Medicines and Healthcare products Regulatory Agency’s Post

📣 Award-winning collaboration ensures the voice of patients plays a prominent role in the way cancer therapies are assessed. The Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials (known as SISAQOL-IMI) consortium have received the prestigious SPAIG (the Statistical Partnerships Among Academe, Industry, and Government) Award for 2024 from the American Statistical Association for their work to improve standards in the design and analysis of cancer trials with patient reported outcomes. The international multidisciplinary consortium, which includes experts from the MHRA, is developing a consensus-based set of best practice recommendations for the design, analysis, presentation, and interpretation of patient reported outcome (PRO) data. The award honours years of intensive work and successful cooperation between the stakeholder groups which include patient representatives. This work will help to better communicate patient reported outcome results between clinicians and patients for the purposes of shared decision making. The recommendations are also likely to be applicable to other therapeutic areas beyond oncology. To learn more about SISAQOL-IMI, visit ➡️ https://bit.ly/4fI0TYZ

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