{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,18]],"date-time":"2026-04-18T00:44:07Z","timestamp":1776473047992,"version":"3.51.2"},"reference-count":48,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,12,28]],"date-time":"2015-12-28T00:00:00Z","timestamp":1451260800000},"content-version":"vor","delay-in-days":27,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2015,12]]},"abstract":"Abstract<\/jats:title>Allergen\u2010specific immunotherapy (SIT<\/jats:styled-content>) is the only disease\u2010modifying treatment for children, adolescents, and adults with allergic diseases. The EU<\/jats:styled-content> has a combined system of national and EU<\/jats:styled-content>\u2010wide marketing authorization for all medicines. Germany introduced a new therapy allergen ordinance in 2008. Allergen products manufacturers had to apply for marketing authorization application for the major allergen groups (grass group, birch group, mites group, bee\/wasp venom). Due to the EU<\/jats:styled-content> pediatric regulation, in force since 2007, manufacturers had also to submit a pediatric investigation plan (PIP<\/jats:styled-content>) for each allergen product. We investigated the allergic rhinoconjunctivitis (ARC<\/jats:styled-content>) standard PIP<\/jats:styled-content>, developed jointly by the European Medicines Agency (EMA<\/jats:styled-content>) and the German Paul Ehrlich Institut (PEI<\/jats:styled-content>). We analyzed the 118 EMA PIP<\/jats:styled-content> decisions, looked for SIT<\/jats:styled-content> trials in children in www.clinicaltrials.gov<\/jats:ext-link>, and further analyzed EMA<\/jats:styled-content>\/EU<\/jats:styled-content> justifications. The PIP<\/jats:styled-content>s request a 1\u2010year dose\u2010finding study in adults, a 5\u2010year placebo\u2010controlled (PC<\/jats:styled-content>) efficacy & safety (E&S) study in adults, and a 5\u2010year PC<\/jats:styled-content> E&S study in children. Fifty\u2010eight PIP<\/jats:styled-content> development programs will have to be performed until 2031. But children benefit even more from SIT<\/jats:styled-content> for ARC<\/jats:styled-content> than adults. There is no convincing medical\/scientific justification for PC<\/jats:styled-content> E&S studies in children in the relevant EMA<\/jats:styled-content> documents. The PIP<\/jats:styled-content> requirement to withhold effective treatment to thousands of children in the placebo group over a 5\u2010year period raises profound concerns. The EMA<\/jats:styled-content> justifications are formalistic and lack scientific foundation. A critical academic review of the ARC PIP<\/jats:styled-content>s and the entire PIP<\/jats:styled-content> system is urgently needed.<\/jats:p>","DOI":"10.1111\/pai.12500","type":"journal-article","created":{"date-parts":[[2015,10,23]],"date-time":"2015-10-23T16:38:55Z","timestamp":1445618335000},"page":"695-701","source":"Crossref","is-referenced-by-count":31,"title":["Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health"],"prefix":"10.1111","volume":"26","author":[{"given":"Klaus","family":"Rose","sequence":"first","affiliation":[{"name":"klausrose Consulting Pediatric Drug Development & More Riehen Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthias Volkmar","family":"Kopp","sequence":"additional","affiliation":[{"name":"Department of Pediatric Allergy and Pulmonology Airway Research Center North (ARCN) University Luebeck L\u00fcbeck Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,12,28]]},"reference":[{"key":"e_1_2_15_2_1","volume-title":"Allergy. 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