Socioeconomic Differences in Referral to Phase I Cancer Clinical Trials: A Danish Matched Cancer Case-Control Study.

PURPOSE: In this nationwide registry study, we investigated socioeconomic and structural patterns in referral to phase I cancer trials in a case-control study design. METHODS: Personal identification numbers on all Danish patients referred to the Danish Phase I Unit at Rigshospitalet from 2005 to 2016, and a control group matched on age, sex, type of cancer, year of diagnosis, and time from diagnosis to referral ensured individual-level linkage between several registries. We examined the association between nonclinical factors-indicators of socioeconomic position and distance to the Phase I Unit-and referral using a conditional logistic regression analysis adjusted for several clinical factors. Association between nonclinical factors and enrollment once referred was examined with a Cox proportional hazards regression analysis in an historical cohort study design. RESULTS: Complete data were available for 1,026 (84%) of 1,220 referred patients. Significantly decreased odds for referral were identified for patients with long distance to the Phase I Unit compared with short distance (adjusted odds ratio [OR], 0.35; 95% CI, 0.30 to 0.41), for less education (less than 9 years) compared with more (more than 12 years; OR, 0.69; 95% CI, 0.56 to 0.91), and for belonging to the lowest income quintile compared with the highest (OR, 0.78; 95% CI, 0.62 to 0.97). Medium education (9 to 12 years) compared with more, being outside the workforce compared with being within, and living alone compared with living with a partner were also negatively associated with referral. Among patients referred, 252 enrolled in a trial. Nonclinical factors were not associated with enrollment. CONCLUSION: On the basis of individual long-term registry data from an unselected cohort, novel anticancer therapies seem to be tested on a socially selected group of patients with cancer.

Patient information in phase 1 trials: A systematic review.

OBJECTIVE: To review what is known about cancer patients' decisions to enter a phase 1 trial and how they and their relatives perceive the information they receive when they are invited to participate. METHODS: This systematic review is based on the principles of "preferred reporting items for systematic reviews and meta-analyses." A systematic search was performed in the PubMed, Embase, and PsycInfo databases, supplemented by a search for unpublished literature. RESULTS: We identified 37 studies for inclusion in this review. Patients' decisions to participate in a phase 1 trial were influenced by the drug being tested, information procedures, physician-related factors, and the patient's individual approach to decision making. Patients have difficulties correctly repeating the purpose of a phase 1 trial. In several studies, most patients expressed expectations of personal benefit from participating. Studies performing analyses of the dialog demonstrated that the language of the physicians was incomplete. The relatives' perceptions of such information remain unexplored. Most studies had a comprehensive risk of bias. CONCLUSIONS: Patients' decisions regarding participation in phase 1 trials are based on more than the information of the trial. The way patients express the information they have been given could be limited by the applied methods for evaluating this variable. While relatives are expected to be resources for patients entering a phase 1 trial, this topic has not been investigated.