Clinical trial

In health care, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.


Depending on the type of product and the stage of its development, clinical trials enroll healthy volunteers and/or patients into small studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.


Contents
1 Overview
2 History
3 Types
4 Design
5 Phases
5.1 Pre-clinical studies
5.2 Phase 0
5.3 Phase I
5.4 Phase II
5.4.1 Trial design
5.5 Phase III
5.6 Phase IV
6 Length
7 Administration
8 Ethical conduct
9 Safety
9.1 Sponsor
9.2 Local site investigators
9.3 IRBs
9.4 Regulatory agencies
10 Accidents
11 Economics
11.1 Sponsor
11.2 Investigators
11.3 Patients
12 Participating in a clinical trial
13 See also
14 Notes
15 References
16 External links
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