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Improving the experience of healthy participants during early phase clinical trials

How ICON’s application of a participant-centric approach is significantly improving recruitment and retention rates of healthy participants in early phase studies.

Healthy clinical trial participants are clinical research heroes – they are essential to early phase trials and are vital elements in developing important, life changing therapies – but healthy participant recruitment and enrolment is a challenge across the industry. Failure to recruit participants can cause significant impacts on study resources. Reorienting the approach to healthy participant recruitment and implementing a volunteer-centric strategy can yield more positive results throughout the recruitment funnel and improve both recruitment and retention rates for early phase clinical trials. 

Sophisticated strategies lead to study efficiency

Sponsors need rapid, flexible recruitment solutions to ensure their early phase studies are properly enrolled with healthy participants to meet their start-up timelines and budgets. Enrolment can be a long process with multiple stages of screening often taking several weeks. Not everyone who applies will be eligible based on the specifics of inclusion and exclusion criteria and there are typically a number of dropouts before the trial even begins. With these losses in the process, only 5-6% of all applicants are dosed in a clinical trial.

Incorporating volunteer centricity as the frame for recruitment and retention strategy focuses on the participant’s experience at key interaction points, including marketing outreach, initial screening and onsite clinical evaluation. Maintaining positive experiences at these points helps steer more efficient processes, resulting in recruitment rate improvement, reduced dropout rates and database growth. These improvements ripple throughout the study as larger participant databases can facilitate faster enrolment and minimised dropouts, therefore preventing schedule delays. Reduced dropout also avoids the high costs of additional recruitment efforts to replace participants lost later in the funnel.

 

Mapping the participant journey

Understanding the healthy participant journey is crucial to ultimately improving recruitment. Mapping the journey can afford more control over the recruitment process and provide concrete, actionable steps for improving the participant experience and retention rates.

The healthy participant journey begins with the decision process and then moves to the screening, onboarding and participation stages. Sophisticated online marketing strategies help maximise impact during the decision journey and grow the participant database. The onboarding stage includes all interaction moments from registration until participation. Optimising the journey at this stage helps reduce dropout rates at the screening stage, thus avoiding study start-up delays. After onboarding, participants move through the clinical trial journey. Optimisation of the overall experience generates positive recommendations, which can be measured by the Net Promoter Score (NPS) which is provided by the participant at the end of the process. A positive overall experience is crucial for volunteer retention, encouraging repeat participation and promotion.

ICON has mapped the participant journey throughout the clinical trial process in order to identify key milestones and potential drop out points. During this process, we identified strategic touchpoints throughout the journey where improvements could enhance the experience. Extensive surveys and panels were conducted to ensure we accurately captured experiences at each stage of the journey, including feedback informs which touchpoints to prioritise and how to best address any associated issues. For example, time and distance traveling to the screening centre was a recurring theme in both the mapping and survey exercises.

 

Measuring the method

While mapping the healthy participant journey provides additional control over the process, tracking and measuring the impact of this approach also allows for tactical refinement. Capturing data like dropout and retention rates and NPS scores provides feedback on the impact of participsnt-centric strategies. For example, after implementing a more strategic approach, the Dutch region’s Net Promoter Scores rose more than 40%, climbing from 17 in 2021 to 24 in 2022. In addition, dropout rates reduced and overall volunteer satisfaction scores improved from 6.5 to 8 on a scale of 1-10. This data can also allow for higher visibility of cost per volunteer acquisition and enhance resource forecasting and budgeting for future trials.

 

Case study: New medical screening centre in Utrecht facilitates easier access for trial volunteers

ICON’s early phase clinic in Groningen, the Netherlands is one of Europe’s largest phase 1 and 2 research centres, where we conduct over 60 studies per year. More than 40% of these are first-in-human trials requiring large numbers of healthy participants. The clinic's location in the northern part of the country was a barrier for volunteers who voiced the need for a more accessible screening location.

ICON has expanded the more centrally located screening centre in Utrecht in response to participant feedback, reducing the travel burden on people from the Netherlands as well as Belgium and Germany. The integration of a well-equipped laboratory ensures that more studies can be fully executed within a more accessible location – participants can attend both pre-trial screening and ambulatory visits during the trial. The reduced travel burden resolves a hurdle in the healthy participant journey and their experience in the new centre will continue to be tracked and measured for continuous improvement. The Utrecht screening centre serves as a pilot program for improving recruitment rates. Future expansion of screening capacity at other locations in Europe is currently being considered. 

Conclusion

Healthy volunteers are a critical part of early phase clinical research. Combining volunteer perspectives with the latest digital tools will result in higher enrolment and retention rates throughout the trial and encourage repeat participation in future research.

To learn more about ICON's approach to healthy volunteer recruitment, contact us. 

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