Year: 2026
Type: article
Abstract: Recognizing these barriers, in 2024 the FDA issued 3 draft guidance documents related to clinical trial eligibility, addressing laboratory values, performance status, and washout periods/concomitant medications.2,4 Recommendations emphasized tailoring eligibility criteria to the investigational drug's mechanism of action, including patients with an Eastern Cooperative Oncology Group performance status ≤2, and liberalizing laboratory thresholds when supported by safety data.
Source: Blood
Author: Mariateresa Fulciniti
Institution: Dana-Farber Cancer Institute
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7127990667