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Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials.

ABSTRACT: The performance of randomized controlled trials (RCTs) is often hindered by recruitment difficulties. This study aims to explore the pre-screening phase of four prostate cancer RCTs to identify the impact of a systematic pre-selection of eligible patients for RCT recruitment.The pre-screening of four RCTs opened at the Comprehensive Cancer Center in Rennes was analyzed retrospectively (French Genitourinary Tumor Group (GETUG) 14, 15, 16, and 17). Data were extracted from electronic multidisciplinary cancer (MDC) reports and manually completed by physicians and medical secretaries. These data were the main source of information for clinicians to discuss treatment alternatives during MDC sessions. The pre-screening decisions made by the clinicians during these MDC meetings were compared with those made after a systematic review of the MDC reports by a clinical research assistant (CRA). Any inconsistencies in decisions between the CRA and the MDC physicians were corrected by the principal investigator (PI).The pre-screening rate was 9.1% during the MDC meetings, while it was estimated to be 12.9% after the final review by the PI, and 29% after the systematic review by the CRA. The study showed that 77% and 67% of the MDC reports did not mention clinical and pathological Tumor, lymph node and metastasis classification of malignant tumors (TNM) staging, respectively, and that 35 of the CRA's 47 proposals rejected by the PI concerned implicit information (not specified in the MDC reports). Only one patient was proposed by the PI, and none by the CRA.These results confirm that pre-screening could be improved by a systematic review of the medical reports. They also highlight the fact that missing data in electronic MDC reports leads to over-enrollment of non-eligible patients, but not to over-exclusion of eligible patients. Thus, our study confirms the potential gain in using semi-automated pre-selection of MDC reports, in order to avoid missing out on patients eligible for RCTs.The trials evaluated in this study were previously registered with clinicaltrials.gov (registration number: NCT00104741 on 3 March 2005; NCT00104715 on 3 March 2005; NCT00423475 on 16 January 2007; and NCT00667069 on 24 April 2008).

SUBMITTER: Campillo-Gimenez B

PROVIDER: S-EPMC4301877 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials.

Campillo-Gimenez Boris B Buscail Camille C Zekri Oussama O Laguerre Brigitte B Le Prisé Elisabeth E De Crevoisier Renaud R Cuggia Marc M

Trials 20150116

<h4>Background</h4>The performance of randomized controlled trials (RCTs) is often hindered by recruitment difficulties. This study aims to explore the pre-screening phase of four prostate cancer RCTs to identify the impact of a systematic pre-selection of eligible patients for RCT recruitment.<h4>Methods</h4>The pre-screening of four RCTs opened at the Comprehensive Cancer Center in Rennes was analyzed retrospectively (French Genitourinary Tumor Group (GETUG) 14, 15, 16, and 17). Data were extr ...[more]

PMID: 25592642

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Project description:Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), and attitudes toward participating in CCOP would directly determine enrollment. We also hypothesized that physicians' characteristics and CCOP organizational factors would influence physicians' attitudes toward participating in CCOP, which in turn would predict enrollment.We evaluated enrollment in National Cancer Institute-sponsored cancer clinical trials in 2011 among 481 physician participants using Structural Equation Modeling. The data sources include CCOP Annual Progress Reports, two surveys of CCOP administrators and physician participants, and the American Medical Association Masterfile.Physicians with more positive attitudes toward participating in CCOP enrolled more patients than physicians with less positive attitudes. In addition, physicians who practiced in CCOPs that had more supportive policies and practices in place to encourage enrollment (i.e. offered trainings, provided support to screen and enroll patients, gave incentives to enroll patients, instituted minimum accrual expectations) also significantly enrolled more patients. Physician status as CCOP Principal Investigator had a positive direct effect on enrollment, while physician age and non-oncology medical specialty had negative direct effects on enrollment. Neither physicians' characteristics nor CCOP organizational factors indirectly influenced enrollment through an effect on physician attitudes.We examined whether individual physicians' characteristics and attitudes, as well as CCOP organizational factors, influenced patient enrollment in cancer clinical trials among CCOP physicians. Physician attitudes and CCOP organizational factors had positive direct effects, but not indirect effects, on physician enrollment of patients. Our results could be used to develop physician-directed strategies aimed at increasing involvement in clinical research. For example, administrators may want to ensure physicians have access to support staff to help screen and enroll patients or institute minimum accrual expectations. Our results also highlight the importance of recruiting physicians for volunteer clinical research programs whose attitudes and values align with programmatic goals. Given that physician involvement is a key determinant of patient enrollment in clinical trials, these interventions could expand the overall number of patients involved in cancer research. These strategies will be increasingly important as the CCOP network continues to evolve.

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Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials.

Publications

Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials.

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