RSC Health New Drug Approval Process Clinical Trial Discussion

USE ATTACHED ARTICLES

 discuss the process by which drugs are taken from idea to wide scale use in humans or animals, and the factors that may limit or influence the overall quality of clinical trials. You can use rivaroxaban and the other oral anticoagulants as examples if you wish, or discuss another drug of your choosing. 

In particular:

Discuss the approval process for a new drug

Discuss what you can learn from clinical trials that have been conducted and which are ongoing

• Discuss  real-world safety issues that may  appear after approval and how they might be mitigated
• What could have been done differently?
• Students often ask how long I want the assignment to be. I am not going to set a target for that, it really depends on your writing style and what you have to say. I am looking for original thought, not just repeating what you read in the powerpoint. A highly insightful and concise paper can be less than a page, where another might be two or three. I will be looking for structure, grammar and logical thinking. 
• Some web sites that may be helpful include: 

https://www.xareltohcp.com/real-world-safety-side-effects-efficacyLinks to an external site.

https://clinicaltrials.gov/ct2/results?term=rivaroxaban&Search=SearchLinks to an external site.

https://www.fda.gov/safety/medwatch/Links to an external site.

• http://www.bmj.com/content/352/bmj.i575