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. 2013 Jul;9(4):e174-81.
doi: 10.1200/JOP.2012.000763. Epub 2013 Mar 5.

Screening intervention to identify eligible patients and improve accrual to phase II-IV oncology clinical trials

Leo Chen  1 , Janice Grant, Winson Y Cheung, Hagen F Kennecke
Affiliations

Screening intervention to identify eligible patients and improve accrual to phase II-IV oncology clinical trials

Leo Chen et al. J Oncol Pract. 2013 Jul.

Abstract

Purpose: Low enrolment rates in clinical trials present a barrier to the development of novel cancer therapies. Currently, only 3% of patients with cancer participate, and many studies fail to achieve necessary enrolment. The objective of this study was to evaluate whether a screening intervention to identify potentially eligible patients (PEPs) would increase accrual rates.

Patients and methods: Over a 4-month intervention period, PEPs for 21 phase II-IV breast, gastrointestinal, genitourinary, gynecology, and lung cancer trials were identified by a screening coordinator. This individual reviewed the electronic medical records of patients attending outpatient clinics and flagged PEPs for 10 medical oncologists at the BC Cancer Agency. Patients who were already documented to be trial eligible by physicians were not flagged. Oncologists were surveyed regarding the helpfulness and accuracy of the intervention.

Results: During the intervention period, 73 patients were enrolled, compared with 61 patients enrolled in the 4 months prior and 51 patients in the 4 months after. A total of 2,098 charts were reviewed, and 120 PEPs were identified during the intervention period, resulting in 19 PEPs who enrolled and four PEPs who declined a clinical trial. Relative accrual rates adjusted for oncologist appointments were 0.85 (P = .15) before and 0.70 (P < .005) after, relative to the intervention period. Oncologist-returned surveys indicated that 67% of flags were helpful, and 70% were accurate.

Conclusions: In this study, manually screening patient records increased enrolment to specific clinical trials. A screening intervention process, involving a dedicated screening coordinator, should be considered to improve clinical trial accrual.

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Figures

Figure 1.
Figure 1.
Identification and outcome of potentially eligible patients for clinical trials and flow chart of clinical trial recruitment process during chart screening implementation.
Figure A1.
Figure A1.
Distribution of the screening coordinator's time.
Figure A2.
Figure A2.
Accrual outcomes by intervention period, showing the number of patients accrued to clinical trials.
See this image and copyright information in PMC

References

    1. National Cancer Institute. Clinical trials search results. //www.cancer.gov/clinicaltrials/search.
    1. Go RS, Frisby KA, Lee JA, et al. Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer. 2005;106:426–433. - PubMed
    1. Comis RL, Miller JD, Colaizzi DD, et al. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. J Clin Oncol. 2009;5:50–56. - PMC - PubMed
    1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA. 2004;291:2720–2726. - PubMed
    1. Ehrlich PF, Newman KD, Haase GM, et al. Lessons learned from a failed multi-institutional randomized controlled study. J Pediatr Surg. 2002;37:431–436. - PubMed

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