The New EU Clinical Trial Regulation Potential Impacts on Sites

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1 The New EU Clinical Trial Regulation Potential Impacts on Sites Angela Papa Associate Director, Clinical Management PPD Pierre-Frédéric Omnes Director, Site Start-Up and Regulatory INC Research

2 Faculty Disclosure In compliance with ANCC Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any commercial service(s) discussed in this educational activity. Angela Papa Associate Director, Clinical Management PPD Pierre-Frédéric Omnes Director, Site Start-Up and Regulatory INC Research

3 Drivers for change Primary Reasons for the Regulation The EU wants to address issues from Directive 2001/20/EC High costs: Increased Admin. costs by 200% Delays 90% ( ) Failure to truly harmonize Significant decline trial conducted 2007 to 2011 by 25% (5000) The new regulation aims to make EU more competitive for clinical trials Provide a modern and consistent regulatory framework for CTs Take account of appropriate adaptations for risk Address the global dimension of CTs when ensuring compliance with GCP 3

4 EU Clinical Trials Survey Report 2015 Source: SCORR Marketing and Applied Clinical Trials,

5 Regulation versus Directive One step forward EU Directive A Directive is mandatory, but aimed at Member States (MS) which then must be transposed into national legislation for implementation EU Regulation A Regulation is mandatory and self-executing without need for Member State (MS) transposition 1 directive 28 national laws 1 law at the EU level * Member State = one of 28 countries in the EU 5

6 EU CTR Key dates Voted in April 2014 Published in the OJEU on 27 May 2014 Entered into force on 16 June 2014 EU CTR Official publication 27 May 2014 Earliest date EU CTR applies 28 May 2016 (Reg) Now expected End 2017* Transition Period 1 Transition Period 2 EU Portal operational from 28 Nov 2015 (Reg) Now from End Q3 2016* New CT submission under current Directive ends 28 May 2017 Now from End 2018 (est**) Old trials must be transferred to EU Regulation by 28 May 2019 Now by end 2020 (est**) * Source = EMA management board highlights 01-02Oct 2015 ** For every day the Portal is delayed the implementation date moves on by one day 6

7 Content of the Regulation 85 recitals and 19 chapters Chapter I: Chapter II: Chapter III: Chapter IV: Chapter V: Chapter VI: Chapter VII: Chapter VIII Chapter IX: Chapter X: Chapter XI: Chapter XII: Chapter XIII: Chapter XIV: Chapter XV: Chapter XVI Chapter XVII: Chapter XVIII: Chapter XIX: General provisions (Art.1-3) (scope, definitions, general principle) Initial authorisation procedure (Art.4-14) (submission, withdrawal, resubmission) Substantial amendments (Art.15-24) (submission, part I and/or II assessment, decision) Application dossier (Art.25-27) (data, language, delegated acts) Protection of subjects and informed consent (Art.28-35) Start, End, temporary halt, early termination (Art36-39) Safety reporting (Art.40-46) Conduct of a clinical trial (Art.47-59) (good practice, monitoring, serious breaches, TMF, ) Manufacturing and import (Art.60-65) Labelling (66-70) Sponsor and Investigator (Art.71-75) (sponsor, co-sponsorship, principal investigator, Legal rep) Damage compensation (Art.76) Supervision by MS, inspections (Art.77-79) (corrective measures, inspections, Union controls) IT infrastructure (Art.80-82) (EU portal, EU database, functionalities) Cooperation between MS (Art.83-85) Fees (Art.87) Implementing acts and delegated acts (Art.88-89) Miscellaneous provisions (Art.90-95) Final provisions (Art.96-99) 7

8 Content of the Regulation 6 main Annexes and a Correlation Table Annex I: Initial application dossier Annex II: Substantial modification dossier Annex III: Safety reporting Annex IV: Clinical Summary Report (CSR) Annex V: Lay persons CSR Annex VI: Labelling of IMPs / AMPS Annex VII: Correlation table (EU CTR / Directive) This includes specifications on the content of some of the core documents, e.g. Study Protocol, Investigator s brochure, Investigational Medicinal Product Dossier Unclear if there will be a harmonized approach to classification of amendments between countries labelling requirement updates: Use period on both the immediate / outer packaging Removal of the ability to use a centralised electronic information system (IxRS) to replace information on product labels 8

