Introductory slides to webinar on EUPATI Guidance for Patient Involvement in Ethical Review of Clinical Trials

1. EUPATI Guidance for Patient
Involvement in Ethical Review of
Clinical Trials
Ingrid Klingmann, EFGCP, on behalf of the EUPATI team

2. Contents
 Why have guidance?
 Process followed (review, workshops,
consultation)
 Content of ethical review guidance
 Key points within each chapter (referencing online
guidance document)
 Questions encouraged

3. EUPATI guidance for patient involvement
in ethical review – Why?
 Patients & patient organisations to be involved more widely
• include early & post-approval stages,
not confined to clinical development
 Overarching guidance on meaningful and ethical interaction
is missing in many areas, especially in R&D, causing insecurity
• Existing codes/regulations hold mostly general legal & ethical
content,
i.e. collaboration, communication, funding
-- do not support the integration of patient involvement in ethical
review of R&D topics in particular and across the entire process of
medicines development
 Concrete recommendations facilitating the collaboration between the
different stakeholders in the different areas are missing.

4. EUPATI Guidance documents to support
the systematic interaction in R&D
After extensive consultation, EUPATI has developed guidances for the
interaction of patient organisations with stakeholders
 in industry-led R&D
 in HTA
 in regulatory processes
 in ethics committees
Intensive public consultation
ended in Sept 2016,
publication in December 2016
Source: EUPATI Guidance documents on patient involvement in R&D (with regulatory processes, industry-led R&D, Ethics Committees
and HTA bodies), https://www.eupati.eu/guidance-patient-involvement/,  EUPATI.eu  Resources  Guidances

5. EUPATI Guidance for patient involvement
in ethical review of clinical trials
 Involvement of patients’ experience in ethics committees is offered as
an important contribution by patients and patient organisations to the
protection of trial subjects provided by ethics committees.
 However, so far, this engagement is not occurring in most European
countries as most national legislations do not foresee this or only in a
very vague way.
 Ethics committees are rather reluctant to push for it
• as involving patients is perceived as “bringing a concerned party into a neutral,
objective committee”,
• as ethics committees do not reliably experience competent input into their
discussions
• as some ethics committees do not expect more than contributions to the Patient
Information Sheet / Informed Consent Form from the patients
• as experience shows that it is difficult to find interested and knowledgeable patients

6. EUPATI Guidance for patient involvement
in ethical review of clinical trials
 All stakeholders, however, agree that patient involvement in clinical
trials should occur much earlier than in the ethics committee review:
the ethically relevant input should occur as early as in the conceptual
phase of protocol development and all along the protocol development
process until preparation of the patient information sheet and other
documents for patients in clinical trials.
 This guidance covers patient involvement in all these steps although
special emphasis is given to involvement of patients in research ethics
committees.

7. EUPATI Guidance for patient involvement
in ethical review of clinical trials
Geissler, Ryll, Leto & Uhlenhopp
8 May 2017