About Clinical Research


What is Clinical Research?



Drug and device research begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.

Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.



How does a clinical trial work?



In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.



Volunteering for a clinical trial



Research participants receive payment for their time, free medical care and procedures along with free treatment. There is no insurance necessary to participate.



What are placebos?



A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.



Questions to ask a physician or medical caregiver:



Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study.<



What questions should be asked before choosing to participate?



  • How long will the trial last
  • Where is the trial being conducted?
  • What treatments will be used and how?
  • What is the main purpose of the trial?
  • How will patient safety be monitored?
  • Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested in the trial?
  • Who is sponsoring the trial?
  • Do I have to pay for any part of the trial?
  • What happens if I am harmed by the trial?
  • Can I opt to remain on this treatment, even after termination of the trial?


What can volunteers expect if they choose to participate?



In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information.



Does information remain confidential and private?



Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.



What are the benefits and risks of joining a trial?



Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.

Possible benefits for volunteers:

  • Play an active role in their health care.

  • Gain access to research treatments before they are widely available.

  • Obtain medical care at health care facilities during the trial.

  • Help others by contributing to medical research.



What are the possible risks for volunteers



There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.

  • The experimental treatment may not be effective.

  • The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

Please note: volunteers may withdraw from a study at any time for any reason.



What happens after the trial?



After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.

If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.

Patients Rights and Informed Consent Explained



What are my patient rights?



Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you.

View Florida Patient’s Bill of Rights