Publication:

Consumer involvement in cancer clinical trials: an Australian experience

Background Healthcare consumer involvement in clinical research is considered best practice, however its relationship to trial success is ambiguous. There is limited Australian evidence. This study seeks to examine whether consumer involvement is associated with trial success in the Australian Cancer Clinical Research Network (CRN) landscape, with a skin cancer focus.

Methods Drawing on the theories of evidence-based medicine and implementation research, published data was studied to characterize cancer research consumer involvement, in particular skin cancer. Mature data from skin cancer trials with the same Australian sponsor was studied to identify, define and evaluate specific consumer initiatives for an association with trials that completed. Trial success was measured by sufficient recruitment that was adequate to answer the research question. Data were extracted and tabulated (grouped, deidentified). Using descriptive statistics, a multi-disciplinary expert team synthesized and interpreted the data.

Results All Australian cancer CRNs demonstrated integrated consumer involvement in their organizational governance and trial operations. During 2008-2020, 56 studies were screened; six studies met the criteria. Four consumer initiatives were described (consumer expertise, trial promotion, trial access, patient safety; with examples). The only metric associated with success was the degree of trial access. Only 2/6 selected studies achieved target accrual. There are several study limitations.

Conclusions Australian CRNs demonstrated integrated consumer involvement that meets the best-practice policies and standards. Trial accrual is challenging including in Australian skin cancer research. Specific consumer initiatives have been identified and described to support trial sponsor governance and trials operations. Future research is warranted.