Abstract:
Research Question: What are the psychosocial factors that affect causality
assessment in early phase oncology clinical trials?
Methods: Thirty-two qualitative interviews were explicated with the aid of
“Naturalistic Decision Making”. Data explication consisted of phenomenological
reduction, delineating and clustering meaning units, forming themes, and
creating a composite summary. Participants were members of the National
Cancer Institute of Canada’s Clinical Trial Group Investigative New Drug
committee.
Results: The process of assigning causality is extremely subjective and full of
uncertainty. Physicians had no formal training, nor a tool to assist them with this
process. Physicians were apprehensive about their decisions and felt pressure
from their patients, as well as the pharmaceutical companies sponsoring the trial.
Conclusions: There are many problem areas when attributing causality, all of
which have serious consequences, but clinicians used a variety of methods to
cope with these problem areas.
