Where to involve (trial level)

Engaging consumers throughout the clinical trial process - from conception to dissemination - enhances the relevance, quality, and impact of research outcomes.

The Duke Clinical Research Institute (DCRI) and research partners have explored and described three distinct patient partnership models, which may help researchers identify which method of engagement and involvement is best for their research:

• Consultative (including patients or consumers as advisory board members)
• Collaborative (including patients or consumers as steering committee members)
• Patient-led (including patients or consumers as co-investigators)

These models provide frameworks for involving patients at various stages of the trial process, from providing feedback on study design to leading research initiatives. (Uhlenbrauck et al., 2018)

Building upon these models, recent literature emphasises the importance of integrating patient engagement throughout the entire research lifecycle. This includes involving patients in setting research priorities, designing study protocols, developing recruitment strategies, and disseminating findings. This helps ensure that research addresses the real-world concerns and experiences of patients, enhancing its applicability and effectiveness. (Shakhnenko et al., 2024).

The following pages provide examples of what involvement could look like at four key stages of a trial’s lifecycle. The 'next' button takes you to the first of these.

References

• Shakhnenko, I., Husson, O., Chuter, D., W. van der Graaf. (2024). Elements of successful patient involvement in clinical cancer trials: a review of the literature. ESMO Open, Volume 9, Issue 4. https://doi.org/10.1016/j.esmoop.2024.102947
• Uhlenbrauck, G., Schulman, J., Jernigan, K., McAdams, P., & Singler, L. (2018). Models of engagement: Patients as partners in clinical research. Applied Clinical Trials. https://www.appliedclinicaltrialsonline.com/view/models-engagement-patients-partners-clinical-research