title: Use of statistical and pharmacokinetic-pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference.
abstract: The application of modeling and simulation (M&S) methods to improve decision-making was discussed during the Trends & Innovations in Clinical Trial Statistics Conference held in Durham, North Carolina, USA on May 1-4, 2016. Uses of both pharmacometric and statistical M&S were presented during the conference, highlighting the diversity of the methods employed by pharmacometricians and statisticians to address a broad range of quantitative issues in drug development. Five presentations are summarized herein, which cover the development strategy of employing M&S to drive decision-making; European initiatives on best practice in M&S; case studies of pharmacokinetic/pharmacodynamics modeling in regulatory decisions; estimation of exposure-response relationships in the presence of confounding; and the utility of estimating the probability of a correct decision for dose selection when prior information is limited. While M&S has been widely used during the last few decades, it is expected to play an essential role as more quantitative assessments are employed in the decision-making process. By integrating M&S as a tool to compile the totality of evidence collected throughout the drug development program, more informed decisions will be made.
authors.affiliation: a Global Clinical Pharmacology , Janssen Research & Development, LLC , Spring House , Pennsylvania , USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Kimko
authors.affiliation: b QuintilesIMS, Overland Park , Kansas , USA.
authors.forename: Seth
authors.initials: S
authors.lastname: Berry
authors.affiliation: c QuintilesIMS , Dublin , Ireland.
authors.forename: Michael
authors.initials: M
authors.lastname: O'Kelly
authors.affiliation: d Office of Clinical Pharmacology , Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Mehrotra
authors.affiliation: e Ann Arbor Pharmacometrics Group , Ann Arbor , Michigan , USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hutmacher
authors.affiliation: f Bristol-Myers Squibb, LLC , Princeton , New Jersey , USA.
authors.forename: Venkat
authors.initials: V
authors.lastname: Sethuraman
mesh_terms: D003198:Computer Simulation; D003226:Congresses as Topic; D003657:Decision Making; D006801:Humans; D015233:Models, Statistical; D010599:Pharmacokinetics; D011336:Probability; D058028:Research Report
keywords: Modeling and simulation; pharmacodynamics; pharmacokinetics; totality of evidence