| Contact Us Toll Free |
| Global |
1 866 629 7100 |
| Local |
402 697 6500 |
| E-mail |
Study Inquires |
|
|
:: A Phase One Study:
Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.
:: A Phase Two Study:
Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.
:: A Phase Three Study:
Similar to Phase II trials, Phase III studies test for drug efficacy and typically involve large numbers, ranging from several hundred to several thousand. These studies are typically conducting in numerous sites throughout the United States and the rest of the world.
:: A Phase Four Study:
Phase IV studies, by definition are conducted after drugs have been approved by the Food and Drug Administration. These studies are designed to assess ongoing safety and as comparisons to other existing treatments. These studies, like Phase III trials, involve large numbers of patients.
:: What’s Clinical Research?
Drug development is a complex activity that requires a broad array of medical and laboratory expertise, including toxicology, preclinical evaluation, clinical trial design and implementation. Today's drug development process has evolved through decades of scientific, technological and regulatory changes — all aimed at improving the safety and efficacy of new drugs before they come to market. As a consequence, it can take up to 14 years or more and close to $1 Billion US to bring a new therapy from discovery to market — a time-consuming, capital- and resource-intensive process. In face of this, many pharmaceutical and biotech companies look to outsourcing some or all of their drug development activities.
Before a pharmaceutical company can initiate testing in humans, it must conduct extensive preclinical or laboratory research. This research typically involves years of experiments in animal and human cells. The compounds are also extensively tested in animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans. This is called an Investigational New Drug application (IND).
:: How are experimental drugs tested in humans?
The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies. At QCS, we will be conducting Phase 1 or Phase 2 clinical research only.
:: Who pays for clinical research?
Funding for clinical research comes from the private industry (pharmaceutical, generic and biotech companies).
:: Should you participate in clinical research?
People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care is offered free of charge.The study participant’s rights and safety are protected in two important ways. First, any CRO awarded a research trial by a pharmaceutical company must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the study participant. Second, anyone participating in a clinical trial in the United States is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a study participant in the study.
Please Email Us to learn more about how participating in a clinical study might be right for you. |
| |
|