Retrospective Study on the Protocol Deviation in Drug Clinical Trial Implementation of Our Hospital / 中国药房
China Pharmacy
;
(12): 3474-3478, 2017.
Article
in Chinese
| WPRIM
| ID: wpr-611023
ABSTRACT
OBJECTIVE:
To study the influencing factors of protocol deviation in drug clinical trial implementation,and pro-vide reference for improving the quality of drug clinical trial.METHODS:
Quality verification was conducted for the drug clinical trial projects in the First Affiliated Hospital of Chongqing Medical University during 2010-2016,and protocol deviations in each year were retrospectively studied,classified and analyzed. Category,frequency,international and domestic pilot projects and the differences of protocol deviation after full-time research nurse participating in trail management were explored,and the measures were put forward.RESULTS:
27 drug clinical trials were implemented in our hospital during 2010-2016,including 949 cases,176 cases with protocol deviation,accounting for 18.55%. Deviation protocol in drug clinical trial was decreased year by year for 7 years. The categories were mainly incompleteness of observation/records (30.11%),checking omission/broaden the window(28.41%),adverse drug events and improper combined medication (14.20%) and omission in drug management (11.93%). The proportion of protocol deviation with full-time research nurse participated was lower than the projects without full-time research nurse(11.11% vs. 28.67%,P<0.01),and proportion of deviation protocol in international multi-center project was lower than the domestic projects(6.60% vs. 28.84%,P<0.01).CONCLUSIONS:
It is suggested to pointedly strengthen the weak links of drug clinical trial. For example,clinical trial institutions should establish the clinical trial data retention system,electronic data should be timely backed up in a different places,etc. Besides,clinical trial institutions should equip professional full-time research nurses as much as possible,learn the rigorous scientific experimental design,standard operational procedures and the authenticity of data pro-cessing from the international multi-center clinical trial projects to effectively reduce the incidence of deviation protocol and im-prove the quality of drug clinical trials.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Controlled clinical trial
/
Practice guideline
/
Observational study
Language:
Chinese
Journal:
China Pharmacy
Year:
2017
Type:
Article
Similar
MEDLINE
...
LILACS
LIS