Autore	Chang Mark
Pubbl/distr/stampa	Hoboken, N.J., : John Wiley, c2008
Descrizione fisica	1 online resource (280 p.)
Disciplina	615.50724 615/.190113
Soggetto topico	Drugs - Testing - Computer simulation Adaptive sampling (Statistics) Clinical trials - Data processing
ISBN	0-470-43856-8 1-281-73255-9 9786611732554 0-470-36871-3 0-470-36997-3
Formato	Materiale a stampa
Livello bibliografico	Monografia
Lingua di pubblicazione	eng
Nota di contenuto	ExpDesign Studio -- Clinical trial design -- Classical trial design -- Group sequential trial design -- Adaptive trial design -- Adaptive trial monitoring -- Oncology adaptive trial design -- Adaptive trial simulator -- Further assistance from ExpDesign Studio.
Record Nr.	UNINA-9910144137403321

Autore	Peace Karl E. <1941, >
Edizione	[1st ed.]
Pubbl/distr/stampa	Boca Raton : , : Chapman and Hall/CRC Press, , 2011
Descrizione fisica	1 online resource (422 p.)
Disciplina	615.5072/4 615.50724
Altri autori (Persone)	ChenDing-Geng
Collana	Chapman & Hall/CRC biostatistics series
Soggetto topico	Clinical trials Drugs - Testing
ISBN	0-429-14207-2 1-58488-918-7
Formato	Materiale a stampa
Livello bibliografico	Monografia
Lingua di pubblicazione	eng
Nota di contenuto	Front cover; Contents; Preface; Chapter 1: Overview of Clinical Trial Methodology; Chapter 2: Overview of the Drug Development Processand Regulation of Clinical Trials; Chapter 3: Ethical Considerations in the Designand Conduct of Clinical Trials; Chapter 4: Sample Size Considerations in ClinicalTrials Pre-Market Approval; Chapter 5: Sequential, Group Sequential, StochasticCurtailment, and Adaptive DesignProcedures in Clinical Trials; Chapter 6: Biostatistical Aspects of the Protocol; Chapter 7: The Statistical Analysis Plan; Chapter 8: Pooling of Data from Multicenter Clinical Trials Chapter 9: Validity of Statistical InferenceChapter 10: Bioequivalence Clinical Trials; Chapter 11: Dose and Frequency Determinationfrom Phase II Clinical Trials in StressTest-Induced Angina; Chapter 12: Confirmation of Clinically Optimal Dosingin the Treatment of Duodenal Ulcers:A Phase III Dose Comparison Trial; Chapter 13: Pivotal Proof-of-Efficacy Clinical Trialsin the Prevention of NANSAID-InducedGastric Ulceration; Chapter 14: Clinical Trials in the Treatmentof Alzheimer's Disease Based uponEnrichment Designs; Chapter 15: A Clinical Trial to Establish Reductionof CHD Risk Chapter 16: Pivotal Proof-of-Efficacy Clinical Trialsin the Treatment of Panic DisorderChapter 17: Combination Clinical Trials; Chapter 18: Monitoring Clinical Trials for Adverse Events; Index; Back cover
Record Nr.	UNINA-9910817366103321

Autore	Brody Tom
Edizione	[1st ed.]
Pubbl/distr/stampa	London, : Academic Press, 2012
Descrizione fisica	1 online resource (673 p.)
Disciplina	615.19 615.50724 615/.19
Soggetto topico	Clinical trials Drugs - Testing
Soggetto genere / forma	Electronic books.
ISBN	1-283-32021-5 9786613320216 0-12-391913-4
Formato	Materiale a stampa
Livello bibliografico	Monografia
Lingua di pubblicazione	eng
Nota di contenuto	Front Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin d. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"? m. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control c. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns
Record Nr.	UNINA-9910457469003321

