Case Study: Streamlining Data Management for a Gene Therapy Trial Integrating EDC and EMR Platforms in a Phase 2 Diabetic Ulcer Study Background A biotech sponsor developing a gene therapy for wound healing in ulcerative patients needed a robust data management strategy to reconcile EHR images with their clinical database (EDC). The Inference DM team …
Integrating EDC & EMR for Gene Therapy in Phase 2 Diabetic Ulcer Trial >
Objective A small oncology biotech company with an expanding pipeline required a flexible resourcing model of statistical programmers to address their immediate priorities. One crucial need was supporting database lock (DBL) and Clinical Study Report (CSR) activities for a Phase 2 solid tumor study while developing project timelines for key objectives. The Inference team prepared …
Presented on: September 16th at 1pm (EST) Overview: Many trials are now underway to find an effective treatment for COVID-19. To show effectiveness of a treatment a number of endpoints can be considered including duration of hospitalization, ventilator use, mortality etc. Is there a preference? Does it depend n the phase of the study? In …
The appropriateness of two-sided vs. one-sided hypothesis tests in clinical trials has been the subject of an old debate. This is probably because of the intra and inter disciplinary disagreements among statisticians, clinicians and regulators on this matter often expressed via conflicting recommendations in the literature. First let’s look at how the current ICH E9 Guidance …
Two-sided vs. One-sided Tests: This Should not be “Controversial” >
They say, “There are 3 types of lies – lies, damn lies, and Statistics”. This is what first came to my mind when I sat down to write a blog on Mahalanobis and the evolution of Statistics in India. Muscle-memory I guess! Having been a student of Statistics and economics, I have always armed myself …
A Missed Train, A Missed Boat, and a Science of Error Terms >