Who primarily designed the clinical trial protocol?

Well, the project plans of foreign companies are generally available in English and Chinese, which are generally formulated by authoritative experts from the medical department or the industry, and they also have program seminars, which are not so much seminars as training meetings. Because the proposals that were brought to the seminar were basically the final version. Domestic projects are generally CRO companies to complete the first draft, submit to the team leader PI for discussion, and then hold a plan discussion meeting, each expert expresses their opinions, and finally summarizes and then makes modifications.

Finalize the version. View the original post

If the sponsor's medical center is very strong, you can design the plan yourself, and if not, you can design it with the team leader. We don't have a medical specialty, so we make an overall program framework based on the existing materials, and the core content, such as efficacy evaluation criteria, observation indicators, etc., needs to be discussed with the team leader unit, and they will complete it.

We mainly provide the first draft from the sponsor, and then invite the principal investigators of each center to solicit comments. After the revision, it will be discussed at the investigator's meeting, where the researcher will approve and sign the content of the protocol. A well-done foreign company basically has a plan when it applies for approval, and after getting the approval document, it will directly organize a researcher meeting without special circumstances.

It also depends on what the company asks. If the second case is difficult to implement for companies with strict costs. View the original post

This question has the following problems:1. China's GCP regulations are established based on the reality of new drug development in China, that is, most pharmaceutical companies lack the ability to set up a small R&D department or development department to undertake or design the trial plan for new drug development, so they are required to discuss the trial research plan with the researcher.

2。Most of the foreign companies are composed of a team composed of medical department, regulatory affairs department, marketing department, clinical pharmacologists and medical consultants to design the program and hold a program discussion meeting to determine the trial research plan. The meeting attended by the investigator is called the investigator meeting, which is a training meeting, including GCP training; It cannot but be said here that China's current drug research registration is still in the second stage of the internationally accepted registration classification. The above views are for reference only.

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1. Before the start of the trial, the State Food and Drug Administration (CFDA) must obtain the approval of drug clinical trials.

2. Clinical research protocol design, record sheet preparation, SOP formulation.

3. The ethics committee reviews and approves the phase I clinical study protocol, informed consent form, case report form and other trial-related documents.

4. Researcher training, preparation of phase I wards.

5. Voluntary subjects will be selected through the physical examination, and then further comprehensive examination, and those who pass will be selected.

6. Before the start of the trial, sign an informed consent form for the qualified subjects.

7. Data entry and statistical analysis.

8. Summary and analysis.

Identify the primary and secondary endpoints of the clinical trial.

1.Human Research Subjects: Animal Experimentation - Animals; Clinical Trials – Individuals (Sick or Healthy); Community-based intervention trials – healthy people.

2.Anthropogenic interventions: Measures that block or alter the natural history of the disease through certain preventive measures, ** finger methods, etc., are called interventions. Clinical trials can observe and analyze the effects of interventions.

3.It is a prospective study.

That is, after the intervention was given, the study subjects had to be followed up for a period of time before Liang Yun could obtain outcome data.

4.A control group must be established: through the control group, other influencing factors other than the experimental factors can be excluded, and the control group is required to be balanced and comparable with the experimental group in other respects except that it is not affected by the treatment factors.

The clinical trial phase of an investigational drug or biological product as defined by the U.S. Food and Drug Administration (FDA). This phase is based on the objectives of the study, the number of participants, and other characteristics. There are five phases:

Early Phase 1 (formerly known as Phase 0), Phase 1, Phase 2, Phase 3 and Phase 4.

Early experiments (previously known as phase 0 experiments).

The research phase of a drug is used to describe an exploratory trial that precedes a traditional phase 1 trial to study how or if a drug affects the human body. They involve very limited drug exposure in humans, and there are no ** or diagnostic goals (e.g., screening studies, microdose studies).

period of experiments. Used to describe clinical trials focused on drug safety. They are usually performed with healthy volunteers with the aim of determining the most common and serious adverse events of a drug, and how it is usually determined how the drug is broken down and excreted by the body (see Pharmacokinetic Experiments).

These trials usually involve only a small number of participants.

period of experiments. A phase of research that describes a clinical trial that collects preliminary data about whether a drug works in people with a specific disease (i.e., the effectiveness of the drug). For example, participants who received a drug can be compared to similar participants who received different**, usually an inactive substance (called a placebo) or a different drug.

