MJoTA.org

Topic 1 objectives:

Workshop 1:

Read article What is a medical writer

Read article on clinical trials at http://www.mjota.org/images/EvolnClinicalTrials.pdf

Read article on diethylene glycol at http://www.mjota.org/images/DEGkills.pdf

Go to FDA website and click around; also clinicaltrials.gov.

Watch food safety video: http://www.fda.gov/Food/InternationalActivities/ucm172944.htm.

Watch patient safety video: http://www.accessdata.fda.gov/psn/index.cfm.

Search for parts of interest inside the federal law that regulates drug marketing, includes role of FDA, 21 CFR: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

Assignments 1:

1. Search for diabetes drugs approved by the Food and Drug Administration and make a list of these, using their generic name.

2. Pick one diabetes drug from the list that has drug trials listed in clinicaltrials.gov

3. Write 100-500 words on the drug you have chosen, including in this article a) whether clinical trials are ongoing after the drug was marketed (these are phase 4 trials; b) how many clinical trials are listed, what phase trials, who were targeted; c) whether any trials have included any patients of African origin; d) make a table giving the information about the clinical trials, include in the table the phase of the trial, the design of the trial. (This article done well is a candidate for publication).

Quiz 1:

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