Incremental Drug Treatment Cost in HIV-Positive Patients in Industry-Sponsored Clinical Trials

BACKGROUND: Drugs used in clinical trials supported by the pharmaceutical industry are supplied free of charge by the companies. However, maintenance of treatment with those drugs when the trials have finished can generate extra cost for patients who participated in the trials. OBJECTIVE: To assess whether HIV-infected patients' participation in clinical trials results in drug cost savings or increases. METHODS: An analysis of all antiretrovirals dispensed to HIV-infected outpatients prior to, during, and after their participation in clinical trials in a university hospital during a 2-year period was conducted. Only patients who completed the trial during the study period were included. The following outcomes were measured: (1) cost saved (difference between cost per day during the trial and cost per day before study entry), (2) cost generated (difference between cost per day at the end of the trial and cost per day before study entry), (3) balance between cost saved and cost generated, and (4) number of days that a patient received a drug once the trial was finished to generate cost, considering costs saved. All data were extracted from the hospital pharmacy database. A stratified analysis by type of clinical trial (ordinary or expanded use) was undertaken. RESULTS: Data from 61 patients were analyzed. The cost of drug therapy during patient participation in a clinical trial was lower than the cost prior to inclusion. Therefore, mean drug savings of $10.38 (US) per patient day resulted (95% Cl -5.9 to 14.84). The mean cost generated was $8.74 per patient day (95% Cl 3.95 to 13.52). CONCLUSIONS: A patient's participation in a clinical trial or expanded-access clinical trial generated extra cost once the trial had finished because the cost of drug therapy was higher at the end of the study. In our study, the daily drug costs saved during the trial were similar to the daily drug costs generated.