DHHSSTRIVE: A Global Clinical Trial Infrastructure for Current and Emerging Infectious Disease Threats
In 2022, leveraging the successful partnerships created through the ACTIV clinical trial platforms during the COVID-19 pandemic, the STRIVE network (Strategies and Treatments for Respiratory Infections and Viral Emergencies) was established to meet the need for a sustainable highly trained global clinical trial network prepared to conduct rigorous clinical trials evaluating therapies for pathogens able to cause infectious emergencies.
STRIVE brings together a highly experienced investigator network built on 30 years of sustained global clinical research (originally in HIV and influenza, including the START and SMART trials, and more recently in COVID-19) and is comprised of blended teams and entities with a truly global footprint. Bringing together nine international coordinating centers (ICCs) across six continents, 40 countries, and over 300 clinical trial sites, the network has been adamant about incorporating deep involvement from low- and middle-income countries to address a critical gap in the global trial eco-system. STRIVE operates through a highly experienced statistical data and management center housed at University of Minnesota, USA, and utilizes pathways for engaging industry partners through a public-private partnership model in association with the Foundation for the National Institutes of Health (FNIH).
STRIVE was developed to respond rapidly and effectively to emerging infectious disease threats. It is capable of designing, implementing, and delivering high quality clinical research, from observational studies through randomised trials of novel investigational or re-purposed agents, as well as through strategies using established interventions across a diverse global consortium.
To date, STRIVE has implemented a master protocol in COVID-19 evaluating in Trial 1 a novel protease inhibitor and in Trial 2 an immune modulator strategy, and is currently adapting an observational respiratory virus protocol to respond to future emerging challenges, as well as actively evaluating possible future interventional studies. STRIVE aims to establish a warm-base research network which can maintain activity and build capacity during peace time, whilst being capable of rapidly flexing to an emergency protocol(s) in times of emerging infectious threats. To this end, STRIVE has recently established an Emergency Response Continency Plan to provide the framework for rapid enablement of clinical trials in response to such an occasion.
STRIVE holds annual retreats, allowing committee members to maintain in-person relationships and to develop and review protocols and evaluate the network’s performance. Gathering together allows attendees to build relationships and collaborations from across the globe, as well as ensure that the available potential of the network is harnessed.
STRIVE’s Executive Committee is committed to promoting diversity, equity, and inclusion internally by selecting diverse committee members, as well as externally by engaging with and including diverse populations in their site staff, participants, and clinical research. STRIVE aims to collaborate with diverse stakeholders, organizations, and communities to ensure STRIVE research has a transformative impact on care.
“Promoting equity in clinical trial capability and access is a key cornerstone of the STRIVE vision,” says Professor Gail Matthews, Chair of the STRIVE Executive Committee. “Only by strengthening the global clinical eco-system internationally and committing to the highest standards in trial design and implementation can we bring the best outcomes to our diverse populations.”
STRIVE Global Clinical Trials Network
The map below contains all countries participating in STRIVE networks, although not all are actively enrolling in STRIVE studies at any one time. The nine international coordinating centers (ICCs) have been pin-pointed via arrows.
