Upcoming Calls For Public Consultation    

UPCOMING CALLS FOR PUBLIC CONSULTATION     

We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if is not addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].

Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
   The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2. E6(R3) Draft Guideline.  [See Section 2.8 – Informed Consent of Trial Participants]

Public consultation dates:
ANVISA, Brazil – Deadline for comments by 31 August 2023
EC, Europe – Deadline for comments by 26 September 2023
MHRA, UK – Deadline for comments by 31 August 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023

FDA Announces Additional Steps to Modernize Clinical Trials
https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials
ICH HARMONISED GUIDELINE GOOD CLINICAL PRACTICE (GCP) E6(R3)
June 06, 2023 Comment period: Aug 6 2023
   Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise…

This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements. These elements have the potential to make trials more efficient and less burdensome. Additionally, the modernized GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors could potentially facilitate more agile data collection and assist with patient recruitment.

Public consultation on WHO guidance for best practices for clinical trials
WHO – 19 July 2023
Call for consultation: Deadline 15 Sep 2023
Draft Guidance PDF: https://cdn.who.int/media/docs/default-source/research-for-health/2023-07_who-guidance-for-best-practices-for-clinical-trials_draft-for-public-consultation.pdf?sfvrsn=7a5c9fa5_3
Overview
   In May 2022, the Seventy-fifth World Health Assembly adopted a resolution on Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination, in which one action requested of the Director-General was to develop WHO guidance on best practices for clinical trials. WHO is launching a public consultation on draft guidance developed in line with this request. We aim to obtain input from all relevant stakeholders, spanning all diseases and health conditions during this consultation, so that these inputs can be taken into account in revision of this draft, following advice from the WHO Technical Advisory Group established to support this process.

Important stakeholder groups for this technical guidance include, (but are not restricted to): public sector researchers, private sector entities engaged in clinical trials, national health authorities or research councils involved in health research, clinical trial registries, research ethics bodies, national or transnational medicinal product regulatory authorities, decision-making bodies making use of evidence such as guidelines developers, and health technology assessment bodies, healthcare practitioners, patient engagement and community engagement entities, and professional associations in disciplines for whom clinical trials of health interventions are relevant. There may also be some relevance to medical journals.

We would like to receive your overall comments on what the draft guidance does well and less well at the moment, as well as comments on the sections of the document and line by line if desired. Please review the request for guidance development in WHA resolution 75.8 before providing comments…

[See Section 2.2.2 – Relevant Consent]