What Clinical Research Is All About

How can researchers prove to the government that a newly-discovered drug or device is safe and effective? This is where the clinical trial comes in. The clinical trial is a research study designed to determine if a new pharmaceutical or medical device is sufficiently safe and effective for human use.

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, there is a catch, however. How can the safety and efficacy of a product for human use be determined if the government will not allow the product to be tested on humans, unless it has been proven safe and effective?

This is where animals come to the rescue. Whereas humans regularly use animals for meat, leather, and other products, there has been a strong animal rights movement opposing animal testing. However, until the day when scientists discover a way to produce “artificial life,” it is pointless to debate whether it is less ethical to test a potentially lifesaving drug on a rabbit than to butcher a cow for its meat.

It is possible to control unnecessary suffering and killing of laboratory animals. Agencies such as the Institutional Animal Care and Use Committee (IACUC) are responsible for the review and approval of all proposed uses of live vertebrate animals in teaching and research. The U.S. Animal Welfare Act mandates IACUC oversight. There is equivalent legislation in most developed countries.

Clinical trials (studies/research) do not include animal studies. Clinical research is, by definition, a study of a drug, biologic material, or device in human subjects, and does not include pre-clinical research on animals.