About Clinical Trials | BeOne Clinical Trials

What are clinical trials?

A clinical trial is a research study that tests a medical treatment such as a drug, therapy, or procedure with the help of volunteers. Volunteers may be either healthy individuals or patients with medical conditions. These studies are conducted by doctors and clinical research staff to help understand if a drug is safe and works well for the people who need it, with the goal to improve people’s health and quality of life.

The study methods are designed to follow closely monitored protocols. These methods are reviewed and approved by regulatory agencies and ethics committees. Your participation may help you as well as future patients receive better care and treatment options.

We are recruiting volunteers for clinical trials across a range of cancers, including blood cancers, lung cancer, gastrointestinal cancers, breast cancer, and other solid tumors.

WHAT TO EXPECT

Why are clinical trials important?

Clinical trials are essential for advancing medical knowledge and improving patient care. They help doctors find better ways to understand, prevent, diagnose, and treat various medical conditions. Most medicines available today are the result of volunteers participating in clinical trials driven by patients needing additional treatment options. Although there is no guarantee of personal benefit, participation contributes valuable knowledge that may help future volunteers or patients.

What rights do you have as a clinical trial participant?

Participating in a clinical trial is completely voluntary. Before agreeing to participate in a study, you will receive clear information about the study, be able to ask any questions you may have, and make your choice without pressure. Even while participating in the study, you have the right to withdraw from it at any time and for any reason without any penalty.

As a study participant, you have the right to learn about any new information that might affect your participation. The study team will protect your personal health information and ensure that personal data collected during the clinical trial will be used only for the purposes explained to you prior to agreeing to take part in the clinical trial.

How are clinical trials designed?

Clinical trials follow a specific plan called a protocol. This plan explains how the clinical trial will be conducted, who can participate, and how study participants will be monitored for safety. Study participants are carefully checked throughout a clinical trial. They have regular checkups to track their health and any responses to the treatment.

What are the various phases of clinical trials?

Clinical trials are done in several steps called “phases.” There are 4 main phases of clinical trials. Each clinical trial phase has a different purpose, usually involves different groups of volunteers, and helps study researchers answer different questions about the study treatment. In phases 1 to 3 of a clinical trial, the study treatment may be one that is not approved yet or is already used for another disease/condition but is now being tested in a new way or for a different disease/condition. Phase 4 studies, on the other hand, use treatments that are already approved specifically for the disease/condition being studied.

Phase 1 clinical trials

These test a treatment in a small group to determine safe dosage and identify side effects. Study participants may either be healthy volunteers or individuals with the disease/condition.

Phase 2 clinical trials

These involve a larger group of study participants with the disease/condition to learn more about how well the treatment may work, the best dosing, and how safe it is.

Phase 3 clinical trials

These involve an even larger group of study participants with the disease/condition to confirm the effectiveness and safety of the study treatment and to compare it to existing standard treatments.

Phase 4 clinical trials

These are conducted after a treatment is approved and available for public use to gather more information on long-term safety and effectiveness in different patient populations.

Find answers to additional frequently asked questions about clinical trials.

EXPLORE MORE FAQS

Glossary

P

Personal health information: Details about your health and medical care, like your name, date of birth, medical history, test results, and treatments you have received.

Protocol: The official plan for how the clinical trial will be done. It explains information such as the purpose of the study, who can take part, what treatments will be given, how often visits or tests will happen, and what information will be collected. All doctors in a specific clinical trial follow the same protocol to keep the study consistent.

S

Standard treatment (also called standard of care): The most common or widely used treatment for a specific disease, like a type of cancer. In some clinical trials, an investigational treatment is often compared to the standard treatment to see which one works better or has fewer side effects.

Study drug: The investigational medicine(s) or investigational treatment(s) being tested in a clinical trial. It may be a drug that is not approved yet or a drug that is already used for other diseases but is now being tested in a new way or for a different disease/condition. The study drug is given to see how safe it is and how well it works.

REVIEW MORE TERMS