Home / Essays / After you have viewed the pdf on Clinical Study Design:

After you have viewed the pdf on Clinical Study Design:

After you have viewed the pdf on Clinical Study Design:

DRUG: Trial of DMXB-A in Schizophrenia NCT00100165
INSTRUCTIONS: Summarize the drug, MOA, study design, with the inclusion and exclusion criteria. What percent of patients (approximately) of the total affected with this disease would be eligible to be treated? If the population studied in the trial are the only patients eligible for treatment when the drug is approved, what percent (approximately) would not be able to take this medication? Discuss the restrictions to the target population, and any other special circumstances for either including or excluding sub groups of patients and include your rationale. 1-2 pages total. No more than 3-5 references are needed (primary publications only)

Here are the comments I got on the first paper:
“This paper has a lot of good information in it, but needs more editing. Each paper appears to be summarized in a different paragraph. Instead, incorporating the information to explain what they investigators did well and what they could have improved upon would make this a much stronger paper. The assignment was for a Phase I trial. This is a phase III trial. There was a phase one dose finding trial in 97 patients. The articles chosen for references are also review articles, not the primary publication for the study. It is important to choose the primary publication which is written by the investigators who did the research and reviewed all of the study data. Review articles summarize and interpret the information in the primary publication, and do NOT have access to all the data, only summary data in tables. Review authors also have not seen the full protocol and you should not base your writing on their opinions. I will grade your paper based on what you submitted. Describing the consequence of F508del would have been a good way to start your paper-it leads to abnormal water and chloride levels, and impacts lung and sweat secretions. Over time, this leads to thick mucus and causes lung damage and increases the risk for lung infections.”
So please make sure you don’t make those same mistakes

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