On June 14, 2019, China's SAMR issued an announcement opening the public consultation period on a draft of 'Clinical Trial Technique Guidelines of Full Nutrition Formulas for Diabetes (Consultation Draft)[1]’, together with another two guidelines for patients with kidney disease and for patients with malignant tumors. Comments need to be submitted to the Special Foods Division of SAMR by July 15, 2019.
Note: The following FSMP (full nutrition formula) is used in patients with diabetes, kidney disease and malignant tumor.
Non-Mandatory Principle
Population Selection and Age Range:
The subjects involved in trials should be patients with specific diseases that are over 10 years old (besides, tumor patients which should be under 80-year old).
Content:
The content mainly includes the rationale for trial design, subject selection, subject withdrawal and suspension criteria, test sample requirements, test program design, observation indicators, results determination, data management and statistical analysis, etc.
Non-Mandatory Principle:
This guideline is non mandatory, and enterprise can consider referencing it when conducting clinical trials of full nutrition formula foods. SAMR pointed out that, based on the product formula, nutritional characteristics, special medical clinical effects and preliminary research applicants can design and propose their own tests which are beyond the scope of the guidelines. In addition, if those applicants can offer a solid scientific basis explaining the rationale for a specific clinical trial design then it can be conducted and accepted by authorities.
Three Factors Determine the Result
In order to assess the suitability of a product to meet the nutritional requirements of special populations the test method in the guideline use approved nutrition formula foods that have been successfully registered as controls during testing and trials. The following three factors are used as indicators to determine whether a patient's nutritional requirements are being met.
Safety Assessment:
Identify whether the sample itself has caused an adverse reaction during use, as well as other adverse events or serious adverse events. For example, nausea, vomiting, and infectious complications.
Nutritional Adequacy:
This criterion requires confirmation that the FSMP can meet the nutritional requirements of specific sub-populations as confirmed by assessment using sub-population specific indexes and criteria.
| Special Population | Concentrations | Measure Indicators |
| Diabetic Patients | Use specific markers to establish normal metabolism of the product | Body weight, mass index, serum visceral protein, hemoglobin, etc. |
| Kidney Disease Patients | The clinical research focuses on the well-recognized nutritional evaluation indicators such as hematological indicators (hemoglobin etc.) and/or body composition of kidney patients. | Body weight, mass index, body composition, serum albumin, total protein, hemoglobin, etc. |
| Tumor Patients | Clinical studies focus on the maintenance or improvement of patient weight, hematological nutrition indicators, and nutritional assessment scale scores. | Body weight, mass index, various protein indicators, nutritional assessment scales, including but not limited to patient-generated subjective global assessment (PG-SGA), etc. |
Judgment of Clinical Effects:
| Special population | Indicators | Judgment/Confirmation Rules |
| Diabetic Patients | Control or mitigation of:
| All indicators are not inferior to the control group, it is judged that the clinical effect is not inferior to the control group; At least one of the indexes 1 and 2 is superior to the control group and the other indicators are not inferior to the control group, the clinical effect is judged to be superior to the control group. |
| Kidney Disease Patients |
| |
| Tumor Patients |
| Most of the indicators (which must include the No. 5 indicator) are not inferior to the control group, the clinical effect is judged not to be inferior to the control group; The majority of the indicators (which must include the No. 5 indicator) are superior to the control group, the clinical effect is judged to be superior to the control group. |
At the end of the guidelines, SAMR states that the data from above-mentioned clinical trial and subsequent statistical analysis can refer to ‘Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (For Trial) [2]’.
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