Phase I Clinical Trials
What is a clinical trial?
ClinicalTrial, refers to any systematic study of a drug in humans (patients or healthy volunteers) to confirm or reveal the action, adverse effects and/or absorption, distribution, metabolism and excretion of the test drug, with the aim of determining the efficacy and safety of the test drug. Clinical trials are generally divided into Phase I, II, III, IV clinical trials and EAP clinical trials.
What is a Phase I clinical trial?
Including preliminary clinical pharmacology, human safety evaluation tests and pharmacokinetic tests, to provide the basis for the development of drug delivery program. Including: Tolerability test: preliminary understanding of the safety of the test drug to humans, observation of human tolerance and adverse reactions to the test drug. Pharmacokinetic test: to understand the disposition of the test drug in human body, i.e. the absorption, distribution, metabolism and elimination of the test drug.
① In order to complete the requirements specified in this study protocol, investigators should follow the CP and relevant standard operating procedures.
② The ethics committee validates the phase I clinical study protocol and informed consent form.
③ The voluntary subjects will be initially selected through medical examination, and then further comprehensive examination will be conducted, and those who are qualified will be enrolled.
④ Before the start of the trial, the informed consent form is signed for the subjects who are qualified to be enrolled.
⑤ Single tolerance test
⑥ Cumulative tolerability test
⑦ Data entry and statistical analysis
⑧ Summarization and analysis
Clinical trial procedure specification
1. Clinical research must be reviewed and approved by the State Food and Drug Administration (CFDA for short).
2, must be in the State Food and Drug Administration approved “drug clinical trial institutions” to carry out.
3.The clinical trial must be conducted by qualified medical experts.
4, must be reviewed and approved by an independent ethics committee to confirm that the study conforms to ethical principles, and to supervise the entire process of clinical trials and ensure the legitimate rights of the subjects.
5. All patients have the right to be fully informed and sign the informed consent form before participating in the clinical study of new drugs.
6.Clinical studies of antineoplastic drugs usually select patients who have been ineffective by conventional standard treatment.
7. New drugs for clinical research should be provided to the subjects free of charge.
Subject Protection
To ensure the rights and interests of subjects in clinical trials, an independent ethics committee shall be established and filed with the State Food and Drug Administration. The ethics committee shall be composed of at least five members who are engaged in pharmaceutical-related professionals, non-pharmaceutical professionals, legal experts and personnel from other units, and have members of different genders. The composition and work of the ethics committee should not be influenced by any participant in the trial. The trial protocol should be considered and approved by the ethics committee and signed before implementation. During the trial, any modification of the trial protocol shall be approved by the ethics committee; any serious adverse events occurring in the trial shall be reported to the ethics committee in a timely manner. In the process of drug clinical trials, the personal rights and interests of the subjects must be fully protected and the scientific accuracy and reliability of the trials must be ensured. The rights, safety and health of subjects must take precedence over consideration of scientific and social interests. The ethics committee and informed consent are the main measures to safeguard the rights of subjects.
Significance
For pharmaceuticals, clinical trials are much more important than preclinical experimental studies (but preclinical studies are also important because they are both indispensable parts of new drug development), because the most basic properties of drugs – effectiveness and safety – are ultimately tested by them. According to statistics, foreign research on a new class of drugs from basic research until recognition, production and marketing, generally takes more than 10 years, the average development cost of each new drug is about 1.2 billion U.S. dollars, and of which, more than 70% of the costs and time spent on clinical research, which shows the importance of clinical trials.
Clinical studies of new drugs are very important. On the one hand, the evaluation of the efficacy of a new drug varies depending on the test animals; the response in animals is different from the response in humans. On the other hand, the toxic reactions in animals and humans are also different. It can be said that clinical trials are very important, both in terms of efficacy and safety, and in terms of financial investment. Ultimately, the identification of a new drug depends on human trials. Therefore, clinical trials must be more careful to prevent serious toxic side effects from occurring and to prevent the production of ineffective or even harmful drugs.