Active were more sick than those on placebo

Reference no: EM133432773

Question: This is all about design, design flaws and analysis. On a very related note, the program I spent 6+ years on read-out this time last year and the public was made aware we didn't meet the primary (or any of the secondary) endpoints. In some cases, with pediatric rare disease, if there are trends (i.e., the data is heading in the right direction), there can be a justification for talking with the FDA, but in our case, it wasn't enough. The news was very difficult to deliver on the community and families, perhaps more so because it is a pediatric disease and one that comes with a life sentence. So onto the discussion question. What went wrong? The Phase 2 data was solid, there was more than enough enrolled to see an effect despite losing a handful to compliance issues and early terms. Even with limited experience, one can walk through the scenario and ask, did you check this? Did you check that, etc., etc., so lets do that. We are still reviewing the data - is it possible those randomized to active were more sick than those on placebo? Possibly yes and in a disease where the younger you start treatment, the better, is it possible those on active were older, even by months?

Reference no: EM133432773

Questions Cloud

What is the data collection for grounded theory : What is the rationale of grounded theory in digital age influence in IT? What is the data collection for grounded theory?

What can be put in place or done to limit these occurrences : Are further amendments and updates to guidances or even ICH standards necessary (ex. ICH Q7 Documentation and Records)

What are the three fundamental rights of every employee : When should a company think about either promoting and hiring from within or hiring from external? Name three advantages and disadvantages of each

How can hipaa be used for compliance : What HIPAA is, and it's history. Are there any current issues with HIPAA compliance? How can HIPAA be used for compliance?

Active were more sick than those on placebo : We are still reviewing the data - is it possible those randomized to active were more sick than those on placebo? Possibly yes and in a disease where the younge

Identify the defining differences of interpretation : identify the defining differences of interpretation that occurs between health care providers, regulatory authority and patients. Are there any laws in your

What do you think is the most difficult part of the process : What do you think is the most difficult part of the process for the general public to understand about legislators? Please elaborate.

How does angina pectoris affect the cardiovascular : What are some additional diagnostic tests that can be done to illuminate the diagnosis? For example, when you injure your ankle, they take an x-ray

Describe a cross-site scripting attack : Suggest ingenious design solutions for preventing a cross-site scripting attack and describe effective procedures for hardening the application.

User Account

All Pages