FAQ's For Your Medical Research Clinic

Table of Contents

1. Why are clinical trials needed? 
2. Who conducts clinical trials? 
3. Why should I participate in a clinical trial? 
4. Who is eligible to be in a clinical trial? 
5. What is a clinical trial like? 
6. What is needed of me? 
7. What can I expect from the clinical trial team?
8. Am I a guinea pig? (Slang for a person who is the first to try something new.)
9. Why do I need to know if I suffer from a psychiatric disorder?
10. Why should I take psychiatric medications, if indicated?
11. What are some of the risks of living with mental illness, without the proper treatment?
12. How am I protected as a clinical trial participant?

Glossary of Terms

1. Clinical Trial 
2. Clinical Investigator 
3. Food and Drug Administration 
4. Informed Consent Form 
5. Institutional Review Board (IRB) 
6. Investigational Treatment 
7. Pharmaceutical Company 
8. Protocol 
9. Sponsor 
10. Standard Treatment

Why are clinical trials needed?
The medical world cares about the human condition. That's why researchers constantly look for better or new ways of treating illness and disease. But their large numbers of discoveries cannot be put into general use until controlled evaluations have been completed with actual patients. Clinical trials are the only scientifically valid way that these evaluations can be completed. The Food and Drug Administration (FDA) requires carefully monitored and well-controlled clinical trials before it can approve a new treatment as safe and effective for public use. Clinical trials are the link between research and the relief of human suffering.
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Who conducts clinical trials?
Many pharmaceutical companies, research institutions, or other health organizations may be the sponsor of a clinical trial. They are responsible for funding and for designing its protocol. A protocol is a set of detailed guidelines that research organizations, like Pharmacology Research Institute (PRI), are required to follow in order to conduct the same clinical trial at several different locations throughout the United States, and often times in several foreign countries as well.

Although pharmaceutical companies sponsor (i.e. provide grant monies for) a clinical trial, only trained doctors, nurses, and medical researchers actually conduct the trial itself. 
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Why should I participate in a clinical trial?
Two reasons: to help yourself and to help others. 
It's possible the treatment being tested will improve your health. A new drug or new procedure may reduce symptoms or perhaps even cure your illness. All clinical trial participants receive a great deal of personal medical attention. You may also decide to participate in a clinical trial for the satisfaction that comes from being a part of scientific research that may help many others. Every day, there are people hoping for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical trial volunteers help make those discoveries available to people all across the country and around the world! 
Remember: Deciding whether or not to participate, or to continue to participate, in a trial is entirely up to you. 
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Who is eligible to be in a clinical trial?
Every clinical trial attempts to answer some very specific research questions. To do this, each trial has certain requirements about your health, medications you may be taking, age, and other things. You must meet the requirements of a particular trial to be an eligible volunteer. Ask the doctor or nurse about the eligibility requirements for a particular trial. 
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What is a clinical trial like? 
Participating in a clinical trial is somewhat like a regular visit to a medical clinic, hospital or doctor's office, but with more one-on-one personal attention. Once you have enrolled in a study, you will receive a physical examination. The physician or a research staff member will review your medical history as well. A detailed description of the specific clinical trial suggested for you, and what's expected of you, will be outlined in an informed consent form.

In a clinical trial, a volunteer is usually assigned to a specific study group. Sometimes volunteers in one study group will receive the study drug. Sometimes volunteers will receive a placebo or a treatment already commercially available.

A placebo is a harmless, inactive product used to compare the results of the study drug. You, the study physician and the research staff will not know who is receiving a placebo and who is not. In this way, volunteers in a clinical trial can be observed by the physicians and research staff more fairly, i.e. more objectively. Whether you receive the placebo, a currently marketed medication, or the investigational drug, the level of medical attention and care that you receive is the same. 
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What is needed of me? 
Your first responsibility is to fully understand your commitment to be open and honest throughout the trial. The trial investigators and sponsor need you to be at your appointments on time, to follow their instructions carefully, and especially to take any medication exactly as told. They need you to take the trial seriously. Your full cooperation and participation is needed if the investigators are to collect the reliable and valid information they must have for a successful study. 
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What can I expect from the clinical trial team? 
More than anything else, you have the right to expect complete information about the trial. Don't participate in any clinical trial unless your questions have been reasonably answered. 
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Am I a guinea pig? 
Volunteers in large scale drug trials are not the first people to try the medication/drug. The study drug, even before reaching the large scale human trials, has to withstand years of scientific research and experiments. First, the molecule of the drug is studied extensively. Then, the manufacturer(s) of the drug(s) often evaluate the effects on several species of animals. Subsequently, healthy volunteers are given the drug as hospitalized inpatients, where they are closely monitored and evaluated. The next phase of evaluation is testing the drug on a limited number of patients, who suffer from the problem for which the drug is being developed. At each of these stages, the research studies are intended to reveal the overall safety and the effectiveness of the drug for the indicated purposes. Also, the FDA is kept apprised of the design, conduct and outcomes from each phase of study. Eventually, if everything goes well and the targeted effective dose of the drug is narrowed down, the clinical evaluations proceed to the next stage, which is to provide the new medicine, under double-blind carefully controlled experimental conditions, to a larger number (i.e., in the thousands) of patients all across the country—and usually in other countries as well. This is usually the level at which you might participate as a volunteer at PRI… and it is often the last stage of the trial, before the drug—if successful—is submitted to the FDA for possible approval and marketing.
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Why do I need to know if I suffer from a psychiatric disorder?

