What is the meaning of clinical research is introduced as follows:
Clinical research is the diagnosis, treatment, prognosis, etiology and prevention of disease as the main content of the study, to the patient as the main object of study, to the health care institutions as the main research base, by multidisciplinary personnel *** with the participation of the organization of the implementation of scientific research activities.
Types
Clinical research is divided into a variety. People use research to test whether tumor prevention, screening, treatment and methods can improve the quality of survival of tumor patients. People use clinical studies to evaluate the safety and effectiveness of potentially effective tumor treatments. Just because a patient enters a treatment study does not mean that he receives only experimental treatment; it is often the case that a new drug or therapy is applied in combination with an effective drug or method to see if there is an additional effect.?
Clinical studies of drugs include clinical trials and bioequivalence trials.
Clinical trials
Clinical trials are divided into phases I, II, III, and IV.
Phase I clinical trials: preliminary clinical pharmacology and human safety evaluation tests. Observe the degree of human tolerance to the new drug and pharmacokinetics, to provide a basis for the development of drug delivery programs.
Phase II clinical trials: preliminary evaluation of therapeutic effects. The purpose is to initially evaluate the therapeutic effect and safety of the drug in patients with the target indication, and also to provide a basis for the design of the phase III clinical trial study and the determination of the dosage regimen. The study design for this phase can take several forms, including randomized blinded controlled clinical trials, depending on the specific study objectives.
Phase III clinical trials: the phase of confirming the therapeutic effect. The purpose is to further validate the therapeutic effect and safety of the drug in patients with the target indication, to evaluate the relationship between benefit and risk, and ultimately to provide a sufficient basis for the review of the drug registration application. The trial should generally be a randomized blinded controlled trial with sufficient sample size.
Phase IV clinical trials: the post-launch application of new drugs. Its purpose is to examine the efficacy and adverse effects of the drug under conditions of widespread use, to evaluate the benefits and risks of use in general or special populations, and to improve the dosage of the drug.
Bioequivalence test is a human test that compares the degree and rate of absorption of the active ingredient in the same or different dosage forms of the same drug under the same test conditions using bioavailability studies and pharmacokinetic parameters as indicators.
2. Usually conducted by a full-time clinical researcher.