Crosas, Harvard University
 * Mike Dean, University of Utah
 * Natalie Dean, University of Florida
 * David DeMets, University of Wisconsin
 * Francesca Dominici, Harvard University
 * Victor De Gruttola, Harvard University
 * Susan Ellenberg, University of Pennsylvania
 * Kenneth Getz, Tufts University
 * Steve Goodman, Stanford University
 * Betz Halloran, University of Washington
 * Dan Hanley, Johns Hopkins University
 * Frank Harrell, Vanderbilt University
 * Adrian Hernandez, Duke University
 * Jacob Hodes, Relevant Healthcare
 * Jeff Leek, Johns Hopkins University
 * John Marshall, University of Toronto
 * Leslie McClure, Drexel University
 * Lee Nadler, Harvard University
 * Megan Singleton, Johns Hopkins University
 * Alex Volfovsky, Duke University
 * Rui Wang, Harvard Pilgrim Health Care Institute
 * David Williams, University of Michigan
 * Scott Zeger, Johns Hopkins University


DISCLAIMER


None of the individuals or organizations affiliated with or contributing
material to this Site, nor any of their units, programs, employees, agents, or
individual trustees, shall be liable for any improper or incorrect use of
information obtained through the use of this Site.

Copyright 2020 COVID-19 Collaboration Platform. Contact us