Do I have enough time? The impact of recruiting patients to a randomised controlled trial at recruiting centres

Ellis, Pamela; Bradley, Rebecca; Sandy, Jonathan R; Deacon, Scott; Griffiths, Helen; Atack, Nikki; Moore, Matthew; House, Kate; Wenger, N. A.; Worth, Victoria; Ireland, Anthony J

doi:10.1038/sj.bdj.2012.986

Cited by 2 publications

(4 citation statements)

References 6 publications

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“…It takes time to recruit patients to clinical trials, and there are few data available on this topic. A recent study of an orthodontics multicenter RCT showed that it took on average 19 min to recruit a patient to the study and then a further 110 min per patient to fully recruit to the study and ensure all administrative data were available [44]. The variations between the centers were large in respect to the administrative data time as it often depended on the research support staff that was available.…”

Section: Discussionmentioning

confidence: 99%

Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia

Zakrzewska

Palmer²,

Ettlin

et al. 2013

Trials

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BackgroundTrigeminal neuralgia (TN) is a rare severe unilateral facial pain condition. Current guidelines in trigeminal neuralgia management recommend sodium channel blockers – carbamazepine or oxcarbazepine – as the first-line treatment. However, the currently available drugs are often associated with poor tolerability resulting in sub-optimal pain control. CNV1014802 is a novel sodium channel blocker that is being assessed in the treatment of trigeminal neuralgia. Due to the severity of the condition, it is not ethical to conduct a traditional placebo-controlled randomized controlled trial. It is also difficult to use an active control such as carbamazepine, the current gold standard, because of its complex pharmacology and potential for drug interactions.Methods/DesignThe trial uses a randomized withdrawal design to assess efficacy in this rare condition. There is a 21-day open-label phase followed by a randomized 28-day placebo-controlled phase for responders. Thirty patients will be randomized. The primary outcome measure will be pain relief, but secondary measures of quality of life will be of significant importance given the effect of this condition on activities of daily living. Safety and adverse event endpoints are described.DiscussionThere have been very few well-controlled, randomized, placebo-controlled studies in trigeminal neuralgia, and the majority of drugs have had other primary uses. Due to the severity of the pain, minimizing the time a patient is administered placebo was a key factor in designing this study. This study will not only provide data on the efficacy of CNV1014802 in trigeminal neuralgia, but will also provide information on the effectiveness and acceptability of a novel trial design in trigeminal neuralgia.Trial registrationTrial number NCT01540630

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Section: Discussionmentioning

confidence: 99%

Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia

Zakrzewska

Palmer²,

Ettlin

et al. 2013

Trials

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“…Two were prospective studies (Coffey, Berridge, Lyddiard, & Briggs, 2011; Penberthy, Dahman, Petkov, & DeShazo, 2012). Five were nonrandomized studies (Ellis et al, 2012; Gwede et al, 2000a, 2000b; McCarthy, 1997; Oddone, Weinberger, Hurder, Henderson, & Simel, 1995; Roche et al, 2002). Finally, one was a quality improvement study (Cusack et al, 2004a, 2000b; Jones et al, 2004) and two were expert opinion or commentary (Cassidy & Macfarlane, 1991; Smuck et al, 2011).…”

Section: Resultsmentioning

confidence: 99%

“…In relation to psychometric assessments, eight had no reliability and validity data reported (Berridge et al, 2010; Ellis et al, 2012; Good et al, 2013; Gwede et al, 2000a, 2000b; James et al, 2011a, 2011b; McCarthy, 1997; Roche et al, 2002; Smuck et al, 2011). Five studies mentioned reliability and validity but no data were presented (Briggs, 2008; Coffey et al, 2011; Cusack et al, 2004a, 2000b; Jones et al, 2004; Oddone et al, 1995; Penberthy et al, 2012).…”

Section: Resultsmentioning

confidence: 99%

“…One article proposed a tool to measure the impact of a study on workload at different phases, including planning, implementation, data management, and closure (Berridge et al, 2010). Many articles (Berridge et al, 2010; Briggs, 2008; Coffey et al, 2011; Ellis et al, 2012; Good et al, 2013; Gwede et al, 2000a, 2000b; Hancock et al, 1995; James et al, 2011, 2011b; McCarthy, 1997; Oddone et al, 1995; Penberthy et al, 2012; Smuck et al, 2011) introduced the importance of capturing workload and complexity of clinical trials and proposed methods of measurement, but did not discuss conceptual frameworks or report data on psychometric testing.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Patient Acuity Related to Clinical Research: Concept Clarification and Literature Review

et al. 2018

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In research settings, clinical and research requirements contribute to nursing workload, staffing decisions, and resource allocation. The aim of this article is to define patient acuity in the context of clinical research, or research intensity, and report available instruments to measure it. The design was based on Centre for Reviews and Dissemination recommendations, including defining search terms, developing inclusion and exclusion criteria, followed by abstract review by three members of the team, thorough reading of each article by two team members, and data extraction procedures, including a quality appraisal of each article. Few instruments were available to measure research intensity. Findings provide foundational work for conceptual clarity and tool development, both of which are necessary before workforce allocation based on research intensity can occur.

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Do I have enough time? The impact of recruiting patients to a randomised controlled trial at recruiting centres

Cited by 2 publications

References 6 publications

Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia

Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia

Patient Acuity Related to Clinical Research: Concept Clarification and Literature Review

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