Proper diagnosis often leads to effective treatment. It may also relieve most of the confusion, shame, guilt and other negative feelings about psychiatric problems, while providing the opportunity for proper treatment and the prevention of potentially harmful consequences as a result of not getting treatment.

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Why should I take psychiatric medications, if indicated?

Like most things in life, it is not prudent to refuse to take medications if their potential benefits significantly outweigh their potential risks. It is usually a personal decision to maximize one’s quality of life by taking a medication. 

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What are some of the risks of living with mental illness, without the proper treatment?

    ~ More frequent or more severe recurrent episodes of the same psychiatric condition in the future; 
    ~ Increased difficulty in finding and maintaining successful relationships;
    ~ Significantly lower probability of a successful career; 
    ~ Financial insecurity; 
    ~ Diminished life expectancy; 
    ~ Elevated risk for substance, alcohol and prescription medication abuse—including tranquilizers and/or narcotic pain medications; 
    ~ Increased chance of affliction with additional psychiatric and medical problems—untreated mental illness may cause gradual brain and other physical damages; and, 
    ~ Considerably higher likelihood of harming—emotionally, financially and physically—one’s self, family, friends and society at large. 
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How am I protected as a clinical trial participant? 
As a clinical trial participant under a doctor's supervision, you are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect you by making sure you have been given all the necessary information about a trial. The FDA and IRBs regulate clinical trial advertisements to reduce misleading claims.

When you participate in a clinical trial your privacy is protected. Your medical records are confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name or the names of other individuals participating in the study. Confidentiality is just one of PRI's commitments to you!

According to the Declaration of Helsinki (worldwide ethical principles regarding human experimentation; prepared and approved by the World Medical Association), the fundamental principle is respect for the individual, their right to self-determination and their right to make informed decisions regarding participation in research, both initially and throughout the course of the research. The investigator's duty is solely to the patient or volunteer, and while there is always a need for research, the subject's welfare and ethical considerations must always take precedence over the interests of science and society, as well as over laws and regulations. The FDA has also adopted and implemented the international quality standard of Good Clinical Practice Guidelines (GCP) for clinical trials, which include similar standards on how clinical trials should be conducted. GCP guidelines prioritize the protection of human rights for all subjects in clinical trials, as well as provide assurance of the safety and efficacy of the newly developed compounds.
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Clinical Trial: A scientific study that tests the effectiveness of a potentially new medical treatment, drug, or device with patients. 
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Clinical Investigator: A medical researcher in charge of carrying out a clinical trial's protocol. Pharmacology Research Institute's physicians are clinical investigators.
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Food and Drug Administration: The government agency that sets guidelines on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.
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Informed Consent Form: The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical trial between clinical investigators and potential participants. The FDA requires all participants to sign an informed consent form before participating in a trial. 
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Institutional Review Board (IRB): A group of health care professionals as well as laypersons from the communities where the clinical trial takes place. The Board is responsible for seeing that there is no unreasonable risk to the patient and that the informed consent form accurately informs the participant about his/her role in the study, along with the potential risks and benefits associated with one's participation. 
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Investigational Treatment: The drug or device being tested during a clinical trial. 
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Pharmaceutical Company: A business that researches, develops, tests, manufactures, and/or sells medical drugs and devices. 
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Protocol: A detailed written plan carefully designed by a clinical trial sponsor and reviewed by the IRB, as well as the FDA. It sets guidelines for a trial and usually involves several different trial locations. 
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Sponsor: The pharmaceutical company, research institution, or other health/governmental organization that funds a clinical trial and designs its protocol. 
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Standard Treatment: A treatment currently in wide use (i.e. currently marketed in the United States) and approved by the FDA for a particular disease or illness. In some trials involving new investigational treatments, there may be no pre-existing treatment at all. In these cases the lack of any treatment is itself considered the standard treatment. Generally, the investigational treatment is hoped to be safer and or more effective than the standard treatment(s).
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