Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

Abstract

There are inadequate data on the outcomes of patients who declined to participate in randomised clinical trials as compared with those of participants. We retrospectively reviewed the patient characteristics and treatment outcomes of both participants and non-participants in the two randomised trials for chemotherapy-naive advanced non-small-cell lung cancer. Trial 1 compared four platinum-based combination regimens. Trial 2 compared two sequences of carboplatin plus paclitaxel and gefitinib therapies. Nineteen of 119 (16%) and 153 (37%) patients declined to participate in Trials 1 and 2, respectively. Among the background patient characteristics, the only variable associated with trial participation or declining was the patients' attending physicians (Po0.001). Important differences were not observed in the clinical outcomes between participants and non-participants, for whom the response rates were 30.6 vs 34.2% and the median survival times were 489 vs 461 days, respectively. The hazard ratio for overall survival, adjusted for other confounding variables, was 0.965 (95% confidence interval: 0.73 -1.28). In conclusion, there was no evidence to suggest any difference in the characteristics and clinical outcomes between participants and non-participants. Trial designs and the doctor -patient relationship may have an impact on the patient accrual to randomised trials.

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials

“…As documented in the literature, patient enrollment in a clinical trial requires a gateway offer to participate, most frequently coming from a physician. 55–57 Only 20% of those eligible for a clinical trial are explicitly offered the opportunity to enroll, 58 and physicians tend to be selective about offering participation on the basis their perception of a patient’s likelihood of adhering to the protocol. 59 Addressing these systemic barriers to the participation of minorities in clinical trials is critical and can be accomplished by integration of trained lay PNs into the clinical trial teams.…”

Enrollment of Patients With Lung and Colorectal Cancers Onto Clinical Trials

“…17,18 Nationally, attempts to influence provider behavior through financial incentives are under scrutiny. [19][20][21][22] The independent effect of financial compensation was not demonstrated in this study.…”

Characteristics and Outcomes of Patients With Advanced Gastric Cancer Who Declined to Participate in a Randomized Clinical Chemotherapy Trial

“…3 In this issue of Journal of Oncology Practice, Tanai et al 4 describe characteristics and outcomes of patients with gastric cancer who declined to participate in a chemotherapy randomized clinical trial (RCT). In brief, The Japan Clinical Oncology Group recently conducted a three-arm, phase III trial testing irinotecan plus cisplatin versus S-1 versus continuous fluorouracil infusion in patients with incurable gastric cancer.…”

“…Nevertheless, there is a consistent problem in that low accrual rates limit the progress of RCTs. [1][2][3] Several factors that act as barriers to participation in trials have been documented, [1][2][3][4][5][6] and some have been successfully targeted for improvement. [4][5] Major barriers include a lack of availability of appropriate trials, limitations of eligibility criteria, socioeconomic factors (including insufficient awareness of clinical trials, lack of medical insurance, and geographical limitations), physician triage, and patient decision making.…”