HCR557 Medical Assignment Help UK

As we all know the cases of COVID-19 have reached pandemic proportions, and the spread of the virus has affected people globally. The international medical community is working unitedly to resolve this crisis.

Read the articles below or the most current on the subject.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html

(https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/summary.html)

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic (https://www.fda.gov/news-events/press-

announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic)

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins

(https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins)

https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19

(https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19)

https://www.biospace.com/article/coronavirus-update-gilead-struggles-to-recruit-patients-for-

coronavirus-study/ (https://www.biospace.com/article/coronavirus-update-gilead-struggles-to-recruit-patients-for-coronavirus-study/)

https://www.clinicaltrialsarena.com/comment/covid-19-clinical-trials/

(https://www.clinicaltrialsarena.com/comment/covid-19-clinical-trials/)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic (https://www.fda.gov/regulatory

information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic)

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/portfolio-items/luciana-borio/

(https://research.usu.edu/tedxusu/portfolio-items/luciana-borio/)

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. (20points)

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)

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)