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About Clinical Research

What is a clinical trial?

A clinical trial (also clinical research or clinical study) is a research study in human volunteers to answer specific health questions.  Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.  Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.

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.

Why participate in clinical research?

There are several reasons why many volunteers choose to participate in clinical research:

  • Study participants play a more active role in their own health care.
  • Study participants gain access to industry leading healthcare professionals and potentially useful new treatments before they are widely available to the public.
  • Study participants receive medical attention and study supplies at no additional cost and are often reimbursed for their time and travel.
  • Study participants help others with the same medical conditions by contributing to clinical research.

What should people consider before participating in a 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 it, 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 is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental 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 experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?

We invite you to discuss participation with your Primary Care Physician or one of our Physicians. If you need any additional information, please do not hesitate to call and ask for us. Additional information can also be found by visiting https://clinicaltrials.gov/ct2/about-studies/learn.

If you would like additional information about participating in a clinical research trial, please call our office to speak with one of our experienced Research Coordinators. We can be reached at 334-836-3346.