Continue to assess safety and study short-term adverse events.

period of experiments. A phase of research that describes a clinical trial that gathers more information about the safety and efficacy of the drug by studying different populations and different doses and combining the drug with other drugs. These studies usually involved a larger number of participants.

period of experiments. Describe the research phase of a clinical trial conducted after FDA approval puts a drug on the market. They include post-market demand and commitment studies that are required or agreed to by the study sponsor.

These trials collect additional information about the drug's safety, efficacy, or best use.

The objectives of the Phase IV trial are:

1. Pass the first phase of the experimental tolerance test: preliminarily understand the safety of the test drug on the human body, and observe the human tolerance and adverse reactions of the test drug. There are also pharmacokinetic tests:

Understand the human body's disposal of the test drug, that is, the absorption, distribution, metabolism, and elimination of the test drug.

2. The phase II clinical trial is mainly the preliminary evaluation stage to understand the effect of **. Its purpose is to preliminarily evaluate the efficacy and safety of the drug for patients with target indications, and also to provide a basis for the study design and dosing regimen of phase III clinical trials.

3. Phase III clinical trials are mainly in the stage of confirmation. Its purpose is to further verify the best effect and safety of the drug on patients with target indications, evaluate the relationship between benefits and risks, and finally provide a sufficient basis for the review of drug registration applications.

4. Phase IV clinical trial is the applied research stage conducted by the applicant after the new drug is marketed. Its purpose is to investigate the efficacy and adverse effects of drugs under widely used conditions, to evaluate the benefits and risks of use in general or special populations, and to improve the dosage of drugs.

Extended Materials. Phase I clinical trials are open-label post-marketing trials that do not require a control group, but do not preclude small-sample randomized controlled trials for certain indications or in some test subjects as needed. The number of phase clinical trial cases is required to be 2,000 according to SDA regulations.

Although the phase phase clinical trial is an open trial, the design requirements of the phase clinical trial can be referred to the selection criteria, exclusion criteria, exit criteria, efficacy evaluation criteria, adverse reaction evaluation criteria, and various observation indicators for judging efficacy and adverse reactions.

The following points should be included:1The title and rationale of the trial.

2 Elaboration of the goals and objectives of the experiment. 3. The location of the trial, the name of the sponsor. 4 Name, mailing address and qualifications of each investigator.

5. Describe the type of trial (controlled, open-label), trial design (parallel-group, cross-over method), blinding method (double-blind, single-blind), randomization (methods and procedures).6 Describe the inclusion and exclusion criteria of subjects, and the manner, method, and time of subject allocation. 7 Statistically based on the number of participants who were required to complete the trial.

8 The route of administration, dose, dose interval and course of administration of the trial drug and the reference substance, and the description of the reason, and the dose-response relationship that should be considered. 9 Any other ** that can be given or permitted to be given at the same time. 10 Clinical and laboratory tests, pharmacokinetic analysis, etc. to be performed.

A trial protocol is a document that describes the purpose, design, methodology, statistical considerations, and organization and implementation of a clinical trial.

The trial protocol describes the background, rationale, and purpose of the trial, the design, methodology, and organization of the trial, including statistical considerations, and the conditions under which the trial was performed and completed. The protocol must be signed and dated by the principal investigator, research institution, and sponsor participating in the trial. It is the preparation for scientific experiments, and the detailed test plan is the guarantee of the results of the test results.

Clinical trial protocol design

The success of clinical trials requires rigorous trial design, and randomized controlled trials are the "gold standard" in clinical research. Clinical studies of medical devices, especially confirmatory clinical trials that provide critical evidence, are generally conducted in a randomized controlled design. For products with a very high degree of innovation, it is difficult to rationalize the true effectiveness of the product, or there may be risks that are difficult to predict in advance, so it is a prudent strategy to carry out a small sample feasibility test before conducting a confirmatory test.

For innovative medical devices, well-designed randomized controlled trials remain preferred. In the case that randomization is not feasible, a single target value clinical trial can be an alternative to the slag stool and can also provide key evidence for product registration. When conducting a single-group target value experiment, the target value should be determined based on solid scientific evidence, and the target value should be conservatively estimated considering the inherent limitations of the single-group design.

1) the degree of change in the subject of the study;

2) the magnitude of the error required or allowable (i.e., accuracy requirements);

3) The degree of confidence in the inference is required. That is, when the phenomenon studied is more complex and the difference is greater, the larger the sample size requirement; When the required accuracy is higher, the higher the pushable seepage beam intermittent requirements, the larger the sample size.