What are the critical aspects of the development of new anti-tumour drugs to market?
Anti-oncological treatment is one of the most important means of treating oncology. Clinical trials are the safest and most efficient way to find new anti-tumour drugs. Clinical research is at the heart of the development of medicines, and it is also a guarantee of their safety and effectiveness once they are on the market. So what are the key steps that new drugs need to go through from research to marketing? New drugs are a complex and time-consuming process from development to listing. The main steps in the development of new drugs for listing are as follows:
I. Phase of drug detection. First researchers need to synthesize, through experiments, a range of lead compounds that may be treatable, based on the disease ‘ s symptoms. These precursor compounds are only reservists of new drugs, and they need to be screened to meet us. The first is in vitro cytology, which pre-screens low-toxicity and high-activity “winners” and then improves the structure and activity of candidate drugs to improve their efficacy and selectivity. Through the structural relationship study, the selection of a few rounds to optimize all the selected primary bioactive best compounds is generally selected for development.
II. Preclinical research phase. Pharmacological studies: assessment of the pharmacological and toxicological effects of drugs, their absorption, distribution, metabolic and excretion (ADME), as well as studies on production processes, quality control and stability (CMC). These experiments need to be carried out at the animal level to determine the efficacy and safety of the drug. Formulational development: To study how drugs can be better absorbed, e.g., drugs that are locally given can be produced as aerosols, anointants, etc.; drugs that lose activity in stomach acids can be developed as intestines. Scientists assess the absorption, distribution, metabolic and excretion properties of drugs in the body, use them in many small and large animals, observe the reactions and toxicity of animals after use, and screen potential safe and effective candidate drugs. Because of the great differences between humans and animals, there is also a need for scientific and rigorous research in the human body through animal experiments on candidate drugs, to determine the safety and effectiveness of new drugs for human use, and to determine what frequency and dosage are most appropriate, which is the ultimate test.
Thirdly, the clinical trial stage must also do an important thing before the ultimate test: clinical trial approval. Non-clinical research data and clinical trial plans are submitted to drug regulators, usually the National Drug Supervisory Authority (e.g. the FDA), which reviews IND applications and assesses clinical trial plans, non-clinical research data and drug safety. With IND approval, researchers can start clinical trials. Phase I Clinical Trials: An initial assessment of the safety of the new drug is carried out, usually by health volunteers, in about 20 to 100 cases. Phase II Clinical Trials: Assessing the efficacy of new drugs for specific diseases, mainly for patients, in about 100 to 300 cases. In some cases, phase II clinical trials are further divided into phases IIa and IIb. Phase III Clinical trials: further validation of the efficacy and safety of new medicines, increasing the sample to 300-5000 patients. This is the most important stage of certified clinical research before the new drugs are listed. IV Clinical trial (post-market research): After new drugs are listed, long-term observations are made to assess the long-term efficacy and safety of new drugs. The number of people tested is usually greater than 2,000. During the first phase of clinical trials, researchers recruit a small number of healthy volunteers for drug trials, to verify the safety of the drug by observing how they are taking them and to make a preliminary assessment of how many doses the patient should take. In the second phase, researchers will divide volunteers into groups, with different groups of volunteers taking different doses or taking different drugs to assess the efficacy of the drug and the side effects. The third phase will involve more volunteers, who will be divided into two groups, one taking a new drug and the other taking a placebo or a classic old drug, conducting double-blind tests to assess the efficacy, safety and adverse effects of the new drug.
This will be followed by the approval stage for new drug listing applications. The application for permission for new drugs or biological products is submitted to a pharmaceutical institution, which reviews clinical test data, non-clinical data and manufacturing quality data, approves the listing of new drugs after they have been qualified and issues a drug licence.
V. Listing and monitoring. Did everything go well after the new medicine came on the market? Nope. It continuously monitors the quality, safety and effectiveness of drugs in the market and reports on adverse reactions and safety problems in the market.
It is important to note that the procedures and requirements for the listing of new medicines may differ from one country to another and from one country to another. The whole process of developing new medicines for listing usually takes time, financial and human resources and carries high risks. Therefore, a new drug requires careful planning and organization of the entire development process to ensure that the new drug can be successfully listed and benefit patients.
