What are clinical trials ?

Clinical trials are research studies that test the performance of new medical approaches work in people. Each study answers certain scientific questions and tries to find efficeint ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a classical treatment that is already available.

The majority of the trials can be descibed as planned studies aiming to obtain safety and efficacy data for new drugs or medical devices. The trials can only be initiated place once satisfactory preliminary information has been gathered on the quality of the product and its non-clinical safety. Health Authority/Ethics Committee approval is a requirement in the country where the trial is taking place.

Initially, investigators enroll healthy volunteers and/or patients into small pilot studies. Healthy volunteers and/or patients are enrolled into small pilot studies. During the long course of the study as positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary vastly in volume from a single center in one country to multicenter trials in multiple countries.

The burden of paying for all the necessary people and services is usually borne by the sponsor who may be a governmental organization, a pharmaceutical, or biotechnology company. Often a clinical trial is managed by an outsourced partner such as a contract research organization.

Home - ClinicalTrials.gov
http://www.controlled-trials.com/
http://www.nlm.nih.gov/medline...
http://www.cancer.gov/clinical...