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

1 The Prologue PHASE III clinical trial is a key trial in the clinical phase of a new drug and a clinical basis for the final approval of a new drug.
Phase III clinical trial, also known as confirmed clinical trials, is intended to further confirm the data obtained by Phase II Clinical Trials (Exploratory Clinical Trials) on the efficacy and safety of new drugs and provide sufficient evidence for new drugs to be licensed for market.
Phase III clinical studies are generally about a wider population, different stages of disease, or combined drug use.
, Phase III clinical studies will conduct trials of drug delay exposure for drugs that are expected to be taken for a long time.
2 Phase III Clinical Trial Panorama 2.1 What (Who) Phase III Clinical Trials are part of the therapeutic action confirmation phase of clinical trials, and the new drug has been proven to be safe and effective for patients with target adaptation through Phase III clinical trials, with an acceptable benefit/risk ratio, providing a sufficient basis for drug registration, and providing adequate data for drug specifications and doctor's prescriptions.
2.2 Why (Why) Phase II clinical trial subjects have a small sample size and have insufficient data on efficacy and safety of new drugs to support new drug approval.
and Phase III clinical trials can further confirm the efficacy, long-term safety and benefit/risk ratio of the new drug in Phase II clinical terms by sufficient sample size, providing definitive evidence for the final approval of the new drug for market.
2.3 What (What) Phase III Clinical is primarily used to answer a question: What is the benefit/risk ratio of new drugs? To answer this question, Phase III clinical trials are generally randomized blind control trials with sufficient sample sizes for subjects.
Phase III clinical trials can also be studied in quantitative-effect relationships, but also according to the characteristics of the drug, the specific conditions of the target patients, drug interaction and other studies.
phase III clinical trials are required to provide statistically significant conclusions, including: new drug target indications, included disease populations, key efficacy indicators, pathways of administration, dosage and course of treatment, adequate support for registration applicationsafetinformation, and a comprehensive risk/benefit assessment of effectiveness safety data.
In addition, according to different indications or combination drug use, the applicant will further subdivide Phase III clinical sub-iiIa and IIIb, the filer can apply for listing approval after completing the IIIa clinical trial, so that it can generally speed up the listing progress, improve market revenue, and through THE IIIb clinical trial can further expand the new drug adaptation, increase market revenue.

2.4 How Test Principle: Generally, phase III clinical trials are classified as efficacy trials and non-inefficiencies by comparing new drugs with existing standard treatments.
test process often uses random izedodes and positive control trials, and when there are no commercially available positive drugs, a placebo can be used for control.
subjects: targeted indications patients; sample size: typically hundreds to thousands of people; and the next focus is on common Phase III clinical trial designs.
Phase III Clinical Trial Design Phase III Clinical Trials are generally designed with randomized, parallel control trials to confirm the effectiveness and safety of new drugs in specific target populations.
the selection of experimental design types is critical in specific clinical trial designs, as this determines the estimation of sample volume, the research process, and its quality control.
therefore, the researchers should choose different test design sings according to the different purpose and test conditions.
4 Revelations A new drug has gone through the first human trials of dozens of healthy subjects (First Human, FIH) until five or six years later, a Phase III clinical trial of hundreds of target patients.
the whole process has been subjected to human tolerance tests, pharmacokinetic tests, preliminary pharmacodynamic seisphons, large-scale confirmed tests, which may also include specific population stakes (old people, children, functional defects, etc.), drug interactions, and so on.
clinical trials are the decisive stage in whether new drugs are approved for market, and any problem is huge 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 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-based concept, that is, first of all, the applicant 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, with the TPP as the main line and objectives to guide and effectively guide and plan the full range of innovative drug clinical development and research, improve the efficiency of the participants and management in the clinical development process (especially technical review and conference) communication efficiency, and ultimately improve the efficiency of clinical development.
References: 1, New Approaches to clinical trials: Adaptive Designs 2, U.S. Anti-Tumor Drugs Phase III Clinical Design and Evaluation Introduction 3, Target Product Profile - A Strategic Development Process Tool 4, FDA "Target Product Characteristics (TPP) Guiding Principles (Draft) "Introduction 5, ICH E8 6, General Principles of Clinical Research of New Chinese Medicines 7, Pharmaceutical Clinical Trial Methodology 8, Clinical TrialS Design and Analysis 9