Table 3.

Recommendations for enhancing patient and caregiver involvement in the design and conduct of clinical trials in multiple sclerosis.

Investigator	Funder	Patient advocacy groups	Journal editors
Include patients in the design and management of the trial	Include stakeholder engagement (involvement) section in grant application	Identify, train, and support people with MS and caregivers to be patient representatives	Require stakeholder engagement section in reports of clinical trials, similar to how data-sharing statements are required by many journals
Include stakeholder engagement section in grant application	Grant progress reports should include section that describes ongoing patient/caregiver involvement throughout the trial	Support investigators in reaching underrepresented groups to serve as patient representatives	Require the use of the Guidance for Reporting Involvement of Patients and the Public (GRIPP)2 reporting checklist30
Obtain feedback regarding lay summaries of study findings for publications and meetings from patient representatives	Require lay summaries of the results of every funded study. Provide support or consultancy with paMS in the process of preparing the grants especially around lay summary development	Disseminate lay summaries of research	Publish lay summaries of research with each paper reporting results of a clinical study(ies)
Establish standard operating procedures for role of patient representatives throughout the project. Create terms of reference for patient representatives so expectations, roles, and responsibilities are clear	Include people with MS and/or caregivers in the grant review process	Provide clear written roles and responsibilities and expectations of contributions from paMS
Include a budget for reimbursement of patient time and travel expenses	Make reimbursement of patient or caregiver representatives’ time and travel expenses an allowable budget expense
Use methods (e.g. phone call, video call) that reduce barriers to participation	Encourage investigators to use methods (e.g. phone call, video call) that may reduce barriers to participation by representatives in rural or remote communities, by people with physical impairments that make travel difficult, and those of lower socioeconomic status
Report PPI in detail in journal publications to promote an understanding of what works, for whom, where, and when (in what setting) so that other investigators can learn from the experience	Advocate to journals to require information about how patients or caregivers are involved in a study, similar to how data sharing statements are required now in many journals		Consider patients as lay reviewers for papers with potentially high clinical impact

MS: multiple sclerosis; PPI: patient and public involvement.