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4 edition of Publication and disclosure issues in antidepressant pediatric clinical trials found in the catalog.

Publication and disclosure issues in antidepressant pediatric clinical trials

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations.

Publication and disclosure issues in antidepressant pediatric clinical trials

hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, second session, September 9, 2004

by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations.

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Published by U.S. G.P.O., For sale by the Supt. of Docs., U.S. G.P.O. in Washington .
Written in English

    Subjects:
  • Antidepressants -- United States -- Evaluation,
  • Depression in children -- Chemotherapy -- United States -- Evaluation,
  • Clinical trials -- United States

  • The Physical Object
    Paginationiii, 716 p. :
    Number of Pages716
    ID Numbers
    Open LibraryOL15563732M
    ISBN 10016074184X
    OCLC/WorldCa57368670

    David Healy, Joanna Le Noury, and Jon Jureidini present their re-analysis of pediatric antidepressant trial data in a new piece published in the International Journal of Risk and classifying the trials as positive or negative according to primary outcome measures, the authors found that all 20 trials conducted between and were negative on their primary outcomes. Information about NCI publications including PDQ cancer information for patients and health professionals, patient-education publications, fact sheets, .

    Research in many clinical areas suggested very real differences in the absorption, distribution, metabolism, excretion, efficacy, and safety of some medications in children and adolescents compared with adults. 18 Most salient to this paper were a series of published findings from multiple studies that provided no evidence of efficacy of the typical tricyclic antidepressants in the pediatric population, Cited by: SLOUGH, England and RICHMOND, Va., Ap /PRNewswire/ -- Indivior PLC (LON: INDV) today announced the publication of long-term safety data .

    ANTI-DEPRESSANTS AND CHILDREN: SUICIDALITY, OFF-LABEL USE, AND TRIAL PUBLICATION Timothy J. Hixson INTRODUCTION Antidepressants, specifically Selective Serotonin Reuptake Inhibitors (SSRis), have been used to treat a plethora of neurological diseases, such as major depressive disorder (MDD)and obsessive compulsive disorder (OCD). 1File Size: 4MB. First, patients receiving antidepressants in clinical trials improve a great deal—the standardized mean effect size of for antidepressant treatment is large. Second, being assigned to placebo in an antidepressant trial is far from “no treatment,” since it entails intensive contact with health care staff that greatly exceeds what is Cited by:


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Publication and disclosure issues in antidepressant pediatric clinical trials by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations. Download PDF EPUB FB2

Publication and disclosure issues in antidepressant pediatric clinical trials: hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Eighth Congress, second session, September 9,   Main Outcomes and Measures Publication rate, trial registration rate, study quality, and risk of bias.

Results A total of abstracts were indexed in the PAS database. Of these, were clinical trials, and met eligibility by: 2. Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased.

Selective publication of clinical trials — and the outcomes within those trials — can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit by: Todays hearing is on the publication and disclosure issues in the antidepressant pediatric clinical trials.

As part of the committees jurisdiction over public health, the subcommittee today will examine the publication and disclosure of clinical studies conducted on prescription drugs. Fluoxetine 20 mg daily appears to be well tolerated and effective for acute treatment of MDD in child and adolescent outpatients.

Fluoxetine is the only antidepressant that has demonstrated efficacy in two placebo-controlled, randomized clinical trials of pediatric depression. complete and unbiased.

Selective publication of clinical trials — and the outcomes within those trials — can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit ratio. Methods We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involv patients.

We identified 15 randomized, placebo-controlled trials of SRIs for pediatric depression. Trials with negative findings had a significantly longer time to publication (median years ± standard.

Conflict of Interest and Disclosure. After a paper is accepted by Pediatrics for publication, all authors must submit conflict of interest and disclosure forms.

Pediatrics adheres to the policy and uses the standardized disclosure form of the International Committee of Medical Journal Editors (ICMJE). The collection of the forms is automated within the online system.

NCI's popular patient education publications are available in a variety of formats. Download one or more of these booklets to your e-book device, smartphone, or tablet for handy reference, or open them as a PDF directly in the browser.

Childhood Cancer. Clinical Trials. Coping and Support. For Family and Caregivers. Tobacco Cessation. NIMH offers brochures and fact sheets on mental health disorders and related topics for patients and their families, health professionals, and the public. Printed materials can be ordered free of charge.

Brochures and fact sheets are also offered in digital formats and are available in English and Spanish. Major depressive disorder (MDD) has a lifetime incidence of 10% to 15%.

1 The main treatment options include pharmacological and psychological interventions, with many patients receiving combination treatment. Although randomized clinical trials (RCTs) have established the efficacy of antidepressants, 2 acute and long-term effectiveness is limited, and one-third of patients develop treatment.

Please note that Clinical Practice in Pediatric Psychology does not count e-publication of an academic thesis/dissertation as required by the degree granting institution as prior publication. We welcome journal submissions based on this academic work, but ask that authors disclose in. Persons with disabilities having problems accessing the above PDF files may call for assistance.

Resource to assure that all FDA-regulated clinical trials enrolling children are. In total, an estimated children were enrolled in trials that were never completed.

Patient accrual (n = 38, %) was cited to be the most common reason, followed by conduct problems (n = 13, %) and informative termination, (n = 13, %).Cited by: TITLE: Second Generation Antidepressants for Pediatric patients with Major Depressive Disorder and Anxiety Disorder: A Review of the Clinical Effectiveness and Safety DATE: 11 June CONTEXT AND POLICY ISSUES Major depressive disorders (MDD) and anxiety disorders fall within a.

As reported by investigators from the Duke Clinical Research Institute and the FDA, the economic return for conducting pediatric clinical trials can produce significant gains.

These researchers estimated a range of economic returns as high as US$ million and as low as a loss of US$9 million [34].Cited by: To the Editor: The importance of the study reported by Turner et al. (Jan. 17 issue), 1 on selective publication of antidepressant trials, can hardly be overstated because it shows how researchers.

Nineteen trials of a range of newer antidepressants compared with placebo, containing participants, were trials excluded young people at high risk of suicide and many co-morbid conditions and the participants are likely to be less unwell than those seen in clinical practice.

We judged none of these trials to be at low risk of bias, with limited information about many aspects. FDAAA and the Final Rule. This page summarizes the clinical trial registration and results information submission requirements described in Section of the Food and Drug Administration Amendments Act of (PDF), known as FDAAA The statutory requirements have been in effect since Septemhave been codified at section (j) of the Public Health Service (PHS).

DIY Blood Sampling for Pediatric Clinical Trials—The Patients Perspective. By Enaksha Wickremsinhe, Mary Short, Brandon Talkington, Leanne West. A recent survey shows that 40% of pediatric trials conducted between and were never finished or published. One of the main challenges is the need to collect multiple sequential blood samples.

A fact sheet outlining how a teenager’s brain grows, matures, and adapts to the world. This fact sheet also briefly covers the teen brain’s resiliency, onset of some mental illnesses, and sleep patterns in teens.

Understanding Psychosis. This fact sheet covers the signs, symptoms, and treatment options for .Pharmacoepidemiology and Drug Safety.

Graduating pediatric resident reports on procedural training and preparations. Acad Pediatr. ;18 (1) US pediatricians' attitudes regarding public policies for low-income children and their profession's advocacy priorities.

Acad Pediatr. In press. Office-based primary care pediatricians.BACKGROUND: Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials - and the outcomes within those trials - can lead to unrealistic estimates of drug effectiveness and alter the apparent risk-benefit by: