Background: Cancer clinical trials collect participant demographic data. Data collection and reporting on gender identity and sexual orientation is limited.
Study Aims: Document what is known about collection of gender and sexuality data in cancer clinical trials, current practices, and perceptions among health care professionals regarding barriers and facilitators to collecting this data.
Methods: Our mixed methods study comprised two components:
i) Literature Review: Relevant peer-reviewed literature was identified by searching Proquest and Pubmed databases with consistent search parameters published between 1 January 2019 and 3 June 2024. Articles were screened, selected, and data extracted in EndNote and Excel by author 2.
ii) Qualitative interviews: Individuals (clinician, researcher, or other professional) with expertise in cancer clinical trials were recruited for structured interview within Australia. Interviews were conducted by two researchers experienced in qualitative research. Data will be analysed thematically, a sample of 5-10 individuals was determined pragmatically based on resources.
Results:
Conclusions: Cancer clinical trialists need clear recommendations about how to collect gender identity and sexual orientation data, communication about why it is important, and training on how to incorporate its collection in cancer clinical trials.