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If you are considering enrolling in a clinical research trial, the following information might be helpful in understanding the role of the participant in a clinical research. Should you have any further questions, please call us at (207) 941-9965

A clinical trial is a research study designed to answer specific questions about vaccines, new therapies, or new ways of using known treatments. Clinical trials (also called medical research or research studies) are essential to understanding diseases, improving treatment methods, and providing alternative therapies to participants. Clinical trials are used to determine whether new drugs and treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

What is a clinical trial?
A clinical trial is a research study designed to answer specific questions about vaccines, new therapies, or new ways of using known treatments. Clinical trials (also called medical research or research studies) are essential to understanding diseases, improving treatment methods, and providing alternative therapies to participants. Clinical trials are used to determine whether new drugs and treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Why participate in a 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?
Clinical trials have guidelines about who can participate. 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. Using inclusion/exclusion criteria is an important principle of medical research that helps produce reliable results. Before joining a clinical trial, a participant must qualify for the study. 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?
What happens during a clinical trial depends on the kind of trial being conducted. The clinical trial team (which includes doctors and nurses as well other health care professionals) check the health of the participants at the beginning of the trial, give specific instructions for participating in the trial, monitor the participants 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 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?
To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Next, 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. 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.

What should people consider before participating in a clinical trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about the trial, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?
  • Who will participate in the study?
  • Why do researchers believe the new treatment being tested may be effective?
  • Has the treatment being tested been tested before?
  • What kinds of tests and treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the treatment?
  • Will I be reimbursed for other expenses (i.e. time off from work and childcare)?
  • What type of long-term follow-up care is part of this study?
  • How will I know that the treatment is working?
  • Will results of the trials be provided to me?
  • Who will be in charge of my care?

While taking part in a clinical trial participants will continue to work with their primary healthcare provider. Most clinical trials provide short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

What are the benefits of participating in a clinical trial?
Well-designed and well-executed clinical trials are the best treatment approach for eligible participants to. Benefits to participating include allowing participants to play an active role in their health care, access to new research treatment not available outside of a clinical trial.

Research treatments may be more effective than the standard approach. Participants in a study receive close monitoring, advice, care and support by a research team. they are widely available, access to expert medical care during the trial and helping others by contributing to medical research.

For more information please visit clinicaltrails.gov

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