Please choose a product you would like to develop in this class. For this product it can be fake/made-up/sci-fi or it can be a product that is already in place but used in a different way. After reading Chapter 3 Module, you should have an idea of what class your product is and a rough idea of your regulatory plan. Example on Page 79 in your textbook. What is your Regulatory Environment, Global Strategy, Influences on Regulatory Environment, and Regulatory Risks. In the risks category, try and use some knowledge from Chapter 4 about compliance. What are some things that might hinder compliance?
Nonclinical studies, performed in vitro and in animals, are primary means of measuring potential product risk and much of this testing precedes clinical trials. Results of nonclinical studies serve to better ensure product benefit will indeed outweigh risk once it reaches clinical studies and the marketplace.
Create a clinical protocol for your product. What type of studies or trials will you have to conduct in order for you product to make it to market? Depending on your product, this may be only safety testing, or could require all preclinical and clinical trial phases. Design your protocol using the framework below, only use the elements that are relevant to your product. This protocol can be for either a study or trial. The information for this protocol can be found in the book, Box 9.4.
Study or Trial objectives with Purpose and State Hypothesis
Study or Trial design
Selection and Withdrawal of Subjects
Treatment of Subjects
Assessment of Efficacy
Assessment of Safety
Access to Source Documents or Data
QC or QA
Data Handling and Record Keeping
Finance and Insurance
Appendicbcies (if you feel you need them)