INTERESTED PARTICIPANTS

Please be sure to bring the proper identification to your first visit. During this visit, you will be given an Informed Consent Form to sign. You will be welcomed into a private room with the physician to learn about the study, the risks, benefits, known side effects, together with all procedures you must undergo during the trial, should you choose to participate.

Some studies may require a caregiver, Legal Authorized Representative (LAR) and/or any other such individual to be present during this process. Once the consent form has been reviewed, discussed and signed by all applicable parties, you will be taken to begin the procedures of the study or you may be scheduled to come in another day depending upon each study’s requirements.

The clinical trial process depends upon the type of research that is being conducted. The site staff will check your health at the start of the trial, provide detailed instructions and guidance for what you will be doing during the study. The staff will keep an eye on your health throughout the trial, and make sure that the study protocol is followed methodically.

In order to determine whether you meet all of the requirements for a study, a questionnaire and/or physical examination is usually conducted during the screening process. All of the information obtained during the screening period and throughout the study is kept confidential and secure. Once all the results from the screening tests are in and the study staff has reviewed your results together with your medical history, the doctor will decide on your qualification to participate.  The study coordinator will call you to inform you.  If you do qualify you will be scheduled for your baseline visit.

All studies vary in length.  Some studies may last just a few weeks, while others can last years.  The length of your study determines the number of study visits you will have. At the start of the study, the visits are usually more frequent and as the trial progresses you will be required to come in less often. Typically, you will need to bring your study medication and any diaries you were dispensed to each study visit.

FREQUENTLY ASKED QUESTIONS

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 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.

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