Adaptive clinical trial design has been on the increase to improve the efficiency and ethical balance of clinical trials. On November 8, 2019, Colorado State University (CSU) will host its first Adaptive Design Workshop for Preclinical, Veterinary, and Translational Human Studies at the university’s new Translational Medicine Institute (TMI).
Presented by Heather Pidcoke, CSU’s first medical chief medical research officer and associate director of research at the TMI met with Colorado State University Source to discuss the adaptive clinical design.
Adaptive Clinical Design
A strategy employed to support continual modifications to major pieces and components of clinical trials as data is collected, evaluating the treatment outcomes (e.g. positive impact, side -effects) throughout the trial as prescribed in the trial protocol. Modifications could include dosage, sample size, drug undergoing trial, patient selection criteria and “cocktail” mix. In some cases, the sponsor will design a trial that regularly adds and drops therapies and patient groups as more information is obtained. The sponsor must establish the protocol prior to trial commencement, ensuring that the protocol pre-specified adaption schedule and related processes for example. The goal is to more expeditiously and effectively identify drugs or devices that possess a therapeutic effect and focus on appropriate patient populations.
About CSU’s Translational Medicine Institute
CSU’s TMI represents a high-tech innovation hub, bringing together scholars, creators and entrepreneurs to work in collaborative spaces where innovation can thrive. The TMI goal is to discover and delivers solutions that utilize the body’s healing capacity and improve the lives of animals and humans that care for them.
Heather Pidcoke Interview
Follow the link below to the Source to read the entire interview to learn more about adaptive clinical trial design.
Heather Pidcoke, medical chief medical research officer and associate director of research at the TMI
Call to Action: If you are near CSU Nov 8, 2019, consider attending the lecture.