Clinical trials to test new drugs are commonly classified into four phases. It may take several years for a drug to pass through all the phases. If the drug successfully passes through the first three phases, it will usually be successfully approved for use in the general population.
Quality Clinical Research hosts studies for drugs in Phase II through Phase IV. Currently we do not host studies for Phase I drugs.
Phase I trials are the first-stage of testing in human subjects. Normally a small (20-80) group of healthy volunteers will be selected. This phase is designed to assess the safety and tolerability of a therapy.
Phase II trials are performed on larger groups (20-300) and are designed to assess clinical efficacy of the therapies. This phase can also be broken down to phase IIA and phase IIB.
Phase III trials are controlled trials on large patient groups (300-3000+). This phase is aimed at the efficacy of the new therapy. Some phase III trials are an attempt at “label expansion”. In other words, exploring additional uses beyond the original use for which the drug was designed. This phase is also used to support marketing claims.
Phase IV trials involve the post-launch safety surveillance and ongoing technical support of a drug. This phase is designed to detect any rare or long-term adverse effects over a much larger patient population and timescale.
You will receive study related care at no cost to you which may include a physical exam, medical monitoring, laboratory tests, & x-rays. Before signing the informed consent, you will receive a full disclosure of the risks and benefits of participating in a study, and will have the opportunity to ask questions and discuss all aspects of your trial participation with the medical staff. During the trial, you will be scheduled for regular follow-up visits.
Each research study has specific criteria that must be met in order to participate. Since QCR performs Phase II through IV testing, most studies involve patients that already have some type of ailment. There are however some studies in which the patient must be completely healthy. To find out more information on a study criteria you may call us at 402-934-0044. Also feel free to complete the participation form and submit it with any questions you may have.
With any type of medical treatment there is risk associated. In connection to clinical research you will receive an “informed consent”. In this consent the drug company has laid out the risk associated with the study. As you can imagine there are different risks associated with each different study. At QCR we will take the time to review the informed consent with you and answer any questions you may have.
Requirements to participate in a research study are set by the drug company hosting that particular study. The drug companies set the criteria that must be met, called the inclusion criteria. These are qualifications that the participant must meet to be eligible. There is also exclusion criteria. This is specific criteria that the participant must not have in order to be eligible to participate. There are also stipulations throughout the study that must also be met. Some of these criteria will be explained at the screening visit. Some of these criteria will not be told to the participant in order to keep the study non-biased.
Payment is determined by the drug company that is hosting the study. Most studies do have compensation. Compensation is usually made when the patient completes the visit and qualifies for the next visit.
