Legal Regulation on the Financial Conflicts of Interests of Researchers in Drug Clinical Trials
- VernacularTitle:药物临床试验中研究者经济利益冲突的法律调控初探
- Author:
Xin LI
;
Liping LIU
- Publication Type:Journal Article
- Keywords:
Drug clinical trials;
Financial conflict of interests;
Legal regulation
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To put forward suggestions for the legal regulation on the financial conflict of interest of researchers in drug clinical trials.METHODS:The definition and harm of the financial conflict of interest of the researchers in clinical trials were analyzed,and the legal measures of FDA on regulating and controlling the financial conflict of interest of the researchers were evaluated.RESULTS & CONCLUSIONS:The Chinese legislature should draw useful legal experiences from USA to establish suitable legal measures to regulate and control the financial conflict of interest of researchers in clinical trials,clarify the definition of the financial interest of researchers,require the applicant for clinical trial to disclose his financial interest and the applicants for drug registration to submit the statement about the financial conflict of interest of researchers to the drug administration department.