How to Design a Clinical Trial VCH Research Institute

How To Design A Clinical Trial Vch Research Institute-PDF Download

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Why do clinical trials,How to review a study protocol. How to design a study protocol,Why do a clinical trial. Why do a clinicaltrial,To answer a clinical problem. To gain new knowledge about a new or,established treatment. To support a claim,for gaining government regulatory.
for marketing a drug device or technique,What is a clinical trial. A clinical trial is a tool for testing a,drug device or technique. Guiding principles,Scientific validity and integrity. Medical relevance,Regulatory and medicolegal issues. What is step one,Start with a hypothesis,must be in the form of a statement.
Then turn it into a specific question,the question must be answerable. this forms the basis of the study,Objectives,Next steps. The study specifics flow from the,objectives,intervention efficacy. intervention safety,Design the details of your intervention. Choose the outcome you wish to,It s good to be a control freak.
It s good to be a control freak,Intervention must be compared to. something else,How do you choose a control,intervention. Usually compare study intervention to,standard intervention. Go back to your original question,Who is going to be recruited in the trial. Go back to your original question,Determines the patient population to.
which the study results will apply,Minimize the effect of confounding. Eligibility inclusion and exclusion,What is the minimum number of patients. to conduct a clinical trial,What is the minimum number of patients. to conduct a clinical trial,Eligibility pitfalls,Narrow definition. homogeneous patient group fewer confounding,results applicable to narrow patient profile.
harder to recruit patients,Broad definition,greater potential for confounding variables to. affect results,results more broadly applicable,easier to recruit patients. How to design a study protocol Why do a clinical trial Whydo a clinical trial To answer a clinical problem To gain new knowledge about a new or established treatment To support a claim for gaining government regulatory approval for marketing a drug device or technique What is a clinical trial A clinical trial is a tool for testing a drug device or

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