Interested Participants

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 A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.

 All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that disallow volunteers from participating are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.

 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.

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.

 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.

Questions to ask a physician or medical caregiver:

• 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?

The answers to these questions can also be found in the informed consent. When considering whether or not to participate in a research study, you may request a copy of the informed consent for your review and to discuss with your physician, family and friends.

 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.

Volunteers in a clinical trial are randomly assigned to a specific study group which may be one of the following:

1. A group receiving an investigational medication;
2. A group receiving a placebo (sugar pill); or
3. A group receiving a comparator medication already available on the market.

In most studies, neither the research team nor volunteer knows which product was assigned to each group. This ensures that the research teams remain unbiased when assessing the volunteers results. All volunteers will be treated equally, no matter what assignment the group has received.

 Each clinical trial is different.

Upon qualification into the study, this information would be provided to you.

The time for each visit can vary.

The initial visit is typically the longest (about three hours) because of the comprehensive and thoroughness of the initial assessment. Most subsequent visits are typically 45-60 minutes.

 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.

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.

 Yes.

In nearly all of our trials, we will reimburse you a flat fee for your travel expense for each office visit. The reimbursement rate varies per study and will be discussed with you in detail on your visit to the office.

 No, medical insurance is not required. Study participants will receive study-related medical examinations and study-related medication at no cost. Eligible participants may receive compensation for their time and travel.

 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. 

 Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.

Researchers must take several steps to make clinical trials as safe as possible, including:

• A written examination about the content of clinical research and ethical responsibility of the researchers.
• Preclinical studies that show that a new investigational treatment is safe and effective in laboratory animal tests.
• Use of strict protocol – an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
• A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called an informed consent.

 You are free to leave a clinical trial at any time for any reason. If you do decide to leave, you should let the study team know and tell them why you are leaving the study. Early study termination procedures will be done to ensure your safe exit from the study. Some studies may offer you suggestions about how to leave the trial, particularly if the study medication needs to be withdrawn gradually, but ultimately, you have the final decision.

 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.

 There are several organizations that offer information about research studies. Here are a few:

ClinicalTrials.gov  www.clinicaltrials.gov

CenterWatch  www.centerwatch.com

Center for Information & Study on Clinical Research Participation (CISCRP) www.ciscrp.org 

National Institutes of Health  https://www.nih.gov/health-information/nih-clinical-research-trials-you

U.S. Food and Drug Administration   https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm