Intelligent drug development : trials and errors in clinical research /

Intelligent drug development : trials and errors in clinical research /

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Bibliographic Details
Author / Creator:	Tansey, Michael, author.
Imprint:	Oxford ; New York : Oxford University Press, [2014]
Description:	1 online resource (241 pages)
Language:	English
Subject:	Clinical trials -- Ethics. Clinical trials -- Methods. Drug approval -- Methods. Medical protocols. Drug Approval -- methods. Clinical Protocols. Clinical Trials as Topic -- ethics. Clinical Trials as Topic -- methods. Medical protocols. Clinical trials. Drug approval. Methods (Music)
Format:	E-Resource Book
URL for this record:	http://pi.lib.uchicago.edu/1001/cat/bib/11754369

Hidden Bibliographic Details
ISBN:	9780190200657 0190200650 9780199974580 0199974586
Notes:	Includes bibliographical references (pages 213-215) and index. Print version record.
Summary:	Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the proces.
Other form:	Print version: Tansey, Michael. Intelligent Drug Development. Oxford : Oxford University Press, 2014 9780199974580

Table of Contents:

Aiming for excellence
The target product profile and its uses
Planning the individual clinical trial
Distilling the essence of the protocol: the protocol synopsis
Redistillation: eliminating impurities by carrying out protocol feasibility
The optimal blend: the approved synopsis and the final protocol
Of chickens and eggs: the sponsors' dilemma
Clinician or clinical trialist: the physicians' dilemma
What about the customer? the patients' dilemma
About time: making meetings matter
The brain-scrambling, fit-inducing, mind-numbing technicolor laser show.