As we move away from 2020 and start looking forward into a more positive 2021, this blog looks at some of the important changes and updates occuring in clinical trials.
TGA: change from CTX to CTA
The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to Clinical Trial Approval (CTA) scheme. Click here for more information.
The public consultation for review of sections 4 and 5 of the National Statement closed in October 2020 with no date yet on when changes will be released. Current information available here.
No date given as yet for the release of ICH GCP R(3). More information on current status here.
Changes to clinical trials globally as a result of Covid
An excellent article in The Lancet that discusses how the Covid19 pandemic has impacted clinical trials
An article describing how clinical trial managers in the UK have responded to trial management during Covid
A Nature article on clinical trial recovery post Covid
A detailed review of how Covid will change clinical trials from Novartis Head of Global Development Operations
Covid 19 in Australia - an article that examines how we will need to think differently and digitally for clinical trials
A fascinating article on how Australia could become a global leader in medical research post Covid
An EY report on the impact of Covid19 on the clinical trials sector
A great read on how Covid 19 in accelerating transformation in the clinical trials sector
An article describing the rise of tele-trials in Australia as a result of Covid
An excellent article about how tele-trials provided a lifeline for a cancer patient in Tasmania