𝗪𝗲𝗲𝗸𝗹𝘆 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 #18 📢

Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment

🧪  The increasing importance of patient-centered approaches in cancer drug development is explored in this article. Traditionally, cancer drug approvals have focused on clinical efficacy and safety, often neglecting patient perspectives such as quality of life (QoL). This gap led to the integration of patient-reported outcomes (PROs) and QoL assessments into clinical trials, ensuring that patient experiences are considered in the evaluation of new therapies.  🧑‍⚕️.

🔍 Agencies such as the FDA are now more inclined to consider patient input during the approval process. This shift aims to balance the traditional focus on cancer treatment responses with the real-world impact of treatments on patients' lives. Additionally, a comprehensive value assessment framework that includes both clinical benefits and patient-centered outcomes is also needed.

💊 By incorporating patient perspectives into drug development, regulatory approval, and value assessment, a more holistic approach that aligns treatment goals with patients’ needs can be achieved, ultimately improving the relevance and effectiveness of cancer care.

📚 Reference:
Gyawali et al., Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment. Am Soc Clin Oncol Educ Book 39, 374-387(2019).