Oncology Spotlight (Part IV: A New Paradigm in Trial Design)

With the rapid emergence of immunology and targeted therapies, the field of oncology is quickly shifting. Regulators like the FDA are embracing this transformation, prioritizing speed and innovation in clinical trial design. In the final installment of our oncology series, we explore how.

 

SHORTER CLINICAL TRIAL

 

 

NEW ONCOLOGY TRIAL DESIGN

PILOT GROUPS AND EXPANSION COHORTS

 

 

MASTER PROTOCOLS

 

 

 

HOW WILL YOU KEEP UP

With this new paradigm, there are more opportunities than ever to develop life-saving treatments. To meet the greater speed and adaptability of modern oncology trials, researchers need eClinical tools that are equally fast and flexible:

 

 

EASY TO USE

Intuitive software and robust onboarding

 

 

 

SPEED

Rapid study-build and mid-study changes

 

 

 

FLEXIBILITY

Manage the adaptive trial designs common in oncology

 

 

 

 
With the rapid emergence of immunology and targeted therapies, the field of oncology is quickly expanding. In this fourth and final installment of Medrio’s spotlight on the growth in the oncology clinical trial market, we discuss how regulators are embracing oncology’s transformation by prioritizing speed and innovation through Breakthrough Therapy Designation as well as adaptive trial design and Master Protocols.

A primary change in oncology clinical trials design is the emphasis on reducing timelines. While traditionally “overall survival” has been the primary trial endpoint, in 2018 the FDA established a number of surrogate endpoints with the goal of clarifying how to meet safety requirements while speeding up patient access to treatments. Additionally, smaller trials are becoming more common and some targeted therapies have achieved FDA approval with trials of only a few patients.

Adaptive designs, master protocols, and Breakthrough Therapy Designation in oncology

Expedited approval marks another critical step in the transformation in oncology. In 2017, the Oncology Center of Excellence (OCE) was established to streamline the development of cancer therapies by expediting the review process for oncology products. Combined with this, Breakthrough Therapy Designation now holds the power to speed up the review process when preliminary evidence suggests substantial improvement over traditional therapies. From 2013 – 2017, oncology products accounted for 56% of breakthrough therapy designations.

Finally, new oncology adaptive trial designs are emerging. Pilot Groups and Expansion Cohorts are moving past the traditional 3 + 3 dose escalation approach and giving way to more novel methods. Master Protocols, which are becoming increasingly common in later-stage oncology trials, including platform studies, basket protocols, and umbrella designs, permit more rapid and flexible testing of drug combinations from multiple sponsors.

With this new paradigm, there are more opportunities than ever to develop life-saving treatments. Read this infographic now for vital information on oncology trends and be sure to view the other infographics in the series. To meet the greater speed and adaptability of modern oncology trials, researchers need eClinical tools that are equally fast and flexible. Medrio is here to help oncology researchers achieve their goals.