In the US, medical foods and enteral nutrition products are not classified as drugs, even when they are administered only under the supervision of a physician. Thus, while nutritional products do not require the same development process as a new drug, in general, products to support growth do require a clinical trial conducted in accordance with GCP. Parenteral nutrition products, including additions or changes to the formula, are generally regulated as prescription drugs and thus must follow the complex approval process for new drugs, including adequate and well-controlled studies conducted under GCP prior to approval.
In Europe, the situation differs somewhat. All health claims made on foods or food ingredients requires scientific evidence of “the highest possible standard,” which means human clinical studies are essential for the substantiation of claims. Infant formula and products intended to support growth must conform to specific requirements, which include clinical studies. Parenteral nutrition products, which were developed in the 1960s in Sweden, are also regulated as drugs and must be evaluated in clinical trials. However, in Europe, there is a long tradition of using certain herbal preparations as medicinal products. In those cases, it may be possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on more than 30 years of clinical experience. In those cases, pre-clinical tests are not considered necessary, but herbal medicines remain subject to general provisions applying to all medicines such as pharmacovigilance, good manufacturing practices, etc.
Increasingly, regulatory agencies are moving towards greater oversight and scientific regulation of medical and nutritional products. Rigorous clinical studies conducted in accordance with GCP are the standard by which nutritional studies are now judged.
Our technology and expertise introduce the necessary rigor for your nutrition study.
Clinipace introduces rigor to nutrition studies through the use of TEMPO™, our fully integrated, single-database technology platform. Given the complex nature of these studies, more robust statistical analyses are typically required to account for potential confounders. Based on our expertise in experimental design, statistical analyses and requirements of regulatory agencies that are appropriate for this research area, we can help develop the most appropriate analysis plan that will ensure success during protocol development.
Control your trial costs through real-time, risk-based monitoring.
Traditional, on-site monitoring visits can account for up to 30 percent of your study costs. With TEMPO, you have access to a technology-amplified, risk-based approach to monitoring that will help you:
- Ensure integrity of trial data and patient safety
- Optimize trial efficiency and quality
- Streamline sponsor, CRO and trial site team interaction
…all while ensuring your study costs will be lower than the industry average.
We’ve run a wide range of multiphase global nutrition trials, including programs for:
- Infant formulas
- Total parenteral nutrition (TPN)
- Functional foods
- Food hypersensitivity (e.g., peanut)
- Food for Special Medical Purposes (FSMP)
- Nutritional intervention for autism