Physician barriers and dilemmas in the execution of clinical trials impacting decision-making in the DAHANCA 35 proton therapy trial for head and neck cancer

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  • Anne Wilhøft Kristensen
  • Cai Grau
  • Kenneth Jensen
  • Susanne Oksbjerre Dalton
  • Friborg, Jeppe Tang
  • Annesofie Lunde Jensen
Background
Physicians manage multiple obligations, providing best-practice treatment and patient- centred care in the standard treatment pathway while contributing to clinical trials simultaneously. These multifaceted responsibilities may introduce barriers and dilemmas to clinical trial execution, potentially impacting the clinical trial decision- making process. This study explores physicians’ barriers and dilemmas in executing clinical trials and the impact on clinical trial decision-making.

Method
Qualitative semi-structured interviews were conducted with experienced oncologists. Moreover, participant observations were performed during clinical encounters involving discussions about clinical trials. The analysis followed a structured approach: (1) transcription of data, (2) inductive text coding, (3) exploration of patterns, and (4) interpretation, leading to the results. The results were discussed and validated by the study participants.

Results
The results comprise (1) a description of the clinical practice, which presents the setting of clinical trial execution; (2) results regarding physicians’ barriers and dilemmas in executing clinical trials, leading to (3) the impact on clinical trial decision- making. The results involve barriers to time constraints for clinical trial tasks, dilemmas emerging from trial requirements or deviations from standard guidelines, and challenges with providing sufficient trial communication and adequate decision-making support, balancing between a paternalistic approach and respecting patient autonomy.

Conclusion
The demanding obligations of clinical practice constitute a complex setting for executing clinical trials, resulting in numerous barriers and dilemmas that impact the decision-making process in clinical trials. The study emphasises the need for tailored clinical trial decision-making interventions to facilitate supportive, informed, and non-directive clinical trial decision-making.
OriginalsprogEngelsk
Artikelnummer100259
TidsskriftTechnical Innovations and Patient Support in Radiation Oncology
Vol/bind31
Antal sider6
ISSN2405-6324
DOI
StatusUdgivet - 2024

Bibliografisk note

Funding Information:
This work was supported by the Danish Comprehensive Cancer Centre (DCCC) under Grant number 0310 and by a grant from the Novo Nordisk Foundation (NNF18OC0034612).

Publisher Copyright:
© 2024 The Author(s)

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