11018 Background: Patient Public Involvement and Engagement (PPIE) is essential in healthcare and cancer research. Currently, there is no objective method to assess at which stage of a clinical trial PPIE is effectively implemented. In this study, we developed a simple method for objectively assessing PPIE with an international scale. Methods: A novel, simple scoring method was developed to evaluate the PPIE implementation in cancer research. It follows the EUPATI Patient Engagement Roadmap and assesses PPIE at eight steps: defining research priorities, fundraising, protocol, informed consent, ethical review, investigator meeting, study results reporting, and application. PPIE level was self-rated by investigators on a five-level engagement scale: no engagement, considered, informed, actively involved, and co-creation. It was submitted to 124 Japanese and 203 European principal investigators (PI) of non-commercial sponsor cancer research clinical trials, conducted between January 2018 and December 2022, identified from publicly available databases (EudraCT, UMIN, jRCT). Results: The questionnaire was answered by 66 (53.2%) and 45 (22.2%) of the Japanese and European PIs, respectively. Overall, the PPIE implementation was low in both regions, with a “no engagement” rate of 61.7% in Europe and even lower, 78.5%, in Japan. Forty percent of the European PIs actively engaged patients (“actively involved” and “co-creation”) in at least one research step, versus only 16.7% of the Japanese PIs. The percentage of PIs answering “no engagement” in all eight steps was 47.0% in Japan and 11.1% in Europe. PPIE was the highest for the informed consent domain, with 73.3% of the European and 20.3% of the Japanese PIs reporting some level of engagement. Similarly, 55.6% of the European and 18.8% of the Japanese PIs involved PPIE in the ethical review domain. PPIE was notably low in the earlier steps of the research. Conclusions: Our innovative PPIE scoring method allowed us to objectively assess PPIE in cancer clinical trials and compare its implementation among different countries. This 2018-2022 snapshot revealed low (EU) to very low PPIE (Japan) levels, especially in the research design. Future assessments should help to monitor the enhancement of PPIE in cancer research on an international scale.
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