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# 3 Friends of Cancer Research White Papers
- URL: https://www.fdaweb.com/3-friends-of-cancer-research-white-papers/
- Published: 2026-11-04T19:28:11.000Z
- Updated: 2026-11-04T19:28:11.000Z
- Author: David McFarland
- Tags: Drugs

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.”](https://friendsofcancerresearch.org/wp-content/uploads/A-Risk-Based-Weight-of-Evidence-Approach-toNonclinical-Safety-Assessment-for-First-in-HumanOncology-Drug-Development%5FWhite-Paper.pdf?ref=fdaweb.com)

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.”](https://friendsofcancerresearch.org/wp-content/uploads/Reducing-Avoidable-Delays-in-U.S.-Oncology-First-in-Human-Studies%5FWhite-Paper.pdf?ref=fdaweb.com) 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.”](https://friendsofcancerresearch.org/wp-content/uploads/A-Framework-for-Incorporating-Model-Informed-Drug-Development-MIDD-into-Decisions-for-Selecting-the-Registrational-Dosage-in-Oncology-Drug-Development%5FWhite-Paper.pdf?ref=fdaweb.com) 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.