General considerations for clinical data management of antineoplastic drugs
10.12092/j.issn.1009-2501.2022.09.013
- Author:
Yadong MIAO
1
;
Min ZHOU
1
;
Xi LI
2
;
Yan WANG
3
;
Po GAO
4
;
Hao YU
5
Author Information
1. Chia Tai Tianqing Pharmaceutical Group co., Ltd
2. Duality Biologics, Shanghai
3. Akeso Biopharma Co., Ltd.
4. Lynk Pharmaceuticals Co., Ltd.
5. School of Public Health Nanjing Medical University
- Publication Type:Journal Article
- Keywords:
case report form;
clinical data management;
complex study design;
data cut-off;
oncology drugs development
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2022;27(9):1055-1060
- CountryChina
- Language:Chinese
-
Abstract:
With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.
