ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trials
In June 2020, ICMRA members committed to stepping up the global collaboration and prioritisation of COVID-19 clinical trials, with the aim of expediting COVID-19 medicine and vaccine development and approval based on robust scientific evidence.
ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trials (24 June 2020)
In the joint statement on clinical trials, ICMRA members:
- describe the key characteristics of clinical trials that are most likely to generate the conclusive evidence needed to enable the accelerated approval of potential treatments and vaccines against COVID-19;
- set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to collect, analyse and report the data required to determine which investigational or repurposed medicinal products would be safe and effective for the treatment or prevention of COVID-19;
- emphasise their commitment to cooperate, expedite and share the evaluation of all COVID-19 trial results submitted to them;
- pledge to provide clear and transparent benefit-risk analyses in order to support the approval of effective and safe medicines, biologics, and vaccines against COVID-19.