RGA6463 Regulatory Strategy for Product Development and Life-Cycle Management Case Study Write-Up: Adaptive Platform Trials: The Clinical Trial of the Future?
A critical learning outcome for the course is to give students an opportunity to study the
compliance standards required to formulate regulatory strategies to support product
development and life-cycle management. 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?
• You may collaborate with your fellow classmates to complete the Assignment –
however, your work should be submitted independently and in your own words
• 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 – please include your name in your
submitted file (e.g. Desai Shrenik – RGA6463 Case Study #2 Assignment.pdf)
Completed Case #2 Write-ups are due as per the date listed on Canvas– please submit
your completed work through the link provided in Canvas
This Write-Up is worth 10 % of your grade for the course.