Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "e;study schema"e; and related features of study design Offers a "e;hands-on"e; reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: tinyurl.com/awwutvn

Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "e;study schema"e; and related features of study design Offers a "e;hands-on"e; reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: tinyurl.com/awwutvn

1;Front Cover;12;Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines;43;Copyright Page;54;Contents;85;Acknowledgments;166;Preface;186.1;The Study Schema and Study Design;186.2;Intent to Treat Analysis;186.3;How to Choose the Endpoints;186.4;Diagnostic Tests;196.5;Mechanism of Action;196.6;Standards;196.7;Methodology;196.8;Clinicaltrials.Gov and other Registries for Clinical Trials;207;Introduction;248;Abbreviations and Definitions;289;Biography;3410;1 The Origins of Drugs;3610.1;I. Introduction;3610.2;II. Structures of Drugs;3710.2.1;a. Origins of warfarin;3710.2.2;b. Origins of methotrexate and 5-fluorouracil;3810.2.3;c. Origins of ribavirin;3910.2.4;d. Origins of paclitaxel;3910.2.5;e. Origins of cladribine;4010.2.6;f. Origins of drugs in high-throughput screening;4210.2.7;g. Origins of therapeutic antibodies;4210.3;III. The 20 Classical Amino Acids;4410.4;IV. Animal Models;4610.4.1;a. Introduction;4610.4.2;b. Estimating human dose from animal studies;4810.4.2.1;1. NOAEL approach;4910.4.2.2;2. MABEL approach;4910.4.3;c. Scaling up the drug dose, acquired from animal studies, for use in humans;4911;2 Introduction to Regulated Clinical Trials;5211.1;I. Introduction;5211.2;II. Study Design;5411.3;III. The Study Schema;5511.3.1;a. Examples of schema from clinical trials;5711.3.2;b. Sequential treatment versus concurrent treatment - the Perez schema;5911.3.3;c. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schema;6111.3.4;d. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema;6111.3.5;e. Forwards sequence and reverse sequence - the Puhalla schema;6211.3.6;f. Both arms received three drugs, each arm at a different schedule - the Sekine schema;6311.3.7;g. Staging - the Blumenschein schema;6311.3.8;h. Staging and restaging - the Czito schema;6511.3.9;i. Methodology tip - staging;6511.3.10;j. Decision tree - the Baselga schema;6611.3.11;k. Decision tree - the Katsumata schema;6611.3.12;l. Methodology tip - what is "tumor progression"?;7011.3.13;m. Methodology tip - unit of drug dose expressed in terms of body surface area;7011.3.14;n. Run-in period - the schema of Dy;7111.3.15;o. Methodology tip - c-kit and imatinib;7211.3.16;p. Run-in period - the Hanna schema;7211.3.17;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)...;7311.3.18;r. Methodology tip - bevacizumab and VEGF;7611.3.19;s. Dose escalation - the Moore schema;7611.3.20;t. Pharmacokinetics - the Marshall schema;7811.4;IV. Further Concepts In Study Design;7911.4.1;a. Active control;7911.4.2;b. Add-on design active control;8111.4.3;c. Three-arm study - clinical trial with two different active control arms;8211.5;V. Summary;8211.6;VI. Amendments to the Clinical Study Protocol;8312;3 Run-In Period;8612.1;I. Introduction;8612.1.1;a. Washout period;8712.1.2;b. Detecting baseline adverse events;8712.1.3;c. Excluding potential study subjects who have safety issues correlating with the study drug;8712.1.4;d. To include only study subjects with controllable pain;8812.1.5;e. To determine the maximal tolerable dose;8912.1.6;f. To achieve and ensure steady state in vivo concentrations of study drug;8912.1.7;g. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns;9012.1.8;h. To ensure that metabolic characteristics of all study subjects are similar, prior to administering drugs;9112.1.9;i. To ensure that potential study subjects can adhere to, or comply with, the study protocol;9112.1.10;j. To confirm that all study subjects meet the inclusion and exclusion criteria;9212.1.11;k. Detecting potential study subjects who show a predetermined desired response to the study drug, with the goal of including only these subjects;9312.1.12;l. Methodology tip - anti-cancer