Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: Formal consensus method for the development of guidelines for standardised time-to-event endpoints¡¯ definitions in cancer clinical trials

详细信息    查看全文

• 作者：Carine A. Bellera^a ; ^b ; ; Marina Pulido^a ; ^b ; Sophie Gourgou^c ; Laurence Collette^d ; Adé ; laï ; de Doussau^b ; ^e ; ^f ; Andrew Kramar^g ; Tienhan Sandrine Dabakuyo^h ; Monia Ouali^d ; Anne Auperinⁱ ; Thomas Filleron^j ; Catherine Fortpied^d ; Christophe Le Tourneau^k ; Xavier Paoletti^l ; Murielle Mauer^d ; Simone Mathoulin-Pé ; lissier^a ; ^b ; ^f ; ^o ; Franck Bonnetain^m ; ⁿ ; ^o
• 关键词：Guidelines as topic ; Clinical trial surrogate endpoints ; Endpoint definitions ; Survival analysis ; Clinical protocol
• 刊名：European Journal of Cancer
• 出版年：2013
• 出版时间：March, 2013
• 年：2013
• 卷：49
• 期：4
• 页码：769-781
• 全文大小：917 K

文摘

Introduction

In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial¡¯s results by affecting estimation of treatments¡¯ effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials.

Methods

We will use a formal consensus methodology based on experts¡¯ opinions which will be obtained in a systematic manner.

Results

Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs).

Discussion

The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials¡¯ results.