By Phillip I. Good
Chapter 1 reduce expenses and elevate earnings (pages 1–8):
Chapter 2 instructions (pages 9–14):
Chapter three Prescription for Sucess (pages 15–18):
Chapter four Staffing for achievement (pages 19–28):
Chapter five layout judgements (pages 29–46):
Chapter 6 Trial layout (pages 47–54):
Chapter 7 Exception dealing with (pages 65–72):
Chapter eight Documentation (pages 73–94):
Chapter nine Recruiting and holding Physicians and sufferers (pages 95–108):
Chapter 10 Computer?Assisted information access (pages 109–124):
Chapter eleven information administration (pages 125–140):
Chapter 12 Are you prepared? (pages 141–144):
Chapter thirteen tracking the rigors (pages 145–154):
Chapter 14 handling the pains (pages 155–164):
Chapter 15 information research (pages 165–198):
Chapter sixteen money (pages 199–208):
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Extra resources for A Manager's Guide to the Design and Conduct of Clinical Trials
You should also determine how the adverse event data are to be collected. By use of a checklist—“Since your last appointment, did you experience fever? nausea? ” Elicited responses tend to yield a higher frequency of complaints. To be on the safe side, use both methods. Of course, hospitalizations, emergency treatment, and phoned-in complaints between visits must always be recorded. Some secondary end points may also concern efficacy. For example, in a study of sedatives, you might be interested in how rapidly the patient obtained relief.
I told them I was very impressed—we consultants lie a lot—then asked what they expected to include in their final report? “The number of subjects that stopped smoking or reduced their smoking by 50%. ” “You can’t afford what you don’t need either. ” We had our budget. anticipated side effects in your hypothetical report. Once this prototype report is fleshed out, you’ll know what data you need to collect and will not waste your company’s time on unnecessary or redundant effort. THE WRONG WAY The wrong way to plan a study is to begin with the forms that were used in a previous set of trials.
Ask patients to volunteer concerns? Or do both? How long will the follow-up period be? See Chapter 5. CHAPTER 3 PRESCRIPTION FOR SUCCESS 15 Specify eligibility requirements. Too narrow a patent will force you to repeat the trials later and may make it difficult to recruit the necessary number of subjects. Too broad a patent may doom the success of the trials by including those unlikely to benefit from the intervention. Specify baseline measures. Include all variables that might impact treatment outcome.
A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good