Issue Panel 12: What are the opportunities and challenges in developing transparency of clinical (trial) data?

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1 Issue Panel 12: What are the opportunities and challenges in developing transparency of clinical (trial) data? ISPOR 18 th Annual European Congress Milan, 10 November 2015 Presented by Noel Wathion Chief Policy Adviser An agency of the European Union Clinical trial data transparency EMA commitment to clinical trial data transparency is achieved through: Reactive release of data under Access to Documents legislation Publication of information through the EU clinical trials register (current legislation) Proactive publication of clinical data submitted for the marketing authorisation process (new policy) Transparency under the new clinical trial regulation (development of EU portal and database) 1 1

2 EMA policy on clinical data publication: Rationale EMA has since its creation launched several initiatives to increase transparency of information on medicinal products Documents submitted as part of marketing authorisation applications (MAAs) have been released since November 2010 (under the EMA Access to Documents (AtD) policy) Ever increasing demands for greater transparency, with a shift seen over the past years from transparency on the outcome of the scientific review process towards transparency on the scientific data underpinning the decision-making EMA is committed to continuously extend its approach to transparency, hence the development of a policy on publication of clinical data 2 EMA policy on clinical data publication: Objectives Three main objectives: To enable public scrutiny establishing trust and confidence in the regulatory system To avoid duplication of clinical trials limiting unnecessary patient exposure To enable application of new knowledge in future research increasing efficiency of medicine development learning from experience 3 2

3 EMA policy on clinical data publication: The journey A long process of consultation with stakeholders: Article published in PLoS Medicine, April 2012: Open clinical trial data for all? A view from regulators Public workshop on 22 November 2012 Review of 1,138 comments from 169 stakeholders following a 3 months public consultation in 2 nd half of 2013 Final round of targeted consultation with key stakeholders on envisaged amendments to draft policy: May 2014 Adoption of EMA policy (unanimously) by the EMA Management Board: 2 October 2014 Entry into force of the policy: 1 January EMA policy on clinical data publication: The challenges Strong public demand to share clinical data that support marketing authorisations EMA has taken a proactive approach despite the absence of any specific legal provision mandating the EMA to publish documents submitted by 3 rd parties Need to find, within the limitations of the current legislation, the best possible balance taking into account different stakeholders competing interests 5 3

4 EMA policy on clinical data publication: The final deliverable (1/4) Scope: Clinical data: clinical reports (i.e. clinical overviews (module 2.5), clinical summaries (module 2.7) and clinical study reports - CSRs (module 5), together with appendices , and ) and individual patient data (IPD) Submitted under the centralised procedure Not within scope: Legacy data for centrally authorised products (CAPs) Clinical data for non-caps 6 EMA policy on clinical data publication: The final deliverable (2/4) Achieving a balanced approach addressing competing interests: need to allow access to clinical data and discourage unfair commercial use of the data, through the introduction of a publication process, based on 2 pillars: Two sets of Terms of Use (ToU), depending on the user s need, governing the access to and use of clinical reports Clinical reports, available on-screen, for any user For general information purposes Simple and limited registration process Clinical reports, downloadable, available to identified users: For academic and non-commercial research purposes Registration process includes the need to provide elements concerning the identity of the user User-friendly tool allowing access to the clinical reports 7 4

5 EMA policy on clinical data publication: The final deliverable (3/4) Common elements to both sets of ToU: Trial subjects may not be re-identified Clinical reports may not be used to support a MAA/post-authorisation procedure, and no unfair commercial use may be made Watermark is applied to the published information EMA accepts no responsibility for compliance with the ToU 8 EMA policy on clinical data publication: The final deliverable (4/4) Stepwise implementation: First phase: publication of clinical reports only Second phase: review of various aspects in relation to IPD Effective date: 1 January 2015 for any new MAA and Article 58 applications submitted as of that date 1 July 2015 for extensions of indication/line extension applications for CAPs submitted as of that date Other post-authorisation procedures: effective date TBD 9 5

