Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey

Area of Science:

• Health Services Research
• Clinical Trials Methodology
• Patient and Public Involvement

Background:

• Consumer involvement in clinical trials is increasingly recognized as important.
• Understanding the current extent and nature of this involvement is crucial for future integration.
• Coordinating centres play a key role in the organization of multi-centre trials.

Purpose of the Study:

• To evaluate the extent of consumer involvement in UK clinical trial coordinating centres.
• To describe the nature of consumer engagement in randomized controlled trials.
• To gauge researcher attitudes towards consumer participation.

Main Methods:

• National surveys conducted using structured questionnaires.
• Data collected from 103 UK clinical trial coordinating centres.
• Involvement assessed through contacts at 62 centres and investigators in 60 trials.

Main Results:

• 23 of 62 eligible centres reported existing consumer involvement, with positive feedback.
• 17 centres planned future consumer involvement; only 4 deemed it irrelevant.
• Investigator feedback on 48 trials indicated consumer input improved research questions, patient information, and trial relevance.

Conclusions:

• Consumer involvement in clinical trial design and conduct is expanding.
• This involvement is largely welcomed by researchers.
• Consumer participation is likely to enhance the relevance of trial questions and outcomes.