An evaluation of barriers to accrual in the era of legislation requiring insurance coverage of cancer clinical trial costs in California.
OBJECTIVE
Clinical trials are essential to improve cancer therapy, but only 3% of newly diagnosed adult cancer patients enroll annually. We previously conducted a prospective analysis of factors affecting trial accrual at the UC Davis Cancer Center between 1997 and 2000. It was found that the accrual rate was 14% and that patients with private insurance were significantly less likely than patients with government insurance to enroll, suggesting that fear of insurance denial was a barrier. In 2002, a new California law (SB37) required insurers to reimburse routine costs of care for cancer trials.


METHODS
To assess the impact of SB37 on accrual, we repeated our study using the same sur vey instrument. Oncologists seeing new patients at the UC Davis Cancer Center from August to November 2002 completed questionnaires that inquired about patient characteristics and eligibility, protocol availability, and patient willingness to participate.


RESULTS
Physicians considered clinical trials for 55% (118/216) of patients, but trials were available for only 53% (62/118). Eligibility criteria were met by 82% (51/62). Of these, 69% (35/51) agreed to participate (vs 51% previously). No patient declined to participate because of insurance limitations (vs 8% previously). Furthermore, insurance type was no longer a significant factor in determining whether patients would enroll. This suggests that although the overall rate of accrual is only slightly increased after passage of SB37, patients may be more willing to enroll. Efforts to increase participation must include enhancing physician and patient awareness of SB37.
Martel
Cynthia L
CL
University of California Davis Cancer Center, Sacramento, California 95817, USA.
Li
Yueju
Y
Beckett
Laurel
L
Chew
Helen
H
Christensen
Scott
S
Davies
Angela
A
Lam
Kit S
KS
Lau
Derick H
DH
Meyers
Frederick J
FJ
O'donnell
Robert T
RT
Richman
Carol
C
Scudder
Sidney
S
Tanaka
Michael
M
Tuscano
Joseph
J
Welborn
Jeanna
J
Wun
Theodore
T
Gandara
David R
DR
Lara
Primo N
PN
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002140:California; D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D019458:Insurance Coverage; D007348:Insurance, Health; D007349:Insurance, Health, Reimbursement; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection; D011446:Prospective Studies; D012017:Referral and Consultation; D045808:Refusal to Participate / Q000523:psychology / Q000706:statistics & numerical data; D035842:Research Subjects / Q000523:psychology; D011795:Surveys and Questionnaires