The International Conference on Harmonization Guideline “Statistical Principles for Clinical Trials”: Issues in Applying the Guideline in Practice Alan PhillipsAlan EbbuttDavid Morgan OriginalPaper 30 December 2000 Pages: 337 - 348
On the Definition of Therapeutic Equivalence Anders KällénPer Larsson OriginalPaper 30 December 2000 Pages: 349 - 354
A Behavioral Bayes Method for Determining the Size of a Clinical Trial John GittinsHamid Pezeshk OriginalPaper 30 December 2000 Pages: 355 - 363
A Decision Analytic Approach to Determining Sample Sizes in A Phase III Program Allan Pallay OriginalPaper 30 December 2000 Pages: 365 - 377
The Number of Centers in a Multicenter Clinical Study: Effects on Statistical Power Zhengning Lin OriginalPaper 30 December 2000 Pages: 379 - 386
Randomized Designs for Early Trials of New Cancer Treatments—An Overview Marc Buyse OriginalPaper 30 December 2000 Pages: 387 - 396
Design and Analysis of Studies to Assess the Effect of Inhaled Corticosteroids on Growth Susan P. DukeSara H. HughesColin Reisner OriginalPaper 30 December 2000 Pages: 397 - 409
Symmetrical Crossover Designs for Bilateral Pharmacokinetic Drug Interactions Francois VandenhendeBenito J. Cerimele OriginalPaper 30 December 2000 Pages: 411 - 419
Dual-Objective Bayesian Optimal Designs for a Dose-Ranging Study Qi ZengWei ZhuWeng Kee Wong OriginalPaper 30 December 2000 Pages: 421 - 428
A Class of Designs Using a Fold-over Hadamard Matrix for Screening Experiments Stan AltanDamaraju Raghavarao OriginalPaper 30 December 2000 Pages: 429 - 431
The Merck Internal Contract Research Organization Project A. Lawrence GouldAdam B. PolisCharles L. Bernd OriginalPaper 30 December 2000 Pages: 433 - 445
Statistical Validation of Surrogate Endpoints: Problems and Proposals Marc BuyseGeert MolenberghsHelena Geys OriginalPaper 30 December 2000 Pages: 447 - 454
Blinded Sample Size Reestimation in Multiarmed Clinical Trials Meinhard KieserTim Friede OriginalPaper 30 December 2000 Pages: 455 - 460
Operational Difficulties with Internal Pilot Studies to Update Sample Size Simon Day OriginalPaper 30 December 2000 Pages: 461 - 468
Quality-Days Incrementally Gained: A New Approach for Short-Term Evaluations Based on the Extended Q-TWiST Method Illustrated in a Clinical Study of Reflux Disease Patients Dave P. MillerDavid J. PastaJames M. Henning OriginalPaper 30 December 2000 Pages: 469 - 481
Statistical Issues Involved in Medical Device Postmarketing Surveillance Chang S. Lao OriginalPaper 30 December 2000 Pages: 483 - 493
Pooling in Integrated Safety Databases Damian J. McEntegart OriginalPaper 30 December 2000 Pages: 495 - 499
A Study on the Consistency Between Flagging by Statistical Tests and Biological Evaluation Tsuyoshi TakizawaToshiji IgarashiHideo Yokouchi OriginalPaper 30 December 2000 Pages: 501 - 509
Adjustment of Treatment Effect for Covariates in Clinical Trials: Statistical and Regulatory Issues Dongsheng TuKatherine ShalayJoseph Pater OriginalPaper 30 December 2000 Pages: 511 - 523
Handling Missing Data in Clinical Trials: An Overview William R. Myers OriginalPaper 30 December 2000 Pages: 525 - 533
Equivalence Testing in Dose-Response Studies Edward J. Channon OriginalPaper 30 December 2000 Pages: 551 - 562
Statistical Methods for Demonstrating Equivalence in Crossover Trials Based on the Ratio of Two Location Parameters Meinhard KieserDieter Hauschke OriginalPaper 30 December 2000 Pages: 563 - 568
Tests for Equivalence or Noninferiority Between Two Proportions James J. ChenYi TsongSeung-Ho Kang OriginalPaper 30 December 2000 Pages: 569 - 578
Statistical Approaches to Detecting Dose-Response Relationships Toshimitsu HamasakiTatsuya IsomuraMasashi Goto OriginalPaper 30 December 2000 Pages: 579 - 590
Sequential and Multiple Testing for Dose-Response Analysis Walter LehmacherMeinhard KieserLudwig Hothorn OriginalPaper 30 December 2000 Pages: 591 - 597
Estimation of Response Probability in Correlated Binary Data: A New Approach Sin-Ho JungChul Ahn OriginalPaper 30 December 2000 Pages: 599 - 604
Properties of the Hui and Walter and Related Methods for Estimating Prevalence Rates and Error Rates of Diagnostic Testing Procedures Michael D. SinclairJoseph L. Gastwirth OriginalPaper 30 December 2000 Pages: 605 - 615
Statistical Methodology for Maximally HIV-RNA Suppressive Treatments in HIV-Infected Subjects George YuNeil ClendeninnLisa Greenberg OriginalPaper 30 December 2000 Pages: 617 - 629
Statistical Models for Toxicity and Safety Pharmacology Studies Helle AndersenHenrik SpliidSøren Larsen OriginalPaper 30 December 2000 Pages: 631 - 643
Emerging Technologies and Business Pressure: The Driving Forces for an Information Management Reengineering Strategy Roberto Gomeni OriginalPaper 30 December 2000 Pages: 645 - 655