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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 thequoted as being made on behalf of the EMA and/or its scientific committees

Drug Information Association www.diahome.org 2

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Why clinical trial registers?• Transparency - Many trials would otherwise be unpublished and not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 DevelopmentDrug Information Association www.diahome.org 3

Eudra information systems on clinical trials and medicinal productsE d CTEudraCT

• 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 databaseEV CTM

• EudraVigilance Clinical Trials Module

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EudraCT (current Version 8.0, launched on 10th March 2011), includes data related to Clinical Trials from 1st May

20042004

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

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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

EudraCT• Information sharing between national authorities in trial oversight• Alerts• Analysis of data – data warehouse• Source of data for EU CTR

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TransparencyChanged legal requirements have led to development of

EudraCT V 8 0 and EU CTREudraCT V 8.0 and EU-CTRTwo Regulations:

– Article 57(2) of Regulation (EC) No 726/2004 • Relates to all clinical trials in EudraCT

A ti l 41 f R l ti (EC) N 1901/2006

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– Article 41 of Regulation (EC) No 1901/2006 • Relates to paediatric clinical trials

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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.”

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In details Regulation 1901/2006 art. 41

1. “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 y y g pArticle 11 of Directive 2001/20/EC, the Agency shall make public part of the information on paediatric clinical trials entered in the European database.”

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Implementing GLs:Both Regulations require the EC to draw up guidances on the nature of the information to be displayed to the generalthe nature of the information to be displayed to the general

public.

Two implementing guidelines (GLs) published by Two implementing guidelines (GLs) published by Commission are the following:Commission are the following:– Article 57(2) related guideline published - Final July

2008 is 2008/C 168/022008 is 2008/C 168/02– Paediatric guideline published– Final February 2009 is

2009/C 28/01

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TransparencyChanged legal requirements have lead to

development of V 8.0

Two lists of data fields to be made publicTwo lists of data fields to be made public– Both published – Final February 2009Protocol related data will be available with EudraCT v Protocol related data will be available with EudraCT v

8.0 and EU CTR V 1.08.0 and EU CTR V 1.0Development EudraCT V 9 0 (2012) Results relatedDevelopment EudraCT V 9 0 (2012) Results related

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Development EudraCT V 9.0 (2012) Results related Development EudraCT V 9.0 (2012) Results related data and EU CTR V 2.0data and EU CTR V 2.0

Technical Guidance on Results Information Publication-Draft for public consultation- deadline for comments was 30th September 2010

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Legal requirementsGeneral issues

Art. 57 Art. 57 • Phase II-IV adult trials conducted in the EEA

Art. 41 Art. 41 • Phase I-IV paediatric trials + third country trials in a PIP (including phase I trial in adults that are part of PIP)

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• Trials of products with or without MAA

• The same

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• 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

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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

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European Union Clinical Trials Register

- Publication of Clinical Trials will take place going backwards starting with more recent CTs 2011 going back to 2004.- Only CTs that meet the publication criteria will make available to the general public - Excluded are trials exclusively in phase I and in adults- 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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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

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• International initiatives - WHO• All looking for similar or overlapping data sets, varying

timings apply

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Standardisation• Protocol related information• 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.govRes lts related information

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• Results related informationlimited standardisation of data elements

Results Information• “At present, EudraCT does not contain results-related

information on clinical trials Publication of clinical trialinformation 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.“

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• Development of data structure and standards for Results information:– Requires data standard (semantic interoperability) and – XML standard – single sponsor source to multiple

registry destinations

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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

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• 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

Future priorities

D t Q lit E d CT• Data Quality – EudraCT• Improved validation

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Thank you

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