Contemporary clinical trials
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Contemp Clin Trials · May 2012
Randomized Controlled TrialComparative study on the pharmacodynamics of cisatracurium: continuous infusion or intermittent bolus injection.
To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. ⋯ Although cisatracurium consumption was significantly lower in continuous infusion than in intermittent bolus injection, continuous infusion can obtain more stable neuromuscular blockade than intermittent bolus injection.
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Contemp Clin Trials · May 2012
Research without results: inadequate public reporting of clinical trial results.
In order to increase transparency in the medical literature, the Food and Drug Administration (FDA) Modernization Act of 1997 and the FDA Amendment Act of 2007 required registration of all "applicable trials" with required "basic results" reporting. We evaluated the rate of compliance with the FDA mandatory results reporting in www.clinicaltrials.gov. ⋯ The majority of studies registered in clinicaltrials.gov are not required to report data. Of studies that may be required to report data, compliance with data reporting has improved. The clinicaltrials.gov website is not yet a comprehensive resource for study results.
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Contemp Clin Trials · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyCognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol.
Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care. ⋯ The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to 'talking therapies', the results of this study will be timely.
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Contemp Clin Trials · Mar 2012
Exact two-stage designs for phase II activity trials with rank-based endpoints.
Features common to phase II clinical trials include limited knowledge of the experimental treatment being evaluated, design components reflecting ethical considerations, and small to moderate sample sizes as a result of resource constraints. It is for these reasons that there exist many two-stage designs proposed in the literature for use in this context. ⋯ We present exact two-stage Mann-Whitney designs in the context of two-arm randomized clinical trials. In addition to describing the designs, we present tables of decision rules under a variety of assumed realities for use in trial planning.
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Contemp Clin Trials · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyClinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial.
The NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators. ⋯ We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.