title: Patients' perceptions of research biopsies in phase I oncology trials.
abstract: OBJECTIVE
  Research biopsies are increasingly incorporated into phase I oncology trials resulting in ethical and logistical challenges for patients and clinicians. Patients' understanding and willingness to undergo these biopsies are crucial.
  
  
  METHODS
  Over 12 months, we administered a questionnaire comprising three sections: demographics and previous cancer therapy, understanding of phase I trials and personalized medicine, and understanding of biopsies and associated risks.
  
  
  RESULTS
  Out of 56 patients approached, 47 patients completed the questionnaire. Overall, the patients were well informed about the concepts of personalized medicine and 89% (n = 42) were aware that early phase clinical trials aim to define a dose and explore side effects of new drugs. Interestingly, 76% (n = 36) expected early phase trials to improve symptoms, quality of life and survival. Offering hope and feeling in control of their treatment were important components for 80% (n = 38) and 57% (n = 27), respectively. The majority of this highly selective patient cohort understood the concept of research biopsies, with 59% (n = 28) willing to have a fresh research biopsy for trial participation. Although 72% (n = 34) felt that research biopsies should be optional, only 19% (n = 9) would not participate in a clinical trial with mandatory biopsies. Compared to diagnostic biopsies, the patients were less likely to accept associated risks with research biopsies.
  
  
  CONCLUSIONS
  As research biopsies are crucial to many components of the drug development process, our study provides evidence for patients' overall willingness to undergo research biopsies for trial purposes. A consent process tailored to the biopsy site may help patients weigh up the associated risks versus benefits.
authors.affiliation: Sarah Cannon Research Institute, London, UK.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Lemech
authors.forename: Divyanshu
authors.initials: D
authors.lastname: Dua
authors.forename: Joshua
authors.initials: J
authors.lastname: Newmark
authors.forename: Matilde
authors.initials: M
authors.lastname: Saggese
authors.forename: Emily
authors.initials: E
authors.lastname: Simmons
authors.forename: Paulina
authors.initials: P
authors.lastname: Spiliopoulou
authors.forename: Hendrik-Tobias
authors.initials: HT
authors.lastname: Arkenau
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D017321:Clinical Trials, Phase I as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000473:pathology*; D010465:Perception; D057285:Precision Medicine; D011795:Surveys and Questionnaires