high risk medical device product development • completed write H e a l t h M e d i c a l

high risk medical device product development • completed write H e a l t h M e d i c a l

The clinical research process is an integral part of the biopharmaceutical and high risk medical device product development process. This Case Study illustrates an example for why a long-utilized research study design may not be appropriate to support the marketing approval for all such products. The case also illustrates how the aforementioned research study design may potentially be improved through the use of additional statistical techniques. The Assignment questions for this Case Study write-up require you to explain the critical components of the case from a situational perspective, as well as to develop replies to specific questions presented by the case.

Case Study Write-Up Questions

1. In 2-3 paragraphs please present a situational description of the case that addresses: Who is Dr. Brian Alexander? What types of patients does he treat? Why is he working with GBM AGILE? 2. What are the distinguishing features of traditional randomized controlled trials (RCTs)? What are the advantages and disadvantages of traditional RCTs versus other clinical trial designs? Why have RCTs been widely considered to be the ‘gold standard’ for clinical research for the past few decades? 3. What are the primary ways in which an adaptive platform trial differs from an RCT? What are the statistical considerations? 4. What do you anticipate will be the biggest challenge for Dr. Alexander and his colleagues as they launch the GBM AGILE trial? If you believe that there will be multiple major challenges, please prioritize your answers 5. What business models for the Global Coalition for Adaptive Research (GCAR) do you believe are the most promising and why?

  • In addressing the questions presented, please feel free to develop and utilize diagrams to support your answers • Please ensure that you integrate an explanation for why clinical trials are needed to support biopharmaceutical and high risk medical device product development • Completed write-ups should be approximately 5-7 pages in length, single or double-spaced (your choice) in 12 pt font