Cases of COVID-19 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
| Assignment 3_HCR557 | ||
| Criteria | Ratings | Pts |
| This criterion is linked to a Learning Outcome PART 1: 1. COVID-19 Pandemic. The World’s effort to contain the disease.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 at least one cited example of each of the following: prospective, retrospective, observational, interventional, cohort, and randomized controlled trial. Describe how the international and national communities working together (Governmental bodies, Healthcare Providers, Scientists, Pharmaceutical industries and Philanthropists)? | 25 ptsFull MarksCompletely and accurately described the pandemic of COVID-19 in numbers, compared this to the SARS-C0V-1 outbreak of 2002-2004. Described studies and research designs that provided the information. Provided a cited example for each of the following: prospective, retrospective, observational, interventional, cohort, and randomized controlled trial. Described how are the international and national communities worked together (Governmental bodies, Healthcare Providers, Scientists, Pharmaceutical industries and Philanthropists)10 ptsincomplete marksProvided incomplete or inaccurate response.0 ptsNo Marksnot done or erroneous | 25 pts |
| This criterion is linked to a Learning Outcome PART 1: 2. Research Challenges during COVID-19 pandemic2. There are challenges involved in a global clinical trial (distance, language, culture, economic statuses, political (NOT politicians), 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 ptsFull MarksDescribed at least 5 challenges inherent to a global clinical trial will be addressed in a COVID-19 global clinical trial. Some examples of global trial challenges addressed: -distance, -language/communication, -culture, -economic statuses, -political, -bureaucratic & administrative, – ethical, -educational, -environmental concerns, -and many more.10 ptsincomplete marksProvided incomplete or inaccurate response.0 ptsNo Marksnot done or erroneous | 25 pts |
| This criterion is linked to a Learning Outcome PART 2: Study Design A or Study Design B for a New Investigational treatment for COVID-19?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. | 25 ptsFull MarksAdequately and accurately: – Identified the type of interventional study design in hospital A, and B. Provided a cited example where this study design has been used. – Justified which study design superior to the other. Referenced the TEDX Talk and its content.8 ptsincomplete marksProvided partially incomplete or inadequate response.0 ptsNo Marksnot done or erroneous | 25 pts |
| This criterion is linked to a Learning Outcome PART 3: Study Protocol Abstract: 1. Study ObjectiveState the study objective. | 5 ptsFull MarksProvided a reasonable study objective2 ptsincomplete marksProvided partially incomplete or inadequate response.0 ptsNo Marksnot done or erroneous | 5 pts |
| This criterion is linked to a Learning Outcome PART 3: Study Protocol Abstract.2. State the study design (prospective or retrospective, phase, randomized – nonrandomized; open – blind; multicentric national or global, safety and/or efficacy) | 10 ptsFull MarksProvided an adequate study design suited to answer the primary objective(s) of the study.5 ptsincomplete marksProvided a design that was partially inadequate in answering the study question.0 ptsNo Marksnot done or erroneous | 10 pts |
| This criterion is linked to a Learning Outcome PART 3: Study Protocol Abstract.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. | 20 ptsFull MarksProvided the two most important Inclusion criteria and explanation why. Provided the two most important exclusion criteria and justification why needed.10 ptsincomplete marksProvided a partial response or justification for IC or EC.0 ptsNo Marksnot done or erroneous | 20 pts |
| This criterion is linked to a Learning Outcome PART 3: Study Protocol Abstract.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 ptsFull MarksProvided at least two study endpoints/outcomes. Provided description of the tools (methods) for the outcome measurements. Stated the tests that will be used for statistical analyses.10 ptsincomplete marksProvided a partial responses or inadequate responses.0 ptsNo Marksnot done or erroneous | 20 pts |
| This criterion is linked to a Learning Outcome PART 3: Study Protocol Abstract.Calculate an estimated sample size for the study. If you must; use power as 80% and ⍺ as 0.05. | 20 ptsFull MarksProvided an accurate description how the sample size for each study endpoint/outcome is/will be estimated and calculated. Answered the question how sample size is calculated.10 ptsincomplete marksSome of the provided results are without description of how they are obtained. Some of the reached results are inaccurate or responses are inadequate.0 ptsNo Marksnot done or erroneous | 20 pts |
| Total Points: 150 | ||
