Over the time I’ve been involved in the industry, clinical trials have witnessed an increase in complexity in terms of their execution – where multiple site visits for patients have become the norm. Sometimes even before they are accepted into the trial. Additionally, there can often be a need for the patient to maintain ongoing records of their well-being and response to the prospective treatment. Which places a significant burden on the participant. Who, after all, is a volunteer in the process.

Perhaps most significantly, the inclusion and exclusion criteria for trials have grown more intricate, demanding very specific criteria to be met in order to qualify for participation. This inevitably narrows the potential pool of participants – which may already be quite limited, especially in the case of trials focused on rare diseases.

Patient-facing materials can also be excessively complex and challenging to comprehend, potentially resulting in a decline in interest from individuals who may otherwise be willing to participate.