Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

Area of Science:

• Clinical Trials Methodology
• Qualitative Research in Health
• Health Services Research

Background:

• The integration of qualitative research alongside randomized controlled trials (RCTs) is increasingly common.
• Clinical Trials Units (CTUs) in the UK are managing more qualitative research, developing standard operating procedures.
• This integration aims to assess intervention feasibility, acceptability, and improve trial conduct.

Purpose of the Study:

• To review the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs in conducting qualitative research concurrently with RCTs.
• To identify potential challenges and risks associated with this integrated approach.
• To provide recommendations for improving the management of qualitative research within CTUs.

Main Methods:

• A review of experiences from 15 studies conducted within two UKCRC-registered CTUs.
• Analysis of potential conflicts and risks arising from concurrent qualitative research and RCTs.
• Focus on the feedback mechanisms of qualitative findings during ongoing RCTs.

Main Results:

• Qualitative research integrated with RCTs can potentially undermine trial completion and scientific integrity.
• Specific risks identified include the premature or inappropriate feedback of interim or final qualitative findings.
• Reporting qualitative findings while the RCT is ongoing poses particular challenges.

Conclusions:

• Effective management strategies are crucial for the successful integration of qualitative research with RCTs.
• Clear protocols for handling and disseminating qualitative findings are needed to safeguard RCT integrity.
• Recommendations are provided to enhance the management of qualitative research within CTUs.