Planning a clinical study is much more than determining the basic study design. Who will you be studying? How do you plan to recruit your study subjects? How do you plan to retain them in the study? What data do you plan to collect? How will you obtain this data? How will you minimize bias? All these decisions must be consistent with the ethical considerations of studying people. This book teaches how to choose the best design for your question. Drawing on their many years working in clinical research, Nancy G. Berman and Robert A. Parker guide readers through the essential elements of study planning to help get them started. The authors offer numerous examples to illustrate the key decisions needed, describing what works, what does not work, and why. Written specifically for junior investigators beginning their research careers, this guide will also be useful to senior investigators needing to review specific topics.
- Over 200 examples in multiple research areas illustrate different issues in clinical study design, including examples illustrating what does not work
- Many of the examples are presented in several parts, illustrating the thought process involved in planning a study
- In addition to separate chapters on ethical issues and informed consent, the authors discuss specific ethical issues arising from the activities discussed in each chapter
Read more
Customer reviews

Not yet reviewed
Be the first to review

Log in to review

Review was not posted due to profanity
×

, create a review

(If you're not , sign out)

Please enter the right captcha value

Please enter a star rating.

Your review must be a minimum of 12 words.

How do you rate this item?

Reviews must contain at least 12 words about the product.

×

Product details
- Date Published: December 2016
- format: Hardback
- isbn: 9780521840637
- length: 352 pages
- dimensions: 255 x 180 x 28 mm
- weight: 0.93kg
- availability: In stock
Table of Contents
Part I. Introduction:
1. Questions before starting on the details
2. Ethics
3. Informed consent
Part II. Study Designs:
4. Overview of study designs
5. Designs for interventional studies
6. Cohort studies
7. Case-control studies
8. Cross-sectional studies
9. Record reviews
10. Selecting a design
Part III. Core Concepts Applicable to All Study Designs:
11. Generalizability and validity
12. Study population
13. Getting and keeping participants
14. Study data - how variables are used
15. Study data - endpoints
16. Predictor and confounding variables
17. Bias
18. Avoiding bias
Part IV. Additional Concepts for Interventional Studies:
19. Describing your intervention
20. Randomization - what and why
21. Techniques for randomization
22. Blinding
23. Techniques needed for blinding intervention studies
24. Compliance and adherence
Part V. Additional Concepts for Observational Studies:
25. Defining populations for cohort studies
26. Identifying participants for case-control studies
27. Matching in nonrandomized studies
28. Blinding in observational studies
Part VI. Practical Issues:
29. Acquiring high-quality data
30. Data storage.
Look Inside

General Resources

Resources

Find resources associated with this title

Back to resources home

Type	Name	Unlocked *	Format	Size

Showing of

This title is supported by one or more locked resources. Access to locked resources is granted exclusively by Cambridge University Press to lecturers whose faculty status has been verified. To gain access to locked resources, lecturers should sign in to or register for a Cambridge user account.

Please use locked resources responsibly and exercise your professional discretion when choosing how you share these materials with your students. Other lecturers may wish to use locked resources for assessment purposes and their usefulness is undermined when the source files (for example, solution manuals or test banks) are shared online or via social networks.

Supplementary resources are subject to copyright. Lecturers are permitted to view, print or download these resources for use in their teaching, but may not change them or use them for commercial gain.

If you are having problems accessing these resources please contact [email protected].

Authors
Robert A. Parker, Harvard Medical School, Massachusetts
Robert A. Parker has been a consulting biostatistician for nearly forty years. He has worked in academic medicine, industry (a top 25 global pharmaceutical company) and government (the World Health Organization and the US Centers for Disease Control). In industry, he was the arbiter of statistical methods for more than 100 statisticians in the company. Having worked with junior investigators for most of his professional life, he is dedicated to mentoring the next generation of medical researchers. This book reflects his passion to train junior investigators in the art of clinical research.
Nancy G. Berman, Harbor-UCLA Medical Center
Nancy G. Berman has been a consulting biostatistician for more than thirty-five years. She has worked in private consulting for the US National Institutes of Health (NIH) and other government studies. In Los Angeles, she was chairperson of the annual Statistical Workshop and Treasurer for the Southern California Statistical Association. As the General Clinical Research Centers statistician and consultant at the Harbor-UCLA Medical Center, she worked with both junior and senior investigators developing protocols for clinical studies. Doing this work she identified the need for a book that would provide details of clinical design in an accessible format for all investigators. Planning Clinical Research is intended to fulfill that need.