THE!EMWA!!! BUDAPEST!WORKING!GROUP!! Florence-slides-HamiltonSa… · May 2014 Jun – Oct Nov 2014 - Jan 2015 Feb Mar – Aug Sep Oct 2015 – Mar 2016 Apr ! ICH E3 DE NOVO REVIEW:

THE EMWA BUDAPEST WORKING GROUP

A 2-‐year collabora=on to make recommenda=ons for aligning the ICH E3 guideline

with current prac=ce and developing clinical study protocol guidance

Sam Hamilton, Walther Seiler, Art Gertel

1

Why Should Medical Writers Care? •  We are oQen principal authors of clinical study reports (CSRs) and clinical study protocols (CSPs)

•  Important to ensure guidelines reflect current prac=ces

•  Protect trial par=cipant anonymity •  Safeguard Company Confiden=al Informa=on (CCI)

2

WHY ICH E3 & E6? (1) •  Clinical Study Report (CSR) ICH E3 1995

–  ambiguity in guidance –  incomplete global and regional ‘clarifica=ons’ –  effec=ve May 2016: European Clinical Trial Direc=ve (ECTD) 536-‐2014 Annex IV, Sec=on A

[publicly posted results summary = CSR synopsis?]

•  Clinical Study Protocol (CSP) ICH E6 1996 –  E6 almost no guidance –  Protocol elements further defined

•  SPIRIT 2013 •  ECTD 536-‐2014 Annex I, Sec=on D •  CDISC structured protocol

•  20 years evolu=on –  Drug development –  Regulatory environment –  Technology

•  eSubs, eDC •  ePos=ng of results

–  Disclosure/transparency –  Responsible clinical trial data sharing

3

WHY ICH E3 & E6? (2) •  CSR and CSP inextricably linked •  No current ICH ini=a=ves to update E3 or develop CSP guidance – but appe=te exists

•  EMWA ini=a=ve supported by regulatory authori=es and other stakeholders –  Stakeholders are partners in developing recommenda=ons

•  Time is ripe for update –  It is hoped recommenda=ons will be readily adopted by ICH

–  Stakeholder involvement in development work

4

OBJECTIVES •  Review and adapt E3 CSR guidance text •  Develop CSP detailed guidance text •  Adhere to principles of ICH as guidance not template •  Consider increased access to CSPs and CSRs •  Align CSP elements with CSR elements when appropriate

•  Facilitate clear fit-‐for-‐purpose informa=on sharing •  Encourage ‘disclosure-‐ready’ CSRs as far as possible requiring minimum ‘redac=on’ aQer submission and before publica=on

•  Facilitate – not hinder – process of licensing medicines

5

METHODS (1)

•  De novo team (end users) –  review & development of E3 guidance –  development & review of CSP content guidance

•  Oversight team review of de novo outputs •  Stakeholder review of consolidated de novo and oversight team recommenda=ons

•  Consolida=on & integra=on of stakeholder comments

è FINAL RECOMMENDATIONS

6

METHODS (2) •  De novo Review

-‐  3 MWs + 2 ‘other’ reviewers -‐  MW focus: clarify ambiguity; transparency/disclosure -‐  One MW leads on one-‐third of E3; one MW produces CSP content text for review by two MWs

-‐  Rotate -‐  Consolidate -‐  ‘Other’ focus: biosta=s=cal/PK -‐  Consolidate -‐  Resolve conflicts -‐  Finalise for Oversight Review

7

METHODS (3)

•  Oversight Review -‐  4 reviewers -‐  Focus: GCP; transparency/disclosure; alignment with other guidelines; interna=onal MW community; global acceptability; industry trends

-‐  Consolidate -‐  Discuss -‐  Resolve conflicts -‐  Finalise for Stakeholder Review

8

METHODS (4) •  Stakeholder Review

-‐  EMA, FDA, PMDA – ICH (EU, US, Japan) representa=on -‐  Health Canada – global RA acceptability -‐  CDISC, DIA (US and EU) – global industry acceptability -‐  Cross-‐industry bodies –TransCelerate

-‐  Pharma (3 major players) – senior execu=ves -‐  Pa=ent (EU) & medical establishment (US)

-‐  Consolidate -‐  Discuss & resolve conflicts

è FINAL RECOMMENDATIONS

9

ROADMAP

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FIGURE 1 Hamilton et al. MEW 23.4 December 2014 in press

!May 2014 Jun – Oct Nov 2014 - Jan 2015 Feb Mar – Aug Sep Oct 2015 – Mar 2016 Apr

! ICH E3 DE NOVO REVIEW:

Suggested guideline updates ICH E6 DE

NOVO REVIEW: Suggested content for

CSP

STAKEHOLDER REVIEW: EMA, FDA, PMDA, CDISC, DIA,

Health Canada patient interest and medical establishment representation

CONTENT

RECOMMENDATIONS TO BE AGREED AS ACCEPTABLE TO

ALL STAKEHOLDERS

DELIVER FINAL CONTENT RECOMMENDATIONS FOR ICH

E3 (CSR) AND CSP CONTENT

Consolidation and integration of stakeholder comments

ICH E6 OVERSIGHT EVALUATION:

ICH E3 OVERSIGHT EVALUATION:

Start

MEW publication ♯1 December 2014

MEW publication ♯2 December 2015

Publication ♯3: Prominent open-access journal, Q2 2016

• Good Clinical Practice • Transparency/disclosure, including responsible

clinical trial data sharing • Alignment with other relevant guidance

documents • International medical writing community • Global acceptability, industry trends

BWG TEAM MEMBERS

11

WHERE ARE WE NOW?

•  Oversight evalua=on: near complete for E3 •  Stakeholder Introduc=on Packs: distributed •  de novo review: star=ng for CSP guidance What next? •  BWG reviews comple=on expected Jan 2015 •  Stakeholder reviews will begin in Mar 2015

12

HELP SPREAD THE NEWS: THIS EXERCISE IS UNDERWAY!

•  Propagate through email

•  @EMWA, @SamHamMW –  Retweet, comment – Sam’s Twiterview 26 Sept 2014

•  Join ‘EMWA’ group –  Like, comment, forward

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OPEN ACCESS PUBLICATION 1

•  Hamilton S, Seiler W, Gertel A. •  The EMWA Budapest Working Group: a 2-‐year collabora@on to make recommenda@ons for aligning the ICH E3 guidelines with current prac@ce and developing clinical study protocol guidance.

•  Medical Wri@ng 23(4) Dec 2014, in press –  E-‐pub ahead of print:

htp://www.maneyonline.com/doi/full/10.1179/2047480614Z.000000000254

HELP US SHARE IT!

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ANY QUESTIONS?

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NEXT UPDATE: DUBLIN MAY 2015 Thank you. We are

•  Sam Hamilton [email protected] @SamHamMW

•  Walther Seiler [email protected]

•  Art Gertel [email protected]

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Documents

THE!EMWA!!! BUDAPEST!WORKING!GROUP!! Florence-slides-HamiltonSa… · May 2014 Jun – Oct Nov 2014 - Jan 2015 Feb Mar – Aug Sep Oct 2015 – Mar 2016 Apr ! ICH E3 DE NOVO REVIEW: