{"id":742,"date":"2012-06-01T00:00:45","date_gmt":"2012-06-01T07:00:45","guid":{"rendered":"http:\/\/rhochistj.org\/RCP_TEST\/?p=742"},"modified":"2014-02-17T16:26:42","modified_gmt":"2014-02-17T23:26:42","slug":"challenges-pediatric-clinical-drug-trials-drug-product-labeling","status":"publish","type":"post","link":"https:\/\/rhochistj.org\/RhoChiPost\/challenges-pediatric-clinical-drug-trials-drug-product-labeling\/","title":{"rendered":"The Challenges of Pediatric Clinical Drug Trials and Drug Product Labeling"},"content":{"rendered":"

By: Shannon Tellier, Associate Student Editor<\/span><\/p>\n

–<\/p>\n

The disease burden in children outweighs the number of pediatric clinical drug trials currently being conducted.\u00a0 The lack of data in pediatrics leads to drugs being used off-label and without sufficient knowledge of doses, tolerability, and efficacy.\u00a0 In 1975, only 22% of products in the electronic Physicians\u2019 Desk Reference had pediatric labeling, which increased to 46% in 2009.1<\/sup>\u00a0 Even though there has been an increase in the last three decades, the large number of medications without pediatric labeling could lead to detrimental effects in children.\u00a0 This deficiency in pediatric clinical drug trials is due to many factors: lack of financing, as well as legal and ethical problems.<\/p>\n

Since most of the currently available medications do not include pediatric labeling, healthcare professionals face difficult decisions.\u00a0 The two options include (1) not treating children with potentially beneficial medications or (2) extrapolating doses of medications from adult trials.\u00a0 The former raises an ethical question and the latter is dangerous because the pharmacokinetic, pharmacodynamic, and toxic properties of drugs in children are quite different from adults.\u00a0 These extensive differences could lead to dosing errors and adverse events in the pediatric population.<\/p>\n

Even though the information gained from pediatric clinical drug trials is extremely valuable, conducting these trials is difficult.\u00a0 Finding parents willing to enroll their child in a trial is one of the biggest hurdles.\u00a0 Many parents are hesitant because of the fear of hurting their children by subjecting them to treatment that may not provide immediate benefit.\u00a0 The idea of their child receiving a placebo also turns parents off.\u00a0 It becomes easier to recruit children in trials studying potentially lethal illnesses, particularly where current therapies are unsatisfactory.<\/p>\n

Within the past couple of decades, there have been numerous legislative acts aimed to increase pediatric drug development.\u00a0 The FDA Modernization Act (FDAMA) of 1997 offered pharmaceutical companies an extra six months of market exclusivity to conduct pediatric studies and create pediatric labeling.\u00a0 The Best Pharmaceuticals for Children Act, passed in 2002 and 2007, provided methods for studying drugs in pediatrics.2<\/sup> It called for (1) identifying and prioritizing drugs that need to be studied in children and (2) conducting studies on priority drugs if manufacturers do not complete them.<\/p>\n

Even though these Acts are currently available to promote pediatric drug trials, since the majority of medications still do not carry pediatric labeling, we need to provide additional incentives to encourage more research in the pediatric population.\u00a0 The extremely valuable information gained through pediatric drug trials will not only reduce the risk of adverse effects in children but will also allow children to safely use medications that have been previously unused in the pediatric population.\u00a0 Moving pediatric trials forward will take the combined efforts of many healthcare professionals (e.g. <\/i>pharmacists, pediatricians, researchers, manufacturers and pharmacologists).\u00a0 Additional pediatric randomized controlled trials will provide the necessary information needed to make evidence-based guidelines instead of using expert opinion, case reports, or trial and error to dose medications in children.<\/p>\n

SOURCES:<\/span><\/b><\/p>\n

    \n
  1. Sachs AN, Avant D, Lee CS, et al.\u00a0 Pediatric Information in Drug Product Labeling.\u00a0 JAMA.\u00a0 2012;18: 1914-1915.<\/i><\/li>\n
  2. Background of the Best Pharmaceuticals for Children Act.\u00a0 http:\/\/bpca.nichd.nih.gov\/about\/index.cfm<\/a>.\u00a0 Accessed May 24, 2012.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    By: Shannon Tellier, Associate Student Editor – The disease burden in children outweighs the number of pediatric clinical drug trials currently being conducted.\u00a0 The lack of data in pediatrics leads to drugs being used off-label and without sufficient knowledge of doses, tolerability, and efficacy.\u00a0 In 1975, only 22% of products in the electronic Physicians\u2019 Desk…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,4,8],"tags":[343,702,1566,2241,15,163,13,2229,2227,29,577,2232,314,2251,363,968,1625,704,2230,31,36,33,16,17,1061],"class_list":["post-742","post","type-post","status-publish","format-standard","hentry","category-clinical","category-featured","category-advice-opinions","tag-and","tag-children","tag-complete","tag-deficiency","tag-disease","tag-dose","tag-drug","tag-drugs","tag-ebola-virus-disease","tag-editor","tag-extra","tag-fda","tag-for","tag-guidelines","tag-of","tag-one","tag-or","tag-pediatric","tag-pharmaceutical","tag-research","tag-risk","tag-student","tag-treatment","tag-trial","tag-with"],"views":762,"_links":{"self":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/742","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/comments?post=742"}],"version-history":[{"count":0,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/posts\/742\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/media?parent=742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/categories?post=742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rhochistj.org\/RhoChiPost\/wp-json\/wp\/v2\/tags?post=742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}