By Fineline Cube 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.
Emphasizing Patient Needs in Clinical Research and Development
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.
Patient-Centered Clinical Design and Experience
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.
Implementation of Patient-Centered Clinical Trials
The implementation of clinical trials centered around patients should prioritize the protection of subject safety and rights, and consider scientific and social benefits. To avoid blindly pursuing new technologies and models, research teams should fully explore their rationality, necessity, and feasibility before initiating clinical trials. Compliance with medical and pharmaceutical laws and regulations is mandatory, and patient opinions should be heard to avoid adding additional burdens to the research and affecting the conduct of the trial.
Patient-Centered Drug Benefit-Risk Assessment
Patient-centered drug benefit-risk assessment focuses on the clinical needs of patients, incorporating patient experience data collected from clinical trials into the benefit-risk assessment framework. Patient perspectives can be integrated into treatment background analysis, drug benefits, risk and risk management, and uncertainty analysis. Patient experience data, combined with a comprehensive clinical evidence chain, supports dynamic benefit-risk assessment throughout the entire life cycle, with the drug benefit-risk ratio being fully evaluated from the patient’s perspective.-Fineline Info & Tech