Clinical trial conduct during the COVID-19 pandemic
Beyond COVID-19: A solution-focussed forum
ACTA, PRAXIS Australia, ARCS Australia and CT:IQ have come together to create Beyond COVID-19: a solution-focussed forum after identifying a need for the clinical trial sector to collaborate and share information.
Clinical trialists can instantly share their knowledge, assist with responses and point each other to useful resources or contacts; from ethics to telehealth, pharmaceutical supply to remote monitoring to guide. Solving problems is at the heart of clinical trials, and the COVID-19 pandemic has seen the sector becoming more agile; adapting existing trials, finding new ways to commence planned trials, or moving quickly to help test treatments and solve the riddles of coronavirus.
The pathway out of the pandemic will also see some twists and turns, more problem-solving for the sector and an important discussion around which of the adaptations and innovations we should sustain – where Beyond COVID-19: a solution-focussed forum will continue to be a sharing space.
It is open for anyone to read, and registration to participate is simple.
COVID-19: Guidance
- NSW Health COVID-19 Research Grants: Designed to ensure that research results are obtained as quickly as possible to directly support the NSW Health response to the COVID-19 pandemic, this research program will facilitate public health research, rapid diagnostics, clinical trials and trialling new vaccines. It will also support social, behavioural and mental health research, and health systems responsiveness.
- ACTA Covid-19 Resources & news
- AAHMS Webinars:
- Recorded 29 Apr 2020: COVID-19 webinar: Where to from here? Charting a course for resilience and recovery
- 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
- Recorded 23 Mar 2020: Part 1 - Investigators and Study Coordinators
- Recorded 31 Mar 2020: Part 2 - Peak Bodies and TGA
- Recorded 06 Apr-2020: Part 3 - Jurisdictions: Federal/States
- Recorded 20 Apr-2020: Part 4 - Ethics Committees and Governance
- Recorded 28 Apr-2020: Part 5 - Role of Clinical Trial Sponsors
- Recorded 04 May-2020: Part 6 – Academics
- Recorded 11 May 2020: Part 7 – Private Sector
- Recorded 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
- 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
- NIH Collaboratory Ground Rounds Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem? Robert Califf, MD, MACC, Head of Clinical Policy and Strategy, Verily Life Sciences and Google Health.
- 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
COVID-19: Clinical Trials Registries
- Clinical trials registries:
- COVID-19 meta-registries:
- European collaborative project: EPPICentre A living mapping and systematic review of COVID-19 studies
- US-led global collaboration: Review of active international clinical trials for COVID-19
- Cochrane Study registry
- ClinTrialRefer: Covid-19 trials