Journal of Clinical Research and Pharmacy

Journal of Clinical Research and Pharmacy 44 7897 074717

Scholarly Peer Review Journal Of Clinical Trials

It is estimated that 30–50% of all the clinical trials that are conducted and completed are still not published in academic journals. However, publication bias in pediatric epilepsy has not been investigated. Epilepsy may be a relatively frequent, serious condition related to high morbidity for patients . Pediatric seizures can have a deleterious impact on a child’s development causing disability and lifelong dependency . additionally , seizures, hospitalizations, emergency department visits, or medication burden disrupt lives of patients and afflicted families . Clinically available anti-epileptic drugs fail to regulate seizures in approximately 30% of epileptic patients . Beyond pharmacoresistance the long-term use of anti-epileptic drugs is restricted by adverse events, drug-drug-interactions, and non-compliance thanks to inconvenient regimens .

Pediatric treatment decisions are often supported incomplete clinical data and are characterized by off-label use thanks to lack of clinical trials in children . Waste of data thanks to incomplete publication of trial results impedes complete assessment of the effect of an intervention . Indeed, outcome data that favor the efficacy of the investigated drug are twice as likely to be published . Consequently, when unfavorable results of drug trials aren't published, the efficacy of a drug could also be overestimated and trials could also 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 deciding about a private treatment . Of note, several historical examples demonstrate that retention of findings especially concerning adverse events seriously impairs treatment decisions . for instance , the retention of reporting increased mortality rates during clinical trials with the antiarrhythmic lorcainide in 1980, concealed early warnings regarding the danger for cardiac death . Beyond the impact on treatment decisions which affects all patients, there's a particular ethical obligation to publish towards study participants mandated by the Declaration of Helsinki. Patients participate in clinical research on the understanding that findings are going to be of public interest. Therefore, non-publication of trial outcome data violates an ethical obligation that investigators have towards study participants.

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