Nutraceuticals
An estimated 68% of Americans routinely use vitamins or some other dietary supplement, and there is an increasing expansion of a ìwellness industryî incorporating supplements and a variety of complementary and alternative interventions outside contemporary health care and the pharmaceutical industry. In the US alone, this consumer driven industry accounted for about $200 Billion in sales in 2002, and is expected to reach the Trillion dollar level by approximately 2012.
For our purposes, ìnutraceuticalsî refers to vitamins, minerals, teas, herbs, food extracts, and related products derived from nature, often intended as much to maintain health, prevent disease and promote wellness as to treat a specific illness.
Many companies are drawn to this market, yet the scientific foundation for understanding and appropriate utilization of nutraceuticals is relatively sparse by Western standards, especially in contrast to the scrutiny required to approve new chemical entities. While many individuals respect the collective wisdom of centuries of observations by traditional healers, and others may be encouraged by anecdotal examples, most within the scientific and medical communities call for additional data, from the level of chemical characterization and basic cellular mechanisms to the level of controlled clinical trials.
Studies with nutraceuticals pose a number of challenges. The ëstudy drugí is rarely a single chemical entity, and formulation may depend on "Good Agricultural Practice"î as well as "Good Manufacturing Practices." Many compounds are non-proprietary and the compound is not intended for FDA registration as a medication to treat a specific indication, thus there is no Form 1572. This involves a different regulatory environment and a different economic environment, where research leans towards smaller studies with smaller budgets, and the outcome is a publication of a pure scientific observation or to describe a possible structure or function claim.
Still, the discipline, principles, and ethics of contemporary clinical research apply in this domain if the data are to be helpful. Studies must be done consistent with the Declaration of Helsinki, including appropriate informed consent and IRB approval. Pacific Pharma Group, LLC is prepared to assist with your nutraceutical studies with:
- Study design
- Protocol writing
- Informed consent writing
- IRB submission
- Site selection for study conduct
- Design of source documents and case report forms
- Data analysis
- Report writing
- Manuscript preparation
