The Center for Drug Evaluation (CDE) has released a series of Technical Guidelines that encompass “Patient-Centered Drug Clinical Trial Design,” “Technical Guidelines for Patient-Centered Clinical Trial Implementation,” and “Technical Guidelines for Patient-Centered Drug Benefit-Risk Assessment.” These guidelines are designed to strengthen the “patient-centered” approach within drug research and development practice in China and are effective immediately.<\/p>\n\n\n\n
Emphasizing Patient Needs in Clinical Research and Development<\/strong> Patient-Centered Clinical Design and Experience<\/strong>
The new guidelines underscore the importance of patient needs throughout the entire clinical research and development process. “Patient-centered” drug development involves a process that considers the perspective of patients in drug development, design, implementation, and decision-making, aiming to efficiently create drugs with clinical value that align with patient needs. Patients should be regarded as active participants in the drug development and decision-making process, with their experiences, views, needs, preferences, and other patient experience data being key considerations in the design and implementation of drug development. This approach is intended to provide scientific evidence for valuable drug development and marketing that meet patient needs.<\/p>\n\n\n\n
The patient-centered clinical design must focus on and collect patients’ experiences and needs regarding disease and treatment, fully reflecting the clinical benefits and risks from the patient’s perspective. Additionally, the feelings of patients participating in clinical trials are considered in the clinical design of experiments to encourage active patient participation and efficiently obtain high-quality clinical trial data.<\/p>\n\n\n\n