Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Area of Science:

• Clinical Research
• Psychiatry
• Intellectual Disabilities Research

Background:

• Randomized controlled trials (RCTs) often underrepresent vulnerable populations, including individuals with behavioral issues or those in care facilities.
• Conducting RCTs in care settings poses significant logistical and ethical challenges.
• Vulnerable individuals with behavioral problems or residing in care facilities are frequently excluded from research.

Purpose of the Study:

• To describe challenges and practical lessons learned from two RCTs involving vulnerable populations.
• To inform researchers on optimizing trial design for similar populations.
• To facilitate the implementation of future clinical trials in care settings.

Main Methods:

• The study details experiences from two RCTs conducted in care settings.
• Participants included long-stay psychiatric inpatients and individuals with intellectual disabilities.
• Five key challenges were identified and addressed: multisite settings, vulnerable participant inclusion, nutritional supplements/placebos, behavioral outcome assessment, and biosample collection.

Main Results:

• Multisite settings require careful coordination.
• Inclusion of vulnerable participants necessitates tailored ethical and consent procedures.
• Use of nutritional supplements and placebos requires specific handling and blinding strategies.
• Assessment of behavioral outcomes demands validated and sensitive measures.
• Collection of biosamples from these populations requires adapted protocols.

Conclusions:

• Sharing practical experiences can significantly improve the design and execution of RCTs involving vulnerable individuals.
• Proactive identification and mitigation of challenges are crucial for successful trial implementation.
• These lessons learned can help minimize difficulties encountered in similar research endeavors.