Assignment 3 Start Assignment Cases of COVID-19 reached pandemic proportions over the last 2+ years, and the spread of the virus has affected people globally. The international medical community is working unitedly to resolve this crisis. PART 1: (50 points) 1. Describe the pandemic of COVID-19 in numbers, compare this to the SARS-C0V-1 outbreak of 2002-2004. What type of studies and research designs

Assignment 3

Start Assignment

Cases of COVID-19 reached pandemic proportions over the last 2+ years, and the spread of the virus has affected people globally. The international medical community is working unitedly to resolve this crisis.

PART 1: (50 points)
1. Describe the pandemic of COVID-19 in numbers, compare this to the SARS-C0V-1 outbreak of 2002-2004.  What type of studies and research designs provided the information?  Provide a cited example of at least one of each of the following: prospective, retrospective, observational, interventional, cohort, and randomized controlled trial.  Describe how the international and national communities are working together (Governmental bodies, Healthcare Providers, Scientists, Pharmaceutical industries and Philanthropists)? (25 points)

2. There are challenges 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)

You May Hold the Cure for the Next Epidemic (Links to an external site.) – this YouTube link is https://youtu.be/IBRK2lEXaOg

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.

– Identify the type of interventional study design in hospital A, and B.  Provide a cited example where this study design has been used.

– Why is one study design superior to the other? Justify your answer. Use the TEDX Talk and its content as a reference.

PART 3: (75 points) 

Design a study protocol abstract for the next viral pandemic:

For this scenario, the virus is H3N6a.  This virus is a previously unknown strain of influenza, with symptoms that resemble the typical seasonal flu lasting 30 (+/-2) days.  There are rare cases of death; however, vascular complications are frequent, resulting in 2% of patients requiring amputation of at least 1 finger or toe, and 25% increased risk of heart attacks and strokes.  There are currently no approved treatments, though it is known that standard flu treatments are ineffective.

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.)? List two inclusion and two exclusion criteria. If no inclusion/exclusion provide an explanation. (20points)
4. State at least two study endpoints, and the tools to measure them. State the tests that will be used for statistical analysis and why those are appropriate for this type of study. (20 points)
5. Calculate an estimated sample size for the study. If you must; use power as 80% and ⍺ as 0.05. (20 points)

Rubric

Assignment 3_HCR557