Exploration of compassionate use patterns in clinical trials of bone tumors
LYU Yu
WANG Chong-ren
SUN Wei
CAI Zheng-dong
HUA Ying-qi
Abstract：Patients with advanced bone tumors are often difficult to enroll in clinical trials for a variety of reasons, facing the dilemma of insufficient drug availability. As a flexible supplement to the traditional clinical trial model, compassionate medication provides a way for patients to obtain drugs and solves their drug use problems in specific situations. The development of compassionate medication in China started late, but it has been initially established and gradually standardized with the successive introduction of a series of policies and laws in recent years. In this study, we explored the positive role of the system in specific contexts, and summarized the relevant experience in the implementation process for a total of 5 patients with advanced bone tumors. As an important way to ensure that patients with advanced bone tumors have access to essential drugs, it is necessary to confirm that patients, clinicians, pharmaceutical companies and management departments respond positively and efficiently to the system to promote its rational operation. At the same time, in view of the challenges in the process of new drug development and diagnosis and treatment of bone tumors, this paper argues that the drug development strategy of bone tumors needs to be transformed to a clinical demand-oriented and patient-centered direction.
Keywords：Bone neoplasmsDrug therapyCompassionate use drug
Publication Date：2025-02-18
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 97-99 )