Pandemic preparedness and response: Adaptive platform trials for pandemic preparedness.
(HORIZON-HLTH-2024-DISEASE-03-11-two-stage)
Deadline model: Two Stage
Opening date: 26 April 2023
Deadline date: 19 September 2023, 11 April 2024
Expected Outcome:
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:
- A diverse and comprehensive EU landscape of multi-country adaptive platform trials (i.e., able to study multiple interventions in a disease or condition in a perpetual manner, thus allowing modification to the trial after its initiation without undermining its validity and integrity) that assess vaccines and therapeutics for infectious diseases and have the capacity to pivot rapidly in the case of epidemic or pandemic health threats.
- Innovative and improved design of clinical studies, suited for pandemic preparedness, is available for the clinical research community, taking into account the high safety standards in the European regulatory environment.
- The scientific and clinical communities make effective use of state-of-the-art information, data, technologies, tools and best practices to develop interventions that are sustainable. Citizens, patients, prescribers, and payers receive more accurate information on available healthcare interventions via ad hoc communication platforms.
- Trial sites across multiple countries have the capacity to deliver robust clinical evidence in a diverse European population, using harmonized research methods, data collection and analysis.
Scope:
As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Health threats are expected to arise due to among others, climate change, and thus a need for proactive approaches to ensure timely availability of medical countermeasures during disease outbreaks is anticipated. The conduct of perpetual adaptive platform trials, with the in-built agility to pivot when an epidemic strikes, is key to be prepared for infectious disease epidemics or pandemics.
This topic aims to provide funding to adaptive clinical platform trials that may be implemented routinely outside of an epidemic or pandemic context, but that are designed to be ready for the timely assessment of novel diagnostics, therapeutics or vaccines in the face of an epidemic or pandemic.
APPLY HERE:
ONE HEALTH CONFERENCE:
https://health.ec.europa.eu/events/one-health-conference-one-health-all-all-one-health-2023-11-13_en
INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM: https://imdrf2023.com/public/berlin/home
EU4HEALTH STAKEHOLDERS’ CONFERENCE:
https://health.ec.europa.eu/events/eu4health-stakeholders-conference-2023-06-09_en