Hepatitis B Research

Clinical Trials for Hepatitis B

Hepatitis B clinical trials are performed to develop and test more effective and safer ways to diagnose, treat, and prevent hepatitis B.
A clinical trial is a research study in volunteer human subjects to determine the safety and efficacy of new treatments, screening methods, preventive techniques, or diagnostic methods for a disease. New devices, drugs, procedures, and medical innovations must be thoroughly tested to ensure that they are safe and effective for human patients.
Human trials are only conducted after both laboratory and animal studies show promising results.

Phases of trials

There are four phases of clinical trials.

Phase I clinical trials

Researchers test a new drug or treatment in a small group of 20-80 patients for the first time. The goal is to evaluate the drug or treatment’s safety, determine a safe dosage range, and identify side effects.

Phase II clinical trials

Researchers study the effects of a drug or treatment in a larger group of 100-300 patients. During this phase, researchers aim to determine the drug or treatment’s efficacy and further assess its safety.

Phase III trials

Researchers study the effect of a drug or treatment in large groups of 1,000-3,000 patients. This type of trial is used to confirm the drug or treatment’s effectiveness and monitor side effects. The drug or treatment is also compared to commonly used treatments and researchers collect information that will help ensure that the drug or treatment is used safely.

Phase IV clinical trials

Phase IV trials are performed after the drug or treatment has been marketed to the general public. These studies are conducted to collect information on the drug or treatment’s long-term effects and side effects in various patient populations.

Who Can Participate?

All patients can volunteer to participate in clinical trials. However, each clinical trial has unique guidelines for who can participate in the study, called criteria. Patients interested in enrolling in a particular study must meet the criteria. This helps ensure the patient’s safety and helps ensure that researchers are able to accurately prove or disprove their hypotheses. Factors that allow a patient to enroll in a clinical trial are called inclusion criteria, and factors that prevent a patient from enrolling are called exclusion criteria. Criteria may include or exclude patients based on factors such as:

  1. age
  2. medical history
  3. gender
  4. current medications
  5. co-existing illnesses
  6. overall health

Weighing the pros and cons of participating in a clinical trial

Participation in clinical trials is completely voluntarily, and the decision should only be made after the patient has carefully considered the potential health benefits and risks. These risks and benefits will be different for each trial and each individual patient. It is important for patients to consult their personal healthcare providers and family members before deciding whether or not to participate in a clinical trial.

Patients will meet with the researchers before being enrolled in the study. This allows patients to ask any questions and address any concerns about participating. Patients should consider writing down questions ahead of time, asking a friend or family member to join them for support, and/or recording the discussion.

Participating in a clinical trial allows patients to take an active role in their healthcare. Participants gain access to new treatments that are not available to the public and participants help others by contributing to medical research. However, risks of participating in a trial may include side effects or adverse reactions, the treatment may not be effective, the trial may take up a lot of the patient’s time, and participation may require hospital visits or involve complex treatment plans.


The federal government has guidelines and safeguards to protect participants in clinical trials. All clinical trials in the United States must be approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are minimal and worth the potential benefits. An IRB is an independent committee that consists of physicians, statisticians, community advocates, and other professionals.

During the trial

The process of each clinical trial is different. The research team generally includes doctors, nurses, and other healthcare professionals. Participants should closely follow the trial’s protocol to ensure their safety. Participants are evaluated at the beginning and end of the trial, and their health is monitored continually throughout the trial. Some researchers will stay in touch with participants after the study to perform follow-up tests and/or questionnaires.

While enrolled in the trial, patients should continue to regularly visit their primary healthcare providers. This helps ensure that the clinical trial protocol is not interfering with the patient’s regular medications or treatments.

Leaving a clinical trial early

Participants can choose to leave a clinical trial at any time. Patients who want to stop participating should let the researcher(s) know why they are leaving the trial.

Paid Participation in clinical trials

Some clinical trials pay participants to enroll in the study, while others do not. Some trials will reimburse participants for expenses associated with the trial, such as transportation costs, accommodations, meals, or childcare. Potential study participants can discuss whether payment is offered when they meet with the researcher(s). Payment is often not offered if a patient leaves the trial early or does not adhere to protocol.

Selected References

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