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Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?
Hans-Georg Eichler1,2, Marco Cavaleri1, Harald Enzmann3,4
1European Medicines Agency (EMA), Amsterdam, The Netherlands.
Abstract:
The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand-alone trials and observational studies of single-agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient-level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision-relevant clinical trials.
Insights
Coordinated clinical trials are crucial for evaluating coronavirus disease 2019 (COVID-19) treatments. Without better trial coordination, the scientific community risks missing opportunities to find effective COVID-19 therapies.
Area of Science:
- Clinical Trials
- Pandemic Response
- Drug Development
Background:
- The scientific community has developed numerous candidate drugs and vaccines for COVID-19.
- Clinical evidence generation for these treatments is hampered by a lack of coordinated trial mechanisms.
- Numerous small, independent trials may not yield robust results for regulatory or patient decisions.
Purpose of the Study:
- To highlight the need for comprehensive clinical trial coordination during the COVID-19 pandemic.
- To discuss essential actions for stakeholders to ensure timely and effective clinical research.
Main Methods:
- Review of current clinical trial landscape for COVID-19 interventions.
- Analysis of challenges in evidence generation due to fragmented research efforts.
- Discussion of stakeholder roles in improving trial coordination.
Main Results:
- Absence of coordinated trial mechanisms hinders the generation of robust clinical evidence for COVID-19 treatments.
- Many ongoing or planned small-scale trials may not produce decision-relevant outcomes.
- A coordinated approach is necessary to maximize the scientific community's response.
Conclusions:
- Stakeholders must act decisively to implement coordinated clinical trial strategies.
- Effective coordination is vital to seize the opportunity to identify safe and effective COVID-19 treatments.
- Ensuring decision-relevant trial outcomes benefits both patients and researchers during the pandemic.
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