“Everything we do in clinical trials is based on statistical principles, and you have to be comfortable with” them to flourish as a clinical trial professional, says Joy Frestedt, PhD, RAC, FRAPS, CPI, FACRP, president and CEO of Frestedt Incorporated and Alimentix, the Minnesota Diet Research Center.
The good news for those with a touch of phobia where numbers are concerned? “It doesn’t have to be too complicated,” Frestedt says.
The bad news? Failure to collect and catalog all relevant data could “invalidate your whole clinical trial design,” she warns. “You can’t analyze what you don’t collect,” she adds.
Frestedt is a big advocate of leveraging and understanding the recent ICH E9 documents from the International Council for Harmonization addressing statistical issues in clinical trials to enhance performance across the board.
ICH E9 provides guidance on the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. It also assists with preparing application summaries or assessing evidence of efficacy and safety, principally from trials in later phases of development.
Webinar – ICH E9: A Review and a Look into the Addendum (R1)
Join Frestedt and colleague Dr. Kasey Sans for this webinar on August 11, when they will give an overview of both the ICH E9 Guideline and the ICH E9 (R1) Addendum. Frestedt and Sans will explore how clinical trials are based on statistical principles and how treatment effects are measured in a clinical trial. Registration is free for ACRP Members!
The ICH E9 addendum (R1) provides clarification on some of the concepts explained in ICH E9, Frestedt says. It presents a structured framework for trial planning, conduct, data collection and interpretation of data analyses. The addendum also refines the role of sensitivity analysis to explore robustness of conclusions from the main statistical analysis.
Clinical trial practitioners with a firm grip on ICH expectations are in a far better position to effectively design trials, Frestedt says. “They’ll have a better understanding of trial context from beginning to end,” she adds.
Author: Michael Causey