Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data

Speich, Benjamin; Niederhäusern, Belinda von; Schur, Nadine; Hemkens, Lars G; Fürst, Thomas; Bhatnagar, Neera; Alturki, Reem; Agarwal, Arnav; Kasenda, Benjamin; Pauli‐Magnus, Christiane; Schwenkglenks, Matthias; Briel, Matthias

doi:10.1016/j.jclinepi.2017.12.018

Cited by 86 publications

(63 citation statements)

References 80 publications

(96 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In the 3 trials in which the EHR infrastructure was well established and was merely redirected for use in the trials, 18,27,34 the cost per patient (median $44) was much lower than often-reported costs in traditional trials. 41 The costs of the 2 trials in which the infrastructure was less integrated (such as actively screening the EHR for assessing the clinical outcome), a median of $1280 per patient, were more similar to those of traditional RCTs. 24,30 A recently published overview of registry trials showed similar trial cost patterns (i.e., a reduction of costs when the outcome data did not require manual collection but, rather, the registry infrastructure was leveraged).…”

Section: Discussionmentioning

confidence: 99%

Current use and costs of electronic health records for clinical trial research: a descriptive study

Cord¹,

Ewald²,

Ladanie³

et al. 2019

cmajo

Self Cite

View full text Add to dashboard Cite

R andomized controlled trials (RCTs) are the standard for evaluating benefits and harms of medical treatments. However, they are often time consuming and expensive to conduct, and some trials rely on strictly standardized research settings that may limit the generalizability of their results. 1 Electronic health records (EHRs)-electronic databases containing patient-level variables that are gathered during routine medical care (Appendix 1, available at www.cmajopen.ca/content/7/1/E23/suppl/DC1)-provide great potential for implementing large and pragmatic trials. 2,3 Randomized controlled trials could be integrated directly into routine care, offering almost perfect generalizability of their results. 4 Recently, the Patient-Centered Outcomes Research Institute awarded US$332 million to 28 pragmatic clinical studies, many of them using EHR infrastructures and many of them integrated in routine care. 5 Great debate regarding the potential barriers and limitations of EHR use in clinical research persists, and further details on these obstacles have been discussed elsewhere. 3,6 Briefly, the 2 largest direct advantages of using routinely

show abstract

Section: Discussionmentioning

confidence: 99%

Current use and costs of electronic health records for clinical trial research: a descriptive study

Cord¹,

Ewald²,

Ladanie³

et al. 2019

cmajo

Self Cite

View full text Add to dashboard Cite

show abstract

“…Within a given category of recruitment strategies, for instance, the median cost of a mailed invitation was 228 USD, ranging from 15 to 1,116 USD per patient. [ 28 ]…”

Section: Discussionmentioning

confidence: 99%

Recruitment and retention strategies in mental health trials – A systematic review

Liu¹,

Pencheon²,

Hunter³

et al. 2018

PLoS ONE

View full text Add to dashboard Cite

BackgroundRecruitment and retention challenges are very common in mental health randomised trials. Investigators utilise different methods to improve recruitment or retention. However, evidence of the effectiveness and efficiency of these strategies in mental health has not been synthesised. This systematic review is to investigate and assess the effectiveness and cost-effectiveness of different strategies to improve recruitment and retention in mental health randomised trials.Methods and materialsMEDLINE, EMBASE, the Cochrane Methodology Register and PsycINFO were searched from beginning of record up to July 2016. Randomised trials involving participants with mental health problems which compared different strategies for recruitment or retention were selected. Two authors independently screened identified studies for eligibility.ResultsA total of 5,157 citations were identified. Thirteen articles were included, 11 on recruitment and 2 on retention. Three randomised controlled trials compared different recruitment strategies, none of which found statistically significant differences between the interventional recruitment strategies and the routine recruitment methods. Retrospective comparisons of recruitment methods showed that non-web-based advertisement and recruitment by clinical research staff each have advantages in efficiency. Web-based adverts had the lowest cost per person recruited (£13.41 per person recruited). Specialised care referral cost £183.24 per person, non-web-based adverts cost £372.03 per patient and recruitment via primary care cost £407.65 for each patient. Financial incentives, abridged questionnaires and pre-notification had a positive effect on retention rates.ConclusionThe recruitment studies included showed differences in strategies, clinical settings, mental health conditions and study design. It is difficult to assess the overall effectiveness of any particular recruitment strategy as some strategies that worked well for a particular population may not work as well for others. Paying attention to the accessibility of information and consent materials may help improve recruitment. More research in this area is needed given its important implications.

show abstract

“…There are many treatment uncertainties in neonatal practice [1] that would benefit from being subjected to high-quality randomised clinical trials [2]. However, the high cost of undertaking large and methodologically robust trials [3] means that only a small number are undertaken each year: the median cost of randomised controlled trials was estimated between US$43 and US$103,254 per participant [4] and publicly funded pragmatic neonatal trials cost £1.5-2 million [5]. A key driver of cost in clinical trials is data collection; the mean costs of trial data collection using conventional Case Record Forms have been estimated to be €1135 per participant [6].…”

Section: Introductionmentioning

confidence: 99%

A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data

Jawad

Modi

Prevost

et al. 2019

Preprint

View full text Add to dashboard Cite

Background We aimed to test whether a common set of key data items reported across high impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD). Methods We systematically reviewed neonatal clinical trials published in four high impact medical journals over 10 years (2006-2015) and extracted baseline characteristics, stratification items, and potential confounders used to adjust primary outcomes. Completeness was examined using data held in the NNRD for identified data items, for infants admitted to neonatal units in 2015. The NNRD is a repository of routinely recorded data extracted from neonatal Electronic Patient Records (EPR) of all admissions to National Health Service (NHS) Neonatal Units in England, Wales and Scotland. We defined missing data as an empty field or an implausible value. We reported common data items as frequencies and percentages alongside percentages of completeness. Results We identified 44 studies involving 32,095 infants and 126 data items. Fourteen data items were reported by more than 20% of studies. Gestational age (95%), sex (93%) and birth weight (91%) were the most common baseline data items. The completeness of data in the NNRD was high for these data with greater than 90% completeness found for 9 of the 14 most common items. Conclusion High impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined. Registration PROSPERO registration number CRD42016046138, registered prospectively 17 th August 2016

show abstract

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data

Abstract: The usefulness of the available empirical evidence on resource use and costs of RCTs is limited. Transparent and comprehensive resource use and cost data are urgently needed to support budget planning for RCTs and help improve sustainability.

Cited by 86 publications

References 80 publications

Current use and costs of electronic health records for clinical trial research: a descriptive study

Current use and costs of electronic health records for clinical trial research: a descriptive study

Recruitment and retention strategies in mental health trials – A systematic review

A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data

Contact Info

Product

Resources

About