european clinical trial regulation liz philpots, head of research, amrc
TRANSCRIPT
European Clinical Trial Regulation
Liz Philpots, head of research, AMRC
Summary
• About me & AMRC
• About the EU Clinical Trials Regulation – what’s new
• Implementation timeline
• What does this mean for UK ethicists?
AMRC established 1987
133 member charities…from large to the small
• All fund medical research
• Spend more than £1Bn on research
• 1/3 of medical research in UK
• Strong drive to benefit people affected by their condition
• 30% of studies in the NHS
A brief history of trial regulation
pre-2001 - national regulation (e.g. CTX Scheme in the UK)
2001 - GAFREC – ethics committees - EU ‘Clinical Trials’ Directive 2001/20/EC 2004 – UK law - Medicines for Human Use (Clinical Trials) Regulations
2005 - Good Clinical Practice Directive 2005/28/EC
BUT – EUCTD seen as a barrier to research:• 25% drop in trials in EU• increased costs• massive increase in delay to get trial started
2012 – proposal for new regulation
Some major issues with EUCTD
• interpretation by Member States not consistent
• lack of clarity over definitions and requirements
• cumbersome procedures, particularly for multi-centre clinical
trials in different Member States
The New EU Regulation on Clinical Trials
• the new EU Regulation (No 536/2014) on clinical trials on medicinal products for human use (and repealing Directive 2001/20/EC) was adopted on 16th April 2014
• it entered into force on 16 June 2014, but will apply no earlier than 28 May 2016 (in the meantime existing provisions continue to apply)
• it’s a regulation - will apply directly to each EU Member States
What’s different -processes?
• a streamlined application procedure via a single entry point - an EU portal and database
• a single authorisation procedure for all clinical trials
• a lighter regulatory regime for low risk clinical trials
• streamlined safety reporting
• strengthened transparency for clinical trials data
What’s different - principles
• clinical trials are a subset of clinical studies
• trial participants should represent the population that might benefit from the
treatment
• co- sponsorship
• encouragement for clinical trials in rare diseases or of orphan products
• ethics committees should be independent and involve lay people
What’s different - consent
• enrolment without informed consent in emergency situations
• simplified consent process for ‘cluster trials’
• special consideration for
• incapacitated subjects
• minors
• pregnant & breast feeding women
• military personnel, prisoners, people in residential care institutions
What’s different - jargon
• RMS
• CMS
• Low intervention clinical trials
Processes - streamlined application procedure
• sponsor must submit an application via an EU online portal
• single entry point for application, assessment and subsequent data
submission
• better communication between sponsor and authorities, and between
authorities in the relevant Member State
• greater transparency of CTs and of the results of CTs
• BUT - the portal needs to be built…..
Processes - single authorisation procedure - I
• for multinational CTs all Member States will be involved in the assessment,
although a ‘Reporting’ Member State (RMS) will lead and coordinate the
assessment
• Member States will retain responsibility for aspects which are entirely
national for example, informed consent, and compensation arrangements
• authorisation process timelines are specified whilst retaining the concept of
‘tacit authorisation’
• possible to extend the CT to additional Member States and clarifies when a
new CT authorisation is required
Processes - single authorisation procedure - II
Each country (CMS) inputs into Part I and conducts its own Part II assessment.
Part I: Reporting member state (RMS) –scientific assessment
Part II: National assessment by each country of site details, ethics, etc :
Processes for authorisation
Processes - low interventional clinical trials
• proportionate rules for monitoring, reporting, traceability and storage of investigational products
• ‘low interventional’ means - authorised medicines used within the terms of their
authorisation OR - ‘off-label’ use of medicines that is supported by appropriate
evidenceAND - trial procedures with minimal additional risk or burden to the
safety of the trial participants
Processes - transparency
• EU portal provides a systematic and transparent way to log CT lifecycle events
• sponsors must submit a publically available summary of the results of the CT within one year of its end, irrespective of the outcome of the trial
• where an EU Marketing Authorisation is granted, a full clinical study report will have to be submitted for publication on the EU database
• all CT must also provide a simplified summary of results for public audience
Implementation timeline
Adopted 16 April 2014
Portal fully functional…..
Dec 2015?
Entry into force28 May 2016
6 MONTHS
What does this mean for UK ethicists?
• Much stays the same
• It’s all about the portal …
• portal needed for implementation
• national systems need to ‘speak’ to the portal
• planned –Dec 2015 ….. watch this space
Thank you
Regulation: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
Dr Liz [email protected]
www.amrc.org.uk