Resources on COVID-19 for the clinical trial sector

Topics:COVID-19

The National Medical Health and Research Council (NHMRC) has committed to supporting its Administering Institutions, and the health and medical research sector to address the multiple challenges posed by the COVID-19 pandemic.

The NHMRC has released advice regarding grant administration matters for NHMRC-funded researchers and clinicians.

TheMedicine and Healthcare products Regulatory Agency (MHRA) in the UK has released guidance advising those involved in clinical trials on specific issues which may arise as a result of COVID-19.

The MHRA has taken a flexible and pragmatic approach with regard to regulatory requirements for clinical trials during this time but has noted that the first priority should be the safety of trial participants.

This guidance will be updated as the situation changes over time. 

Managing clinical trials during Coronavirus (COVID19): How investigators and sponsors should manage clinical trials during COVID-19

The US Food and Drug Administration (FDA) has released guidance designed to help industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials.

The FDA wants to support the continuance of clinical trials in compliance with good clinical practice and minimising risks to trial integrity, while also safeguarding the health and well-being of study participants.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards

ARCS Webinar Series: COVID-19: considerations and strategies for running trials during the pandemic

ARCS is providing a webinar series on the impact of COVID-19 on clinical trials in Australia.

The first webinar, focused on Investigators and Study Coordinators, was held today. ARCS has made the recorded webinar, as well as the presentations from within the webinar and additional questions and answers available on their site.

We distributed notice of the first webinar as soon as it came to our attention. For those who had trouble accessing the webinar due to the number of people registered, we recommend that you access the recording via the link above.

There will be ten webinars altogether in this series run by ARCS:

Go to the ARCS website for more information about the rest of the webinar series and to register

  • Tuesday 31 March: Part 2 – Peak Bodies and the TGA
  • Monday 6 April: Part 3 – Jurisdictions: Federal/States
  • Monday 20 April: Part 4 – Ethics Committees and Governance
  • Tuesday 28 April: Part 5 – Role of Clinical Trial Sponsors
  • Monday 4 May: Part 6 – Academics
  • Monday 11 May: Part 7 – Private Sector
  • Monday 18 May: Part 8 – Pharmacovigilance and Regulatory Affairs
  • Tuesday 25 May: Part 9 – Clinical Trials for COVID-19 Treatment and Prevention
  • Monday 1 June: Part 10 – Trial Participants

Please direct all questions regarding these webinars and its content to: arcs@arcs.com.au

PRAXIS Webinar 
Managing clinical trials in a time of uncertainty: COVID-19

PRAXIS is also running a webinar: Managing clinical trials in a time of uncertainty: COVID-19 at 12pm (AEDT) on Wednesday 25 March.

You can register here for the PRAXIS open discussion forum, where an array of Australian clinical trials thought leaders across health, policy and regulation, HREC and industry will discuss the current and future challenges we face with the emergence of the COVID-19 pandemic.