Developing a clinical trial network
Delays in site initiation of enrollment. Difficulty hiring new coordinators. Extended timeline for regulatory approvals. Limited clinical trial research experience at some sites.
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Facilitating local success through central support
Support sites to fulfill regulatory requirements. Assist with hiring staff and maintaining investigator qualifications. Management of the Clinical Trial Management System. Facilitating regular review of study procedures, study protocol, and changes implemented by the VA Central Office. Early and frequent virtual site visits at each site to:
Discuss recruitment pathways. Provide recruitment tools. Identify workflow or patient interaction barriers to recruitment. Provide a “script” to help discuss trial to facilitate equipoise.
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Shifts in clinical practice for prostate cancer treatment
Evolving approvals of PSMA PET/CT imaging in recurrent and de novo prostate cancer, and consequent shifts in imaging practices. Newly emerging clinical trial data in oligometastasis. Changing standard systemic therapy practices.
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Adapting the study protocol to evolving research
Maintaining awareness on the developments in prostate cancer research and trial results, and regular dialogue with investigators. Study responds to the current research environment through amending the study protocol. Hold study- and site-level trainings on changes made to the study protocol and any operational procedures. Allow for the incorporation of evolving standard of care approaches while continuously reassessing scientific impact to maximize practicality, generalizability, and impact of study.
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Maintaining local study team
engagement
Faltering study coordinator attendance in all staff meetings. Sites’ limited understanding of study procedures. Lowering motivation over the length of the study.
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Maximize local site participation in study procedure development and provide value to local clinical programs through participation in the study
Local clinicians involved in the development of study treatments and assessments. Offer frequent and individualized study procedure trainings as local research staff turnover. Creation of custom clinical algorithms that sites can adapt to improve clinical pathways. Regular discussion with investigators on challenging clinical and RT scenarios, and strategies for implementing solutions. Scientific expert presentations at monthly all-staff meetings that are relevant to both study and non-study clinical care.
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