NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
Health agencies, leading pharmaceutical companies to join forces to accelerate pandemic response.
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- Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation by:
- Establishing a centralized process and repository for harmonizing and sharing methods and evaluating models
- Extending access to high-throughput screening facilities, especially in biosafety level-3 laboratories, with a goal of testing all compounds that have been in human clinical trials to identify the potential to apply these compounds to COVID-19
- Increasing access to validated animal models
- Enhancing comparison of approaches to identify informative assays
- Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential by:
- Establishing a steering committee with relevant expertise and objectivity to set criteria for and rank potential candidates submitted by industry partners for first wave and subsequent evaluation
- Developing a complete inventory of potential candidates with different mechanisms of action and acceptable safety profiles
- Designing, launching and openly sharing master protocols with agreed upon endpoints, sampling and analysis for evaluating candidates
- Using a single control arm to enhance trial efficiency
- Maximize clinical trial capacity and effectiveness by:
- Connecting existing networks of clinical trials to build capacity and capabilities, including specialization in different populations and disease stages
- Leveraging infrastructure and expertise from across NIH networks, including:
- Adjuvant Discovery and Adjuvant Development Programs
- AIDS Clinical Trials Network
- Clinical and Translational Science Awards Program
- Clinical Trials in Organ Transplantation
- Cooperative Centers on Human Immunology
- HIV Prevention Trials Network
- HIV Vaccine Trials Network
- Human Immunology Project Consortium
- International Network for Strategic Initiatives for Global HIV Trials (INSIGHT) Network
- National Cancer Institute Community Oncology Research Program
- National Cancer Institute?s National Clinical Trial Network
- Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network
- Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN)
- T and B Cell Discovery Programs and Immune Epitope Database
- Vaccine Treatment and Evaluation Units
- Establishing a coordination mechanism across networks to expedite trials, track incidence across sites and project future capacity
- Advance vaccine development by:
- Creating a collaborative framework to share insights into natural immunity and vaccine candidate-induced immune response by:
- Mapping epitopes and developing assays
- Establishing protocols for sampling and immunological analyses and reagents
- Collecting clinical data on immunological responses and endpoints, to enable meta-analysis of correlates of protection
- Engaging with regulators on surrogate endpoints for clinical evaluation
- Creating a collaborative framework to share insights into natural immunity and vaccine candidate-induced immune response by: