Challenges for the UK Being the First Choice for FIHS Studies (First Time Into Human)
Much has changed for Phase I clinical trials in the UK, specifically the facilities and trial environment.
Initially through the introduction of the Medicines for Human Use (Clinical Trials) Regulations in 2004.
which was set off by the implementation of the European Clinical Trials Directive into national law? And secondly through the introduction of a Phase I accreditation system, (2008), and was triggered by the TGN1412 incident in March 2006.
Could further regulations impact on the time taken from the assignment of a medical trial to the first volunteer enrolled? Though, the legislation of 2005 has dramatically improved the early phase Research Ethics Committee (REC) approval process through centralising, harmonising and streamlining the application and approval process: the time taken from submission to a REC, to final written approval is now predictable and typically about three weeks.
There is a group of appointed specialist Phase I REC in the UK, some independent and some NHS, with REC meetings taking place across the UK every week, allowing the applicant to start the clock from the moment of a submission being ready.
The regulatory approval timelines were designed to fit into this time frame and the Medicines and Healthcare products Regulatory Agency (MHRA) has an impressive track record of responding within 14 days, i.
e.
one week below the legal target for Phase I trials in the UK.
Approximately one third of trials receive approval upon first review, whereas in two thirds of trials there are grounds for initial non-acceptance.
In that case it will usually take a further 5 days from the time the applicant replies to obtain full approval, i.
e.
the time taken by the MHRA to review an application is typically under 20 days.
Thus the agency is ahead of other European agencies that have longer review times, particularly for more complex studies.
The challenge continues.
Jorg Taubell from Richmond Pharmacology ascertains the Consequential Changes in the market, What the Accreditation of Phase 1 units offer, the specialisation of Clinical Trial providers and the freedom to adapt in early clinical Trials.
Follow the full publication about Why the UK remains to be the first Choice for First Time in Human (FTIH) Studies at http://www.
richmondpharmacology.
com/news/archive_list.
php
Initially through the introduction of the Medicines for Human Use (Clinical Trials) Regulations in 2004.
which was set off by the implementation of the European Clinical Trials Directive into national law? And secondly through the introduction of a Phase I accreditation system, (2008), and was triggered by the TGN1412 incident in March 2006.
Could further regulations impact on the time taken from the assignment of a medical trial to the first volunteer enrolled? Though, the legislation of 2005 has dramatically improved the early phase Research Ethics Committee (REC) approval process through centralising, harmonising and streamlining the application and approval process: the time taken from submission to a REC, to final written approval is now predictable and typically about three weeks.
There is a group of appointed specialist Phase I REC in the UK, some independent and some NHS, with REC meetings taking place across the UK every week, allowing the applicant to start the clock from the moment of a submission being ready.
The regulatory approval timelines were designed to fit into this time frame and the Medicines and Healthcare products Regulatory Agency (MHRA) has an impressive track record of responding within 14 days, i.
e.
one week below the legal target for Phase I trials in the UK.
Approximately one third of trials receive approval upon first review, whereas in two thirds of trials there are grounds for initial non-acceptance.
In that case it will usually take a further 5 days from the time the applicant replies to obtain full approval, i.
e.
the time taken by the MHRA to review an application is typically under 20 days.
Thus the agency is ahead of other European agencies that have longer review times, particularly for more complex studies.
The challenge continues.
Jorg Taubell from Richmond Pharmacology ascertains the Consequential Changes in the market, What the Accreditation of Phase 1 units offer, the specialisation of Clinical Trial providers and the freedom to adapt in early clinical Trials.
Follow the full publication about Why the UK remains to be the first Choice for First Time in Human (FTIH) Studies at http://www.
richmondpharmacology.
com/news/archive_list.
php
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