Participant Co-Design for Clinical Trials

(CONFIRM Trial)

This trial aims to enhance research participation by involving participants in designing the study methods, a process known as participant co-design. Researchers seek to determine if co-creating research procedures with participants increases their willingness to remain involved. The trial focuses on Black women, particularly those who speak English and weigh at least 110 pounds, to assess if this approach improves participation. Participants will either follow pre-designed procedures or help create new, more relevant ones. The goal is to determine if co-designing leads to higher engagement and completion rates. As an unphased trial, this study offers participants a unique opportunity to directly influence research methods and potentially enhance their engagement experience.

The trial information does not specify whether you need to stop taking your current medications. It seems the focus is on co-designing research methods with participants, so medication changes are not mentioned.

Research has shown that involving participants in designing clinical trials is generally safe and well-received. Co-design, where participants help plan the study, makes it more relevant to them. Studies have found that this approach can make trials more attractive and reduce dropout rates. No specific reports indicate negative effects from co-design. Involving participants as co-researchers can lead to better results and satisfaction. Overall, evidence suggests that co-designing studies is a safe and effective method in clinical research.¹²³⁴⁵

Researchers are excited about this trial because it explores how involving participants in designing clinical trial procedures could improve outcomes and participant satisfaction. Unlike traditional trials where procedures are pre-set by researchers, this approach allows participants to have a say in how the trial is conducted, potentially making it more relevant and tailored to their needs. This method could lead to more engaged participants, better adherence to trial protocols, and ultimately more meaningful results.

This trial will compare participant co-designed procedures with pre-designed procedures. Studies have shown that when participants help design research methods, known as co-design, the research becomes more relevant, valuable, and efficient. Specifically, eleven studies found better results when participants helped shape the research approach. Evidence suggests that co-design creates methods that are more engaging and acceptable, increasing participation and completion rates. Participants feel more involved and empowered, often leading to higher satisfaction and better data quality. Overall, co-design improves research effectiveness by aligning it more closely with participants' needs and preferences.²⁶⁷⁸⁹