New European Union Clinical Trial Regulations

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1 New European Union Clinical Trial Regulations Incorporate Monitoring and Safety Reporting Techniques into U.S. and EU Clinical Trial SOPs Anita K. Murthy Deputy Director, Global Regulatory Affairs Bayer Healthcare Page 1

2 Background on New Clinical Trial Regulation Page 2

3 EU Clinical Trial Applications are Currently Prepared and Submitted by the Local Affiliates?! Health Authority Ethics Committees EU CT Regulation Implementation Project Page 3

4 Directive 2001/20/EC will be superseded by the new EU Clinical Trial Regulation?! HA Health Authority EC Ethics Committees EU CT Regulation Implementation Project Page 4

5 Regulation (EU) 536/2014 will be binding as is for all EU member states (no local implementation required) EU CT Regulation Implementation Project Page 5

6 What Regulation 536/2014 entails Consistent rules for the conduct of trials throughout the EU. Single electronic entry point for applications the EU portal. A single application package, including a single set of documents, will be needed regardless of how many Member State are participating in the trial. A harmonized procedure and defined deadlines for the assessment of trials. One decision per Member State participating in the trial. This will replace the current, separate approvals given by competent authorities and research ethics committees. Increased transparency on clinical trials and their outcomes. Page 6

7 New Interface for CT Submissions GRA-SC Template July 2013 Page 7

8 New CTA Process: Page 8

9 Key Process Changes for CTA Application Process Central CTA submission via EU portal One dossier for all planned member states (global part 1, country specific part 2) One single vote on part 1 (combining EC and HA assessment) per member state leading to a single overall decision on part 1 A reporting member state (rms) gives a consolidated vote on part 1 of the dossier Each concerned MS (cms) gives a decision on part 2 for his member state Page 9

10 Clinical Trial Transparency The main aspect of the Regulation with implication on Regulatory Affairs is the creation of a EU Clinical Trial portal and database, applicable to all Clinical Trials conducted in the EU, irrespectively of the Marketing Authorization Procedure (national, central, mutual recognition, decentralized). The database will be publicly accessible by default and the publication of clinical trial related documents and/or information will be an automatic process based on technical features. The exemptions of public access are acc. to Art. 81 of Regulation (EU) No 536/2014: Confidentiality is justified (e.g. protection of commercially confidential information (CCI) Protection of personal data; Protecting confidential communication between MS in relation to the preparation of the assessment report; Ensuring effective supervision of the conduct of a clinical trial by MSs. Page 10

11 Goal of Presentation Chapter VII: Safety Reporting in the Context of a Clinical Trial Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Annex III: Safety Reporting (SUSARS) by the Sponsor to the Agency Impact to Internal Processes Page 11

12 Chapter VII: Safety Reporting in the Context of a Clinical Trial Article 40. Electronic database for safety reporting Agency to set up and maintain an electronic database (for safety reporting) The Agency shall, in collaboration with Member States, develop a standard web-based structured form for the reporting by sponsors to the database for SUSARs. Page 12

13 Chapter VII: Safety Reporting in the Context of a Clinical Trial Article 41. Reporting of adverse events and serious adverse events by the investigator to the sponsor Investigator to report AEs and laboratory abnormalities to the Sponsor in accordance with the protocol Investigator required to report all AEs to the Sponsor; Investigator to report all SAEs to the Sponsor within 24 hours of coming to know of the SAE or in accordance with protocol The sponsor shall keep detailed records of all adverse events reported to it by the investigator Investigator to report serious adverse event with a suspected causal relationship to the IMP even after the end of the clinical trial without undue delay Page 13

14 Chapter VII: Safety Reporting in the Context of a Clinical Trial Article 42. Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency The sponsor of a clinical trial must report the following SUSARs: a) All SUSARs must be reported even if they occur at a site within or outside of the Union b) all SUSARs of the same IMP, regardless of dosage form and strength or indication investigated, in the IMP, occurring in a clinical trial performed exclusively in a third country, if that clinical trial is sponsored: i. by that sponsor, or ii. by another sponsor who is either part of the same parent company as the sponsor of the clinical trial, or who develops a medicinal product jointly, on the basis of a formal agreement, with the sponsor of the clinical trial. c) Report SUSARs even when the clinical trial has completed Page 14

