Communication and informed consent in phase 1 trials: a review of the literature from January 2005 to July 2009

Abstract

Objective and methods: A review conducted in 2005 identified many of the communication difficulties experienced by patients and doctors when discussing phase 1 (P1) oncology trials. The current paper is an update of the area and focuses on studies that measure patient comprehension of information given during the P1 trial discussion and ways to enhance understanding. A literature search was performed for relevant articles published between January 2005 and July 1st 2009.

Results: Only 12/109 studies met the criteria for inclusion in the review. One study recorded the actual trial discussion and compared patients' understanding with what the clinician had communicated. The others used interview techniques and surveys to elicit patients' understanding of P1 trials, motivations for considering trials and expectations of benefit. Two examined interventions to aid patient understanding.

Conclusion: Explaining potential participation in a P1 trial with a patient with cancer is not an easy task: the doctor must ensure that the patient has an accurate understanding of their condition and that standard treatments have now been exhausted. This must be followed by admission of the probable lack of any therapeutic benefit from the P1 drug together with the possibility that there might be unwanted side effects, many of which are unknown. These are all challenging subjects. New educational initiatives informed through research conducted with patients and health care professionals are currently being developed and clearly much needed.