PROspectiVe imaging research DEsign and coNducT (PROVIDENT): Considerations for clinical trials and studies using imaging (Part I).

OBJECTIVES: Imaging is used in a wide range of contexts in clinical research projects, but adds complexity to the design, conduct and analysis. This paper is the first of two in which we use a consensus approach to bring together multidisciplinary perspectives on the challenges in conducting prospective clinical trials and research studies that include imaging. In this first part we consider challenges in ethics, participant information and consent, recruitment, trial/study and site set-up, training and trial or study conduct. KEY FINDINGS: Effective communication with patients regarding the purpose, benefits and risks, and potential future use of imaging data is essential to build trust and support informed participation. Transparency around data handling, including de-identification processes and the right to withdraw consent, underpins ethical research practice. Successful recruitment requires strong collaboration between clinical and imaging teams to ensure clarity, consistency, and efficiency. To reduce participant burden, flexibility should be offered in scheduling and scan requirements, taking into account accessibility and personal commitments. Site setup and staff training benefit from feasibility assessments that evaluate equipment capabilities and identify specific imaging training needs. Clearly defined roles and responsibilities of key personnel support streamlined workflows and accountability. Communication of planned changes to procedures during the study to all stakeholders is key to avoid delays and risks to data integrity. Effective monitoring of procedures, radiation doses (where applicable) and data quality should be pre-planned. CONCLUSION: These considerations derived from a multidisciplinary team will be useful for funding applications, protocol design, trial implementation, conduct, commercialisation and uptake of new imaging techniques. IMPLICATIONS FOR PRACTICE: Many prospective imaging studies could be improved by the upfront awareness of potential challenges and understanding of real-world examples these considerations provide.