Participating in clinical trials is no longer just being a guinea pig

This is the 5156th article of Da Yi Xiao Hu

In 2023, the National Medical Products Administration approved the launch of more than 80 new drugs, including more than 30 Class 1 new drugs, a record high in recent years. Among them is the familiar domestic first treatment for COVID-19, Mindevi (tritiated remdesivir hydrobromide tablets). The launch of new drugs not only means the development of my country's new drug research and development capabilities, but also means that patients have more and newer treatment options.

However, many people may not know that the launch of a new drug is inseparable from clinical trials. When it comes to clinical trials, many patients will have such concerns: Are clinical trials using patients as "guinea pigs"? Will clinical trials have many side effects? Will they delay the best treatment period for patients? The reason why many patients are worried about clinical trials is that they do not understand clinical trials.

The history of clinical trials

Clinical trials refer to any systematic study of drugs on humans (patients or healthy volunteers) to confirm or reveal the effects, adverse reactions, and absorption, distribution, metabolism, and excretion of the test drugs. The purpose is to determine the efficacy and safety of the test drugs. Its history can be traced back to 7000-5000 BC. Cave paintings discovered by archaeology have confirmed that humans began to use mushrooms with hallucinogenic effects. In ancient times, "Shennong tasted hundreds of herbs" was also the beginning of "clinical trials" in my country. In 1061 AD, "Compendium of Materia Medica" recorded a clinical trial to verify the effect of ginseng through human trials: two people were selected as controls, one with ginseng in his mouth and the other without, and walked three to five miles. The one without ginseng panted heavily, while the one with ginseng in his mouth breathed freely, so it was judged that the latter had the effect of invigorating qi and resisting fatigue after taking ginseng orally. This record is considered to be the earliest simple control experiment conducted in ancient China. In 1747, the world's first clinical controlled trial of using citrus and lemons to treat scurvy was conducted: in order to explore effective treatments for scurvy, military doctor Lind selected 12 crew members with scurvy and similar symptoms, gave them the same basic diet to make them comparable, and randomly divided them into 6 groups, each of which was given different treatments. In the end, the symptoms of the two crew members who ate citrus and lemons improved and they recovered.

Importance of clinical trials

At present, there are still many diseases that cannot be cured or have limited efficacy, and new diseases are constantly emerging, such as the new coronavirus. Therefore, it is necessary to continuously develop new drugs to protect the life and health of all mankind. New drugs must undergo scientific and rigorous clinical research, and only after their safety and effectiveness are verified can they be promoted and used. Clinical trials are the only way for new drugs to be launched on the market.

Risks and benefits of participating in clinical trials

Clinical trials certainly have certain risks, and there may be the possibility that new drugs are ineffective or even harmful to the body. However, relevant national ministries and commissions have formulated a series of strict clinical trial implementation standards and requirements. Before clinical trials, new drugs will first be thoroughly studied in cells and animals, and only after being evaluated to achieve a certain level of safety and efficacy can they enter the human trial stage. Afterwards, they must be reviewed by an organization called the Ethics Committee for ethical review. Studies that are extremely harmful to the subjects and attempt to conceal side effects will be rejected to protect the dignity, safety and interests of the subjects. The doctors in charge of clinical trials will fully inform the patients of the risks and benefits of the trials before they participate in the trials, and strictly evaluate whether the patients' physical conditions are suitable. Therefore, the overall risks are safe and controllable. At the same time, the benefits of clinical trials are relatively obvious. For most patients with advanced tumors, they will face the situation of resistance or ineffectiveness of existing standard treatment drugs. At this time, participating in clinical trials is a good choice, and sometimes even the only choice. A considerable proportion of patients benefit from this, with prolonged survival and significantly improved quality of life.

Therefore, participating in clinical research does not mean becoming a "guinea pig". Taking part in clinical trials in qualified medical institutions not only gives you the opportunity to treat diseases with more advanced methods, but also reduces financial pressure.

Author: Clinical Research Department, Shanghai Clinical Research Center

Department of Gastroenterology, Shanghai Changhai Hospital

Yang Geliang