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Research FAQ

What is a clinical trial and why are they important?

Clinical trials are health-related research studies in people that are closely supervised and carefully follow a pre-defined protocol; the main purpose is research. Trials are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may be done to see how a new treatment compares with the standard treatment or to see if a new treatment is safe and effective for a certain condition or disease.

How do clinical trials work?

Clinical trials are research studies that aim to determine whether a medical strategy, treatment, or device is safe for use or consumption by humans. These studies may also assess how effective a medical approach is for specific conditions or groups of people. A research team will likely include doctors, nurses, social workers, health care professionals, scientists, data managers, and clinical trial coordinators. Participation can involve both risks and benefits. Participants must read and sign the "informed consent" document before joining a trial.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides if they want to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Why should I participate in a clinical trial?

The health of millions of people has been improved because of advances in science and technology, and the willingness of thousands of individuals to take part in clinical research. Volunteering for a clinical trial is a personal decision that should be discussed with your family. People volunteer for several different reasons including:

  • A desire to play a more active role in their own health care
  • Gaining access to a new research treatment before it is widely available
  • Aiding in the advancement of knowledge and science for future generations

Who should not participate in a clinical trial?

If a participant has a strong desire to be in one treatment group over another, they should consider not participating in the study. A study participant should be willing to be assigned to any treatment group.

Who can participate in a clinical trial?

All clinical trials have rules about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that prevent 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. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. The criteria are used to identify appropriate participants and keep them safe. Enrolling participants with similar characteristics helps to ensure that the results of the trial will be due to what is under study and not other factors. In this way, the criteria help researchers achieve accurate and meaningful results.

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

Benefits:

  • Play an active role in your own health care.
  • Gain access to new research treatments before they are widely available.
  • Receive regular and careful medical attention from a research team during the trial.
  • Contribute to medical research to help others.

The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. Possible risks of participating in a clinical trial include:

  • New drugs or procedures under study are not always better than the treatment to which they are being compared.
  • New treatments may have side effects or risks that doctors do not expect or that are worse than those resulting from standard care.
  • 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.

How is the safety of the participant protected?

Most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports. An addition, an Institutional Review Board (IRB) committee assures appropriate steps are taken to protect the rights and welfare of people participating in approved research studies.

 

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