In clinical trials, subjects are usually entered one at a time, and their responses to treatment monitored sequentially. Regular monitoring of trial progress in the early stages is crucial for accurate reporting of the final results. This paper discusses in detail the principles of quality data management in clinical trials, with specific reference to three clinical data management systems name...

This critical review examines efficacy of CILT in comparison to traditional treatment methods for adults with aphasia as well as the efficacy of modified versions of the original CILT protocol. Study designs include: individual series pre-post treatment (3), mixed randomized clinical trial (RCT) (2), mixed non-randomized clinical trial (NRCT) (2), mixed randomized block (1) designs. Overall, re...

OBJECTIVE We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). METHODS We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS....

At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such stud...

OBJECTIVE Acupuncture is often used and frequently advocated for the symptomatic treatment of fibromyalgia. A systematic review has previously demonstrated encouraging findings. As it is now outdated, we wanted to update it. METHODS We searched seven electronic databases for relevant randomized clinical trials (RCTs). The data were extracted and validated independently by both authors. As no ...

OBJECTIVE To determine how well therapeutic randomized controlled trials (RCTs) in the Journal of Pediatric Psychology (JPP) met the CONSORT criteria as compared to pediatric trials in the Journal of Clinical and Consulting Psychology (JCCP), which served as a control. METHODS Nine trials were found in JPP and 19 clinical trials were retrieved from JCCP. The modified Consort Checklist and Flo...

background: this study aimed to assess the effectiveness of topiramate, a glutamate-modulating agent, in patients with treatment-resistant obsessive-compulsive disorder (ocd) as an adjunct to serotonin reuptake inhibitors (sris). materials and methods: thirty-eight patients with refractory ocd, were randomly assigned to receive topiramate or placebo. this study was designed as a 12-week, double...

Economic endpoints are increasingly common in randomized clinical trials. As a relatively new addition to the field, methods of measuring and analyzing cost data are still evolving. These developments will be stimulated by the demands of the public for efficient and effective medical care, which will be based on the findings of clinical trials.