EMA Update Clinical Trials

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1 EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union

2 Disclaimer The views presented in this presentation/these slides are those of the author and should not be understood or quoted as being made on behalf of the EMA and/or its scientific committees 2

3 EMA Update Some background numbers Risk based approaches to clinical trials Commission proposal on a regulation for clinical trials Clinical Trial transparency EudraCT and EU CTR Clinical trial reports and data from Marketing Authorisation Dossiers 3

4 The Dilemna Between 2005 and ,891 Patients in pivotal trials (38.11% in Europe, 34.05% in North America, 2.58% Africa, 9.36% Middle East/Asia Pacific, 4.44% CIS, 9.36 % Latin America, 2.1% other) 70,291 clinical trial sites in c. 106countries c. 485 new MAA applications plus line extensions etc, 265 GCP inspections

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8 Risk Based Approaches to Clinical Trials 8

9 Regulatory Requirements and guidelines Directive 2001/20/EC and directive 2005/28/EC Directive 2001/83/EC Annex 1 National Legislation General guidelines GCP, Statistical analysis, Clinical study report, Clinical trials in paediatric or elderly populations Guidelines on clinical development of medicinal products in specific therapeutic areas Scientific advice (non-binding) optional possibility for sponsor to seek scientific advice on the development of a medicine - clinical, pre-clinical, pharmaceutical 9

10 Regulatory requirements for clinical trial design Legislation is general broad principles. More information is in guidance offers considerable flexibility, and reasonable departures, better alternatives can be justified case by case. An awful lot of detail is in established practice, perceived requirements, the oral and written culture which is very open to change. Many of the issues lie in this cultural category as do the obstacles to change. 10

11 Defining Quality Quality sufficient to support the decision making process on medicines throughout the clinical development and use post-marketing authorisation Collecting data, generating information, enabling decision making by: Sponsors Ethics Committees Regulators Investigators Healthcare professionals Study subjects Patients 11 Ensuring: Subject rights, safety and welfare Robustness of data

12 Current developments helping to make that flexibility clear and put into practice EU GCP IWG/CTFG Reflection paper on risk based quality management OECD Draft Recommendation on risk based approach endorsed work on final text in progress FDA Draft guidance on monitoring EU GCP IWG / CHMP draft Points to consider on GCP inspection findings and the benefit-risk balance EU Draft regulation on clinical trials published 12

13 13

14 14

15 Introduction and problem statement Purpose of the paper - facilitate the development of a more: systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of GCP and to complement existing quality practices, requirements and standards. Problem can be summarised: current practices are not proportionate nor well adapted to achieving the desired goals generally very costly, resulting either in success at an unnecessarily high cost or failure which is also very costly. The 15 origins of the problem are multifactorial.

16 FEEDBACK RECEIVED VERY WELCOME - Focus more on trial protocol design and clinical implications. Sponsored trials - more attention should be paid to academic trials Describe central monitoring Encourage use of technological advances Standardise/harmonise risk based monitoring approaches put forward by EMA and FDA Need for standardization, protocols, data collection tools, reporting formats Examples of tolerance limits, windows.. Protocol specific and general approaches. There are also risks linked to data analysis and reporting receive too little attention. First Stakeholder Workshop May 2012 Finalize and publish Q Establish and share experience Case Study Workshop Q1 2013

17 Draft Points to consider on GCP inspection findings and the benefit-risk balance Agreed by GCP IWG, for discussion/adoption by CHMP October Publication once adopted. Discussion paper on key GCP inspection issues impacting risk / benefit considerations by CHMP. Objective - to assist inspectors and assessors in evaluating the consequences of inspection findings in relation to the benefit-risk balance. Building prioritisation and risk assessment into conclusions and decisions based on inspection. Three categories are used: Inspection findings which are likely to influence the benefit-risk evaluation Inspection findings which may influence the benefit-risk evaluation Inspection findings which are less likely to influence the benefit-risk evaluation 17

18 Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away. Antoine de Saint-Exupéry, 18

19 Commission Proposal for a Regulation on Clinical Trials 19

20 Draft regulation on clinical trials Key features: Single dossier, single application portal for EU, encompassing regulatory and ethics review. Joint assessment of core information Part 1 between involved member states and national assessment of Part 2. Single decision per trial and per member state. Low intervention trials marketed product within SPC or established medical practice rapid assessment, dossier is simple, additional labeling only if required by study design. Emergency treatment trials Insurance, labeling Introduced by EU Commission to Council of Member States and then EU Parliament for codecision 20

21 Transparency EudraCT - confidential database - as of Sep ,604 clinical trial applications, representing 34,833 clinical trial protocols EU CTR (EU Clinical Trial Register) public 19,146 clinical trials now available in public domain (all EudraCT trials except adult phase I trials can be made public) Commission guidance on inclusion summary of trial results in EudraCT and EU CTR now published as final, implementation in Clinical study reports from Marketing Authorisation Application dossiers. Can be made available once the decision is finalised. EMA can do this reactively but is looking at how to do so pro-actively. 21

22 Thank you questions suggestions Suggestions for next steps, case study workshops, Q and As etc to and cc: Subject line Risk based quality management 22

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