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PART 1: (50 points)
Do a little external reading.
1. Describe the pandemic of COVID-19 in numbers. What type of studies provided the
information? How are the international and national communities working together
(Governmental bodies, Healthcare Providers, Scientists, Pharmaceutical industries and Financial
aid)? (25 points)
2. There are challenges that would be involved in a global clinical trial (distance, language,
culture, economic statuses, political, bureaucratic, ethical, educational, environmental concerns,
and many more). Select 5 of these or other challenges and write a brief paragraph each regarding
clinical research with COVID-19. (25 points)
PART 2: (25 points)
https://research.usu.edu/tedxusu/por...-borio/*(Links to an external site.)
Listen to the Tedtalk by Dr. Luciana Borio on Ebola. She mentions two hospitals – Hospital A
and Hospital B. The doctors at hospital A have a different way to test the study drug than the
doctors at hospital B. Let’s call the study from hospital A as study design A and the study from
hospital B as study design B. Now, consider that you work for a hospital and the hospital is
treating coronavirus instead of Ebola. You are required to design a study – Would you select
study design A or study design B, or an alternative. Justify your answer.*
Use the Tedtalk and its content as your reference.
PART 3: (75 points)
Design a study protocol abstract for COVID -19 (Coronavirus):
1. State the study objective. (5 points)
2. State the study design (prospective or retrospective, phase, randomized – nonrandomized;
open – blind; multicentric national or global, safety and/or efficacy). (10 points)
3. What would be your study population (treatment naïve patients, a specific time from
diagnosis, based on the severity of the disease etc)? Would there be an inclusion or exclusion
criteria? If yes, list two inclusion and two exclusion criteria. If no, explain your answer.
4. State at least two study endpoints. And the tools to measure them. Also, state the tests that will
be used for statistical analysis. (20 points)

Leslie Nichole Manning
April 2020
HCR557 Assignment 3

5. For epidemic studies, how would you calculate the sample size? Calculate an estimated
sample size for the study. If you must; use power as 80% and ⍺ as 0.05. (20 points)

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