CDE Release | Notice on Publicly Soliciting Opinions on the Technical Guidelines for Clinical Trials of Chimeric Antigen Receptor T Cell Therapy for Lymphatic and Hematological Malignant Tumors (Draft for Comments)
CDE Release | Notice on Publicly Soliciting Opinions on the Technical Guidelines for Clinical Trials of Chimeric Antigen Receptor T Cell Therapy for Lymphatic and Hematological Malignant Tumors (Draft for Comments)
Multiple chimeric antigen receptor T cell therapy products have been launched in China for the treatment of malignant tumors in the lymphatic system. This type of product combines innovation and complexity, and there are many different considerations in clinical trial design compared to traditional ...
Interpreting the roles and responsibilities of relevant personnel from the perspective of clinical trial data flow
Interpreting the roles and responsibilities of relevant personnel from the perspective of clinical trial data flow
Clinical trial data can be defined as any information or fact related to a clinical trial. What information in our daily work belongs to clinical trial data? It can be numbers, characters, medical history, medication records, examination reports, records, and signatures, etc. Data can basically be d...
A Brief Analysis of the Multiple Issues in Clinical Trials
A Brief Analysis of the Multiple Issues in Clinical Trials
Clinical trials can be divided into "exploratory clinical trials" and "confirmatory clinical trials" according to different research purposes, and relevant clinical research conclusions usually need to be drawn from statistical inference in confirmatory clinical trials. If multiple hypothesis tests ...
A Brief Discussion on the Standardization Path of SDTM Finding Domain Program
A Brief Discussion on the Standardization Path of SDTM Finding Domain Program
The processing rules for SDTM Finding Domain are relatively fixed, but in the actual project process, due to differences in projects, EDCs, and Finding Domains, it will always take some time to process and compare. After the baptism of several SDTM projects, the editor has summarized some experience...
Creating CRF Template Library Based on CDASH
Creating CRF Template Library Based on CDASH
We know that the quality of clinical trial data first and foremost depends on the quality of CRF. Therefore, in addition to the trial protocol, CRF, as a tool for data collection, is the most important document in the clinical trial process and can directly affect the success or failure of the trial...