15 Chapter VII: Safety Reporting in the Context of a Clinical Trial The period for the reporting of SUSARs by the sponsor to the Agency shall take account of the seriousness of the reaction and shall be as follows: a) in the case of fatal or life-threatening SUSARs, no later than seven days after the sponsor became aware of the reaction; b) in the case of non-fatal or non-life-threatening SUSARs, not later than 15 days after the sponsor became aware of the reaction; c) in the case of a SUSAR which was initially considered to be non-fatal or non- life threatening but which turns out to be fatal or life-threatening, no later than seven days after the sponsor became aware of the reaction being fatal or life-threatening. b) Follow up report with additional information should be submitted Sponsor may report the SUSAR to the Member State if there is lack of resources and agreement by the Member State/Agency Page 15

16 Chapter VII: Safety Reporting in the Context of a Clinical Trial Article 43. Annual reporting by the sponsor to the Agency Sponsor shall submit annually a safety report for each IMP used in the clinical trial For a clinical trial involving the use of more than one IMP, the sponsor may, submit a single safety report. The annual report shall only contain aggregate and anonymized data. Safety reporting required with the first authorization of a clinical trial and it ends with the end of the last clinical trial conducted by the sponsor with the IMP Page 16

17 Chapter VII: Safety Reporting in the Context of a Clinical Trial Article 44. Assessment by Member States The Agency shall, by electronic means, forward to the Member States safety information. Member States shall cooperate in assessing the safety information reported for a clinical trial. The responsible ethics committee shall be involved in the assessment of the safety information, if it has been provided for in the law of the Member State concerned Page 17

18 Goal of Presentation Chapter VII: Safety Reporting in the Context of a Clinical Trial Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Annex III: Safety Reporting (SUSARS) by the Sponsor to the Agency Impact to Internal Processes Page 18

19 Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Article 52 Reporting of Serious Breaches Sponsor must report any breach of the Regulation for the protocol within 7 days of becoming aware of that breach. serious breach means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial. Page 19

20 Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Article 53. Other reporting obligations relevant for subject safety Sponsor must report through the portal any adverse events that impact the benefit/risk of the IMP (not SUSARs) no later than 15 days. The sponsor must submit, through the EU portal, all inspection reports of third country authorities concerning the clinical trial. Page 20

21 Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Article 54. Urgent safety measures Sponsor must implement urgent safety measures when benefit/risk is impacted Sponsor shall notify of the measures no later than 7 days Page 21

22 Annex III: Safety Reporting (SUSARS) by the Sponsor to the Agency Adverse Events and Causality Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the product, shall be subject to the same obligation to report as adverse reactions.

23 Goal of Presentation Chapter VII: Safety Reporting in the Context of a Clinical Trial Chapter VIII: Conduct of a Clinical Trial, Supervision by the Sponsor, Training, and Experience, Auxiliary Medical Products Annex III: Safety Reporting (SUSARS) by the Sponsor to the Agency Impact to Internal Processes Page 23

24 What Changes for Safety Reporting per Regulation 536/2014 Overall, modest changes regarding safety reporting All safety reporting (AEs, SAEs, SUSARs, ASRs) for clinical trials must be done via a centralized portal, not by local affiliates/countries Web-based structured form for collecting AE information Medication errors, pregnancies, misuse or abuse of IMP should be subject to the same reporting obligations as adverse reactions More detailed timelines on safety reporting than previously (e.g. urgent safety measures to be reported within 7 days in the portal); expedited reporting of safety that impacts benefit/risk by 15 days Reporting of serious breaches of the Regulation Page 24

25 What Has Not Changed Overall safety definitions remain the same in line with ICH guidelines Required safety reporting documents Timelines for reporting are fairly consistent Page 25

26 Standard Internal Processes Overall, most SOPs that detail definition of AEs, SAEs, SUSARs, would remain generally the same as the new regulation did not change these Reporting of medication errors, pregnancy, and abuse of IMPs to be reported as AEs Whether to report as SUSARs is subject to interpretation SOPs may be modified to specify submission of safety data (SUSARs, ASRs) through the EU portal Changes or more specifics on the timelines for submission such as urgent safety measures if not already specified Internal process to include reporting of serious breaches Page 26

27 Discussion What changes is your organization making to PV/safety SOPs as a result of Regulation 536/2014? Given the anticipated timeframe for the regulation to take effect, when will your organization be making modifications to their SOPs/internal processes for safety reporting? Effective date of the Regulation moved to end of 2017 Does your organization require significant changes to SOPs or are they written fairly general (referring to directives/guidelines) so significant changes on safety reporting are not required? Page 27

28 Discussion Are your clinical trial SOPs written globally, meaning refer to the key US and EU regulations or are operating procedures written separately based on region? Page 28

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