Selected discussion topics |
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Regular trial- and country-specific information updates: new or closing study arms, changes in inclusion/exclusion criteria, results and upcoming publications, updates in local standard of care, and drug provision challenges |
Data sharing initiatives and options for the optimal sharing of data across trials and cohorts |
Drug repurposing efforts across Europe and beyond (multi-stakeholder, national and regional initiatives) |
Regional and international evidence synthesis initiatives for the development of guidelines |
Funding calls and programmes for further COVID-19 clinical research |
Opportunities for collaboration and areas of mutual interest with industry for early clinical development and APT management and regulation |
Longer-term consequences of COVID-19, ongoing trials and cohorts of interest and definition of ‘long COVID’ |
New safety signals of interventions being assessed across the COVID-19 APTs |
Correlates of protection and surrogate outcomes |
Laboratory standardisation and synergies |
Trials for COVID-19 in the primary care setting |
Observational cohort studies (e.g. ORCHESTRA project, EU GA 101016167), post-marketing studies, and collaboration with COVID-19 APTs |
Patient recruitment challenges |
Regulatory submission and evaluation processes in the pandemic context, perspective of the regulatory bodies and ethics committees, transition to the Clinical Trials Information System in Europe, regulatory processes in other world regions, and opportunities for growth and mutual recognition |
Scientific and ethical considerations for special populations of pregnant women, immunocompromised patients, and children |