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Pharmaceutical Adviser, Health Care Insurance Board, Diemen, Netherlands; Researcher, Faculty of Science, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
Hospital Pharmacist, Chief Editor, Farmacotherapeutisch Kompas, Health Care Insurance Board, Diemen
Emeritus Professor of Clinical Pharmacology, Department of Pharmacology and Toxicology, Section of Clinical Pharmacology and Toxicology, Radboud University, Medical Centre, Nijmegen, Netherlands
Professor of Pharmacoepidemiology, Faculty of Science, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Reprints: Dr. Leufkens, Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB, Utrecht, Netherlands, fax 31 30 253 9166, H.G.M.Leufkens{at}uu.nl
BACKGROUND: When choosing the active control group in a randomized trial, it is important to maintain standard treatment for the therapeutic indication for which a medicine is studied. This choice is relevant not only for demonstrating the efficacy and safety of a new drug, but also for assessing its place in therapy in comparison with existing medicines. Comparative information is important for decisions on prescribing and reimbursement. However, choosing the most suitable comparator is difficult when recommendations on drugs of first choice vary depending on clinical settings and times.
OBJECTIVE: To evaluate the choice of comparator in premarketing randomized active control trials (RaCTs) in comparison with recommendations for standard treatment.
METHODS: We evaluated drugs that were authorized for use in the European Union market between 1999 and 2005. Information on active comparators in RaCTs was extracted from the European Public Assessment Reports and information on recommendations regarding standard treatment was retrieved from the annual editions of the Dutch reference book on pharmacotherapy. Data on prescribing and indications at the time of authorization and 3 years before authorization were included. The comparator was considered to be in line with standard treatment if there was a similarity in both active substance or therapeutic class and the dosage.
RESULTS: For 58 new medications identified, treatment in the active control group was in line with the recommended standard treatment in 108 of 153 (71%) RaCTs at the time of the drug's authorization; 47 (81%) of the new drugs had been compared with the recommended standard treatment in at least one trial. When dissimilarities occurred, none of the comparators had been recommended as standard treatment 3 years earlier (the supposed time of defining the trials' protocol).
CONCLUSIONS: Most comparators in the premarketing RaCTs of new medicines were in line with the recommended standard treatment at the moment of marketing authorization. In view of this similarity, most of these trials are also fit for postmarketing decision-making on prescribing and on inclusion in clinical guidelines and reimbursement systems.
Key Words: comparators, head-to-head trials, randomized active control trials, standard treatment
Published Online, October 28, 2008. www.theannals.com, DOI 10.1345/aph.1L115
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