What is a Clinical Trial?

A clinical trial refers to any systematic research conducted on humans (patients or healthy volunteers) to confirm or reveal the effects, side effects, and/or the absorption, distribution, metabolism, and excretion of an investigational drug. The aim is to determine the efficacy and safety of the trial drug. Any new drug must undergo clinical trials before it can be marketed.

Drug clinical trials are classified into Phase I, II, III, and IV.

Phase I: Initial clinical pharmacology and safety evaluation trials in humans.

Phase II: Preliminary evaluation of the drug's therapeutic effect and safety in patients with the target condition.

Phase III: Further validation of the drug's therapeutic effect and safety in patients with the target condition.

Phase IV: Monitoring the drug's efficacy and side effects after market approval.

For patients with unsatisfactory outcomes from traditional standard treatments, clinical trials provide an opportunity to try new treatment methods for malignant tumors. Patients in clinical trials have the chance to receive the latest drugs or therapies, potentially leading to better treatment outcomes and improved quality of life.

What Are the Benefits of Participating in a Clinical Trial?

1.       Patients have the opportunity to access the latest treatment drugs or methods in the field, potentially benefiting from cures, extended survival, or reduced suffering through the clinical trial.

2.       The investigational drugs and required tests or examinations in the trial are provided free of charge, easing the financial burden on the patient.

3.       Once enrolled in a clinical trial, patients will receive dedicated care from the entire clinical trial team, including close follow-up, necessary tests and examinations as per the protocol, and monitoring of vital signs.

Is It Safe to Participate in a Clinical Trial?

There are inherent risks in clinical trials, but this does not mean that patients are treated as "guinea pigs." Participating in a clinical trial is the only way for you to receive the latest treatments that have not yet been used in routine clinical practice. If the new therapy proves to be superior to traditional treatments, patients will benefit from it first.

The rights and safety of participants are the primary considerations in clinical trials. Before starting a clinical trial, a series of preclinical studies, including animal testing, must be completed. Data from animal studies, including safety and efficacy, are taken into account, and only after thorough trial protocol design and approval by regulatory authorities can the trial proceed in various medical institutions. Furthermore, before implementation, clinical trials must undergo scientific and ethical review by the hospital's ethics committee, which evaluates the risk-benefit ratio and protection of participants' rights. Once ethically approved, the trial can proceed.

Although clinical trials cannot guarantee benefits for all participants, they are certainly not blind drug experiments. The trial process must comply with the regulations of clinical trial quality management. The entire trial is conducted under strict supervision with close follow-up, ensuring the safety of participants as much as possible. All examination results and treatment outcomes are meticulously recorded, and any discomfort experienced by participants is addressed promptly and effectively.

Does Being Assigned to the Control Group in a Clinical Trial Mean "Wasting Your Time"?

In new drug clinical trials, there are typically two groups: the experimental group and the control group. This means some patients will be randomly assigned to the control group. Many people worry about being in the control group, fearing that it means receiving a placebo and thus "wasting time."

However, some clinical trials, especially for cancer, are "single-arm," meaning there is no control group, only the experimental group. When there is a control group, the experimental group receives the new drug, and the control group generally does not receive a placebo. Instead, they are given the "most commonly used standard therapy," which is free of charge. This design ensures an objective comparison between the new drug and the current standard treatment.

What the research team is truly concerned with is not just whether the new drug is effective, but whether it is as effective as, or even more effective than, the current standard therapy. Sometimes, the experimental treatment may not prove to be better than the standard treatment, and the control group can still achieve good therapeutic outcomes. Therefore, being in the control group doesn't mean "wasting time," as patients are still receiving the best available treatment.

What Are the Requirements to Participate in a Clinical Trial?

The study physician will thoroughly assess the individual condition of the patient and screen them based on the strict "inclusion criteria and exclusion criteria" outlined in the trial protocol. Only those who meet the criteria will be eligible to participate. These criteria are not meant to reject patients from the trial, but rather to determine whether they are suitable to participate, ensuring the safety of those involved in the trial.

What Should You Be Aware of When Participating in a Clinical Trial?

1.       You need to bring past outpatient and inpatient medical records, pathology reports, treatment plans, and test results for consultation.

2.       Patients who meet the inclusion criteria will decide whether to sign the informed consent form after fully understanding the potential risks and benefits.

3.       After enrollment, patients must follow the clinical trial requirements for examinations, treatment, and follow-up.

4.       Promptly report any discomfort to the doctor so that necessary measures can be taken to ensure safety.

5.       Patients have the right to refuse or withdraw from the clinical trial at any time without affecting their medical treatment or rights.