Incremental treatment costs in national XXXX institute-sponsored clinical trials.

@entity1 @entity5
CONTEXT: Concern about additional costs for direct @entity1 care impedes efforts to enroll @entity1 in clinical trials. But generalizable evidence substantiating these concerns is lacking. OBJECTIVE: To assess the additional cost of treating @entity5 @entity1 in the National @entity5 Institute (NCI)-sponsored clinical trials in the United States across a range of trial phases, treatment modalities, and @entity1 care settings. DESIGN: Retrospective cost study using a multistage, stratified, random sample of @entity1 enrolled in 1 of 35 active phase 3 trials or phase 1 or any phase 2 trials between October 1, 1998, and December 31, 1999. Unadjusted and adjusted costs were compared and related to trial phase, institution type, and vital status. SETTING AND @entity1 : A representative sample of 932 @entity5 @entity1 enrolled in nonpediatric, NCI-sponsored clinical trials and 696 nonparticipants with a similar stage of disease not enrolled in a research protocol from 83 @entity5 clinical research institutions across the United States. MAIN OUTCOME MEASURES: Direct treatment costs as measured using a combination of medical records, telephone survey, and Medicare claims data. Administrative and other research costs were excluded. RESULTS: The incremental costs of direct care in trials were modest. Over approximately a 2.5-year period, adjusted costs were 6.5% higher for trial @entity1 than nonparticipants (35,418 dollars vs 33,248 dollars; P =.11). Cost differences for phase 3 studies were 3.5% (P =.22), lower than for phase 1 or 2 trials (12.8%; P =.20). Trial @entity1 who died had higher costs than nonparticipants who died (17.9%; 39,420 dollars vs 33,432 dollars, respectively; P =.15). CONCLUSIONS: Treatment costs for nonpediatric clinical trial @entity1 are on average 6.5% higher than what they would be if @entity1 did not enroll. This implies total incremental treatment costs for NCI-sponsored trials of 16 million dollars in 1999. Incremental costs were higher for @entity1 who died and who were in early phase studies although these findings deserve further scrutiny. Overall, the additional treatment costs of an open reimbursement policy for government-sponsored @entity5 clinical trials appear minimal.
