Adverse event reporting in randomised controlled trials of neuropathic pain: Considerations for future practice

Abstract

High-quality information on the potential benefit and harm of a drug is required for patients and clinicians to make informed treatment decisions and to enable cost-effectiveness modeling to be undertaken. This systematic review describes the collection and reporting of adverse event data as presented in published clinical trials of neuropathic pain for the evaluation of antidepressant or antiepileptic drugs. A total of 74 studies in 16,323 patients published between 1965 and 2012 were identified, of which 43 were published from 2004 onwards. The review found that methods used to collect adverse event data, the frequency of collection, and the selection criteria used by authors for reporting adverse events vary substantially, and these events are often inadequately reported. Consequently, a potential synthesis of valuable harm information across trials is hampered. We make recommendations regarding the reporting of methods used to collect, assess, select, and present adverse event data in publications. Through the Core Outcome Measures in Effectiveness Trials (COMET) initiative, core outcome sets (which include effectiveness and harm) are developed by disease condition. To facilitate data synthesis for adverse events of drug therapies, we suggest that core outcome sets for harms could be developed by therapeutic class (ie, individualized for each class of drug). To improve comparability of information across trials collection methods need to be standardized for patient reports (spontaneous or prompted) and active surveillance (clinical examinations and laboratory tests). Uniform methods for presenting summary information regarding recurrent events, duration and timing of events requires further research.

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review

“…Smith et al [29,30] reviewed AE reporting practices across 3 pain journals and concluded that clinical trials of pharmacologic treatments did not adequately report AE information. Cornelius et al [5] reviewed AE reporting for trials examining the analgesic efficacy of antidepressant and antiepileptic medications for neuropathic pain, also finding numerous reporting inadequacies. The results of Smith et al [29,30] and Cornelius et al [5] suggest that, despite the availability of reporting guidelines, AE reporting practices in published clinical trials of pharmacologic pain treatments do not provide adequate harms information.…”

“…Cornelius et al [5] reviewed AE reporting for trials examining the analgesic efficacy of antidepressant and antiepileptic medications for neuropathic pain, also finding numerous reporting inadequacies. The results of Smith et al [29,30] and Cornelius et al [5] suggest that, despite the availability of reporting guidelines, AE reporting practices in published clinical trials of pharmacologic pain treatments do not provide adequate harms information. Inadequacies in harms reporting, however, are not limited to investigations of analgesic interventions [25].…”

A systematic review of cost-effectiveness modeling of pharmaceutical therapies in neuropathic pain: variation in practice, key challenges, and recommendations for the future

“…Adverse events should be collected within randomized controlled trials (RCTs) as standard; however, they are not consistently reported in findings and publications. Although the Consolidated Standards of Reporting Trials (CONSORT) table outlines the framework for reporting adverse events from clinical trials, the reporting adverse event data in neuropathic pain trials has been described as 'substandard' and 'poor' 43,44 .…”

Effects of Mesenchymal Stromal Cells on the Neuropathic Pain Induced by Chronic Constriction Injury in Rats

“…First line treatment of neuropathic pain is oral amitriptyline or pregabalin and oral duloxetine for painful diabetic neuropathy according to the guidance of National Institute for Health and Clinical Excellence (NICE) [6]. Insufficient pain relief and intolerable side effects of drugs were experienced in NP patients [7]. Some interventional methods are considered for treatment of NP patients that included in neurosurgical interventions, neural blockade and spinal cord stimulation but the effectiveness of interventional management of NP is also limited [8].…”