Many of the requirements detailed in the guidance will be familiar to anyone who has run clinical trials in China or elsewhere. CFDA expects principal investigators, statisticians, data managers, nurses and physicians specialized in the disease under investigation to be involved in clinical trials of medical foods. Many of the tasks involved are similar, too. Clinical trial protocols, informed consent requests and case report forms all apply to trials of medical foods. An ethics committee needs to sign off on these documents and processes before the trial begins.
While these and other aspects of the GCPs overlap with the requirements for drug and device trials, the text is tailored to medical foods in both minor and major ways. The list of people who need to be involved in the study, for example, includes a dietitian. Good manufacturing practices (GMP) apply to medical food trials as they do to more traditional therapeutics, but the details of what is needed to demonstrate quality differs. The design of the trial itself and the endpoints will also differ from drug trials.
Despite these differences, the overarching message of the text is that companies must approach trials of medical foods with the same level of scientific and regulatory rigor as drug studies. This attitude is in keeping with the registration process CFDA adopted for foods for special medical purposes earlier this year. That text established the need for the clinical trial guidance by stating any product intended to be the sole source of nutrition for a patient must undergo clinical trials before it can be approved for use in China.
CFDA has adopted the approaches to the registration and development of medical foods in response to growing interest in using nutrition to manage a range of conditions affecting its population. Diabetes, kidney disease, chronic obstructive pulmonary disease, cancer and other conditions are all potential targets for medical foods.
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