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What are Clinical Trials?

Nowadays a large number of medical conditions can be treated successfully with the help of drugs and medical devices. In spite of this medical success, there are still a number of medical conditions that medical know-how cannot succumb too.

As a result new therapeutic methods are sought, with the help of clinical research.

Before a medication is available in pharmacies it has already traveled a long way. It takes approximately 12 years and $600 million before a drug hits the shelves.

Subsequent to the finding of new biological or chemical substances, new combinations of substances or usage potentialities for known substances, the most promising substances are chosen and tested in a research lab. Thereafter clinical trials made up by four phases take place. The new drug is hereby tested by human participants.

The U.S Food and Drug Administration (FDA) has defined a clinical trial as follows:

"Clinical trial" is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in the studies are treated as safely as possible. Another set of regulations applies to: Research that is conducted or supported by a federal department or agency, whether or not it is regulated as defined in §46.102(e), must comply with all sections of this policy.

Who authorizes clinical trials in humans?

The Center for Drug Evaluation and Research's (CDER) are under the supervision of the U.S Food and Drug Administration (FDA) make sure that drugs are safe and effective and “monitor the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks. Clinical trials are regulated and controlled by law. Before the initiation of a clinical trial, applicants are counselled by their local Research Ethics Board (REB).

Ethical Supervision

The DEPARTMENT OF HEALTH AND HUMAN SERVICES declares that

(1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to department- or agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101(b) or (i).

(2)    INSTITUTIONAL REVIEW BOARD (IRB): 1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.

(3)    PEER REVIEW: Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.