title: Large clinical trials in epilepsy: funding by the NIH versus pharmaceutical industry.
abstract: Different approaches to clinical trials are taken by government-sponsored (NIH, VA, MRC) and industry-sponsored clinical trials. Each sector has a different perspective and funding capacity. Sponsorship often depends on the question. Initial safety and efficacy studies for regulatory purposes usually are industry-driven. Studies of drug use as monotherapy, direct comparisons among drugs, and comparisons between categories of drugs often are more important to prescribers and payors, thereby requiring government funding. The challenge to clinician-investigators is to now find ways to fund comparison trials to determine evidence-based guidelines so patients receive the best treatment both in the short- and long-term, and the health care system gets the best value.
authors.forename: Michael
authors.initials: M
authors.lastname: Privitera
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D004353:Drug Evaluation, Preclinical / Q000191:economics; D004345:Drug Industry / Q000191:economics*; D004827:Epilepsy / Q000188:drug therapy*; D005380:Financing, Government; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000191:economics*; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000379:methods; D012109:Research Support as Topic; D014481:United States
chemical_list: D000927:Anticonvulsants