Highlights of the proposed Clinical Trials Regulation in Europe

Transcription

1 Highlights of the proposed Clinical Trials Regulation in Europe Dr Daryl Rees 22 January 2013

2 Proposed Clinical Trials Regulation On 17July 2012, the Commission adopted the proposal for a "Clinical Trials Regulation" The proposed Regulation, once adopted, will replace the Clinical Trials Directive of 2001

3 Commission objectives General objective to make EU a more attractive place to conduct clinical trials Modern regulatory framework for submission, assessment and regulatory follow up: Reduce administrative costs Reduce delay between finalising protocol and starting trial Regulatory requirements adapted to practical considerations, constraints and needs without compromising participant safety, rights and well being or data robustness Removing some regulatory requirements for some trials; proportionality Address global dimension of clinical trials when ensuring GCP compliance Ensure GCP compliance of trials from non-eu countries used in EU in context of other trials or marketing authorisation applications

4 Current Clinical Trials Directive Ensured high level of patient safety but The Clinical Trials Directive is arguably the most criticised piece of legislation in the Union acquis on medicines The criticisms focus on three main issues The divergent application of the Clinical Trials Directive in the Member States The increased administrative burden for clinical trials in view of regulatory requirements which do not take into account practical necessities and constraints The fact that clinical trial regulation does not sufficiently take into account the increasingly global scale of clinical trials

5 Overview of proposed Regulation Regulation not a Directive Single EU portal Single dossier and single submission Faster approval times for low-interventional trials Shorter authorisation time for multi-member state (MS) clinical trials Risk based approach to the monitoring of trials Simplification of the safety reporting requirements Introduction of rules for emergency clinical trials, cosponsorship and serious breaches National indemnification mechanism Commission inspection powers

6 Scope Interventional clinical trials with human medicinal products Not covered: Non-interventional trials (e.g. observational...) Trials without medicinal products (e.g.: devices, surgery...)

7 New category of trials Low intervention trials The IMPs authorised The IMP is used in accordance with the marketing authorisation OR is used as standard treatment in any of the MS concerned Additional diagnostic/monitoring do not add significant additional risk to patients compared to normal clinical practice Simplified submission/shorter assessment period

8 Three main issues Authorisation procedure Risk-adaptedness of regulation Other aspects

9 Current multiple MS authorisation EC MS CA EC MS CA Sponsor EC MS < 60 days* *directive only EC CA MS CA

10 Proposed multiple MS authorisation Validation & assessment co-ordination EC + Reporting MS CA EC + MS CA Sponsor EU Portal EC + MS < 60 days* CA Part I Part II Single MS decision *legislation EC + CA MS Low intervention studies shorter assessment period

11 Submission Submission of the application via a EU portal Selection of MS concerned Sponsor proposes a reporting MS Documents to be submitted listed in Annex to proposal Language of the documents decided by each MS The proposed reporting MS may decline but has to ensure that another MS takes the lead

12 Submission The proposed reporting MS validates dossier and verifies If the application is complete It is within the scope of the legislation Correct classification as low intervention trial (if applicable) The validation is not a pre-assessment of the dossier

13 Assessment Part I assessed jointly by concerned MS Co-ordinated by reporting MS Reporting MS interacts with concerned MS, collects comments and asks for clarifications to the sponsor when required Reporting MS in collaboration with concerned MS drafts report on part I Part II assessed independently by each concerned MS Each MS prepares independently a report on issues covered by part II This assessment is carried out in parallel with the one of part I MS decide how assessment process is managed No reference to Competent Authority/Ethics Committee

14 Assessment (Part I) Characteristics of and knowledge about the IMP The relevance of the clinical trial (if CT is requested by regulatory authorities) The reliability and robustness of the data generated in the clinical trial Compliance with rules on labelling Compliance with the rules on manufacturing Risks and inconveniences for the subject re IMP, interventions, safety provisions and risks from medical condition Detailed list given in Article 6 of the proposal

15 Assessment (Part II) Requirements for informed consent Arrangements for rewarding or compensating investigators and subjects Arrangements for recruitment of subjects Protection of personal data Suitability of investigators and of trial sites Damage compensation Rules for the collection, storage and future use of biological samples of the subject Detailed list given in Article 7 of the proposal

16 Each MS takes a single decision on the conduct of a CT on its territory The decision is composed of conclusions of the assessment of both Part I: The conclusions of the reporting MS Part II: The conclusions are taken independently by each MS Final decision by each MS CT accepted Accepted with conditions Refused

17 Proposed multiple MS authorisation Validation & assessment co-ordination EC + Reporting MS CA EC + MS CA Sponsor EU Portal EC + MS < 60 days* CA Part I Part II Single MS decision *legislation EC + CA MS Low intervention studies shorter assessment period

18 Other aspects Possibility to file an application initially only concerning Part I Possibility to add further MS to an already authorised CT Qualified opt out when: The CT would expose the patients of a MS to inferior Treatments than the normal clinical practice in that MS The CT would infringe the national legislation on human and animal cells Portal and Database Developed and managed by Commission (not EMA) Financed via Public Health programme EudraVigilance will remain for safety reporting Sponsors notify start and end of trial in each MS

19 Substantial modifications Substantial modifications have to be assessed and authorised Detailed procedures provided Rules introduced consolidate already existing provisions and guidelines

20 Risk-adaptedness of regulation Low-intervention clinical trials Simplified safety reporting Monitoring adapted to the type of trial Simplified labelling for already authorised medicines Consolidated and simplified rules on manufacturing and importation of IMP Insurance

21 Other important aspects National indemnification mechanism Emergency clinical trials Co-sponsorship Clinical trials conducted in third countries Cooperation between MS Inspections and Union controls

22 Process for the Clinical Trials Regulation Proposal published on 17 July European Council Started in September (Meeting monthly) European Parliament First reading Q Timelines Before elections European Parliament 2014 In force late 2016

23