{"product_id":"innovative-designs-and-analyses-for-jingjing-ye-9783031608421","title":"Innovative Designs and Analyses for Small Population Clinical Trials: Development Strategies and Operational Engagement for Pediatric and Rare Disease","description":"This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Jingjing Ye, Lei Nie\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 3031608429\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9783031608421\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Springer\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 11\/20\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 473\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.91lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.25h x 6.10w x 1.06d","brand":"Jingjing Ye","offers":[{"title":"Hardcover","offer_id":46546092163327,"sku":"9783031608421","price":159.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_1887bf86-99f1-4b04-9b70-1bddf68915a7.jpg?v=1738184107","url":"https:\/\/www.whiterainbookhouse.com\/products\/innovative-designs-and-analyses-for-jingjing-ye-9783031608421","provider":"WR Book House","version":"1.0","type":"link"}