Mental health clinical trials are crucial to promote our understanding and treatment of mental health conditions. However, these trials face unique challenges in recruiting and retaining volunteers and participants that may hinder their success. The latest collaboration between MQ and the Boston Consulting Group (BCG) is designed to address these challenges by engaging in experienced people (PWLE) at each stage of the project.
PWLE is involved in all stages
One of the outstanding features of the project is the participation of PWLE at all stages, from study design to data collection, analysis and review of final output.
This approach ensures that the voice of people with life experience is at the heart of the research process, provides valuable insights, and cultivates a sense of ownership and empowerment among participants. Feedback from participants and focus groups highlighted the difference in the program’s feelings, and participants appreciated the authentic engagement and thoughtful consideration of their opinions.
BCG has never worked with PWLES before and is impressed with the knowledge and thoughtfulness of the voice of life/life experience throughout the project. This collaboration not only enriches the research, but also sets new standards for PWLE's participation in mental health trials.
Identify recruitment and retention challenges
Through a comprehensive approach involving focus groups, expert interviews and literature reviews, the project identified 18 recruitment and retention challenges in mental health trials. The impact of the potential impact of these challenges on recruitment and retention was assessed through topic analysis and surveys of 100 respondents. The analysis shows eight overall challenges with the greatest impact, including:
- Recognize that mental health clinical trials will not be conducted in a vacuum: Mental health trials are affected by various external factors, including social stigma and limitations of the health care system.
- Building an evidential foundation for current R&R challenges: Convene funders to strengthen each other's best practices in the input and collation of R&R data.
Participating in the recent MQ focus group is definitely one of the important highlights of my time as a service user researcher.
One of the participants in the project said. “The diverse experience and expertise of other member representatives ensured that the conference was informative and highly accessible on a variety of complex, sometimes challenging issues surrounding mental health clinical trials.
This also combines sensitivity, generosity and excellent listening skills, which means we benefit from hearing a truly diverse perspective. The moderator also makes us all believe that our knowledge is equally valued and respected, whether we are service users, clinical trial experts or consultants. She impressed with the space she provides for experts in low-income and low-middle-income countries.
Key findings and suggestions
The presentation highlights some key findings and suggestions to improve recruitment and retention rates in clinical trials of mental health:
- Landscape of mental health experiments: About 40% of mental health trials are behavioral trials led by academics, and anxiety and depression are the most common signs.
However, mental health trial recruitment is below average and dropout rates are higher than other therapeutic areas
- The Challenges of LMIC and Marginalized Groups: Recruitment and retention are more complex in lower and middle-income countries (LMICs) and marginalized groups
These groups face other challenges such as increased stigma, limited cultural and linguistic adaptation, and lack of access to education and standard care
- Digital tools for recruitment and retention: Despite over 200 companies offering digital tools in 13 core use cases, adoption in mental health trials remains limited
Digital tools such as virtual visits, experimental education, and participant engagement show great potential impact, but need to adapt to a mental health environment
- Recommended advice from sponsors: The speech identified eight key areas where funders could have significant impacts, including accelerating recent impacts, elevating digital barriers, adapting to existing digital recruitment channels, bridging the gap between digital consent and participant education, reducing differences, identifying mental health trials that did not occur in the vacuole, and unlocking the potential for digital endpoints.
Set new standards
The collaboration between MQ and BCG sets new standards for PWLE's participation in mental health clinical trials. By addressing the unique challenges of recruitment and retention, the program provides valuable insights and actionable advice for improving the success of mental health trials. The integration of digital tools and the focus on marginalized groups and LMICs are particularly promising areas for future research and development. As we continue to improve our understanding of mental health, participation and adoption of innovative approaches in PWLE are critical to ensuring that clinical trials are effective, inclusive and impactful.
