A Manager's Guide to the Design and Conduct of Clinical by Phillip I. Good(auth.)

By Phillip I. Good(auth.)

This newly up to date version of the benchmark advisor to computer-assisted medical trials offers a accomplished primer for potential managers. It covers each severe factor of the layout and behavior of scientific trials, together with learn layout, association, regulatory service provider liaison, info assortment and research, in addition to recruitment, software program, tracking, and reporting.

retaining an identical hassle-free structure because the unique, this moment version good points new examples and the newest advancements in regulatory guidance, corresponding to e-submission tactics and automated direct info acquisition. the recent version additionally displays the expanding globalization of medical trial actions, and comprises new information regarding foreign criteria and techniques, together with the typical Technical record and CDISC standards.

This step by step advisor is supported by means of convenient checklists and extracts from submitted protocols. skilled writer and advisor Phillip solid incorporateshumorous but instructive anecdotes to demonstrate universal pitfalls. in keeping with the confirmed commercial formulation of making plans, enforcing, and at last acting crucial assessments, the book's 3 sections-"Plan," "Do," and "Check"-includethe following material:
* should still the pains be conducted?
* positioned it within the computing device and hold it there
* Staffing for success
* Designing trials and identifying pattern size
* Budgeting
* Recruiting and holding sufferers and physicians
* facts management
* tracking the trials
* information analysis
* After motion review
* Exception handling

government and managerial pros fascinated with the layout and research of medical experiments, in addition to scientific examine affiliates, biostatisticians, and scholars in public healthiness will discover a Manager's advisor an fundamental resource.

compliment for the 1st Edition:

". . . readable, informative and every now and then witty . . . by no means stops being concise and good written . . . a booklet worthy a learn . . ."
-Statistics in Medicine

"The booklet is especially prescriptive and whole of lists and tables with which to lead managers in making potent judgements in utilizing computer-assisted medical trials in pharmaceutical studies." -Technometrics

"This e-book is must-have analyzing for someone within the enterprise . . ."
-Clinical ChemistryContent:
Chapter 1 reduce expenditures and bring up earnings (pages 1–6):
Chapter 2 guidance (pages 7–13):
Chapter three Prescription for achievement (pages 15–21):
Chapter four Staffing for fulfillment (pages 23–33):
Chapter five layout judgements (pages 35–53):
Chapter 6 Trial layout (pages 55–74):
Chapter 7 Exception dealing with (pages 75–80):
Chapter eight Documentation (pages 81–106):
Chapter nine Recruiting and preserving sufferers and Physicians (pages 107–121):
Chapter 10 Computer?Assisted information access (pages 123–141):
Chapter eleven facts administration (pages 143–159):
Chapter 12 Are you prepared? (pages 161–164):
Chapter thirteen tracking the pains (pages 165–174):
Chapter 14 coping with the pains (pages 175–188):
Chapter 15 information research (pages 189–223):
Chapter sixteen cost (pages 225–235):

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Additional resources for A Manager's Guide to the Design and Conduct of Clinical Trials, Second Edition

Sample text

16 See Greene et al. (1992) for other possible decisions. CHAPTER 5 DESIGN DECISIONS 47 If you find it is your product that appears to be causing the stomach cramps, you’ll want a thorough workup on each of the complaining patients. It might be that the cramps are the result of a concurrent medication; clearly, modifications to the protocol are in order. You would discontinue giving the trial medication to patients taking the concurrent medication but continue giving it to all others. You’d make the same sort of modification if you found that the negative results occurred only in women or in those living at high altitudes.

Nothing can be more embarrasing or useless than a large-scale trial that ends with signposts pointing in all directions (LRC Investigators, 1984). If the information needed to make these decisions is lacking, additional studies should be performed before proceeding with a full-scale trial. Tertiary End Points Tertiary end points such as costs may or may not be essential to your study. Don’t collect data you don’t need. When in doubt, let your marketing department be your guide. Baseline Data You will need to specify what baseline data should be gathered before the start of intervention and how it will be gathered—by interview, questionnaire, physical examination, specialized examinations (angiograms, ultrasound, MRI) and/or laboratory tests.

D. Form the Implementation Team Include a pharmacologist or manufacturing specialist who will be responsible for providing the necessary supplies. Allocate resources. Have your attorney review physician contracts. Hire documenters, lead programmer, and data manager. E. Line Up Your Panel of Physicians Don’t underestimate the difficulty of recruiting and retaining patients. Decide how many clinical sites are required to recruit the number of patients you need at the time and for the duration you’ll need them.

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