Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature.

Posted: Jan 03, 2013
Ellis PM. Ann Oncol. 2000 Aug. 11. 8. 939-45.
KEYWORDS: Knowledge/Attitudes/Beliefs, Provider-Patient Relationship, Attitudes, Randomization, Consent, Cancer


Patient education improves understanding and preserves autonomy, but may not help recruitment.

Why this item may be useful

A variety of issues affect whether patients and physicians participate in randomized clinical trials. These issues include patient attitudes, physician attitudes, ethical concerns, and patient understanding and education. Several studies suggest that patient education can improve understanding about clinical trials, preserve autonomy and improve recall of information, however, increased knowledge did not lead to increased participation. Demographics indicate that males, patients who are older, less well educated, or from lower socioeconomic backgrounds are more willing to participate as are those who trust their doctor's recommendation to participate. The author urges future research on links between knowledge about clinical trials, anxiety tied to a recent cancer diagnosis, and willingness to enroll in clinical trials.


  • Factors that influence physician participation are:
    • Logistic difficulties: unaware of open trials, lack of time or resources, financial constraints
    • Personal difficulties: effect on doctor-patient relationship, discomfort with randomization, difficulty with informed consent procedures
  • Factors that influence patient participation are:
    • Faith, trust in doctor
    • Preference for a particular treatment
    • Concerns about treatment toxicity
  • Factors related to the clinical trial that may influence participation are:
    • Poorly designed or complex protocols
    • Presence of a no treatment arm
    • Large difference between treatment arms, e.g., surgery verses radiotherapy