Factors associated with clinical trial screening failures in gynecologic oncology.

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. We sought to determine factors associated with clinical trial screening failures in women with gynecologic malignancies at a large urban university health system. A retrospective review was conducted of women with gynecologic malignancies who presented to an urban university system between 12/2009 and 12/2012. Data collected included demographic, clinico-pathologic and trial-related factors, as well as reasons for non-participation. Two hundred twenty-one patients were eligible for a clinical trial. Of these, 44% participated while 56% did not. There were more screening failures when trials were offered at the time of primary treatment than at recurrence (62% vs. 38%, p=0.001). There was no significant difference in participation based on age, ethnicity, hospital setting, payor status, family history, comorbidities, prior treatment, substance abuse, recent surgery or trial type. Of the non-participants, 62% declined the study due to perceived harm and 10% due to socio-economic barriers while 20% were excluded due to co-morbidities and 8% due to noncompliance. Significantly more screening failures for clinical trials occurred when trials were offered at the time of primary treatment. The majority of patients declined based on perceived harm from enrolling in a clinical trial, although 20% of eligible patients were not offered enrollment despite not meeting any exclusion criteria. Our findings underscore the importance of appropriate counseling when offering clinical trials, as well as overcoming physician biases in deciding who is an appropriate candidate.

Original languageEnglish (US)
Pages (from-to)450-454
Number of pages5
JournalGynecologic Oncology
Volume134
Issue number3
DOIs
StatePublished - 2014

Fingerprint

Clinical Trials
Neoplasms
Urban Health
Substance-Related Disorders
Comorbidity
Counseling
Therapeutics
Economics
Demography
Morbidity
Physicians
Recurrence
Research

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Factors associated with clinical trial screening failures in gynecologic oncology. / Manders, Dustin B.; Paulsen, Annette; Richardson, Debra L.; Kehoe, Siobhan M.; Miller, David S.; Lea, Jayanthi S.

In: Gynecologic Oncology, Vol. 134, No. 3, 2014, p. 450-454.

Research output: Contribution to journalArticle

@article{419aede19aa445ab96f3ed5c0646f12f,
title = "Factors associated with clinical trial screening failures in gynecologic oncology.",
abstract = "Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. We sought to determine factors associated with clinical trial screening failures in women with gynecologic malignancies at a large urban university health system. A retrospective review was conducted of women with gynecologic malignancies who presented to an urban university system between 12/2009 and 12/2012. Data collected included demographic, clinico-pathologic and trial-related factors, as well as reasons for non-participation. Two hundred twenty-one patients were eligible for a clinical trial. Of these, 44{\%} participated while 56{\%} did not. There were more screening failures when trials were offered at the time of primary treatment than at recurrence (62{\%} vs. 38{\%}, p=0.001). There was no significant difference in participation based on age, ethnicity, hospital setting, payor status, family history, comorbidities, prior treatment, substance abuse, recent surgery or trial type. Of the non-participants, 62{\%} declined the study due to perceived harm and 10{\%} due to socio-economic barriers while 20{\%} were excluded due to co-morbidities and 8{\%} due to noncompliance. Significantly more screening failures for clinical trials occurred when trials were offered at the time of primary treatment. The majority of patients declined based on perceived harm from enrolling in a clinical trial, although 20{\%} of eligible patients were not offered enrollment despite not meeting any exclusion criteria. Our findings underscore the importance of appropriate counseling when offering clinical trials, as well as overcoming physician biases in deciding who is an appropriate candidate.",
author = "Manders, {Dustin B.} and Annette Paulsen and Richardson, {Debra L.} and Kehoe, {Siobhan M.} and Miller, {David S.} and Lea, {Jayanthi S.}",
year = "2014",
doi = "10.1016/j.ygyno.2014.06.023",
language = "English (US)",
volume = "134",
pages = "450--454",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Factors associated with clinical trial screening failures in gynecologic oncology.

AU - Manders, Dustin B.

AU - Paulsen, Annette

AU - Richardson, Debra L.

AU - Kehoe, Siobhan M.

AU - Miller, David S.

AU - Lea, Jayanthi S.

PY - 2014

Y1 - 2014

N2 - Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. We sought to determine factors associated with clinical trial screening failures in women with gynecologic malignancies at a large urban university health system. A retrospective review was conducted of women with gynecologic malignancies who presented to an urban university system between 12/2009 and 12/2012. Data collected included demographic, clinico-pathologic and trial-related factors, as well as reasons for non-participation. Two hundred twenty-one patients were eligible for a clinical trial. Of these, 44% participated while 56% did not. There were more screening failures when trials were offered at the time of primary treatment than at recurrence (62% vs. 38%, p=0.001). There was no significant difference in participation based on age, ethnicity, hospital setting, payor status, family history, comorbidities, prior treatment, substance abuse, recent surgery or trial type. Of the non-participants, 62% declined the study due to perceived harm and 10% due to socio-economic barriers while 20% were excluded due to co-morbidities and 8% due to noncompliance. Significantly more screening failures for clinical trials occurred when trials were offered at the time of primary treatment. The majority of patients declined based on perceived harm from enrolling in a clinical trial, although 20% of eligible patients were not offered enrollment despite not meeting any exclusion criteria. Our findings underscore the importance of appropriate counseling when offering clinical trials, as well as overcoming physician biases in deciding who is an appropriate candidate.

AB - Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. We sought to determine factors associated with clinical trial screening failures in women with gynecologic malignancies at a large urban university health system. A retrospective review was conducted of women with gynecologic malignancies who presented to an urban university system between 12/2009 and 12/2012. Data collected included demographic, clinico-pathologic and trial-related factors, as well as reasons for non-participation. Two hundred twenty-one patients were eligible for a clinical trial. Of these, 44% participated while 56% did not. There were more screening failures when trials were offered at the time of primary treatment than at recurrence (62% vs. 38%, p=0.001). There was no significant difference in participation based on age, ethnicity, hospital setting, payor status, family history, comorbidities, prior treatment, substance abuse, recent surgery or trial type. Of the non-participants, 62% declined the study due to perceived harm and 10% due to socio-economic barriers while 20% were excluded due to co-morbidities and 8% due to noncompliance. Significantly more screening failures for clinical trials occurred when trials were offered at the time of primary treatment. The majority of patients declined based on perceived harm from enrolling in a clinical trial, although 20% of eligible patients were not offered enrollment despite not meeting any exclusion criteria. Our findings underscore the importance of appropriate counseling when offering clinical trials, as well as overcoming physician biases in deciding who is an appropriate candidate.

UR - http://www.scopus.com/inward/record.url?scp=84908311298&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908311298&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2014.06.023

DO - 10.1016/j.ygyno.2014.06.023

M3 - Article

C2 - 24992676

AN - SCOPUS:84908311298

VL - 134

SP - 450

EP - 454

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -