GCP Update. 16 April 2018

Transcription

1 GCP Update 16 April 2018

2 GCP Updates - Agenda ICH Europe UK US Rest of World 2

3 ICH: E17 Guideline General Principles for Planning and Design of Multiregional Clinical Trials Complements the guidance on MRCTs provided in ICH E5(R1) Ethnic Factors Potential impact of regional differences on results Pre-specified pooling of regions and sub-populations Single primary analysis approach Careful attention to quality (planning, training, monitoring) Communication with regulatory authorities during planning Adopted 17 November 17 uidelines/efficacy/e17/e17ewg_step4_2017_1116.pdf 3

4 Europe (1) EMA Scientific Guidelines: Guideline on the clinical investigation of medicines for the treatment of Alzheimer s disease - Revision 2 EMA/CPMP/EWP/553/95 Rev.2 Adopted 22 Feb 2018 Effective 01 Sept 2018 Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis Revision 2 EMA/CPMP/EWP/556/95 Rev. 2 Published 14 Dec 2017 Effective 01 July B/document_library/Scientific_guideline /2009/09/WC pdf B/document_library/Scientific_guideline /2018/01/WC pdf 4

5 Europe (2) EMA Scientific Guidelines: Guideline on good pharmacogenomic practice - First version EMA/CHMP/718998/2016 Adopted 19 March 2018 Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version EMA/CHMP/778709/2015 Adopted 24 Jan B/document_library/Scientific_guideline /2018/03/WC pdf B/document_library/Scientific_guideline /2018/02/WC pdf 5

6 MHRA (1) DSUR Submission Guidance - updated Submit DSUR using CESP Follow CTA submission guidance Select regulatory activity G Development Safety Update Reports Use CESP submission details as evidence of DSUR submission for TMF 6

7 MHRA (2) GXP Data Integrity Guidance and Definitions Core elements of a compliant data governance system GCP, GMP, GDP, GLP, GVP Addresses fundamental failures identified during inspections Published 9 th March 2018 (Revision 1) loads/attachment_data/file/687246/mhra_gxp_data_integrity_guide_ March_edited_Final.pdf 7

8 HRA (1) Model Clinical Trial Agreements February 2018 Model Clinical Trials Agreement (mcta) Clinical Research Organisation Model Clinical Trials Agreement (CROmCTA) Single templates for use in England, Scotland, Wales and Northern Ireland Pragmatism encouraged any ongoing contract negotiations should not be amended continue to use the previous version of the template. racts-agreements 8

9 HRA (2) GDPR guidance for researchers Published 31 Jan 18 as a living document with links to: We expect that for most existing studies, if you follow our guidance, you will not need to submit amendments for approval. Our guidance will help you to make the necessary changes as nonnotifiable, non-substantial amendments in the vast majority of cases. 9

10 HRA GDPR guidance for researchers Technical briefing notes relevant at organisational level Each activity must have a legal basis under the GDPR For health and social care research, the legal basis is determined by the type of organisation: for universities, NHS organisations or Research Council institutes the processing of personal data for research will be a task in the public interest for commercial companies and charitable research organisations the processing of personal data for research will be undertaken within legitimate interests. 10

11 HRA GDPR guidance for researchers Safeguards consideration to security and storage of data Data minimisation Since consent is not the legal bases no need to re-consent under GDPR unless changes to study processes change what data will be collected and how it will be held Provide transparency information to patients if you collect any new personal data (Table provided) Further guidance planned on wording of transparency information to facilitate non-substantial amendments Further guidance planned on direct or indirect patient identification (not identifiable = GDPR not applicable) Guidance provided on study/recruitment timing and implementation of transparency requirements 11

12 HRA GDPR guidance for researchers Implementation of transparency requirements: A. New study not submitted for approvals before 25 May 18 Incorporate wording into PIS before submitting for approvals B. Study approved and recruiting new participants after 25 May 18 Provide transparency info to new participants using HRA wording record nonsubstantial amendment C. Study approved and participants are still in the study after 25 May 18 If ongoing participants and continued personal data collection, provide new transparency info at next data collection (non-substantial amendment if HRA wording used) PIS change and substantial amendment required if consent was explicitly identified as the prior legal basis for collecting data and/or changes in safeguards, subject rights or use of personal data. D. Study approved, participants will have completed study by 25 May 18 No need to provide transparency info to participants 12

13 US (1) New FDA guidance for Investigators and IRBs - Payment and Reimbursement to Research Subjects Considerations to avoid undue bias Reimbursement of travel, airfare, lodgings to attend trial site are not considered to be undue influence Credit for payment to accrue during study & not contingent on completion Payment of small portion as incentive for completion acceptable provided not coercive IRB to determine All payment info to be included in informed consent 9.htm 13

14 US (2) FDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices Published 21 Feb 2018; effective 21 Feb 2019 Updates to standards for data from inside and outside USA statements and information required on how the investigations conform with good clinical practices Flexibility for multinational studies by reference to which GCP followed New guidance document published (Q & A format) Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions 14

15 US (3) US Final Guidance on E6(R2) Good Clinical practice: Integrated Addendum to ICH E6(R1) Published 28 Feb 2018 Brings E6(R2) into the US ances/ucm pdf 15

16 US (4) US Draft Guidance on Pregnant Women: Scientific and ethical Considerations for Inclusion in Clinical trials Published 06 Apr 2018, so asking for comments Recommendations on how and when to include pregnant women in drug development Primary focus is on drugs NOT aimed at use in pregnancy ces/ucm pdf 16

17 TGA Australian clinical trial handbook Version 2 march pdf 17

18 India New Drugs and Clinical Trials Rules, 2018 (Proposed title) The Ministry of Health and Family Welfare has released a draft document (186 pages) which could become the basis of New Drugs and Clinical trials rules 45 day consultation period Covers all aspects of CTs %20for%20Publication.pdf 18

19 Next meeting Tuesday 20 November 2018 Francis Crick Institute Bookings will open Sept/Oct 19

20 Thank You To all presenters and attendees To UCL and HRA (sponsors) To Helen Cadiou (UCL) (organisational support) ICR (logistical support) From: Ethics Forum: Joan Perou (chair) GCP Forum: Nicky Dodsworth & Janice Hedgecock (co-chairs) Stuart Harris & Julia DeCesare (committee members) 20