Essentials of Clinical Research

Author by : Stephen P. Glasser
Languange Used : en
Release Date : 2014-06-02
Publisher by : Springer

ISBN :

Description : In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike....

Author by : Ravindra B Dr Ghooi
Languange Used : en
Release Date : 2016-06-16
Publisher by :

ISBN :

Description : Introduction, Glossary& Drug Development Process, Clinical Trials on Drugs, Regulatory Strategy, Regulatory Control Over Drugs, Ethical Aspects of Clinical Research, sponsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigator Selection, Subject Recruitment and Selection, Meetings in Clinical Research, Data and Safety Monitoring, IND and NDA, Clinical Data Management, Safety Reporting and Pharmacoviligance, Quality Assurance in Clinical Research, Standard Operating Procedures, Clinical Research Outsourcing, Statistics in Clinical Research, Insurance and Liability, Non-compliance, Misconduct and Fraud, Intellectual Property Rights, Websites for Informa...

Author by : Daniel Clauw
Languange Used : en
Release Date : 2009-04-01
Publisher by :

ISBN :

Description : ...

Author by : Joseph M. Scavone
Languange Used : en
Release Date : 1991
Publisher by :

ISBN :

Description : ...

Author by : Kenneth F. Schulz
Languange Used : en
Release Date : 2006
Publisher by :

ISBN :

Description : The needs of clinicians predominate throughout the text, but these needs overlap with those of researchers especially in chapters covering randomized controlled trials. For readers to assess trials accurately they need to understand relevant guidelines on the conduct of trials that are emerging from methodological research. In presenting these discussions to clinicians these chapters will help researchers who also do randomized trials and provide a methodological background that enhances the quality and quantity of their research productivity....

Author by : William V. Giannobile
Languange Used : en
Release Date : 2009-12-09
Publisher by : John Wiley & Sons

ISBN :

Description : Clinical Research in Oral Health surveys the essentials of clinical research in oral health, anchoring these principles within the specific context of the oral health arena. Addressing research questions exclusively applicable to dentistry and oral health, the book thoroughly illustrates the principles and practice of oral health clinical research. Clinical Research in Oral Health also clarifies the framework of regulatory issues and presents emerging concepts in clinical translation, relating the research principles to clinical improvement....

Author by : T. George
Languange Used : en
Release Date : 2015-03-25
Publisher by : CreateSpace

ISBN :

Description : The book covers training on scientific writing of essential clinical trial documents which includes Protocol, Standard Operation Procedures, Informed Consent Document, Case Report Forms, Data Validation Plan, Clinical Study Report , Publication etc....