Summary & Results from Osteoarthritis Patient-Focused Drug Development Meeting

Our patients have spoken: “We want earlier diagnoses to stop disease progression and better biomarkers for earlier diagnosis”

2017年3月8日,关节炎基金会、美国食品和药物管理局(FDA)、骨关节炎(OA)患者、药物开发者、医疗服务提供者和学术研究人员聚集在一起,讨论了OA疾病的严重负担,特别是最显著的OA相关症状,这些症状的影响,目前可用的治疗和理想的治疗。

TheVoice of the Patient Report是关节炎基金会外部领导的OA以患者为中心的药物开发会议的总结报告,与FDA的以患者为中心的药物开发倡议平行。

The purpose of this meeting was for the FDA to gain an up-to-date understanding of the treatment outcomes most meaningful to patients in the current landscape of OA therapy. This meeting provided key drug development stakeholders the opportunity to hear directly from patients, caregivers, and other patient representatives about their experiences with OA and its treatments. Results of this meeting suggested that current patient preferences are not merely for symptom modifying treatments; most importantly, a paramountpatient priority is for disease modifying treatments that prevent disease early in its course and halt OA disease progression and onset of disability.

The patient input generated through this meeting strengthens the drug development community’s understanding of the burden of OA on patients and the burden of disease management with the treatments currently used to treat OA and its symptoms. Input was provided to directly support the FDA’s benefit-risk assessments for medical products under review. This input is also of value to the drug development process more broadly. For example, it may be useful to drug developers to consider the things that matter most to patients when defining clinical endpoints – dealing with the symptoms that affect a patient’s quality of life like fatigue, functional limitations, impaired mobility and pain while assessing the joint and structural changes.

Most notably, this report emphasizes the need for drug developers to prioritize the focus to disease prevention and stopping progression instead of merely treating symptoms which have no effect on improving the joint environment. Patients emphasized the dire need to explore options which limit disease progression or prevent it altogether. The results inform the design of clinical trials for OA to facilitate selection of outcomes now most meaningful to patients.

Read the full report here, andlearn more about how you can get involved在关节炎基金会的志愿者和患者领导的活动中。

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