Clinical research enables Doctors, Pharmaceutical Companies, Medical Device Companies and Rapid Medical Research to create new and better ways to understand, detect, control, and treat illness. The studies conducted by RMR help answer difficult scientific or health related questions that benefit our society, and find cures for future generations.
2 : What is a protocol?
A protocol is a set of rules that all clinical research sites must obey. It consists of certain criteria that eligible volunteers must meet in order to participate in a study. They determine the schedule, procedures, medications, dosages, and length of a particular study.
3 : What is a clinical trial?
A clinical trial is the testing or studying of a drug or device to evaluate the safety and efficacy of a product. Many drugs or devices are developed and tested in a researchers lab. If proven effective in the lab, many times animal testing is next, both of these stages are considered pre-clinical trials. Drugs and devices must also be proven to be safe and effective for people before the Food and Drug Administration (FDA) can approve them and doctors can prescribe them. This is where RMR comes in, we conduct the human trials for certain drugs and devices. Do not be worried, the FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.
4 : What are phases of a clinical trial?
Phase I clinical trials consist of: Researchers testing a new drug or treatment for the first time in a small group of people, usually the group is about 20-80 healthy volunteers. The tests are done to evaluate safety, determine a safe dosage range, and identify any possible side effects.
Phase II clinical trials consist of: Researchers testing a new drug or treatment for the second time in a larger group of people, usually the group is about 100-300 volunteers. The tests are done to further evaluate safety, effectiveness, and identify any possible side effects.
Phase III clinical trials consist of: Researchers testing a new drug or treatment for the third time in a much larger group of people, usually the group is about 2,000-3,000 volunteers. The tests are done to further evaluate safety, compare the new drug to commonly used treatments, and collect information that will support its relevance to the Food and Drug Administration.
Phase IV clinical trials consist of: Researchers continuing testing the study drug or treatment to collect information about its effectiveness in various geographical and demographical locations and gathering data on any side effects associated with long-term use. This clinical trial is optional and usually done after the drug has begun marketing.
5 : What are blind or masked studies?
Many clinical trials have two groups of volunteers: a group that will be given an experimental drug or receive an experimental treatment, or a group that is "controlled" meaning that the doctors have control of what the group receives. The controlled volunteers receive either a standard treatment for the illness, a placebo, or no treatment at all. Because you are not sure which group you are in until the end of the study, the study is sometimes referred to as "blind" or "masked". Sometimes, clinical trials are "double-blind" or "double-masked." That means that neither the participants, nor the study staff members know who is receiving the experimental treatment and who is in the control group receiving either a standard treatment or a placebo. Studies are performed in this way so that neither the patients' nor the doctors' expectations about the experimental drug can influence the results.
6 : Should you volunteer for clinical studies?
The results generated from clinical research benefits our society, and can possible eliminate the threat of terrible diseases, such as aids, cancer, and allergies for the generations to come. It is important that by taking the steps for a better, safer world today, that we ensure a better and safer future for our children, grandchildren, and great grandchildren. Clinical studies are a vital part of finding new treatments and cures for diseases. Carefully conducted clinical trials are the fastest way to find treatments that work and that are safe. By volunteering for a clinical trial, you are participating in research that may result in a new treatment for a deadly or debilitating disease. If you are unsure whether clinical research is the right way for you to help our community we encourage you to come by for a tour of our facility, and a chance to better understand clinical research by speaking with one of our trained staff members.
7 : What is an informed consent?
An informed consent is a document that describes all study procedures, possible risks, side effects, benefits, and alternative treatments. Before volunteers sign the informed consent, they are given the opportunity to have their questions answered by a trained member of the RMR staff. Even after signing the informed consent, volunteers may leave the trial at any time and are given the opportunity to discuss alternative treatments with the RMR medical staff.
8 : What are the benefits of participating in a clinical trial?
In most clinical trials conducted by Rapid Medicall Research, qualified volunteers will receive study related medication, care, and testing at no charge. Qualified participants will also receive compensation for their time and travel.
9 : How are participants protected?
The FDA requires that every clinical trial be reviewed and approved by the Institutional Review Board (IRB). The IRB is a professional organization consisting of members with both medical and non-medical backgrounds that continually reviews trial activities. The IRB's primary responsibility is to protect the safety and rights of clinical trial volunteers.
10 : Will qualified medical professionals be conducting the research study?
All members of the RMR staff have advanced training and are experienced in the field of clinical research. Rapid Medical Research works with board certified physicians that have several years experience conducting clinical trial testing.
11 : How much does it cost to participate?
In most clinical trials conducted by Rapid Medical Research, qualified volunteers will receive study related medication, care, and testing at no charge. Qualified participants will also receive compensation for their time and travel.
12 : Is there a specific amount of time involved?
The duration of each study is dependent on the type of study. If you are interested in participating in a particular clinical trial, we recommend contacting us for more information.