Launch Although selective reporting of clinical trial results introduces bias into
April 24, 2017
Launch Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making publication bias in pediatric epilepsy is unknown today. Methods We decided the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov PubMed and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria. Results Considering studies that were INCB 3284 dimesylate completed before 2014 (N = 99) 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4 437 individuals. Mean time-to-publication was 25 SD ± 15.6 months more than twice as long as mandated. Conclusion Ten years after the ICMJE’s medical tests registration initiative there is still a considerable amount of selective INCB 3284 dimesylate reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures. Intro
“In the nineteenth century health was transformed by obvious clean water. In the twenty-first century health will be transformed by clean obvious knowledge.” Sir Muir Gray
It is estimated that 30-50% of all the clinical tests that have been conducted and completed are still not published in academic journals [1-5]. However publication bias in pediatric epilepsy has not been investigated. Epilepsy is definitely a relatively frequent severe condition associated with high morbidity for individuals . Pediatric seizures can have a deleterious impact on a child’s development causing disability and lifelong dependency . In addition seizures Rabbit Polyclonal to ZNF225. hospitalizations emergency division appointments or medication burden disrupt lives of individuals and afflicted family members . Clinically available anti-epileptic medicines fail to control seizures in approximately 30% of epileptic individuals [8 9 Beyond pharmacoresistance the long-term use of anti-epileptic medicines is limited by adverse events drug-drug-interactions and non-compliance due to inconvenient regimens [10-12]. Pediatric treatment decisions are often based on incomplete medical data and are characterized by off-label use due to lack of medical tests in children . Waste of knowledge due to incomplete publication of trial results impedes complete assessment of the effect of an treatment . Indeed end result data that favor the efficacy of the investigated drug are twice as likely to be published [1 15 16 As a result when unfavorable results of drug trials are not published the efficacy of a drug may be overestimated and trials may be unnecessarily repeated which consequently wastes resources. Considering insufficient clinical data in pediatrics publication bias can particularly distort the apparent efficacy of a drug which complicates the interpretation of medical literature and decision making about an individual treatment [15 17 18 Of note several historical examples demonstrate that retention of findings especially concerning adverse events seriously impairs treatment decisions [19-21]. For example the retention of reporting increased mortality rates during clinical trials with the antiarrhythmic drug lorcainide in 1980 concealed INCB 3284 dimesylate early warnings regarding the risk for cardiac death [21 22 Beyond the impact on treatment decisions which affects all patients there is an explicit ethical obligation INCB 3284 dimesylate to publish towards study participants mandated by the Declaration of Helsinki. Patients participate in clinical study for the knowing that results will be of open public curiosity. Consequently non-publication of trial result data violates an honest obligation that researchers have towards research individuals [23 24 Stage INCB 3284 dimesylate 3 medical tests are often rigorously designed evaluating the investigational substance against placebo or a dynamic control in the populace of interest and therefore provide a higher level of proof . Furthermore systematic meta-analysis and evaluations looking into treatment plans and treatment recommendations are largely predicated on such tests . Therefore publication bias of phase 3 clinical trials can have.