Aspects of Modernizing Drug Development Using Clinical Scenario Planning and Evaluation
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Aspects of Modernizing Drug Development Using Clinical Scenario Planning and Evaluation Norbert Benda, Michael Branson, Willi Maurer and Tim Friede Drug Information Journal 2010 44: 299 DOI: 10.1177/009286151004400312 The online version of this article can be found at: http://dij.sagepub.com/content/44/3/299
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Aspects of Modernizing Drug Development Using Clinical Scenario Planning and Evaluation Modem drug development requires an efficient
Norbert Benda, PbD Federal Institutefor Drugs and Medical Devices, Bonn, Germany
Micboel Bronson, PbD Novartis Pharma AG, Basel, Switzerland
Will1 Horror, PbD Novartis Pharma AG, Basel, Switzerland Tim Friede, PbD University Medical Center GGttingen, Department of Medical Statistics, Gottingen,Germany
Key Words Clinical scenario evaluation; Critical Path Initiative; Clinical development plan; Clinical design optimization; Simulation; Robustness; Modem protocol design
Correspondence Address Norbert Benda. Federal Institutefor Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee3, D-53175 Bonn, Germany (email: [email protected]).
we propose a genendbmmorkfor compardinical development program to have a moning competing optionsfor dinicalprorograms, triable chanceof s u c c e s s mleading to the submisal designs, and analysis methods as a basis for sion of the themp~given that the thempy is efdecision making and to facilitate the internal fh've, or to earj.stoppingifthis is not the case. and external dialogue with key stakehdders. Clinical trials and programs should be designed 'Ihe final decision making ultimately needs to to ejJh'v$u support this final goal, h+, factor in quantitative aspects as well as addithe statistical planning in drug development is tional qualitative dimensions such as logistic based on pmts of a dinicalprogram in isdation, faibilitr, regulatory a tance, and so on. A conditioned on one fied setting, focusing on tennindogy is introduc that dearfy describes sample size calculation or simple design questhe different aspects of such a fMmmork, the tions. l'here is, howeve an increasing demand mnge of underlying assumptions, the competing for a dinical progmm optimization and acceleroptions, and the metrics that are used to assess ation as well as an unconditional evaluation and compare these options. of relative progmm @ciencu, robrcstness, and 'Ihmspmic case studies are presented that validity 'Ihe complex@ of the development illustmte these concepts a
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