Frequently Asked Questions

Click on the questions to display the answers
 

Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
1. What is a clinical trial?
A clinical trial (clinical research) 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 care. Interventional trials use controlled circumstances to determine whether experimental treatments or new ways of using known therapies are safe and effective. Observational trials address health issues in large groups of people or populations in natural settings.
2. Why participate in a clinical 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.
3. Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion and 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.
4. What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses, as well as study coordinators and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and follow up with the participant.
 
Some clinical trials involve more tests and doctor visits than the participant would normally have for a specific illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the study protocol is carefully followed and there is frequent contact with the research staff.
5. What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an Informed Consent Form 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 Form. 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.
6. What are the benefits and risks of participating in a clinical trial?
Benefits:
Clinical trials that are well designed and well executed are the best approach for eligible participants to:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks:

  • There are risks to clinical trials.
  • There may be unpleasant, serious, or even life-threatening side effects to treatment.
  • The treatment may not be effective for the participant.
  • The study protocol may require more of a participant’s time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
7. What are side effects and adverse reactions?
Side effects are any undesired actions or effects of drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects.
8. How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, which is a study plan that outlines what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain confidential and will not be mentioned in these reports.
9. Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals, such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veterans Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
10. What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants, as well as answer specific research questions. A protocol describes what types of people may participate in the trial, the schedule of procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
11. What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. It is also described as a “sugar pill.” In clinical trials, experimental treatments are often compared to placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
 
The above information was provided by ClinicalTrials.gov, a service of the National Institute of Health. For further information, visit the Introduction to Clinical Trials page.
12. What about my privacy?
When you participate in a clinical trial your privacy is protected. Any statistical data provided to the FDA and/or the clinical trial sponsor will not include your name or any other identifying information. OCCI, Inc. is committed to ensuring your privacy. A copy of our privacy policy is available upon request.
13. How are my rights protected?
OCCI, Inc. is an organization dedicated to protecting the rights of ALL individuals who volunteer to receive the investigational medication therapies we study. As such, prior to participation in any study-related procedures, every volunteer is made fully aware of the reasons we are conducting the current clinical trial and of all possible benefits and risks that may be experienced. Other available treatment alternatives, the length of the study, the number of clinic visits anticipated, and a description of the procedures involved will also be discussed with each individual prior to study entry. All of this information will be provided in both verbal and written formats.
 
The written format used to provide individuals with an understanding of each clinical trial is referred to as an Informed Consent Form. The content of each Informed Consent Form must pass an examination by an independent committee of experts (Institutional Review Board or IRB) to prevent the use of any misleading information. All research centers are required to provide all clinical trial volunteers the opportunity to read, ask questions, and sign a study-specific Informed Consent Form prior to study entry. All clinical trial volunteers will be provided with a photocopy of their signed Informed Consent Form to keep for their records.
Participation in a clinical trial is always voluntary, and may be discontinued at any time for any reason.