Post-Marketing Phase 4 Clinical Trials - Pharmaceuticals vs Natural Products

Recently, a number of questions arose by pharma and industry pertaining to the similarities and/or differences between post-marketing (Phase 4) clinical trials comparing pharmaceuticals vs natural products. First, the main similarity is that all have a definite health benefit and have therapeutic value. Secondly, FDA's "current" approval process is very different for natural products, there is no Phase 1-3 clinical program per se, until of course, FDA "knocks" on your door. It is no surprise that Phase 4, post-marketing clinical research and clinical trials have become the fastest growing area of clinical research today. The stakeholders for the natural products industry remains the same as for pharma, such as but not limited to: consumers, patients, homeopathic, herbal practitioners, physicians, complimentary health professionals, naturophilics, holistics, homeopathics and buyers, with slight differences in one category over the other. Each of these groups must complete clinical Phase 4 trials, with good clinical practice, industry standards of operation, quality control and quality assurance and compliance with FDA regulations. Post-marketing Phase 4 requirements are the same in terms of quality, statistical significance and clinically meaningful results. Data is collected and integrated, summarized, presented, submitted, filed and reviewed by FDA. FDA will act on approvals, approvables or non-approvals. The same process holds true for dietary supplements, cosmeceuticals and neutraceuticals with respect to Phase 4 clinical and regulatory submissions to FDA. In a growing industry that is saturated with "natural" products, clinical research/clinical Phase 4 trials becomes the defining factor in distinguishing a product from its competition, strategically positioning the product against the standard and enhancing the product's characteristics, benefits, attributes and health claims among others.

How to proceed?

• Differentiate your product from others
• Enhance product sustainability
• Increase ROI
• Set and achieve workable and attainable clinical goals, endpoints and objectives
• Attract consumer and patients by enhanced, quality controlled health claims
• "Right" - position the product
• Enhance the brand
• Proceed with data integrity and consistency
• Proceed with data consistency
• Ensure FDA compliance and agreement
• Ensure FDA compliance with guidelines and regulations
• Ensure Good Clinical Practice
• Ensure Good Manufacturing Practice
• Ensure "correctness" and validity of health claims and benefits
• Expect FDA.