Recruitment to Early Phase Cancer Clinical Trials: Barriers and Opportunities

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

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Early phase cancer clinical trials: design, ethics and future directions

British Journal of Hospital Medicine ◽

10.12968/hmed.2015.76.7.409 ◽

2015 ◽

Vol 76 (7) ◽

pp. 409-413 ◽

Cited By ~ 1

Author(s):

Nicholas Coupe ◽

Avinash Gupta ◽

Simon R Lord

Keyword(s):

Clinical Trials ◽

Early Phase ◽

Cancer Clinical Trials ◽

Future Directions ◽

Design Ethics

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Adverse events (AEs) in early phase cancer clinical trials.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.2542 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. 2542-2542

Author(s):

Grace Mishkin ◽

Andrea Denicoff ◽

S. Percy Ivy ◽

Richard Piekarz ◽

Shanda Finnigan ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Early Phase ◽

Cancer Clinical Trials

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Prostate cancer clinical trials consortium: A multicenter mechanism for the rapid design, development, and implementation of early phase clinical trials

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e16065 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e16065-e16065

Author(s):

J. Vinson ◽

P. Mathew ◽

T. M. Beer ◽

M. A. Carducci ◽

W. Oh ◽

...

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Data Storage ◽

Early Phase ◽

Phase 1 ◽

Cancer Center ◽

Cancer Clinical Trials ◽

Research Centers ◽

Design Development ◽

Multicenter Studies

e16065 Background: Leading investigators in prostate cancer have hypothesized that clinical trials (CT) are optimally conducted as multicenter studies. To test this, the Prostate Cancer Clinical Trials Consortium (PCCTC) was formed with support from the Prostate Cancer Foundation (PCF) and the Department of Defense Clinical Consortium Award (DOD). Since the PCCTC's inception in 2006, members have cooperatively designed, carried out, and evaluated phase 1 and 2 multicenter studies in prostate cancer. Methods: PCF and DOD awards support a consortium of 13 cancer research centers. Memorial Sloan-Kettering Cancer Center serves as the coordinating center and is charged with creating an infrastructure to conduct early phase, multicenter trials. Annually, each participating center is required to introduce at least one CT for consideration by the PCCTC and accrue at least 35 patients to PCCTC studies. Investigators meet face-to-face twice per year to discuss the PCCTC's progress, and hold monthly conference calls to discuss scientific objectives, trial design, and ongoing studies. Results: Since inception, the PCCTC has expanded from 8 to 13 leading research centers. Through September 2008, it has opened 47 trials and accrued 1,282 patients at member sites. Members utilize a CT management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review have been established. Each year, the number of trials presented and patients accrued increases, and three concepts have progressed to the next phase of clinical testing. Conclusions: The PCCTC fulfills a congressional directive to create a CT instrument dedicated to rapid accrual to early-phase, multicenter studies in prostate cancer. The member institutions have built a shared administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. As the PCCTC has expanded and taken an increasingly active role in designing and evaluating protocols, clinical trials continue to open and accrue in excess of federally mandated goals. No significant financial relationships to disclose.

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