9 EU CTR Overview (1) Scope and definitions Scope: Remains identical to the current Directive Applies only to interventional trials of medicines Definitions: Most remain substantially the same as in the Directive except for: Clarification of clinical trial and non-interventional study Introduction of low-intervention clinical trial to allow simplification of the rules for lower-risk trials Substantial Amendment changed to Substantial Modification Introduction of legally designated representative in relation to informed consent for minors and incapacitated adults, to avoid confusion with legal representative of the sponsor Introduction of Auxiliary Medicinal Product (AMP) to replace the term non-investigational Medicinal Product (NIMP), also used in EU guidances 9

10 EU CTR overview (2) Most significant update): Introduction of an EU Portal and Database Authorization process Allow a single point of entry for a single submission by sponsors to all MS concerned in their trial. Encompasses regulatory, ethics and public registration requirements in one package Used for all applications, regardless of the number of MS involved. Coordinated assessment of the scientific dossier (Part 1) with one MS taking the lead. Ethics review (part 2) remains national Outcome = Unique decision per country Admin changes associated with submission Each trial to have unique EU trial number (currently EudraCT number) Each medicinal product and active substance to have a unique product number (before submission of first CT) 10

11 EU Clinical Trials IT systems Submissions via the EU Portal. Applicants will interact with the system via a Dashboard and this is contained in the User Workspace The public will access the publicly available information via the EU Database (more extensive information than now) 11

12 New EU Submission process Full operational details on the Portal functionalities not yet available Part 1: No local country process Part 2: Review by national EC remains Part 1 and 2 can be in parallel or sequential Submission (via EU CT Portal) Tacit approval once timelines have passed PART I (Scientific) 1 Reporting MS only Validation & Assessment FR GE UK CR etc Validation & Assessment PART II (Ethics) Part I Evaluation Report MS Op.1 MS Op.2 MS Op.3 MS Op.4 Single MS Decision 1 Single MS Decision 2 Single MS Decision 3 Single MS Decision 4 12

13 EU CTR overview (3) New requirements for notifications, though all performed via EU Portal Start, conduct and end milestones (country, EU, global for some) Suspension / Temporary halt / new events of significance Early termination within 15d Safety reporting simplified as all interactions with RA/EC through single Portal Annual safety report(s) Detailed SUSAR reporting via EudraVigilance If more than 1 IMP, possibility to submit in the Clinical Trial EudraVigilance database a single safety report on all IMPs used in that trial The protocol may provide that not all adverse events (AE) and serious adverse events are recorded and reported Other notifications All third country inspection reports 13

14 EU CTR overview (4) Co-Sponsorship Reinforced / additional GCP, GMP rand IMP requirements (now part of EU law) Sponsor to monitor/conduct compliance with Regulation, GCP Adaptation to risk level: Low Intervention Clinical trials, Risk based monitoring EU wide report of serious breaches within 7 days Track storage, traceability, return and destruction of IMP Introduction of the Auxiliary Medicinal Product status to clarify NIMP Damage compensation insurance or national scheme Power for suspension, revocation, modification by Concerned Member States Clinical trial approval revoked if no patient recruited within 2 years CT Master file kept for at least 25 years, readily available and accessible Mechanism for further updates established (via additional Delegated Acts) Much of the Guidances from Eudralex Volume 10 (Clinical trials) now part of the Regulation / Annexes or of upcoming texts (delegated acts) => Further texts expected for clarification / operational details 14

15 Informed consent (IC) Art Risks and degree of distress must be well-defined in the protocol and constantly monitored IC process: understanding, adequate time to consider decision When patient is unable to write, the IC process should be recorded via appropriate alternate means Clinical trial with minors: If during a clinical trial the minor reaches the age of legal competence to give IC as defined in law of MS concerned, his or hers express IC shall be obtained before that subject can continue to participate in the clinical trial There are now clear rules concerning IC in emergency situations when neither patient nor legally designated representative can give IC before enrollment Withdrawal of IC shall not affect the activities already carried out and use of data (EU DP Regulation?) Simplified consent rules for cluster trials (conducted exclusively in one MS) The Regulation is without prejudice to national law requiring that : Child assent is being sought in addition to the legally designated representative both the signature of the incapacitated person and of his or her legal representative may be required => Potential variabilities to remain at country level around consent management 15

