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One such condition, fibrodysplasia ossificans progressiva (FOP; MIM#135100), is characterized by progressive heterotopic ossification (HO) that leads to severe disability. Individuals with FOP are extremely sensitive to even minor traumatic events. There has been substantial recent interest in clinical trials for novel and urgently\u2010needed treatments for FOP. The International Clinical Council on FOP (ICC) was established in 2016 to provide consolidated and coordinated advice on the best practices for clinical care and clinical research for individuals who suffer from FOP. The Clinical Trials Committee of the ICC developed a focused list of key considerations that encompass the specific and unique needs of the FOP community \u2013 considerations that are endorsed by the entire ICC. These considerations complement established protocols for developing and executing robust clinical trials by providing a foundation for helping to ensure the safety of subjects with FOP in clinical research trials.<\/jats:p>","DOI":"10.1111\/bcp.13777","type":"journal-article","created":{"date-parts":[[2018,10,5]],"date-time":"2018-10-05T13:34:36Z","timestamp":1538746476000},"page":"1199-1207","source":"Crossref","is-referenced-by-count":33,"title":["Special considerations for clinical trials in fibrodysplasia ossificans progressiva (FOP)"],"prefix":"10.1111","volume":"85","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8924-106X","authenticated-orcid":false,"given":"Edward C.","family":"Hsiao","sequence":"first","affiliation":[{"name":"Division of Endocrinology and Metabolism, and the Institute for Human Genetics, Department of Medicine University of California  San Francisco CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Di Rocco","sequence":"additional","affiliation":[{"name":"Unit of Rare Diseases, Department of Pediatrics IRCCS Giannina Gaslini Institute  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Cali","sequence":"additional","affiliation":[{"name":"Radiant Hope Foundation and the Ian Cali FOP Research Fund, PENN Medicine Center for Research in FOP &amp; 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