The patient, as the person who experiences the disease first-hand, has the most direct and accurate experience of the pain of the disease and the most accurate need for health products. Although there is a vast array of technological means to combat disease and maintain health, the human burden of disease has not been reduced and the health needs of patients have not been fully met. Therefore, "patient-focused drug development" is imperative. Gathering comprehensive information from patients through multiple channels and incorporating this information into the entire drug development process can help ensure that patients’ experiences, perspectives, needs and priorities are taken into account and valued. This article will introduce the concept, development process and the specific problems it faces in patient-focused drug development.
In order to better incorporate patient input in clinical trials, the US Food and Drug Administration has included "patient-focused drug development" in the selection and development of clinical outcome assessments, and formulated a series of guidelines. Based on the third guiding principle, "Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments", this article summarizes the clinical outcome assessments from five aspects: concept, development process, scoring mechanism, interference factors and sensitivity, and introduces four different types of clinical outcome assessments, providing new ideas for "patient-focused drug development" efficacy evaluation in clinical trials.
As subjects in drug clinical trials and participants in medical practice, patients can best understand their own conditions and needs. With this in mind, the FDA proposed "patient-centered drug discovery" and issued a set of guidelines to incorporate patient experiences, perspectives, needs, and preferences into the drug development and evaluation process. Guideline (2), methods for identifying important patient information, mainly describes methods and precautions for collecting and extracting patient experience data. This paper will focus on the characteristics, common methods and precautions of qualitative, quantitative and mixed research methods in the collection of patient experience data, in order to provide help for the comprehensive collection of patient experience data.
To ensure the scientific and recognized evaluation of patient-centered clinical research outcomes, the drug development tool qualification certification website of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have disclosed the information of clinical outcome assessment (COA) submitted for certification, and encouraged the use of certified COA. This paper searched all COA and approval decisions on the website, analyzed the submitted information and certification status of COA, and interpreted the certification technology and process of COA, so as to provide references and suggestions for the development of patient-centered clinical research outcome evaluation.
Shared decision making (SDM), as a healthcare service model, requires clinical practice to follow the “patient-centred” medical principle and emphasizes patient participation in the medical decision-making process, which promotes medical equality and improves the quality and effectiveness of healthcare services. However, its methodology has not yet been introduced into the field of Chinese medicine (CM), and there is still a lack of clear guidance on how to implement SDM in clinical practice. This study provided the method of establishing the conceptual framework of SDM in CM, introducing multiple methods according to evidence-based medicine, and conducing an implementation study to explore the applicability of SDM model in CM clinical practice, with the aim of providing references for the application of the SDM in the clinical practice of CM in the future.