Streamlining the Frequency, Conduct, and Location of Assessments in Registrational Lung Cancer Clinical Trials for Supplemental Applications: Recommendations of a LUNGevity Foundation Multistakeholder Working Group.

Abstract

The amount of data collected in oncology clinical trials has grown exponentially over recent years, posing significant burdens on trial participants, investigators, and trial sites. The frequency, magnitude, and strict standardization of trial-related assessments and data collection do not reflect routine clinical care and can limit participation of some patients and trial sites in clinical research. Though the use of simplified trial designs to align trial conduct more closely with routine care has been promoted across stakeholders, including the US Food and Drug Administration, there remains a dearth of guidance as to how to put this concept into practice in specific use cases. Focusing specifically on trials intended to support a supplemental application for a new indication of an approved therapy, a multistakeholder working group convened by LUNGevity Foundation developed recommendations for streamlining lung cancer clinical trial assessments. The present report details important considerations raised by the working group for establishing the frequency, conduct, and location of common lung cancer trial protocol assessments.