16 Impact on activities Feasibility & Site Identification EU CTR Impact: Moderate Timing of activities to comply with EU Clinical trial Application submission milestone Evolution of the qualification questionnaire content to address site readiness Submissions and approvals Site Contracts negotiation & execution Essential Documents Collection EU CTR Impact: Significant Unique Portal, new sequence of event for submission management (part 1, part 2) New management approach: short timelines for answer, no clockstops, tacit approvals EU CTR Impact: Limited Site contracts remain regulated at country level (no impact from EU CTR) Evolutions to expect for improved country competitiveness? EU CTR Impact: Moderate Limited changes expected: potential changes to country requirements Expect new CV template associated with new transparency rules 16

17 Impact for stakeholders Industry 2 concomitant frameworks to execute trials in the 3 years of transition Update to most procedures, systems and trainings relating to EU clinical trials New roles and functions to be considered due to the new framework of submission activities All submissions centralized via Portal All communication to/from RA/EC coming through the EU Portal Update to trial conduct management (new notifications, serious breaches, etc.) RA/EC General reorganization of RA/EC to occur (local pilots are starting already) Set up of an EU collaboration between countries for Part 1 (scientific) assessment Revision of assessment processes, whether for Part 1 (Scientific) and/or Part 2 (Ethics) All communication with applicants via EU Portal Strict timelines (no clock stops) Laypersons (patients, patients) referred in Regulation but actual composition up to MS Final deliverable = unique country decision (from a competent authority to be determined by MS law) 17

18 Impact for stakeholders (2) Countries Readiness with both Directive and Regulation for 3 years Unique fee process at country level Local regulations to be revised to describe the RA/EC collaboration at country level Consider attractiveness to retain clinical trial activities in a more competitive environment Global clinical strategies Competitive enrolment More evidence based decisions USA and other regions also working on developing their own competitiveness What the countries can control... Member States free to select whether a legal representative or a contact person should be implemented for a trial conducted on their territory EU CTR not affecting more restrictive country laws on human / animal cells, Abortifiants, Narcotics (Art. 90) EU CTR without prejudice to other EU texts on GMO, Radiation and Blood / Cells / Tissues (Art. 91) 18

19 Transparency requirements EU database publically accessible by default, with justified exceptions: Protection of commercially confidential information Protection of personal data Protection of confidential communication between the MS in preparation of the assessment report Ensuring effective supervision of the conduct of clinical trial by Member States Operational impacts in daily study conduct for all stakeholders to be considered in the future Scientific Aim Providing the trial design elements to support subsequent entry, publication of summary results For the patient Have all clinical trials been publicly registered? Is there a trial in which I could participate? What was the outcome of the trial I did participate in? 19

20 Regulation Take home messages Biggest change CT conduct in EU in the last 15 years Key attributes: Single EMA portal for CAs and ECs Greater results transparency (lay language CSR, IB, Protocol, available to the general public via EU DB) New: EU-wide Serious Breach reporting New: class of clinical trial, low interventional, with less stringent reporting and monitoring (details TBC) Stakeholder Readiness: Many clinical operational process changes New collaboration and IT platforms (RA/EC) Communication and trainings Two trial management systems to run simultaneously, with a phased implementation Entry into force: EU CT Regulation to replace the existing EU CT Directive Regulates interventional clinical trials with medicinal products conducted in 1 or more EU countries Only once Portal and Database readiness have been officially confirmed by EU Commission via audit (now expected end 2017) Transition periods: 1 year for submissions / 3 years for ongoing CTs 20

21 QUIZ When will the EU-CTR 536 be in place? 1. It s already in place, as it entered into force on 16 June Whenever the EU Portal is operational, now previewed from End Q Only at least 6 months after the EU Portal is operational, now previewed to be from End 2017 How will a Substantial Amendment be called, after the EU-CTR 536 is in place? 1. Substantial Change 2. Substantial Modification 3. Important Amendment Is a tacit approval previewed in the EU-CTR 536? 1. Yes, a tacit approval is given once timelines have passed 2. Yes, a tacit approval is given once timelines have passed but only in case of substantial amendments 3. No, a tacit approval is not possible Which are the elements considered as an introduction to the adaptation to risk level present in the EU-CTR 536? 1. EU wide report of serious breaches 2. Low Intervention Clinical trials, Risk based monitoring 3. Possibility for Co-Sponsorship 21

22 22 Any questions?

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