Research and Markets: Clinical Trials Handbook: Best Practices for Conducting Effective and Safe Clinical Trials

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/971ea1/clinical_trials_ha) has announced the addition of John Wiley and Sons Ltd's new report "Clinical Trials Handbook" to their offering.

Best practices for conducting effective and safe clinical trials.

Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.

With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue.

Chapters cover every key aspect of preparing and conducting clinical trials, including:

• Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems)
• Biostatistics, pharmacology, and toxicology
• Modeling and simulation
• Regulatory monitoring and ethics
• Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more

With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Key Topics Covered:

Preface.

1 Introduction to Clinical Trials (John Goffin).

2 Regulatory Requirements for Investigational New Drug (Venkat Rao).

3 Preclinical Assessment of Safety in Human Subjects (Nancy Wintering and Andrew B. Newberg).

4 Predicting human adverse drug reactions from non-clinical safety studies (Jean-Pierre Valentin, Marianne Keisu & Tim G. Hammond).

5 History of Clinical Trial Development and the Pharmaceutical Industry (Jeffery Peppercorn and Thomas Roberts).

6 Organization and Planning (Sheila Sprague and Mohit Bhandari).

7 The Process of Data Management (Nina Trocky and Cynthia Barndt).

8 Clinical Trials Data Management (Eugenio Santoro and Angelo Tinazzi).

9 Clinical Trials and the FDA (Tarek M. Mahfouz and Janelle S. Crossgrove).

10 Clinical Trials in Interventional Cardiology: Focus on the XIENCE Drug-Eluting Stent (Doostzadeh J, Bezenek S, Cheong W-F, Sood P, Schwartz L, Sudhir K).

11 Methods of Randomization (Gladys McPherson and Marion Campbell).

12 Randomized Controlled Trials (Giuseppe Garcea and David P. Berry).

13 Cross-Over Designs (Raphael Porcher and Sylvie Chevret).

14 Biomarkers (Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari).

15 Review Boards (Maureen Hood, Jason Kaar, and Vincent Ho).

16 Size of Clinical Trials (Jitendra Ganju).

17 Blinding and Placebo (Artur Bauhofer).

18 Pharmacology (Thierry Buclin).

19 Modeling and Simulation in Clinical Drug Development (Jerry Nedelman, Frank Bretz, Roland Fisch, Anna Georgieva, Chyi-Hung Hsu, Joseph Kahn, Ryosei Kawai, Phil Lowe, Jeff Maca, Jose' Pinheiro, Anthony Rossini, Heinz Schmidli, Jean-Louis Steimer, Jing Yu).

20 Monitoring (Nigel Stallard and Susan Todd).

21 Inference Following a Sequential Clinical Trial (Aiyi Liu and Kai F. Yu).

22 Statistical methods for Analysis of Clinical Trials (Duolao Wang, Ameet Bakhai, and Nicola Maffulli).

23 Explanatory and Pragmatic Clinical Trials (Rob Herbert).

25 Regulations (Ramzi Dagher, Rajeshwari Sridhara, Nallaperumal Chidambaram, and Brian P. Booth).

26 Future Challenges in the Design and Ethics of Clinical Trials (Carl-Fredrik Burman and Axel Carlberg).

27 Proof-of-Principle/Proof-of-Concept trials in Drug Development (Ayman Al-Shurbaji).

For more information visit http://www.researchandmarkets.com/research/971ea1/clinical_trials_ha