CDE releases 2 technical guidelines for clinical trials involving weight control and advanced prostate cancer

On December 8, the CDE official website issued the "Technical Guidelines for Clinical Trials of Weight Control Drugs" and "Technical Guidelines for Endpoints in Clinical Trials of Advanced Prostate Cancer (Draft for Comment)".
The guidelines will be implemented from the date of issuance, and the time limit for soliciting comments is from One month from the release date
.
The original text is as follows: Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of "Technical Guidelines for Clinical Trials of Weight Control Drugs" (No.
52 of 2021) In recent years, the number of overweight and obese patients in China has increased significantly.
Control has become an urgent clinical need
.
In order to encourage and promote the research and development of weight control drugs, and standardize clinical research design and related technical requirements, the Center for Drug Evaluation has organized and formulated the "Technical Guidelines for Clinical Trials of Weight Control Drugs" (see appendix)
.
In accordance with the requirements of the "Notice of the General Department of the State Drug Administration on Issuing the Procedures for Issuing the Technical Guidelines for Drugs" (Yao Jian Zong Yao Guan [2020] No.
9), it is hereby issued with the approval of the State Drug Administration, as of the date of issuance From implementation
.
Attachment: Notice on Technical Guidelines for Clinical Trials of Weight Control Drugs Regarding the Public Solicitation of "Technical Guidelines for Endpoints for Advanced Prostate Cancer Clinical Trials (Draft for Comment)" Prostate cancer is a common urinary system malignant tumor, which is unique compared to other solid tumors The characteristics of the disease, such as different disease stages according to the sensitivity to androgen deprivation treatment and whether it has metastasis, high incidence of bone metastasis and serum biomarker PSA, etc.
, clinical trial endpoints have special definitions and considerations
.
For patients with advanced prostate cancer at different disease stages, how to choose reasonable clinical trial endpoints, scientifically and objectively evaluate the clinical value of drugs, save research and development time, and allow patients to receive effective treatment as soon as possible is an important issue that needs to be resolved.
Therefore, our center The "Technical Guidelines for Endpoints of Advanced Prostate Cancer Clinical Trials (Draft for Comment)" was drafted for industry reference
.
We sincerely welcome all sectors of the society to put forward valuable comments and suggestions on the solicitation of comments, and feedback them to us in time for follow-up improvement
.
The time limit for soliciting opinions is one month from the date of publication
.
Please send your feedback to the email address of the following contact: Contact: Tongxin Contact: tongx@cde.
org.
cn Attachment: 1.
"Technical Guidelines for Endpoints of Advanced Prostate Cancer Clinical Trials (Draft for Comment)" 2.
"Technical Guidelines for Endpoints in Advanced Prostate Cancer Clinical Trials (Draft for Comment)" drafting instructions 3.
Feedback form for "Technical Guidelines for Endpoints for Advanced Prostate Cancer Clinical Trials (Draft for Comments)"