It looks like the UK’s MHRA is moving in a similar direction to Australia’s CTN framework with its new package of clinical trial regulations coming into force in April:
"Under the new rules, around one in five studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies. The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research." Source: https://www.gov.uk/government/news/patients-to-benefit-sooner-as-uk-boosts-clinical-trials-attractiveness-with-faster-assessments-and-agile-regulation
It's not a full CTN equivalent (there's still a formal authorisation step), but the overall shift toward risk-proportionate, faster approvals feels very much in the same spirit.
Have to wonder why US companies aren't running their early stage trials in Australia if it's that much faster/easier. Makes me think there is something missing from this description.
“U.S. companies themselves have increasingly started to move their early-stage trials to Australia where possible. So much so that in informal interviews with founders I have heard of the problem of the Australian trial system becoming “too clogged”.”
Australia doesn’t have an Imperial government with a global Empire, we do.
A restless one abroad and especially at home,
Empire wasn’t discussed or voted on, we were nudged into it and it’s presented as fait accompli, recent elections are saying loudly it’s not liked.
Australia is in a vassalage relationship, we 🇺🇸 aren’t- yet.
Australia doesn’t have half of Australia mistrusting and disliking the other half, we do.
We all agree we don’t trust the government especially on !SCIENCE! and medicine.
Recently some “safe and effective” vaccines were mandated upon a very reluctant population and most assuredly rapidly tracked to MARKET, to the dismay of many, while the others called for punishment and sanctions unto internment camps for the unvaccinated.
We can probably call mRNA vaccines 💉 Biotechnology. As for safe and effective, they seem to have been a very safe investment and as to effective… it depends upon the desired effect.
Into this swirling, distrusting and shall we mention often violent and certainly heavily armed milieu the author proposes rapidly accelerating “life saving” rapid clinical trials on human subjects with our memories still raw of being dragooned into being human subjects by coercion and government force.
Perhaps leave Australia to the rapid clinical trials, certainly they have a government with far greater power over their population Constitutionally and a more trusting and in any case disarmed and supine citizenry. This is what vassals are for, ask the remaining Ukrainians.
Australia’s Constitution and legal regime are so different from America’s it’s surprising to consider any such transplant to America can be seriously considered. Perhaps check with American lawyers? Never mind Public Relations.
Also Australia is an island surrounded by salt water in case anything goes wrong…
Introducing this into the present American environment will not likely get far and won’t improve anyone’s health overall, as noted the risks of Constitutional, political, legal and biotechnological novelties into the armed camps - plural - in America isn’t healthy.
The Australians may follow their custom, we shall follow ours, which has included quarantine of islands before.
It looks like the UK’s MHRA is moving in a similar direction to Australia’s CTN framework with its new package of clinical trial regulations coming into force in April:
"Under the new rules, around one in five studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies. The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research." Source: https://www.gov.uk/government/news/patients-to-benefit-sooner-as-uk-boosts-clinical-trials-attractiveness-with-faster-assessments-and-agile-regulation
It's not a full CTN equivalent (there's still a formal authorisation step), but the overall shift toward risk-proportionate, faster approvals feels very much in the same spirit.
Have to wonder why US companies aren't running their early stage trials in Australia if it's that much faster/easier. Makes me think there is something missing from this description.
They are.
“U.S. companies themselves have increasingly started to move their early-stage trials to Australia where possible. So much so that in informal interviews with founders I have heard of the problem of the Australian trial system becoming “too clogged”.”
Australia doesn’t have an Imperial government with a global Empire, we do.
A restless one abroad and especially at home,
Empire wasn’t discussed or voted on, we were nudged into it and it’s presented as fait accompli, recent elections are saying loudly it’s not liked.
Australia is in a vassalage relationship, we 🇺🇸 aren’t- yet.
Australia doesn’t have half of Australia mistrusting and disliking the other half, we do.
We all agree we don’t trust the government especially on !SCIENCE! and medicine.
Recently some “safe and effective” vaccines were mandated upon a very reluctant population and most assuredly rapidly tracked to MARKET, to the dismay of many, while the others called for punishment and sanctions unto internment camps for the unvaccinated.
We can probably call mRNA vaccines 💉 Biotechnology. As for safe and effective, they seem to have been a very safe investment and as to effective… it depends upon the desired effect.
Into this swirling, distrusting and shall we mention often violent and certainly heavily armed milieu the author proposes rapidly accelerating “life saving” rapid clinical trials on human subjects with our memories still raw of being dragooned into being human subjects by coercion and government force.
Perhaps leave Australia to the rapid clinical trials, certainly they have a government with far greater power over their population Constitutionally and a more trusting and in any case disarmed and supine citizenry. This is what vassals are for, ask the remaining Ukrainians.
Australia’s Constitution and legal regime are so different from America’s it’s surprising to consider any such transplant to America can be seriously considered. Perhaps check with American lawyers? Never mind Public Relations.
Also Australia is an island surrounded by salt water in case anything goes wrong…
Introducing this into the present American environment will not likely get far and won’t improve anyone’s health overall, as noted the risks of Constitutional, political, legal and biotechnological novelties into the armed camps - plural - in America isn’t healthy.
The Australians may follow their custom, we shall follow ours, which has included quarantine of islands before.
Good evening.