Lead Investigator: David Carter, MMS Holdings
Title of Proposal Research: International COVID-19 Data Alliance COVID-19 Workbench
Vivli Data Request: 7277
Funding Source: Mastercard and Microsoft AI for Health
Potential Conflicts of Interest: None
Summary of the Proposed Research:
ICODA Vision and Overview
Data sharing is critically important for all stakeholders involved in Covid-19 research. Researchers gain visibility, valuable insights, funding, and networking opportunities. For research teams, data sharing is necessary for access to sources, increased efficiency and cost-effectiveness. Funders benefit as it allows funding decisions to be based on complete data, increase the impact of their funds, and provide accountability. With regard to the general public and patients, open data sharing provides transparency for trust generation and answers questions they may have. Data Sharing for Policy Makers is crucial to inform decision making; allowing them to act on the most complete data and providing enhanced accountability.
The International Covid-19 Data Alliance (ICODA), convened by Health Data Research UK (HDR UK), exists to enable, and accelerate responsible research related to SARS-CoV-2. ICODA centers around a novel research tool known as the COVID-19 Workbench. The Workbench unites a combination of tools and processes and can connect to regional or national data infrastructures used by ICODA members. The trusted research platform that consolidates data and metadata from federated repositories to allow teams to work collectively on a focused research question.
ICODA created the ‘COVID-19 Workbench’ to counteract the current “infodemic” of viral disinformation around clinical research data on SARS-CoV-2. Eliminating commercialization from the process and developing integrity are crucial aspects of the ICODA ecosystem.
Driver Project 1
The value of ICODA ‘COVID-19 Workbench’ will be demonstrated through use cases informed by research questions that will guide the initial Driver Projects. Based on a survey administered by ICODA, researchers, policy makers and other stakeholders were most interested in research questions related to the safety and efficacy of treatments for COVID-19.
Driver Project 1 aims to harness data from randomized controlled trials (RCTs) and the graduated arms of platform trials to provide a holistic evaluation of the efficacy and safety of treatments of COVID-19. More specifically, ICODA is targeting enriched summary level data from the most rigorous of these trials across industry, academia and government for inclusion in the COVID-19 Workbench. Enriched summary level data is not as entangled with privacy concerns, are readily useable, and can be of value to many research questions. To maximize the value of this summary level data in research, ICODA together with its collaborators, developed a data dictionary to harmonize variable definitions and subgroup classifications from all trials. This allows side-by-side comparison of the data from these trials making the data readily useable to interpret findings about COVID-19 trials. Researchers can also view data from individual trials in the context of other available trials thus expanding their insights. ICODA’s visual analytics and meta-analyses tools further enhance the researchers’ ability to work quickly.
To help facilitate the harmonization and standardization of summary level data, ICODA has partnered with MMS holdings. MMS is a data-focused clinical research organization (CRO) which has supported data and submission from many of the world’s leading pharmaceutical, biotech, and medical device companies. MMS can help reduce the burden on the contributing data center by taking on the task of creating summary-level data sets and ensuring that the data conforms to the ICODA Data Dictionary. MMS will be responsible for aggregating the data to ICODA’s enriched summary standard, and the subsequent transfer the enriched summary data, that is the Analysis Results, to the ICODA workbench.
Aggregating this level of summary data and making it accessible in the Workbench to accredited researchers with approved proposals means that important assets will be widely available to the community of researchers, allowing them to more readily interpret findings about COVID-19 trials. Researchers can also view this data in the context of other available evidence, thus expanding their insights.
MMS is targeting the following trials from Roche and Genentech, Inc. through Vivli, on behalf of ICODA, for inclusion into the Workbench:
➢ A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Severe COVID-19 Pneumonia (COVACTA) – NCT04320615
➢ Data Sets A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (EMPACTA) – NCT04372186
Statistical Analysis Plan:
We aim to produce an enriched summary data using our standardized data dictionary (data dictionary). Our analysis is descriptive in nature. The result of the analysis will be uploaded in the ICODA workbench to be used by health researchers from all over the world.
The enriched summary data will include the following (if available):
- Baseline Variables
- Age, sex, race, ethnicity, comorbidities at trial entry, meds at entry, and COVID -19 disease severity
- Efficacy endpoints – Number of patients and/or time to and/or duration:
- 8-point scale
- NEWS and NEWS2 score
- Improvement based on 8- point scale and NEWS and NEWS2 Score
- Mechanical ventilation
- Oxygen use
- Non-invasive Ventilation/High-Flow Oxygen Use
- Mechanical Ventilation/ECMO
- Hospitalization
- Fever
- Viral clearance
- CRP
- D-dimer
- Serum ferritin
- Discharge/Ready for Discharge
- Safety Endpoints – Number of patients with:
- AEs overall
- AEs by category including cardiac, gastrointestinal, infections, metabolism, renal and respirator
- CTC Grade 4 AEs
- SAEs
- Safety Endpoints – Time to:
- CTC Grade 4 AEs
- Death
- Exposure and Retention
- Number of patients remaining in the trial
- Number of patients remaining on study drug
Requested Studies:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04372186
Sponsor ID: ML42528
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04320615
Sponsor ID: WA42380
Summary of Results:
This project standardized summary results from the COVACTA and EMPACTA clinical trials and uploaded them to an Aridhia workspace, which was governed by the International Covid-19 Data Alliance (ICODA). The ICODA team aggregated that data with other trial data and added it to the ICODA workbench, to which accredited researchers were given access.