The impact of COVID-19 on Clinical Trials has been enormous. With so much information available, CT:IQ has gathered all the COVID-19 relevant resources and guidance, locally and internationally, for our sector and will continue to keep this up to date to keep you informed.
Clinical trial conduct during the COVID-19 pandemic
COVID-19: Guidance
- NHMRC COVID-19 impacts
- TGA, Department of Health, NHMRC COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors
- Research and Development Task Force (RDTF), sponsored by AusBiotech, Medicines Australia, and the Medical Technology Association of Australia Joint media release and position statement
- Bellberry
- COSA Tele-trials: A national Guide for implementation & General resources
- VCCC Tele-trials – Victorian specific resources & SOPs
- QLD Health Tele-trials Pilot analysis report
- NSW Health COVID-19 clinical trial guidance
COVID-19: Resources
- ARCS Webinars
- 23-Mar-2020: Part 1 - Investigators and Study Coordinators
- 31-Mar-2020: Part 2 - Peak Bodies and TGA
- 06-Apr-2020: Part 3 - Jurisdictions: Federal/States
- 20-Apr-2020: Part 4 - Ethics Committees and Governance
- 28-Apr-2020: Part 5 - Role of Clinical Trial Sponsors
- 04-May-2020: Part 6 – Academics
- 11-May-2020: Part 7 – Private Sector
- 18-May-2020: Part 8 - Pharmacovigilance and Regulatory Affairs
- 25-May-2020: Part 9 - Clinical Trials for COVID-19 Treatment and Prevention
- 01-Jun-2020: Part 10 – Trial Participants
- Praxis Webinars
- 24-Mar-2020: Managing clinical trials in a time of uncertainty: COVID-19
- 20-Apr-2020: Best Practice Guidance for Clinical Trial Sites in Covid-19: Consolidating the information
- 18-May-2020: Strategies for participant recruitment, retention and effective communication in clinical trials
- 9-Jun-2020: Leadership and Management skills in times of uncertainty
- Preserving Clinical Trial Integrity During the Coronavirus Pandemic: JAMA viewpoint paper published 25 March 2020
- Contingency planning: Savvy Cooperation in conversation with Craig Lipset, former Head of Clinical Innovation for Pfizer, about contingency plans for clinical trials amidst the unexpected disruption of COVID-19.
COVID-19: International Guidance
- EU - European Medical Agency: Guidance on the management of clinical trials during COVID-19 pandemic
- US - FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- International Coalition of Medicines Regulatory Authorities (ICMRA): Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
- CTTI: Listen to best practices on conducting clinical trials during COVID-19
- ICMRA: COVID-19 Disruptions of International Clinical Trials: Comparing Guidance’s Issued by FDA, EMA, MHRA & PMDA