title: An evaluation of barriers to accrual in the era of legislation requiring insurance coverage of cancer clinical trial costs in California.
abstract: 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.
authors.affiliation: University of California Davis Cancer Center, Sacramento, California 95817, USA.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Martel
authors.forename: Yueju
authors.initials: Y
authors.lastname: Li
authors.forename: Laurel
authors.initials: L
authors.lastname: Beckett
authors.forename: Helen
authors.initials: H
authors.lastname: Chew
authors.forename: Scott
authors.initials: S
authors.lastname: Christensen
authors.forename: Angela
authors.initials: A
authors.lastname: Davies
authors.forename: Kit S
authors.initials: KS
authors.lastname: Lam
authors.forename: Derick H
authors.initials: DH
authors.lastname: Lau
authors.forename: Frederick J
authors.initials: FJ
authors.lastname: Meyers
authors.forename: Robert T
authors.initials: RT
authors.lastname: O'donnell
authors.forename: Carol
authors.initials: C
authors.lastname: Richman
authors.forename: Sidney
authors.initials: S
authors.lastname: Scudder
authors.forename: Michael
authors.initials: M
authors.lastname: Tanaka
authors.forename: Joseph
authors.initials: J
authors.lastname: Tuscano
authors.forename: Jeanna
authors.initials: J
authors.lastname: Welborn
authors.forename: Theodore
authors.initials: T
authors.lastname: Wun
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
authors.forename: Primo N
authors.initials: PN
authors.lastname: Lara
mesh_terms: 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