Autore	Piantadosi Steven
Edizione	[2nd ed.]
Pubbl/distr/stampa	Hoboken, N.J., : Wiley-Interscience, c2005
Descrizione fisica	1 online resource (717 p.)
Disciplina	610/.72 615.50724
Collana	Wiley series in probability and statistics
Soggetto topico	Clinical trials - Statistical methods
Soggetto genere / forma	Electronic books.
ISBN	1-280-27719-X 9786610277193 0-470-35561-1 0-471-74013-6 0-471-72781-4
Formato	Materiale a stampa
Livello bibliografico	Monografia
Lingua di pubblicazione	eng
Nota di contenuto	CLINICAL TRIALS; CONTENTS; Preface; Preface to the First Edition; 1 Preliminaries; 1.1 Introduction; 1.2 Audience and Scope; 1.3 Other Sources of Knowledge; 1.3.1 Terminology; 1.3.2 Review of Notation and Terminology Is Helpful; 1.4 Examples, Data, and Programs; 1.5 Summary; 2 Clinical Trials as Research; 2.1 Introduction; 2.1.1 Clinical Reasoning Is Based on the Case History; 2.1.2 Statistical Reasoning Emphasizes Inference Based on Designed Data Production; 2.1.3 Clinical and Statistical Reasoning Converge in Research; 2.2 Defining Clinical Trials Formally 2.2.1 Mixing of Clinical and Statistical Reasoning Is Recent2.2.2 Clinical Trials Are Rigorously Defined; 2.2.3 Experiments Can Be Misunderstood; 2.2.4 Clinical Trials as Science; 2.2.5 Trials and Statistical Methods Fit within a Spectrum of Clinical Research; 2.3 Practicalities of Usage; 2.3.1 Predicates for a Trial; 2.3.2 Trials Can Provide Confirmatory Evidence; 2.3.3 Clinical Trials Are Unwieldy, Messy, and Reliable; 2.3.4 Other Methods Are Valid for Making Some Clinical Inferences; 2.3.5 Trials Are Difficult to Apply in Some Circumstances; 2.3.6 Randomized Studies Can Be Initiated Early 2.4 Summary2.5 Questions for Discussion; 3 Why Clinical Trials Are Ethical; 3.1 Introduction; 3.1.1 Science and Ethics Share Objectives; 3.1.2 Equipoise and Uncertainty; 3.2 Duality; 3.2.1 Clinical Trials Sharpen, but Do Not Create, the Issue; 3.2.2 A Gene Therapy Tragedy Illustrates Duality; 3.2.3 Research and Practice Are Convergent; 3.2.4 The Hippocratic Tradition Does Not Proscribe Clinical Trials; 3.2.5 Physicians Always Have Multiple Roles; 3.3 Historically Derived Principles of Ethics; 3.3.1 Nuremberg Contributed an Awareness of the Worst Problems 3.3.2 High-Profile Mistakes Were Made in the United States3.3.3 The Helsinki Declaration Was Widely Adopted; 3.3.4 Other International Guidelines Have Been Proposed; 3.3.5 Institutional Review Boards Provide Ethical Oversight; 3.3.6 Ethical Principles Relevant to Clinical Trials; 3.4 Contemporary Foundational Principles; 3.4.1 Collaborative Partnership; 3.4.2 Scientific Value; 3.4.3 Scientific Validity; 3.4.4 Fair Subject Selection; 3.4.5 Favorable Risk-Benefit; 3.4.6 Independent Review; 3.4.7 Informed Consent; 3.4.8 Respect for Subjects; 3.5 Methodologic Reflections 3.5.1 Practice Based on Unproven Treatments Is Not Ethical3.5.2 Ethics Considerations Are Important Determinants of Design; 3.5.3 Specific Methods Have Justification; 3.6 Professional Conduct; 3.6.1 Conflict of Interest; 3.6.2 Professional Statistical Ethics; 3.7 Summary; 3.8 Questions for Discussion; 4 Contexts for Clinical Trials; 4.1 Introduction; 4.1.1 Some Ways to Learn about Trials in a Given Context; 4.1.2 Issues of Context; 4.2 Drugs; 4.2.1 Are Drugs Special?; 4.2.2 Why Trials Are Used Extensively for Drugs; 4.3 Devices; 4.3.1 Use of Trials for Medical Devices 4.3.2 Are Devices Different from Drugs?
Record Nr.	UNINA-9910147223003321