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Regulatory knowledge, strong communication skills and flexibility to adapt helped move this novel trial forward.
SITUATION
George Clinical was contracted by a globally recognized leader in the field of nutritional science to conduct a prospective, multi-center, randomized, open-label clinical trial to compare the effects of immunonutrition in patients undergoing surgery for gastrointestinal cancer with two parallel groups in China. The investigational product (IP) is categorized as a food for special medical purpose (FSMP)—a formula food specially processed and prepared to meet special needs for the nutrient needs or diet of those suffering from food intake restriction, disorder of digestive absorption, disorder of the metabolic system or certain diseases. These foods are used under the guidance of a doctor or clinical nutritionist. FSMPs help improve the nutritional status of patients, increase recovery rate and reduce complications caused by malnutrition and the number of hospitalization periods.
This was the first oncology FSMP clinical trial performed in China, and George Clinical was the first CRO involved in a Chinese oncology FSMP trial. One of two FSMPs were given to gastrointestinal cancer surgical patients for five days before and seven days after surgery during the trial. As China is currently in the process of upgrading regulations and guidelines for FSMPs, and specifically for their use with cancer patients, it was essential to provide continuous regulatory surveillance and collaborate smoothly and effectively with Chinese clinical and regulatory professionals.
George Clinical has been conducting clinical trials in China since 2007 with an extensive network of over 260 trial centers in 60 cities for Phase II-IV trials, and a wider network that includes community health centers in semi-urban and rural areas for Phase IV trials. We are experienced in navigating the nuances of the changing Chinese regulatory landscape and ensuring that the quality of data from China will support a sponsor’s global program and meet key endpoints.
CHALLENGES
As this was the first oncology FSMP trial in China, there were many challenges during the process of the full-service trial scope provided by George Clinical, beginning with protocol development which took time to develop and was amended several times. This trial involved an FSMP rather than a traditional pharmaceutical, so it was necessary to establish cooperation between the Surgery/ Oncology and Nutrition departments who needed to work together to conduct the trial.
