Results from the in-trial patient feedback questionnaires pilot at CRUK Centre for Drug Development


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Helen Turner, Sarah Day, Lesley Robson, Helen Wilkinson, Karen Hill, Pooja Shah, Habiba Hussain, Sarah Potter, Lesley Mcguigan

Abstract

Background

Recent initiatives to improve patient-centricity in clinical trials have had varied results with limited published data. Cancer Research UK’s Centre for Drug Development (CDD), a Sponsor of early phase oncology trials, set out to obtain patient feedback on trial conduct. CDD’s Patient Involvement Working Group (PIWG) has completed a pilot to evaluate the usefulness of obtaining patient feedback on trial conduct in our trials.

Method

A template patient experience questionnaire was developed in collaboration with patient representatives, to obtain feedback on clinical trial conduct. Following ethical approval, the questionnaire was used over a two-year period in a limited number of Phase I trials. Questionnaires were provided to patients by research nurses when patients were waiting for an assessment or results. This ensured that the questionnaire completion did not add to the time that patients were already at the hospital. Feedback was reviewed by each trial team and centrally by the PIWG.

Results

Over the two-year period, 36 patients were recruited to the trials taking part in the pilot, 11 of whom (30.6%) completed questionnaires. From the 11 patients, 100.0% responded “Yes” to the question “Did you have a good experience of taking part in the clinical trial”. Five  patients (45.5%) expressed concerns before taking part in the trial, and three patients (9.1%) experienced the issue they were concerned about prior to participating. Four patients (36.4%) made recommendations for improvements to future trials. Following initial lower response rates, the timing of questionnaire completion was adapted to allow feedback earlier in trials.

Conclusion

Results are being used to improve current and future clinical trials to provide a better patient experience. The CDD has used the feedback to improve the information included in informed consent documentation. Feedback has informed the planning of trials and consulting patients from the outset is becoming business as usual. The PIWG and trials team have found questionnaires useful to inform trial conduct and better support those living with cancer who join our trials. They will be refined and rolled out in all new trials at CDD.

Impact statement

Pilot results mean CRUK-CDD will seek in trial feedback from patients on all future trials.