Case study – Clinical Trial Experience
ENSURING PARTICIPANTS FEEL LIKE A PERSON, AND NOT A ‘STUDY EYE’
PLACEBO HIGHLIGHTED AS A ‘RED FLAG’
A placebo-controlled trial was being designed to investigate a novel treatment in an early stage of a progressive eye disease. If uncontrolled, the disease progresses to vision threatening complications.
In assessment interviews with patients, they expressed uncertainty about whether they would enrol into the study due to the placebo arm.
Developing a placebo mitigation strategy
After uncovering this challenge with patients, we asked sites how this could be best overcome. Their advice was built into the trial engagement strategy and protocol:
- Build communication materials as part of the trial for sites highlighting the value of increased monitoring in a progressive disease.
- Cover the cost of treatment in the case of progression for the length of the trial.
These were designed to ensure patients felt valued whilst assuaging concerns that participation may put their health at risk.
