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On September 26, the Drug Evaluation Center (CDE) of the State Food and Drug Administration of China released the Technical Guidelines for the Clinical Development of New Drugs for the Treatment of Ovarian Cancer (Draft for Comment) to improve the efficiency
of new drug research and development.
Firstly, the background of the drafting guidelines and the current status of ovarian cancer diagnosis and treatment are introduced, and then the key issues that need to be paid attention to in the design of the protocol are introduced from the exploratory and confirmatory stages of clinical development of new drugs
Screenshot source: CDE official website
First, the frontier
First, the frontier The annual incidence of ovarian cancer ranks third among female reproductive system tumors, while the case fatality rate ranks first, which is a malignant tumor
that seriously threatens women's health.
Provide reference for anti-tumor drug R&D personnel in the design and endpoint selection of ovarian cancer clinical trials, and improve R&D efficiency
This Guidelines apply to the design of clinical trials and their endpoint selection
that support the registration of drug ovarian cancer indications.
Clinical trial design and endpoint selection that support drug ovarian cancer indication registration
Background
Background(1) Biomarkers related to ovarian cancer treatment prediction
(1) Biomarkers related to ovarian cancer treatment prediction Risk factors for ovarian cancer include age, reproductive risk factors, obesity, smoking, lifestyle, environmental risk factors, and family history and genetic risk factors
.
Risk factors for ovarian cancer include age, reproductive risk factors, obesity, smoking, lifestyle, environmental risk factors, and family history and genetic risk factors
.
(2) Current status of ovarian cancer diagnosis and treatment
Surgery and chemotherapy are the main means
of treatment for ovarian cancer.
Surgery and chemotherapy are the main means
of treatment for ovarian cancer.
3.
Exploratory trials were conducted on the effectiveness study endpoints of the appropriate population and the most reflective characteristics of the new drug's effects
4.
4.
Design confirmatory clinical trials with the ultimate goal of patient clinical benefit
5.
5.
At this stage, prolonging survival time and improving quality of life remain core goals of advanced tumor treatment
For more details, please click "Read the original article" at the end of the article to view the full text of the
exposure draft.
Resources:
Resources:[1] Notice on the Public Solicitation of Opinions on the Technical Guidelines for the Clinical Development of New Drugs for the Treatment of Ovarian Cancer (Draft for Solicitation of Comments).
[1] Notice on the Public Solicitation of Opinions on the Technical Guidelines for the Clinical Development of New Drugs for the Treatment of Ovarian Cancer (Draft for Solicitation of Comments).
Retrieved Sep 26, 2022.
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