Why would a doctor recommend a clinical trial? Should I participate?

In the medical field, every breakthrough discovery and innovation is the result of the joint efforts of countless medical experts, researchers, and volunteers participating in clinical trials. Patients are the promoters of medical research and explorers who start the journey of health revolution. Why do doctors recommend patients to participate in clinical trials? What are the pros and cons of participating in clinical trials? Can all patients participate?

What is a clinical trial?

On May 20, 1947, James Lind, a Scottish naval doctor, divided 12 sailors with scurvy into six groups, with two people in each group. The six groups received different dietary supplements and compared them with each other. Eventually, the symptoms of the two sailors who ate citrus and lemons gradually improved. This experiment helped people realize that vitamin C can treat scurvy.

This is the famous "scurvy clinical trial", which opened the precedent for modern clinical trials. Later, people designated May 20 as "International Clinical Trials Day".

Clinical trials are a scientific research method that aims to evaluate the safety and effectiveness of new medical strategies, treatments or drugs. These trials provide a reliable data foundation for medical research through rigorous scientific design.

Why participate in a clinical trial?

1. Promote medical progress: Participating in clinical trials can promote the development of new drugs and treatments, bringing hope to more patients.

2. Obtaining the latest treatment opportunities: If assigned to the trial group, patients may have access to the latest treatments and drugs, even those that are not yet available on the market. The purpose of exploring new drugs is to find treatments that are more effective, safer, and have fewer side effects than current treatments. Therefore, most clinical trials will not directly use ineffective placebos as controls, but will use "standard treatments" (the best treatment currently available) as controls. Even if assigned to the control group, the best treatment currently available will be used.

3. Receive professional monitoring and care: When participating in clinical trials, patients will be monitored and cared for by a professional medical team. They will pay close attention to the patient's health status and ensure that they receive appropriate medical protection during the trial.

4. Reduce financial pressure: Drugs and examinations related to the trial are free of charge, which may achieve better therapeutic effects while also reducing certain financial pressures.

Is it safe to participate in a clinical trial?

Some people may wonder, "Am I being a guinea pig when I participate in a clinical trial? Is this safe?"

Before clinical trials, a series of preclinical basic research, including cell and animal experiments, is required. Combined with the drug use data of animal experiments, including safety and effectiveness, after careful clinical trial design, it is submitted to the national drug regulatory department for review before it can be applied for in various medical institutions. Before specific implementation, in accordance with ethical and scientific principles, it must be reviewed by the local ethics committee, which will determine whether the risk-benefit ratio of the clinical trial is reasonable and whether the protection of the rights and interests of the subjects is sufficient. Only clinical trials that have passed ethical and scientific reviews can be carried out in medical institutions.

During the clinical trial, if the subjects feel that their rights and interests are violated or have any questions about their rights and interests, they can contact the ethics committee of the participating medical institution for help. The ethics committee will also pay close attention to new information and new situations that arise in the clinical trial at any time and take appropriate measures to protect the safety of the subjects to the greatest extent possible.

It has to be said that, precisely because it is in the clinical trial stage, participating in clinical trials may not necessarily achieve the expected therapeutic effect, and there may be certain drug safety issues. However, once patients enter the clinical trial, they will receive careful care from the entire clinical research medical team, including close follow-up tracking, various tests and examinations as needed, vital signs monitoring, etc. Once an abnormal situation occurs, it will be promptly handled and closely monitored by the medical team.

Can anyone participate in clinical trials?

no.

Researchers of clinical trials need to fully assess the individual's condition and screen according to the strict "inclusion and exclusion criteria" of the trial. Only those who meet the conditions can participate in the clinical trial and become a subject.

These criteria are not intended to exclude people from participating in trials; on the contrary, they are used to determine whether people are suitable for participating in trials and to ensure the safety of participants.

Things to note when participating in clinical trials

1. Understand the content of the trial: Before participating, carefully understand the purpose, process, possible risks and benefits of the trial to ensure that you have a full understanding and knowledge of the content of the trial.

2. Communicate with your doctor: Before participating in a clinical trial, fully communicate with your attending physician. Understand their views on the trial and make sure they understand the patient's health status so that you can make an informed decision.

3. Follow the doctor's advice: During the trial, follow the advice and instructions of the medical team. Report any discomfort in time to ensure timely help and support.

4. Understand the expected effects of clinical trials: Participating in clinical trials may not necessarily achieve the expected therapeutic effects. Before participating, understand the possible effects of the trial and have a full understanding of the uncertainty of the trial results.

How to participate in clinical trials?

If you are interested in participating in a clinical trial, there are several ways to get relevant information:

1. Drug Clinical Trial Registration and Information Disclosure Platform Query: The National Drug Administration has set up a drug clinical trial registration and information disclosure platform, where you can query ongoing or upcoming clinical trials. Enter relevant information on the website to obtain clinical trial information related to your disease so that you can understand whether you meet the requirements. (Website: www.chinadrugtrails.org.cn)

2. Recruitment advertisements: Some clinical trials will post recruitment advertisements on hospital bulletin boards, official WeChat public accounts, official Weibo accounts and other online platforms. These advertisements usually provide basic information about the trial, eligibility requirements for participation and contact information. If you meet the requirements, you can contact them directly for consultation.

3. Inquiry through hospitals or medical institutions: You can also directly inquire with the hospital or medical institution in your area. Hospitals usually have dedicated personnel responsible for clinical trial projects, who can provide you with relevant information and guide you on how to participate.

4. Query through the Sichuan Cancer Hospital WeChat service account: The patient recruitment mini program can be accessed through the Sichuan Cancer Hospital mini program (outpatient service-subject recruitment) and the Sichuan Cancer Hospital Clinical Research Department WeChat official account (recruitment information). The mini program and official account usually provide the latest clinical trial information, including recruitment conditions, trial description and contact information.

References:

[1] National Medical Products Administration. Good Practice for Clinical Trials of Drugs. July 2020

[2] Wang Fuling. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects[J]. Chinese Journal of Medical Ethics, 2016, 29(03): 544-546.

[3] Bartholomew M. James Lind's Treatise of the Scurvy (1753). Postgrad Med J. 2002;78(925):695-696.doi:10.1136/pmj.78.925.695

[4] Kang Sihan, Lu Yuhan, Pang Dong, et al. Research progress on the quality of informed consent of subjects in tumor clinical trials[J]. Chinese Journal of Nursing Management, 2023, 23(09): 1431-1436.

[5] Zhuo Ling. Analysis of factors affecting subject participation and compliance in clinical trials[D]. Nanchang University, 2023. DOI: 10.27232/d.cnki.gnchu.2022.000173.