EnprEMA Working Group 4

Dialogue and Interaction with Ethics Committees

WG4 Participants

• Allison Needham (SickKids/GRIP) – Chair • Pirkko Lepola(FINPEDMED) • Peter Sallabank (Regulinx) • Jo Mendum (PRA International) • David Neubauer (European Academy of

Pediatrics/Ljubljana University) • Ivana Silva (EMA) • Richard Trompeter (GOSH/ IPTA) • Alan Boddy (Newcastle University)

Agreed activities for WG Report Preparation

1) Compile a list of the problems in attaining ethics approval for multi centered trials across jurisdictions and countries.

2) Find examples of good practice (ethics boards that are on the right track towards efficient and consist ethics approval)

3) List recommendations for practice informed by the EC’s outlined in number 2

EC Issues Summarized

General EC Issues: • Overall the approval process is complex, costly,

heterogeneous, and time consuming • Variation in informed recruitment and consent

regulations • Vast difference in the interpretation and

implementation of core regulatory documents • The data requirements for submission vary

between ECs

EC Issues Summarized

Pediatrics specific concerns: • National requirements for ICFs are varied

– Age ranges for providing assent and consent – Parental requirements for providing consent (ie 1

parent vs two parent signatures).

• Justification for appropriate age grouping • Age appropriate test procedures for children

i.e. minimizing blood draw frequencies

External problems (1) Internal problems (2)

Solutions for these problems

Short Term Proposal (≤6 months)

I. Check lists of EC submission documents for both applicants (sponsors, investigators) and ECs

II. Training program structure for EC members; increasing knowledge and competency for pediatric trials

III. Guideline with good existing examples to support communication between ECs; meetings and information exchange – how it could be done

IV. Draft of Standardized meeting processes (local /national) V. Draft of Standardized evaluating processes (local / national) – based

on ICH Guideline E11 for Clinical Trials of Pediatric Population (2000) and EU Commissions Guideline on Ethics for Pediatric Trials (2008)

VI. Risk lists for ECs with practical examples for; Minimal risks, Low risks and High risks to be used for evaluation of trial risk levels and benefits and possible long term effects (health) for the participant (e.g. need for different IC procedures, like both parents consent procedure instead of normal one, or minors independent IC)

Long Term Proposal (1-10 years)

I. Create infrastructure needed for harmonised EC practice including electronic data capture systems, forums for common document access and training material

II. “An EC Tool kit” for Pharma Industry; can be used immediately (includes table of differences between every EU Member State / Country)-example incl.

III. Creating new “GEP-Ped; Good Ethical Practice for Pediatric Studies” -guideline

IV. Political discussions to be started V. Discussions between Competent Authorities to be

started

Who will be responsible for these deliverables and tasks?

What are the available resources?