Conducting qualitative research within Clinical Trials Units: Avoiding potential pitfalls

The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: 1. Unplanned modifications of the trial intervention during the full RCT 2. Selection bias and threats to external validity 3. Unblinding of group allocation 4. Breach of participant anonymity and confidentiality in small RCTs 5. Unplanned modifications of the trial processes and procedures 6. Threats to completion of recruitment, retention and outcome measurement. We make recommendations for improving the management of qualitative research within CTUs