Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

Abstract

Introduction Patient group engagement is increasingly used to inform the design, conduct, and dissemination of clinical trials and other medical research activities. However, the priorities of industry sponsors and patient groups differ, and there is currently no framework to help these groups identify mutually beneficial engagement activities. Methods We conducted 28 qualitative, semi-structured interviews with representatives from research sponsor organizations (n = 14) and patient groups (n = 14) to determine: (1) how representatives define benefits and investments of patient group engagement in medical product development, and (2) to refine a list of 31 predefined patient group engagement activities. Results Patient group and sponsor representatives described similar benefits: engagement activities can enhance the quality and efficiency of clinical trials by improving patient recruitment and retention, reduce costs, and help trials meet expectations of regulators and payers. All representatives indicated that investments include both dedicated staff time and expertise, and financial resources. Factors to consider when evaluating benefits and investments were also identified as were suggestions for clarifying the list of engagement activities. Discussion Using these findings, we refined the 31 engagement activities to 24 unique activities across the medical product development lifecycle. We also developed a web-based prioritization tool (https://prioritizationtool.ctti-clinicaltrials.org/) to help clinical research sponsors and patient groups identify high-priority engagement activities. Use of this tool can help sponsors and patient groups identify the engagement activities that they believe will provide the most benefit for the least investment and may lead to more meaningful and mutually beneficial partnerships in medical product development.

Patient and Healthcare Professional Insights of Home- and Remote-Based Clinical Assessment: A Qualitative Study from Spain and Brazil to Determine Implications for Clinical Trials and Current Practice

“…In general, and in the context of clinical trials, training of both HCPs and patients in H/RMT is essential and should include methods to improve communication between both parties to increase trust. Finally, use of a tool, such as the Patient Group Engagement Prioritization Tool that was developed by the Clinical Trials Transformation Initiative to assist in the development of medicinal products [ 12 ], may facilitate collaboration between clinical trial sponsors and patient groups, leading to meaningful and mutually beneficial collaboration in the context of decentralised clinical trials.…”

“…While several articles describe how the trial process is changing and the benefit of patient involvement in the design of clinical trials [ 1 – 4 , 6 – 12 ], little evidence describes the actual experiences of patients in clinical trials [ 13 , 14 ] and none describe the experience of patients in clinical trials with H/RMT. Instead, there is abundant literature on home-based rehabilitation, as well as home-based monitoring of symptoms and delivery of medicines [ 15 – 18 ].…”

Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies

“…Participants should be consulted during the study design phase when selecting outcomes, endpoints, and technologies to appropriately address their needs and preferences [ 68 ]. Focus groups [ 69 ] allow participants to test technologies before deployment and provide an opportunity to collect valuable feedback on the study design and usability of accompanying technology (e.g., study applications). This facilitates the early identification and mitigation of design and operational issues.…”

Optimizing Patient Recruitment for Clinical Trials: A Hybrid Classification Model and Game-Theoretic Approach for Strategic Interaction

“… Patient Awareness: Firms aim to inform potential patients about clinical trials, benefits, risks and the eligibility criteria for the same [42].  Patient Screening: Firms evaluate interested patients based on their medical history, eligibility criteria and suitability for the trial [43].…”