3 Friends of Cancer Research White Papers
Ahead of its 11/10 annual meeting, which will focus on early-phase oncology drug clinical trial development, Friends of Cancer Research (FCR) has issued three white papers for discussion during the day. Session 1, on risk-based nonclinical strategies to support early-phase development, will use a paper entitled “A Risk-Based, Weight-of-Evidence approach to Nonclinical Safety Assessment for First-in-Human Oncology Drug Development.”
FCR says a working group developed a framework and identified these key principles for its application:
- address scientific and clinical factors collectively;
- focus on the expected value of additional evidence; and
- ensure the resulting strategy remains sufficient to support FIH (first-in-human) development.
Session 2 will be on fit-for-purpose expectations for FIH studies and will use the paper entitled “Reducing Avoidable Delays in U.S. Oncology First-in-Human Studies.” FCR says the work group that developed this paper identified four areas where targeted approaches could help:
- aligning evidence expectations with initial protocol objectives;
- improving the actionability of pre-IND interactions;
- strengthening product-specific, risk-based approaches; and
- minimizing downstream operational disruptions.
FCR says the third session will cover model-informed drug development (MIDD) and AI for oncology dose optimization, using the paper “A Framework for Incorporating Model-Informed Drug Development into Decisions for Selecting the Registrational Dosage in Oncology Drug Development.” The working group that developed this paper offered recommendations in four steps:
- defining the question of interest;
- selecting the appropriate context of use and MIDD approach;
- evaluating the risks and credibility of relying on model-informed evidence; and
- integrating MIDD findings with the totality of evidence.
FDA staff are listed among the working group members for each of the papers.