Dr Panos Tsintis Senior Advisor - CIOMS Berlin - October 2018 CIOMS WG XI TABLE OF CONTENTS Dr Panos Tsintis Senior Advisor - CIOMS Berlin - October 2018

CIOMS Working Group XI – Patient Involvement Table of Contents (Proposed) Introduction Landscape of patient initiatives Rules of engagement Patient involvement during drug development    (Comment from Stephen: This section overlaps with section 5.c below)

CIOMS Working Group XI – Patient Involvement Table of Contents (Proposed) 5. Patient involvement in pharmacovigilance Guiding principles for patient involvement in the content and formatting of labelling Guiding principles for patient participation in design, implementation and evaluation of additional risk minimization measures Guiding principles for patient input in the generation of benefit risk data throughout the life cycle of a medicinal product Guiding principles for patient input in developing safety issue communications regarding medicinal products Guiding principles for patient participation in therapeutic decision-making 

CIOMS Working Group XI – Patient Involvement Table of Contents (Proposed) Patient involvement in benefit-risk Key stakeholders     . Future directions   Conclusions and recommendations Comment from Meredith: Do we need a separate chapter on this?  Discuss further, WG members to provide their views. If stakeholders are clear and we have nothing additional to say we may not need this chapter.   Comments from Stephen: On the other hand, especially for the public, the involved stakeholders may not be all that clear, and the different healthcare systems (HCS), may in fact have different stakeholders, e.g., HCS that are run by national governments and their representative “officers”. This might be linked as well to “Regulatory Landscape”.  The authors of such a chapter will have the additional responsibility of acquiring the perspectives of major international patient advocacy groups and not just limited to those CIOMS XI members to ensure objectivity. CIOMS XI can consider sponsoring a survey in this regard.  However, as in other CIOMS e.g. CIOMS IX, this chapter summarised the feedback from stakeholders. We should also discuss if a standalone chapter on patient perspectives on medicines is written by the patient groups participating in the WG to appeal to a patient audience that may find other parts of the book not so relevant to them.    We should also discuss if a standalone chapter on patient perspectives on medicines is written by the patient groups participating in the WG to appeal to a patient audience that may find other parts of the book not so relevant to them. Comment from Stephen: This is absolutely essential to do  Comment from Meredith: I would recommend that each chapter include a “Future Directions” section at the end. That’s how we did it with CIOMS IX.  While this is possible not all chapters are amenable to having a section on future directions. Some, however could have this section: Development, PV, risk minimisation...feedback needed from WG members.

CIOMS Working Group XI – Patient Involvement Table of Contents (Proposed) Appendices Glossary: The glossary will combine and update all prior CIOMS reports’ glossaries, and include other sources of relevant definitions. Ethical considerations . Stakeholder feedback    (meetings and surveys): Patient organisations; Healthcare Professional organisations; Pharmaceutical companies Practical examples   of patient involvement in the medicines’ lifecycle   Comment from Stephen: An ethicist is essential to provide ethical oversight for the WG and can author this section.  Comment from Meredith: Feedback about what?  Feedback could be in 2 areas: (i) Current practices and thinking in the different stakeholder groups about optimal ways for engaging patients throughout the medicines lifecycle; this feedback should be sent out early during the WG to inform further evolution of the topic; (ii) Draft proposals from CIOMS XI WG; this feedback should be obtained after the first stakeholder feedback is received, reviewed and incorporated in draft WG proposals, perhaps mid-way or later in the course of the WG.  Comment from Stephen: It will be interesting and helpful for a section to be written separately by pharma, regulators, HCP organizations/societies, regarding where they have had experience, and where it is going, and what benefit they see from involving patients. Perhaps this can be linked to the introduction and landscape of patient initiatives above.  Comment from Meredith: The recent CIOMS report on Vaccine Risk Communication integrated practical examples into the main body of the report to illustrate recommendations and “lessons learned.” I thought it was very effective- could we consider that each chapter of our CIOMS XI report include at least one short case study as part of it?  I suggest we embrace both approaches: summarise key examples in the main body of the report and where sufficient detail is available include the detailed examples in the Appendix.

CIOMS Working Group XI – Patient Involvement Table of Contents (Proposed)  Comment from Stephen: An ethicist is essential to provide ethical oversight for the WG and can author this section.  Comment from Meredith: Feedback about what?  Feedback could be in 2 areas: (i) Current practices and thinking in the different stakeholder groups about optimal ways for engaging patients throughout the medicines lifecycle; this feedback should be sent out early during the WG to inform further evolution of the topic; (ii) Draft proposals from CIOMS XI WG; this feedback should be obtained after the first stakeholder feedback is received, reviewed and incorporated in draft WG proposals, perhaps mid-way or later in the course of the WG.  Comment from Stephen: It will be interesting and helpful for a section to be written separately by pharma, regulators, HCP organizations/societies, regarding where they have had experience, and where it is going, and what benefit they see from involving patients. Perhaps this can be linked to the introduction and landscape of patient initiatives above.  Comment from Meredith: The recent CIOMS report on Vaccine Risk Communication integrated practical examples into the main body of the report to illustrate recommendations and “lessons learned.” I thought it was very effective- could we consider that each chapter of our CIOMS XI report include at least one short case study as part of it?  I suggest we embrace both approaches: summarise key examples in the main body of the report and where sufficient detail is available include the detailed examples in the Appendix.