title: The procedure of new drug application and the philosophy of critical rationalism or the limits of quality assurance with good clinical practice.
abstract: K.R. Popper's philosophy of critical rationalism is concerned with the detection and removal of error. Fundamental contradictions exist between Popper's theory of knowledge and the present-day practice of the clinical investigation of new drugs. Currently, the public authorities concerned with the licensing of drugs pass judgment on trials, which are closely linked by the one-sponsor problem: the assertions made by the sponsor are not independently confirmed. This lack leads to excessive documentation and to costly monitoring and auditing, which are intended to ensure the credibility of results. In Popper's view, confirmatory trials, independent of the sponsor and supervised by the regulatory bodies, would be a better way to achieve reliable knowledge. The consequence would, among other things, be a reorganization of phase III of the clinical investigation of new drugs by dividing it into independent parts, one under the control of the sponsor and one under the control of the public authority. The implementation of this suggestion would lead to a more scientific manner of dealing with new drugs and to savings in terms of unproductive measures during the application process.
authors.affiliation: University of Ulm, Department of Biometry and Medical Documentation, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Högel
authors.forename: W
authors.initials: W
authors.lastname: Gaus
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D004282:Documentation / Q000191:economics; D017277:Drug Approval / Q000379:methods*; D004341:Drug Evaluation; D016903:Drug Monitoring / Q000191:economics; D004335:Drug and Narcotic Control; D006801:Humans; D008128:Logic; D008485:Medical Audit / Q000191:economics; D010686:Philosophy, Medical; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D012107:Research Design