6 Preparing for implementation: EMA s challenges Completely new activity for EMA requiring several new arrangements to be put into operation in the most cost-efficient way (several new end-to-end business processes, several new IT systems or customisation of existing IT systems, development of guidance) Continuing the dialogue with all stakeholders: Undertaken through a more targeted stakeholder consultation with representatives from all stakeholders (targeted in view of the complexity of the project and the available timeframe for its finalisation) Ongoing discussions with the EO and the EDPS 10 Guidance on the identification and redaction of CCI in clinical reports for publication As a matter of principle, only in limited circumstances clinical reports may contain CCI and could be subject to redaction EMA policy identifies certain types of information that potentially may be considered CCI Proposals for redaction need to be justified and will be reviewed by EMA who will take the final decision Additional guidance is being finalised and will focus on what EMA does not consider CCI: Information that is already in the public domain or publically available Information that does not bear any innovative features Additional information the disclosure of which would be in the public interest Any information lacking sufficient or relevant justification 11 6

7 Guidance on the anonymisation of clinical reports for publication (1/2) Pharmaceutical companies have the responsibility for submitting clinical reports that have been rendered anonymous for the purpose and use of such clinical reports (publication under EMA policy) EU data protection legislation needs to be complied with by EMA and by the pharmaceutical companies: Data in the clinical reports must be processed in such a way that it can no longer be used to identify a natural person by using all means likely reasonably to be used (Directive 95/46/EC) Article 29 Data Protection Working Party Opinion on anonymisation techniques has been the basis of the guidance developed. In addition, several available standards have also been taken into account The information contained in the guidance is not binding and should be considered EMA recommendations to pharmaceutical companies on how best achieve anonymisation. Is not intended to provide an exhaustive list of the techniques available or to mandate a specific methodology but rather to highlight to pharmaceutical companies the anonymisation process to be followed to ensure that clinical reports submitted to EMA for publication are rendered anonymous prior to publication 12 Guidance on the anonymisation of clinical reports for publication (2/2) Anonymisation techniques: Several techniques are available to pharmaceutical companies (legislation is not prescriptive) Is a field of active research and rapidly evolving EMA guidance, currently being finalised, recommends to pharmaceutical companies on how to best achieve anonymisation: EMA favours anonymisation techniques that will optimise the clinical usefulness (data utility) of the information published EMA understands that in an initial phase pharmaceutical companies are likely to use masking (due to the need for retrospective anonymisation of the data) which may decrease the clinical utility of the data in an initial phase 13 7

8 Transparency under the new clinical trial legislation Establishment of an EU portal and EU database Functional specifications for the EU portal and EU database to be audited went through public consultation Rules on transparency have been finalised following discussion with MSs, EC, patients and HCPs organisations and academic researchers 14 Requirements of the new clinical trial regulation EU database publically accessible by default, the only exceptions being possible on the following grounds: Protection of personal data Protection of CCI (MA status of the medicinal product, overriding public interest in disclosure) Protection of confidential communication between MSs (preparation of assessment report) Ensuring effective supervision of the conduct of a clinical trial by MSs 15 8

9 Summary of rules (1/2) The rules apply in the same way whether the sponsor is a pharmaceutical company or academic research group or other type of organisation The rules depend on the IMPs used in a trial and how they are used Trials defined as belonging to one of three categories, based on the IMPs and protocol, at the time of initial assessment of the clinical trial application: Category One: Pharmaceutical development clinical trials essentially Phase I trials in healthy or patient volunteers, bio-equivalence and biosimilarity trials Category Two: Therapeutic exploratory and confirmatory clinical trials - essentially Phase II and III trials of novel products or new indications or formulations of existing products Category Three: Therapeutic use clinical trials essentially Phase IV and low-intervention trials Depending on the category of trial the sponsor will have the possibility to defer publication of certain data and documents up to a maximum time limit, if needed, to protect commercially confidential information The use of deferrals will be monitored and should not exceed what is really needed 16 Summary of rules (2/2) The default is to make public at the first opportunity All data and documents in the system will be made public except for manufacturing/quality information, details of financial agreements between sponsors and investigators, and specified personal data Public registration of trials at their start including all information needed for patients who may wish to participate in trials with therapeutic, diagnostic or preventive objectives Publication of all results (summary, layperson summary and in case of MA application the clinical study report) Possibility of justified deferral only for summaries in case of category I trials up to a maximum of 30 months post trial Option to defer publication of the IMPD, IB, protocol and subject information sheet, after end of trial up to 7 years for category one and 5 years for category two or or if earlier the time of MA using that trial 17 9

10 In conclusion Transparency is important because of... Trust: information is available Confidence: I understand what is happening Empowerment: gives people knowledge to support their decision-making 18 Thank you for your attention Further information European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us 10

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