Premarket Safety and Efficacy Studies for ADHD Medications in Children
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{"title"=>"Premarket safety and efficacy studies for ADHD medications in children", "type"=>"journal", "authors"=>[{"first_name"=>"Florence T.", "last_name"=>"Bourgeois", "scopus_author_id"=>"7006196289"}, {"first_name"=>"Jeong Min", "last_name"=>"Kim", "scopus_author_id"=>"56263925400"}, {"first_name"=>"Kenneth D.", "last_name"=>"Mandl", "scopus_author_id"=>"7003721828"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"25007171", "doi"=>"10.1371/journal.pone.0102249", "pui"=>"373506525", "issn"=>"19326203", "sgr"=>"84904097478", "scopus"=>"2-s2.0-84904097478"}, "id"=>"4f40e1a8-8e11-3dd8-a12c-5f57bb62f637", "abstract"=>"BACKGROUND: Attention-deficit hyperactivity disorder (ADHD) is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.\\n\\nMETHODS: We identified all ADHD medications approved by the Food and Drug Administration (FDA) and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.\\n\\nRESULTS: A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419). Eleven drugs (55%) were approved after <100 participants were studied and 14 (70%) after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9), with 5 (38%) drugs approved after participants were studied <4 weeks and 10 (77%) after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.\\n\\nCONCLUSIONS: Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.", "link"=>"http://www.mendeley.com/research/premarket-safety-efficacy-studies-adhd-medications-children", "reader_count"=>32, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>5, "Librarian"=>1, "Student > Doctoral Student"=>2, "Researcher"=>3, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Student > Master"=>5, "Other"=>6, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>5, "Librarian"=>1, "Student > Doctoral Student"=>2, "Researcher"=>3, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Student > Master"=>5, "Other"=>6, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Environmental Science"=>1, "Medicine and Dentistry"=>10, "Agricultural and Biological Sciences"=>1, "Philosophy"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Physics and Astronomy"=>2, "Psychology"=>9, "Social Sciences"=>1, "Computer Science"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>10}, "Social Sciences"=>{"Social Sciences"=>1}, "Physics and Astronomy"=>{"Physics and Astronomy"=>2}, "Psychology"=>{"Psychology"=>9}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Computer Science"=>{"Computer Science"=>2}, "Unspecified"=>{"Unspecified"=>4}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"Netherlands"=>1, "United States"=>1, "Germany"=>1, "Spain"=>1}, "group_count"=>4}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1586234"], "description"=>"<p>Compliance of pre-approval ADHD clinical drug trials with ICH guidelines overall and during past 10 years.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "pediatrics", "pharmacology", "Drug research and development", "research design", "pre-approval", "adhd", "trials", "ich", "guidelines", "10"], "article_id"=>1098307, "categories"=>["Biological Sciences"], "users"=>["Florence T. Bourgeois", "Jeong Min Kim", "Kenneth D. Mandl"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0102249.t003", "stats"=>{"downloads"=>2, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Compliance_of_pre_approval_ADHD_clinical_drug_trials_with_ICH_guidelines_overall_and_during_past_10_years_/1098307", "title"=>"Compliance of pre-approval ADHD clinical drug trials with ICH guidelines overall and during past 10 years.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-09 03:11:02"}
  • {"files"=>["https://ndownloader.figshare.com/files/1586235"], "description"=>"a<p>All drugs approved by the FDA under a New Drug Application (NDA).</p>b<p>Approval date for treatment of ADHD.</p>c<p>Date derived from first product labeling to include ADHD as an indication as the FDA approval package for biphetamine and desoxyn do not include ADHD as one of the drug indications.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "pediatrics", "pharmacology", "Drug research and development", "research design", "approved", "fda"], "article_id"=>1098308, "categories"=>["Biological Sciences"], "users"=>["Florence T. Bourgeois", "Jeong Min Kim", "Kenneth D. Mandl"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0102249.t001", "stats"=>{"downloads"=>5, "page_views"=>23, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Medications_approved_by_the_FDA_for_the_treatment_of_ADHD_/1098308", "title"=>"Medications approved by the FDA for the treatment of ADHD.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-09 03:11:02"}
  • {"files"=>["https://ndownloader.figshare.com/files/1586232"], "description"=>"a<p>All information on the trials obtained from ClinicalTrials.gov.</p>b<p>Five trials were conducted by Novartis after the approval of Focalin XR, but all were <1 year in length (longest trial 5 weeks) and none focused on adolescents.</p>c<p>Three phase 4 trials have been registered in ClinicalTrials.gov by Shire since the FDA approval of Vyvanse, including two trials focusing on adolescents. None are listed as completed (NCT01552915, NCT01552902, NCT01328756).</p>d<p>Assuming 135 participants were equally distributed between active and placebo arms.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "pediatrics", "pharmacology", "Drug research and development", "research design", "trials", "recommended", "fda"], "article_id"=>1098305, "categories"=>["Biological Sciences"], "users"=>["Florence T. Bourgeois", "Jeong Min Kim", "Kenneth D. Mandl"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0102249.t004", "stats"=>{"downloads"=>7, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Clinical_trials_recommended_or_required_by_the_FDA_at_the_time_of_drug_approval_a_/1098305", "title"=>"Clinical trials recommended or required by the FDA at the time of drug approval<sup>a</sup>.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-09 03:11:02"}
  • {"files"=>["https://ndownloader.figshare.com/files/1586233"], "description"=>"a<p>Assumed equal distribution of randomized participants between the two study arms.</p>b<p>Not all unique patients as some participants from efficacy trial subsequently enrolled in safety trial.</p>c<p>Methylin was a new formulation of FDA-approved methylphenidate.</p>d<p>FDA approval package includes information on pre-clinical trials only and there is no mention of the conduct of clinical trials.</p>e<p>The FDA approval package included clinical trials of Dexedrine and Biphetamine for the treatment of obesity in adults, but no clinical trials assessing their use for the treatment of ADHD were identified.</p>f<p>Adderall was originally approved in 1960 as an anorectic under the brand name Obetrol, but no clinical trials assessing their use for the treatment of ADHD were identified.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "pediatrics", "pharmacology", "Drug research and development", "research design", "trials", "conducted", "fda", "adhd", "drugs"], "article_id"=>1098306, "categories"=>["Biological Sciences"], "users"=>["Florence T. Bourgeois", "Jeong Min Kim", "Kenneth D. Mandl"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0102249.t002", "stats"=>{"downloads"=>1, "page_views"=>32, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Clinical_trials_conducted_for_the_FDA_approval_of_ADHD_drugs_in_children_/1098306", "title"=>"Clinical trials conducted for the FDA approval of ADHD drugs in children.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-07-09 03:11:02"}

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Relative Metric

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