An absence of pediatric randomized controlled trials in general medical journals, 1985-2004

ArticleinJournal of Clinical Epidemiology 60(2):118-23 · March 2007with8 Reads
DOI: 10.1016/j.jclinepi.2006.03.015 · Source: PubMed
Abstract
There are numerous potential barriers to conducting randomized controlled trials (RCTs) in children. The purpose of this study was to compare the quantity, trends over time, characteristics, and quality of pediatric RCTs published in general medical journals (GMJs) with adult RCTs. We conducted an electronic search of adult and pediatric RCTs from 1985-2004 and a manual search of published RCTs in the year 2000 in five high-impact GMJs (New England Journal of Medicine, Journal of the American Medical Association [JAMA], the Lancet, British Medical Journal [BMJ], Canadian Medical Association Journal [CMAJ]). Linear trends were identified and the 1-year sample was analyzed for publication characteristics (location of recruitment, sample size, number of centers, funding sources, and results) and quality scoring (Jadad score, intention-to-treat analysis, and citation frequency since publication). Adult RCTs increased by 4.71 RCTs/year (95% confidence interval (CI) 3.62-5.80; P<0.001), which was significantly higher (P<0.0001) than pediatric RCTs, which increased by 0.4 RCTs/year (95% CI -0.02 to 0.9; P=0.06). Adult RCTs were more likely to be hospital-based (P=.001) and to involve more centers in multicenter studies (P=0.02). Quality scores were similar, although adult RCTs were cited more frequently (P=0.003). There may be significant barriers to the publication of high-quality pediatric RCTs in GMJs.
    • "Moreover, the lack of financial rewards for the pharmaceutical industry is an additional obstacle for pediatric clinical trials that involve drug therapy [5, 6] . Those obstacles are well recognized and result in a lack of pediatric clinical studies [7, 8]. To address the paucity of pediatric research and to encourage investment by pharmaceutical companies, the United States and Europe enacted new legislations around efficacy and safety of drug trials in children910111213141516. "
    [Show abstract] [Hide abstract] ABSTRACT: Background The ethical, methodological, and technical aspects of pediatric research, often results in complications and delays in implementation. Our objective was to identify factors associated with the implementation duration of hospital-based pediatric studies. Methods All hospital-based pediatric studies sponsored by AP-HP between 2002 and 2008 were retrospectively identified. Association of the funding mechanism and methodological factors with the implementation duration was assessed using a multivariable mixed linear model. Pharmaceutical factors were explored as part of a subgroup analysis restricted to the studies involving drug therapy. Given that we took an exploratory approach, factors associated with implementation duration with p < 0.10 were kept in the final models. Results A total of 139 studies were evaluated. The median implementation duration was 17.1 months (range: 0.9-55.3 months), and tended to increase over time (from 14.9 [25th percentile-75th percentile: 11.5-19.9] months in 2002 to 23.7 [15.2-31.0] months in 2008, p = 0.01). External (coefficient [95 % confidence interval]: -7.7 [-11.9;-3.5] months, p < 0.001) and internal funding (-5.3 95 % CI [-9.8;-0.8], p = 0.02) compared to governmental funding and number of centers (-0.1 95 % CI[-0.2;0.02] months for 1 center increase, p = 0.07) were associated with reduced duration, whereas interventional study (either involving drug therapy (6.0 95 % CI[0.7;11.3] months, p = 0.03 or not (3.5 95 % CI[-0.3;7.3] months, p = 0.06) was associated with increased duration compared to observational study. Regarding the 35 studies involving drug therapy, external funding decreased duration (-6.7 95 % CI[-13.2;-0.2] months, p = 0.05), whereas studies involving solely a pediatric population (7.8 95 % CI[1.1;14.5] months, p = 0.01) (compared to mixed adult-pediatric population), a placebo-controlled design (6.6 95 % CI[0.9;12.3] months, p = 0.01), and inappropriate drug formulation for at least one drug used in the study (6.9 95 % CI[-0.2;14.0] months, p = 0.06) were associated with increased duration. Conclusion Implementation of hospital-based pediatric studies primarily faced delays when they were interventional and, in particular, when they involved drug therapy. Regarding the latter, difficulties that resulted in delayed studies arose with respect to the supply of drugs and placebo in age-appropriate dosages and route of administration. Therefore, difficulties related to the use of pharmaceuticals need to be anticipated earlier in order to avoid implementation delays.
    Full-text · Article · Dec 2016
    • "Furthermore, several reports have demonstrated the current state of EBP competence and use is relatively suboptimal. For example, multiple studies conducted in the the U.S. and other countries have demonstrated (a) nurses continue to use colleagues and personal experience to base their clinical decision-making [13,15161718; (b) inconsistencies in whether nurses value research1920212223; (c) nurses reasons for not implementing EBP may be due to individual and/or organizational barriers [24,25]; and (d) EBP competence and use is particularly problematic within pediatric nursing262728293031323334. With respect to the interventions currently available to promote EBP in nursing, they mostly focus on nurses who work in specialties other than pediatric populations353637383940. "
    Full-text · Article · Jan 2014
    • "Prior work has demonstrated concerning findings with respect to the medical evidence guiding the clinical care of children. First, there appears to be a paucity of clinical research —and particularly randomized controlled trials—conducted in pediatric relative to adult patients[1,333435. This pattern exists across a number of disease conditions and has been attributed chiefly to the smaller disease burden among children as well as issues around the cost and complexity of conducting research in children, all of which translate into a lower potential for profitability363738. "
    [Show abstract] [Hide abstract] ABSTRACT: Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric trials in order to optimize the information derived from pediatric participation in clinical trials.
    Full-text · Article · Dec 2013
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