Frequently Asked Questions
What is a Pharmaceutical Research Study?
A pharmaceutical research study is a scientific evaluation of an investigational product conducted to determine if it is a safe and effective treatment option. Pharmaceutical and biotechnical companies spend years analyzing investigational compounds in the laboratory. Once the pharmaceutical research company identifies a compound that they feel will be an effective medication, a protocol is devised to test the product. The U.S. Food and Drug Administration and Institutional Review Boards review protocols to determine if they are safe and ethical, prior to any testing on humans. There are four phases (phases are listed below) of clinical trials, ranging from testing the compound on a small number of healthy adult volunteers to studies that encompass thousands of patients and involve a comparison of the investigational drug to placebo (inactive substance) and other, approved, treatment options. If the data collected during the research studies proves the drug to be a safe and effective treatment option, the FDA then approves it as a new prescription medication.
WHAT ARE THE PHASES OF CLINICAL TRIALS?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trails, researcher’s test a new drug or treatment in a small group of people (20-80) for the first time to evaluate ifs safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
What are the benefits of participating in a research study?
Patients in research studies receive study-medication, tests and exams at no charge throughout the course of the study. Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits. Study coordinators and physicians closely monitor the study patients, and perform physical exams, laboratory tests and other medical procedures to collect information on the patient. Often, these procedures are described as an extension of what is traditionally conducted to manage the patient’s health and medical condition.
"Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits."
In addition to the medical and health-associated benefits, patients in research studies have the unique opportunity to contribute to the advancement of medical research. Your participation in a research study can affect and improve the treatment of medical conditions for generations to come.
Cutting-edge treatments & medications not yet available to the public.
Study-medication provided free of charge.
Study-related exams, including health assessments, blood work and EKG's provided free of charge.
Compensation provided for time & travel involved with office visits.
What are the risks involved in a research study?
Exposure to an investigational product is associated with some risk. Your body may respond in an unexpected way to the investigational product, you may not receive the intended benefit, or you may experience unexpected or unwanted side effects. However, both the U.S. Food and Drug Administration and the Institutional Review Boards monitor research studies closely. Studies that are deemed unsafe or unethical by the Institutional Review Board are not conducted. Your study coordinator and physician also closely monitor your health status and response to the study drug throughout study participation. At your first study visit all of the risks and benefits are outlined in a very detailed document called the Informed Consent Form. This form is reviewed and the study patients can discuss any questions with the study coordinator and doctor prior to any study procedures being conducted.
Who makes sure my rights are protected?
An ethics committee must review clinical research studies before they begin. In addition the FDA (Food and Drug Administration), a department of the US government, set requirements for drug testing. They also review the results from certain clinical research studies to decide if an investigational drug should be made available to the general public.
An ethics group that reviews a clinical research study is called an IRB (Institutional Review Board). The IRB is a group of doctors, nurses, and people from the community. The IRB’s job is to review all clinical research studies to help protect participants’ rights and safety.
Who can be in a clinical research trial?
People with the condition being studied as well as healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied.
Each study has specific requirements such as age, sex, and medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects involved in participating in a clinical study. Study procedures, risks, and benefits are explained to volunteers during the informed consent. (See GLOSSARY OF CLINICAL STUDY TERMS)
Should I volunteer and what can I expect?
Every day, research uncovers new information about medical conditions and possible therapies. Your involvement in clinical studies could help in the development of new medications. You and many other people may benefit from your willingness to become involved.
Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for a broad range of health problems.
Each year, thousands of people volunteer to participate in clinical drug studies. Benefits to you as a volunteer may include:
Participating in the research process that may lead to new therapies.
Receiving medical care from physicians during the study.
Learning new information about your condition, as well as meeting people with similar conditions.
During the study, the team will review your medical history, give you instructions for participating, and monitor your health. Some clinical research studies may involve more tests and doctor visits than you would normally have for an illness or condition.
How can I become a study volunteer?
If you are interested, you can talk to your doctor or healthcare provider to see if a clinical research study is right for you.
To learn more about being a clinical research study, or if you are looking for a clinical research study that is right for you, please call (602)773-3037.
If you are interested in participating in one of our studies click HERE to complete online qualification form.
Glossary of Clinical Study Terms:
Blind Study: One in which the subject or the investigator (or both=Double Blinded) are unaware of what trial product a subject is taking.
Clinical Study: A clinical research study is also called a clinical trial. Each study tests the safety, effectiveness, and side effects of an investigational medicine(s) or an investigational device on a group of volunteers. Clinical research studies are an important step in making new investigational medications available for future use.
Control or Control Group: A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
Exclusion Criteria: A list of criteria, any one of which excludes a potential subject from participation in a study.
Food and Drug Administration (FDA): A government agency that enforces laws on the manufacturing, testing, and use of drugs and medical devices. The FDA must approve an investigational drug for marketing before it can become readily available to the medical community and the public.
Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Inclusion Criteria: The criteria that prospective subjects must meet to be eligible for participation in a study.
Informed Consent: A discussion of procedures, benefits, and risks of clinical research study between clinical investigators and persons interested in participating in the study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study.
Institutional Review Board (IRB): An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Investigator: A person responsible for the conduct of the clinical trial at a trial site.
Open Study: A trial in which subjects and investigators know which product each subject is receiving.
Pharmacology: The science that deals with the characteristics, effects, and uses of drugs and their interactions with living organisms.
Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with 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.
Principal Investigator or Study Physician: A medical researcher in charge of carrying out a clinical research study. Researchers are usually doctors, nurses, pharmacists, or other healthcare professionals.
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 tests, 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.
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