Fergus Sweeney, European Medicines Agency

Transcription

1 Fergus Sweeney, European Medicines Agency 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 Drug Information Association 2 1

2 Why clinical trial registers? Transparency - Many trials would otherwise be unpublished and not publically known Assist patients/carers/healthcare providers to locate trials and join them Build public trust and confidence Support public scrutiny Support research process Avoid unnecessary trials Assist reviews of trial information Support Policy Development Drug Information Association 3 Eudra information systems on clinical trials and medicinal products EudraCT Is a confidential database of interventional clinical trials of medicinal products in the EU/EEA accessible to EU/EEA regulators EudraPharm is the database of medicinal products authorised in the European Union, is a public source of information on medicinal products in the EU EU Clinical Trials Register EU-CTR Is part of EudraPharm, displays public information extracted from the EudraCT database EV CTM EudraVigilance Clinical Trials Module 2

3 EudraCT (current Version 8.0, launched on 10 th March 2011), includes data related to Clinical Trials from 1 st May 2004 Legal Framework: Article 11 of Directive 2001/20/EC A European database accessible only to the Competent Authorities, European Commission and EMA containing: Extracts from the request for authorisation Any amendments made to the request Any amendments made to the protocol Opinion of the Ethics Committee Declaration of the end of the clinical trial Reference to inspections 5 EudraCT Information sharing between national authorities in trial oversight Alerts Analysis of data data warehouse Source of data for EU CTR 6 3

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7 13 Transparency Changed legal requirements have led to development of Two Regulations: EudraCT V 8.0 and EU-CTR Article 57(2) of Regulation (EC) No 726/2004 Relates to all clinical trials in EudraCT Article 41 of Regulation (EC) No 1901/2006 Relates to paediatric clinical trials 14 7

8 In details Regulation 726/2004 art.57(2) Where appropriate, the database (EudraPharm described under art. 1(l)) shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (EudraCT). The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public. 15 In details Regulation 1901/2006 art The European database created by Article 11 of Directive 2001/20/EC shall include clinical trials carried out in third countries which are contained in an agreed paediatric investigation plan (PIP), in addition to the clinical trials referred to in Articles 1 and 2 of that Directive.. By way of derogation from the provisions of Article 11 of Directive 2001/20/EC, the Agency shall make public part of the information on paediatric clinical trials entered in the European database. 16 8

9 Implementing GLs: Both Regulations require the EC to draw up guidances on the nature of the information to be displayed to the general public. Two implementing guidelines (GLs) published by Commission are the following: Article 57(2) related guideline published - Final July 2008 is 2008/C 168/02 Paediatric guideline published Final February 2009 is 2009/C 28/01 17 Transparency Changed legal requirements have lead to development of V 8.0 Two lists of data fields to be made public Both published Final February 2009 Protocol related data will be available with EudraCT v 8.0 and EU CTR V 1.0 Development EudraCT V 9.0 (2012) Results related data and EU CTR V 2.0 Technical Guidance on Results Information Publication- Draft for public consultation- deadline for comments was 30th September

10 Legal requirements General issues Art. 57 Phase II-IV adult trials conducted in the EEA Trials of products with or without MAA Art. 41 Phase I-IV paediatric trials + third country trials in a PIP (including phase I trial in adults that are part of PIP) The same 19 EU-CTR European Clinical Trials Register EU-CTR will make public information on clinical trials conducted in adults: Conducted in the EEA Phase II-III-IV trials Started after 2004 Only phase I trials conducted in adults that are also part of a PIP will be make public -small percentage- NCA decision positive and IEC opinion positive recorded in section N of EudraCT 20 10

11 European Clinical Trials Register EU-CTR will make public information on clinical trials conducted in paediatric population: Conducted in the EEA Conducted in third countries if they are part of a PIP Phase I-II-III-IV clinical trials Started after 2004 NCA decision positive and IEC opinion positive or negative (displayed) recorded in section N of EudraCT 21 European Union Clinical Trials Register - Publication of Clinical Trials will take place going backwards starting with more recent CTs 2011 going back to Only CTs that meet the publication criteria will make available to the general public - Excluded are trials exclusively in phase I and in adults that are not listed in a PIP. - EMA is closely working with NCAs to update the info on EudraCT section N

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18 35 International Context EU: Directive 2001/20/EC, Regulation No (EC) 726/2004, Regulation No (EC) 1901/2006 USA: FDAAA (FDA Amendmends Act) Many other national requirements, numbers increasing Each country or region needs to fulfill its legal obligations International initiatives - WHO All looking for similar or overlapping data sets, varying timings apply 36 18

19 Standardisation Protocol related information already significant degree of convergence, data can be mapped between systems to a good degree but can be improved de facto standards in use EudraCT, WHO, ICMJE, ClinicalTrials.gov Results related information limited standardisation of data elements 37 Results Information At present, EudraCT does not contain results-related information on clinical trials. Publication of clinical trial results, both positive and negative, will take place as the information actually becomes available in EudraCT. Work to standardise reporting is ongoing and guidelines on the nature of the data collection process, structure of the collected data and structure of the public data will be included in this document and, if necessary, in additional technical documents. Development of data structure and standards for Results information: Requires data standard (semantic interoperability) and XML standard single sponsor source to multiple registry destinations 38 19

20 EMA/EU Activities EudraCT EudraCT and HL7 CTRR Participating in CTRR discussions Mapping ongoing by CTRR project test XML standard for clinical trial registry (including EudraCT protocol related information anticipated) EudraCT and WHO ICTRP Technical and procedural exchanges ongoing Links likely in Version 8.X EudraCT and ClinicalTrials.gov Exchange discussions on state of progress, issues and lessons learned, future plans Rationalise unnecessary data divergence and unnecessary difference in business rules Develop ways of working together 39 Future priorities Data Quality EudraCT Improved validation 40 20

21 Thank you