Clinical research involves a long drawn out process which consists of the following steps:
- Discovery – this is where the idea to create a new medicine begins. Typically whoever develops the idea will seek to register and file for patent protection.
- Preclinical Development – this where the idea starts to take "wings". Metabolic interactions and various dosing models are developed.
- Human Clinical Trials (Phases I, II, III and IV)
Before any human testing can begin with a new investigational drug a Investigational New Drug (IND) application must first be filed with the U.S. Food and Drug Administration (FDA)
Clinical Trials - Phase I Studies
Phase I clinical trials focus on the safety, rather then the effectiveness, of a new compound. During this stage very low doses of the compound are administered to a small group of healthy volunteers under the close supervision of a doctor. Very gradually, doses are increased while doctors monitor the participants carefully to determine how their bodies react to the compound, whether the compound is sufficiently absorbed and persists in the bloodstream, and which dosage levels are safe.
**As a note CCRC doesn’t conduct any Phase I studies
Clinical Trials - Phase II Studies
The second stage of clinical testing focuses on the compound’s effectiveness against the illness it is designed to treat. During Phase II, researchers also see to determine the most effective dosages for the new medicine and the most appropriate method of delivering the drug (for example, oral tablets, extended release capsules, inhaled systems, dermatological patches, or injections). This stage involves testing in about 100-300 patients who are in need of treatment and who volunteer for the tests. The patients for Phase II studies are drawn from research centers and hospitals across the country and around the world. As it true for all studies in all phases of drug development, strict guidelines of informed consent are observed so that the risks and potential benefits are clearly explained to the patients.
**As a note, about 20% of the studies that CCRC conducts are Phase II studies
Clinical Trials - Phase III Studies
In the final stage of human clinical trials, researchers aim to confirm the results of earlier tests in a large, worldwide patient population. This phase can involve 3,000 to 10,000 patients in hundreds of hospitals and research centers. The large number of patients involved also allows researchers to establish a broad database of information about the safety and effectiveness of the drug candidates to satisfy government regulatory requirements in the many countries where it will be sold. The large group of geographically diverse populations also enables researchers to identify those rare adverse effects (or problems) that may affect only a few patients in a thousand.
**As a note, about 65% of the studies that CCRC conducts are Phase III studies
Registration
The filing of a New Drug Application (NDA) with the U.S. FDA or a Market Authorization Application with the European Agency for the Evaluation of Medicinal Products (EMEA) seeking to demonstrate the safety and effectiveness of new medicine to approve to market them.
Approvals
New medicines that are approved for marketing to the general population in the U.S or Europe.
Clinical Trials - Phase IV Studies
These studies are often called “post marketing” studies as the drugs have already been approved and are on the market. These studies are typically developed by the sponsor company’s sales and marketing department in order to provide them more data on the satisfaction of their product.
**As a note, about 15% of the studies that CCRC conducts are Phase IV studies
