CIOMS report on patient involvement covers patient preferences

The role that patient preference information can play received recognition in the recent report from the CIOMS working group XI: Patient involvement in the development, regulation and safe use of medicines. The report devotes a section to patient engagement in patient preference studies, emphasising the importance of including patient perspectives in medical product decision-making. 

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Patient preference data can provide structured information on how patients view their disease and treatment options. This kind of data can support decisions for companies developing medicines, provide input for regulators through assessments of benefit and risks, and support reimbursement and health technology assessments.

The CIOMS report describes the importance of systematically involving patients throughout a medicine’s life-cycle, from early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. In the report, CIOMS provides an overview of the benefits of patient involvement, listing existing initiatives in this area. The report provides several examples and recommendations, and addresses the remaining challenges and practice gaps, aiming to prompt readers to implement best practice recommendations. 

PREFER is happy to note that our work has had an impact! In the report, CIOMS provides a summary of our 13 principles from the PREFER recommendations for interacting with patients in the context of a patient preference study:

  • Use easy to understand, non-technical language, and include glossaries of technical terms where required.
  • Clearly and concisely describe the roles of patient research partners.
  • Undertake outreach work to involve patient research partners in community settings.
  • Enable flexibility around meeting times, including out-of-office hours.
  • Use easily accessible meeting venues (e.g. lifts/ramps, locations)
  • Provide opportunities for patient research partners to contribute remotely (e.g. via email, teleconferences, video meetings).
  • Ensure meetings are structured to accommodate the needs of patient research partners (e.g. frequent breaks, refreshments, lay summaries of presentations/documents, care givers can attend)
  • Reimburse any expenses and payments for time spent.
  • Provide recaps at regular intervals of the study background and objectives, progress updates, and the impact of the patient research partner activities.
  • Allow sufficient time for the completion of involvement activities.
  • Ensure there is no requirement for patient research partners to sign or review lengthy and/or complex documents or legal agreements.
  • Ensure patient research partners have the requisite skills and knowledge to support meaningful involvement (e.g. to enable patients to contribute to aspects of data analysis or study conduct, assertiveness skills to support participation in management meetings). This may require specific training or provision of information or support.
  • Provide training for study sponsors so that they can effectively involve members of the public (e.g. communication skills, needs awareness, outreach training).

Download the CIOMS report

By Josepine Fernow





  • Disclaimer: This website and its contents reflects the PREFER project's view and not the view of IMI, the European Union or EFPIA.


The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).