title: Funding oncology clinical trials: are cooperative group trials sustainable?
abstract: OBJECTIVE
  Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD.
  
  
  METHODS
  We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data.
  
  
  RESULTS
  Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry).
  
  
  CONCLUSIONS
  The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.
authors.affiliation: McMaster University, Canada. seowh@mcmaster.ca
authors.forename: Hsien-Yeang
authors.initials: HY
authors.lastname: Seow
authors.forename: Patrick
authors.initials: P
authors.lastname: Whelan
authors.forename: Mark N
authors.initials: MN
authors.lastname: Levine
authors.forename: Kathryn
authors.initials: K
authors.lastname: Cowan
authors.forename: Barbara
authors.initials: B
authors.lastname: Lysakowski
authors.forename: Brenda
authors.initials: B
authors.lastname: Kowaleski
authors.forename: Anne
authors.initials: A
authors.lastname: Snider
authors.forename: Rebecca Y
authors.initials: RY
authors.lastname: Xu
authors.forename: Andrew
authors.initials: A
authors.lastname: Arnold
mesh_terms: D000046:Academic Medical Centers / Q000191:economics* / Q000458:organization & administration; D002170:Canada; D002173:Cancer Care Facilities / Q000191:economics* / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000191:economics*; D003299:Cooperative Behavior; D017048:Health Care Costs; D019981:Health Care Sector / Q000191:economics* / Q000458:organization & administration; D005102:Health Expenditures; D006801:Humans; D007182:Income; D018803:Models, Economic; D009369:Neoplasms / Q000191:economics* / Q000628:therapy*; D012107:Research Design; D012109:Research Support as Topic / Q000458:organization & administration; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome