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What is a clinical trial?

A clinical trial is a research study in human volunteers to answer specific health questions. Clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study.


Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a clinical trial?

The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.


Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.  Informed Consent will be provide in participant’s native language


The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, benefits, side effects, risks, compensation, and others key contents are explained in detail in the Informed Consent.  


The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. Participation is voluntary.

What are the benefits and risks of participating in a clinical trial?

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Help others by contributing to medical research.


There are also risks to clinical trials:


  • There may be unpleasant, serious or even life-threatening side effects to treatment.
  • The treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?

Side effects are any undesired effects of drugs or treatment. Negative or adverse effects may include headache, nausea, hair loss, diarrhea, skin irritation, dizziness, or other physical problems. All adverse reactions are reported and followed up with the Principal Investigator.

What is the IRB?

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

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