Explain the purposes of Clinical Trials and how they are affected by Health Care Regulations. Make...
Explain the purposes of Clinical Trials and how they are affected by Health Care Regulations. Make sure to list any governing agencies and their roles in Clinical Trials. Use the Internet to find some examples of Clinical Trials to discuss.
Homework Answers
*purpose
-Provide high quality data for health care decision making.
-Provide answer to scientific questions in medical field.
-Contributing to research studies.
-To aid in prevention, diagnosis and treatment.
*Governing Agencies and their roles
-Evaluating safety
-Monitoring adverse reaction.
-Controlling drug promotion and advertising.
In many countries regulation is made by single agency., in others state government have some regulatory authority.
Eg. USA : Food and drug Administration
Canada: Health Canada
An example of a clinical trial is in patients with Alzheimer's disease. In a double blind, placebo controlled, parallel group randomized clinical trial studied efficacy of long term oral treatment with acetyl- L-carnitine in 130 patients. After one year both the treated and placebo group worsned, but the treated group showed slower rate of deterioration.
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