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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (11 April 2022.  GFREI Public Consultation Submission: CIOMS Working Group XI draft report – Patient Involvement in the development, regulation and safe use of medicines, 28 February 2022. https://wordpress.com/page/ge2p2-center.net/22737

GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (11 April 2022.  GFREI Public Consultation Submission: CIOMS Working Group XI draft report – Patient Involvement in the development, regulation and safe use of medicines, 28 February 2022. https://wordpress.com/page/ge2p2-center.net/22737

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GE2P2 Global Foundation on behalf of the Global Forum on Research Ethics and Integrity [GFREI] Working Group. (11 April 2022. GFREI Public Consultation Submission: CIOMS Working Group XI draft report – Patient Involvement in the development, regulation and safe use of medicines, 28 February 2022. https://wordpress.com/page/ge2p2-center.net/22737

GFREI Working Group for CIOMS – Patient Involvement in the development, regulation and safe use of medicines
Thalia Arawi, PhD, American University of Beirut & Medical Center, Lebanon
Beate Aurich, MD, MRCPCH; Member of the c4c Consortium, France
David R. Curry, MS, President, GE2P2 Global Foundation, USA
Gerald Schatz, JD., Senior Fellow, GE2P2 Global Foundation, USA
Yeyang Su, PhD, China Academy of Sciences, China

Overview

The GFREI Working Group [WG] engaged a number of themes and issues from throughout the draft including codes of conduct for pharmaceutical companies, wearable technologies, medicine labelling and safety concerns for ADRs, patient involvement in developing informed consent, among others.

We conducted an analysis comparing he drat report to the final published report as below to assess if there was evidence that our comments were engaged:

Observations from CIOMS Public Consultation Analysis
:: Overall, major structural suggestions by GFREI to the draft, involving movement of sections or overall rewrites, not engaged [not represented in these examples]
:: A number of material text level issues/wording changes suggested by GFREI resulted in identifiable changes…other material text level issues/wording changes suggested by GFREI did not
:: There were a modest number of organizations contributing to the public consultation [10] proving clearer visibility to apparent impacts
:: The scale of the CIOMS WG and its demographics, and the process intensity of the CIOMS WG meetings, especially the editorial working group meeting 20+ times over two years, were substantial
:: Our assessment is that the CIOMS WG seriously engaged GFREI input and made specific changes aligned with some of those inputs
:: This assessment – while positive – does not/cannot in itself “justify” the investment of energies in public consultations…will require continuing assessment

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Final Published Version/Other Supporting Documentation

Final Working group report: Patient involvement in the development, regulation and safe use of medicines. 2022. https://doi.org/10.56759/iiew8982
This report from the Council for International Organizations of Medical Sciences (CIOMS) describes the importance of systematically involving patients throughout a medicine’s life – from its early development, through regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organisational and national needs.

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Original Call for Public Consultation

CIOMS – Patient Involvement in the development, regulation and safe use of medicines
Background
The importance of patient involvement throughout the life cycle of pharmaceutical products, from their development to their use on the market has increasingly been recognized. Patients are now invited to state their perspectives and preferences on new needed medicines, to provide input to regulatory benefit-risk assessments through public hearings and consultations, and to submit adverse reaction reports to pharmacovigilance systems using new technologies such as mobile apps or social media.

Previous CIOMS guidelines have recognized the role of patients as key stakeholders in the safe and effective use of medicines, and some input from patients themselves was obtained for the first time by the CIOMS Working Group (WG) IX when formulating its guidance on Practical Approaches for Risk Minimisation of Medicinal Products.
Working Group objectives

The CIOMS Working Group XI on patient involvement in the development, regulation and safe use of medicines was launched in April 2018. It includes participants from patient organizations, industry, regulators, academia and the World Medical Association. These experts are working together to formulate pragmatic Points to Consider in patient involvement. The guidance will provide a comprehensive overview of present knowledge and existing initiatives, and will address a wide range of the remaining challenges and practice gaps. The optimal consideration of patient perspectives will support the safe and effective use of medicines, thereby helping to improve the health of individuals and the public.