1. Guest Editor’s Note

   • Robert W. Makuch

   EditorialNotes 30 December 2000 Pages: 335 - 335

2. The International Conference on Harmonization Guideline “Statistical Principles for Clinical Trials”: Issues in Applying the Guideline in Practice

   • Alan Phillips
   • Alan Ebbutt
   • David Morgan

   OriginalPaper 30 December 2000 Pages: 337 - 348

3. On the Definition of Therapeutic Equivalence

   • Anders Källén
   • Per Larsson

   OriginalPaper 30 December 2000 Pages: 349 - 354

4. A Behavioral Bayes Method for Determining the Size of a Clinical Trial

   • John Gittins
   • Hamid Pezeshk

   OriginalPaper 30 December 2000 Pages: 355 - 363

5. A Decision Analytic Approach to Determining Sample Sizes in A Phase III Program

   • Allan Pallay

   OriginalPaper 30 December 2000 Pages: 365 - 377

6. The Number of Centers in a Multicenter Clinical Study: Effects on Statistical Power

   • Zhengning Lin

   OriginalPaper 30 December 2000 Pages: 379 - 386

7. Randomized Designs for Early Trials of New Cancer Treatments—An Overview

   • Marc Buyse

   OriginalPaper 30 December 2000 Pages: 387 - 396

8. Design and Analysis of Studies to Assess the Effect of Inhaled Corticosteroids on Growth

   • Susan P. Duke
   • Sara H. Hughes
   • Colin Reisner

   OriginalPaper 30 December 2000 Pages: 397 - 409

9. Symmetrical Crossover Designs for Bilateral Pharmacokinetic Drug Interactions

   • Francois Vandenhende
   • Benito J. Cerimele

   OriginalPaper 30 December 2000 Pages: 411 - 419

10. Dual-Objective Bayesian Optimal Designs for a Dose-Ranging Study

    • Qi Zeng
    • Wei Zhu
    • Weng Kee Wong

    OriginalPaper 30 December 2000 Pages: 421 - 428

11. A Class of Designs Using a Fold-over Hadamard Matrix for Screening Experiments

    • Stan Altan
    • Damaraju Raghavarao

    OriginalPaper 30 December 2000 Pages: 429 - 431

12. The Merck Internal Contract Research Organization Project

    • A. Lawrence Gould
    • Adam B. Polis
    • Charles L. Bernd

    OriginalPaper 30 December 2000 Pages: 433 - 445

13. Statistical Validation of Surrogate Endpoints: Problems and Proposals

    • Marc Buyse
    • Geert Molenberghs
    • Helena Geys

    OriginalPaper 30 December 2000 Pages: 447 - 454

14. Blinded Sample Size Reestimation in Multiarmed Clinical Trials

    • Meinhard Kieser
    • Tim Friede

    OriginalPaper 30 December 2000 Pages: 455 - 460

15. Operational Difficulties with Internal Pilot Studies to Update Sample Size

    • Simon Day

    OriginalPaper 30 December 2000 Pages: 461 - 468

16. 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. Miller
    • David J. Pasta
    • James M. Henning

    OriginalPaper 30 December 2000 Pages: 469 - 481

17. Statistical Issues Involved in Medical Device Postmarketing Surveillance

    • Chang S. Lao

    OriginalPaper 30 December 2000 Pages: 483 - 493

18. Pooling in Integrated Safety Databases

    • Damian J. McEntegart

    OriginalPaper 30 December 2000 Pages: 495 - 499

19. A Study on the Consistency Between Flagging by Statistical Tests and Biological Evaluation

    • Tsuyoshi Takizawa
    • Toshiji Igarashi
    • Hideo Yokouchi

    OriginalPaper 30 December 2000 Pages: 501 - 509

20. Adjustment of Treatment Effect for Covariates in Clinical Trials: Statistical and Regulatory Issues

    • Dongsheng Tu
    • Katherine Shalay
    • Joseph Pater

    OriginalPaper 30 December 2000 Pages: 511 - 523

21. Handling Missing Data in Clinical Trials: An Overview

    • William R. Myers

    OriginalPaper 30 December 2000 Pages: 525 - 533

22. The Many Modes of Meta

    • Stephen Senn

    OriginalPaper 30 December 2000 Pages: 535 - 549

23. Equivalence Testing in Dose-Response Studies

    • Edward J. Channon

    OriginalPaper 30 December 2000 Pages: 551 - 562

24. Statistical Methods for Demonstrating Equivalence in Crossover Trials Based on the Ratio of Two Location Parameters

    • Meinhard Kieser
    • Dieter Hauschke

    OriginalPaper 30 December 2000 Pages: 563 - 568

25. Tests for Equivalence or Noninferiority Between Two Proportions

    • James J. Chen
    • Yi Tsong
    • Seung-Ho Kang

    OriginalPaper 30 December 2000 Pages: 569 - 578

26. Statistical Approaches to Detecting Dose-Response Relationships

    • Toshimitsu Hamasaki
    • Tatsuya Isomura
    • Masashi Goto

    OriginalPaper 30 December 2000 Pages: 579 - 590

27. Sequential and Multiple Testing for Dose-Response Analysis

    • Walter Lehmacher
    • Meinhard Kieser
    • Ludwig Hothorn

    OriginalPaper 30 December 2000 Pages: 591 - 597

28. Estimation of Response Probability in Correlated Binary Data: A New Approach

    • Sin-Ho Jung
    • Chul Ahn

    OriginalPaper 30 December 2000 Pages: 599 - 604

29. Properties of the Hui and Walter and Related Methods for Estimating Prevalence Rates and Error Rates of Diagnostic Testing Procedures

    • Michael D. Sinclair
    • Joseph L. Gastwirth

    OriginalPaper 30 December 2000 Pages: 605 - 615

30. Statistical Methodology for Maximally HIV-RNA Suppressive Treatments in HIV-Infected Subjects

    • George Yu
    • Neil Clendeninn
    • Lisa Greenberg

    OriginalPaper 30 December 2000 Pages: 617 - 629

31. Statistical Models for Toxicity and Safety Pharmacology Studies

    • Helle Andersen
    • Henrik Spliid
    • Søren Larsen

    OriginalPaper 30 December 2000 Pages: 631 - 643

32. Emerging Technologies and Business Pressure: The Driving Forces for an Information Management Reengineering Strategy

    • Roberto Gomeni

    OriginalPaper 30 December 2000 Pages: 645 - 655