CDE issues 3 guiding principles for clinical trial design of new drugs for advanced colorectal cancer

On December 29, CDE's official website released 3 guidelines, covering clinical trial design of new drugs for advanced colorectal cancer, extended cohort research technology for first-in-human trials of antitumor drugs, and single and multiple dose-escalation pharmacokinetics of innovative chemical drugs.
Kinetic research techniques
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The details are as follows: Circular of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Guidelines for the Design of Clinical Trials of New Drugs for Advanced Colorectal Cancer" (No.
56, 2021) , the survival time of patients with advanced colorectal cancer continues to prolong, which brings challenges to clinical trial design and endpoint selection
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In order to provide reference for the industry personnel in the clinical research and development path and clinical trial design, and improve the efficiency of clinical research and development, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Guidelines for the Design of Clinical Trials of New Drugs for Advanced Colorectal Cancer" ( see attachment)
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In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
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Attachment: Guidelines for the Design of Clinical Trials of New Drugs for Advanced Colorectal Cancer Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for the Extended Cohort Study of the First Human Trials of Antineoplastic Drugs (Trial)" (No.
57, 2021) In the development of new anti-tumor drugs, expansion cohort studies are sometimes integrated after (or during) the traditional first-in-human trials.
Challenges and risk management and other issues, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Extended Cohort Research in the First Human Trial of Antineoplastic Drugs (Trial)" (see attachment)
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In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
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Attachment: Technical Guiding Principles for Extended Cohort Study in First-in-Human Trials of Antineoplastic Drugs (for Trial Implementation) The Center for Drug Evaluation of the State Food and Drug Administration issued the Technical Guiding Principles for Clinical Single and Multi-Dosing Dose-Ascending Pharmacokinetic Research of Innovative Chemical Drugs Announcement (No.
58, 2021) Pharmacokinetic studies of single and multiple dose escalation in clinical trials are an important part of the early clinical research of innovative drugs, and provide important information for supporting the exploration of clinically safe and effective doses of drugs and determining dosing regimens.
basis
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The "Technical Guiding Principles for Clinical Pharmacokinetic Research of Chemical Drugs" issued by the former State Food and Drug Administration in 2005 covers relevant content, but it has been 16 years since then.
The "Technical Guiding Principles for Pharmacokinetic Research of Single- and Multiple-Administration Dose-escalation Pharmacokinetics for Innovative Chemical Drugs in Clinical Medicine" (see annex) has been formulated
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In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
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If there is any inconsistency between the 2005 version of the above-mentioned guidelines and this guideline, the guideline shall prevail
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Attachment: Technical Guidelines for Pharmacokinetic Studies of Single and Multiple Administration Dose-escalation Pharmacokinetics for Innovative Chemical Drugs