Clinical research costs money and is time consuming. Clinical research involves human subjects and may therefore require approval from an ethics committee such as an Institutional Review Board (IRB). Clinical research can present unique challenges that must be surmounted. Clinical trials are difficult to design, can be frustrating to carry out, and may require partnerships with people who will be critical of the efforts. Given all these difficulties, why should a company, an individual, an organization, or a government sponsor such a project? The reason is that clinical research, when properly carried out, will place an effective product or idea for health care into a favorable position in the medical world and in the market.

The benefits of clinical research are many. Clinical research will show that a product is safe to use and is effective when used for a particular health issue. Clinical research may be required by the regulatory bodies within a country before marketing can proceed or health claims can be made. (In the United States, those agencies are the Food and Drug Administration, FDA, and the Federal Trade Commission, FTC. Other countries have their own authorities for dealing with the validity of health claims.) Clinical research allows for optimal dosages to be determined and for accurate directions to be written for the product's label. Patents can be protected and marketing claims can be supported by clinical research. Finally, clinical research can provide a competitive advantage over other manufactures that make similar claims about their products. The key point is clinical research will prove that your claims are true using statistically significant data.

Many classes of products as well as ideas can benefit from clinical research. Candidate products and ideas include pharmaceuticals, diagnostic procedures, medical devices, therapy protocols, natural product claims, nutraceuticals, supplements, approaches to life styles, claims associated with cosmetics, and claims associated with specific foods are just some of the candidate products that can benefit from clinical research.

In order to prove a claim for a specific product or idea, the clinical investigations must be performed in a subject (patient) population that has the health issue that needs to be addressed. Furthermore, the subject population should be defined by other parameters such as age, gender, and any other health issues that may exist. By defining the subject population, the sponsor of a clinical trial defines the conditions of using the product under investigation. If a product is directed at more than one condition, the product may need to undergo more than one clinical trial with each trial directed at a specific subject population.

There are different types of clinical trials. Types of clinical trials include treatment trials, prevention trials, diagnostic trials, screening trials, quality of life trials, and supportive care trials. Each of these trials is designed to answer a different kind of question. For example, a trial that shows that a vitamin C supplement can prevent scurvy is very different from a trial that shows that a proposed antihypertensive agent reduces blood pressure. A trial that shows exercise can decrease heart disease is different from a trial that shows a statin can do the same.

The design of a clinical trial is further governed by the specific question a sponsor wishes to have answered. It will require that the sponsor clearly define the product, procedure, or idea under investigation with regard to its purpose. In addition to showing efficacy, the sponsor may need to prove the safety of the product, procedure, or idea. The best dosage may need to be determined or an advantage over a competitive product may need to be shown. The sponsor may wish to develop data that can be used to confront criticism. The size of the clinical trial along with the kind of statistical analysis also needs to be determined. Suitable locations and investigators must be indentified and contracts need to be drawn up. However, in all cases, clinical research, when published, is a public display of a product's efficacy and safety with oversight and approval of impartial researchers.

The benefits of clinical research are many. But how does a company, organization, or individual with limited experience and skill sets go about planning and carrying out a clinical trial? That role can be filled by a Clinical Research Organization (CRO). A CRO will provide the necessary skills and resources that may not be available to a company that owns, manufacturers, or markets a health care product or approach. A CRO will know if regulatory filings are required and how to deal with them. They will design a clinical trial that will answer the questions being posed and will develop the statistical analysis including how many subjects should be enrolled in the trial. A CRO will deal with site and investigator selection, subject recruitment, and Institutional Review Board applications. The CRO will also manage data collection, and carry out data interpretation. Reporting results, and manuscript preparation and publishing, as well as development of public presentations are also handled by CROs. This will all be done while keeping costs in a predetermined budget.

As of this writing, the United States National Institutes of Health keeps a registry of nearly 100,000 clinical trials in locations around the world. There are many more that are not on the US government's registry. In all cases, the research being performed will provide data that describes the safety and efficacy of the product, will provide information to help satisfy the concerns of government regulatory agencies and critics, and will provide clinical data that supports the medical claims being made in the market. It is well worth the effort.