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Low participation rates and disparities in participation in interventional clinical trials for myelodysplastic syndromes.

Abstract：

BACKGROUND:The development of novel therapies for the myelodysplastic syndromes (MDS) is hampered by inadequate trial recruitment. Factors contributing to low trial accrual are incompletely understood. METHODS:This study analyzed a pooled patient database from institutions of the US MDS Clinical Research Consortium to compare the characteristics of participants in interventional trials with those of patients who did not enroll in a trial. RESULTS:Data were identified for 1919 patients with MDS, and 449 of these patients (23%) participated in an interventional clinical trial. The median age of all patients was 68 years, and 64% were male. Patients who participated in trials were significantly younger than nonparticipants (P = .014), and men were more likely to participate in a trial (71% of trial participants were male, whereas 61% of nonparticipants were; P < .001). Race and ethnicity were not associated with trial enrollment. Patients in more affluent ZIP codes had a higher participation rate (P < .001). Patients with intermediate- and high-risk disease according to the revised International Prognostic Scoring System were overrepresented (P = .004), and trial participants less frequently had treatment-related disease (P < .001). In multivariable analyses, participation in a clinical trial was associated with a reduced hazard of death (P = .004). Even at large referral centers, only a minority of patients with MDS enrolled in interventional trials. CONCLUSIONS:Restrictive trial eligibility criteria that exclude patients with MDS on account of age, comorbidities, or a history of another cancer are limit enrollment of MDS patients to clinical trials. Gaining insight into the barriers to trial accrual may help investigators and study sponsors to design trials that will accrue more rapidly and augment treatment options for patients with MDS.

journal_name

Cancer

journal_title

Cancer

authors

Brierley CK,Zabor EC,Komrokji RS,DeZern AE,Roboz GJ,Brunner AM,Stone RM,Sekeres MA,Steensma DP

doi

10.1002/cncr.33105

subject

Has Abstract

pub_date

2020-11-01 00:00:00

pages

4735-4743

issue

eissn

0008-543X

issn

1097-0142

journal_volume

126

pub_type

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Low participation rates and disparities in participation in interventional clinical trials for myelodysplastic syndromes.