New Drug Clinical Trial Design Path: Phase III Clinical Trials.

Wen . . . Yang Liuqing 1 Preamble Phase III Clinical Trial is a key test in the clinical research stage of new drugs, and is the clinical basis for whether new drugs can finally be approved for market.
Phase III clinical trials, also known as corroborative clinical trials, are designed to further corroboration of data on the effectiveness and safety of new drugs obtained in Phase II clinical trials (exploratory clinical trials) and to provide sufficient evidence for new drugs to be licensed for market.
III clinical studies are generally about a wider population, different stages of the disease, or the study of combined medications.
addition, Phase III clinical studies will conduct trials of delayed exposure to drugs that are expected to be taken for long periods of time.
2III Clinical Trials Panorama 2.1 What (Who) Phase III Clinical Trials are part of the therapeutic role of clinical trials, through Phase III clinical trials to prove that the new drug is safe and effective for targeted patients with adaptive disorders, the benefit/risk ratio is acceptable, provide sufficient basis for drug registration, and provide sufficient data for drug specifications and doctor's prescriptions.
2.2 Why (Why) Phase II clinical trial participants had a small sample size and their data on the effectiveness and safety of new drugs were not sufficient to support new drug approval.
And Phase III clinical trials can further confirm the efficacy, long-term safety, and benefit/risk ratio of Phase II clinical trials with sufficient sample sizes to provide definitive evidence that new drugs are finally approved for market.
(What) Phase III clinic is primarily used to answer the question: What is the benefit/risk ratio of the new drug? To answer this question, Phase III clinical trials are generally randomized blind controlled trials with sufficient sample sizes of subjects.
iii clinical trials can also be carried out in the study of the volume-effect relationship, but also according to the characteristics of the drug, the specific situation of the target patient, drug interaction and other research.
Iii clinical trials will require statistically significant conclusions at the end, including: new drug target adaptation, included disease population, key efficacy indicators, route of delivery, usage and course of treatment, safety information sufficient to support registration applications, and comprehensive risk/benefit assessment of validity safety data.
In addition, depending on different adaptations or combination drugs, the applicant will further subdivide Phase III clinical into Phase IIia and Phase IIIb, and filers will be able to apply for listing approval after completing IIIa clinical trials, which will generally speed up the market progress and improve market returns, while through IIIb clinical trials can further expand new drug adaptations and increase market revenue.
2.4 How to do (How) test principle: Generally through the comparison of new drugs with existing standard treatments, Phase III clinical trials are divided into best-effect trials and non-poor-effect trials.
testing process often uses randomized blindness, positive control test, and in the case of non-commercially available positive drugs, a placebo is used for control.
subjects: target adaptive patients; sample size: typically hundreds to thousands of people; followed by a common Phase III clinical trial design.
Phase III Clinical Trial Design Phase III. Clinical Trials generally use randomized, parallel controlled trial design to confirm the effectiveness and safety of new drugs in specific target populations.
in a specific clinical trial design scenario, the choice of the type of trial design is critical because it determines the estimation of the sample size, the research process, and its quality control.
therefore, researchers should choose different test designs according to the purpose and conditions of the experiment.
4 Revealed that a new drug has been tested in the human body of dozens of healthy subjects for the first time (First In Human, FIH) until Phase III clinical trials in five or six years from hundreds of target patients.
The whole process has gone through human tolerability tests, pharmacological dynamics tests, preliminary pharmacological tests, large-scale corroborative tests, which may also include inspections of specific population groups (old people, children, functional defects, etc.), drug interactions, etc.
clinical trials are a decisive stage in whether new drugs are approved for market, and any problems at any point can be devastating or even devastating for pharmaceutical companies, especially start-ups.
, clinical research costs are expensive, accounting for about two-thirds of the total cost of new drug research and development, up to hundreds of millions of dollars.
because of the importance and cost of clinical research, in 2007 the FDA released Target Product Profile - A Strategic Development Process Tool, a product development strategy based on target product characteristics (TPP).
TPP is a mind-starting concept, that is, first of all, the bidder based on pre-drug research, by setting the label of future products to define new drug development objectives, the development of specific clinical trials designed to support product labels(labels), with the TPP as the main line and goal to guide and plan the clinical development and research of innovative drugs, improve the efficiency of the exchange between the bidder and management at all stages of clinical development, especially technical review and meetings, and ultimately improve the efficiency of clinical development of new drugs.
: 1, New Methods to Clinical Trials: Adaptive Designs2, Introduction to Clinical Design and Evaluation of Phase III of Anti-Tumor Drugs in the United States 3, Target Product Profile - A Strategic Development Process Tool4, FDA "Target Product Features ( T) PP) Guiding Principles (Draft) "Introduction 5, ICH E86, General Principle 7 of Clinical Research on New Chinese Medicines, Methodology of Drug Clinical Trials 8, Design and Analysis of Clinical Trials 9, Clinical Trials - Methodology Inquiry 10, General Consideration Guidelines for Drug Clinical Trials."