Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data (RCHD) for at least one outcome were included. RCHD sources and outcome information were extracted. Of 216 RCTs, 102 (47%) planned to use RCHD. A RCHD source was the sole source of outcome data for at least one outcome in 46 (45%) of those 102 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort (NIHR HTA funded trials that had a protocol available) plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of which were carried out in North America (McCord et al., 2019).

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Use of routinely collected data in a UK cohort of publicly funded randomised clinical trials

F1000Research ◽

10.12688/f1000research.23316.1 ◽

2020 ◽

Vol 9 ◽

pp. 323

Author(s):

Andrew J. McKay ◽

Ashley P. Jones ◽

Carrol L. Gamble ◽

Andrew J. Farmer ◽

Paula R. Williamson

Keyword(s):

Clinical Trials ◽

Data Extraction ◽

Sole Source ◽

Outcome Data ◽

Data Sources ◽

Publicly Funded ◽

Routinely Collected Data ◽

Routinely Collected Health Data ◽

Service Resource ◽

Randomised Controlled

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data for at least one outcome were included. Routinely collected data sources and outcome information were extracted. A total of 279 studies were identified with 102 eligible for data extraction. An Electronic Health Record (EHR) was the sole source of outcome data for at least one outcome in 46 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of were carried out in North America (McCord et al., 2019).

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Accessing routinely collected health data to improve clinical trials: recent experience of access

Trials ◽

10.1186/s13063-021-05295-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Archie Macnair ◽

Sharon B. Love ◽

Macey L. Murray ◽

Duncan C. Gilbert ◽

Mahesh K. B. Parmar ◽

...

Keyword(s):

Clinical Trials ◽

Data Access ◽

Cancer Registration ◽

Recent Experience ◽

Application Process ◽

Multiple Data ◽

Routinely Collected Health Data ◽

Clinical Trials Unit ◽

Patch Trial ◽

Randomised Controlled

Abstract Background Routinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up. Despite this, current EHR use is minimal in UK RCTs, in part due to ongoing concerns about the utility (reliability, completeness, accuracy) and accessibility of the data. The aim of this manuscript is to document the process, timelines and challenges of the application process to help improve the service both for the applicants and data holders. Methods This is a qualitative paper providing a descriptive narrative from one UK clinical trials unit (MRC CTU at UCL) on the experience of two trial teams’ application process to access data from three large English national datasets: National Cancer Registration and Analysis Service (NCRAS), National Institute for Cardiovascular Outcomes Research (NICOR) and NHS Digital to establish themes for discussion. The underpinning reason for applying for the data was to compare EHRs with data collected through case report forms in two RCTs, Add-Aspirin (ISRCTN 74358648) and PATCH (ISRCTN 70406718). Results The Add-Aspirin trial, which had a pre-planned embedded sub-study to assess EHR, received data from NCRAS 13 months after the first application. In the PATCH trial, the decision to request data was made whilst the trial was recruiting. The study received data after 8 months from NICOR and 15 months for NHS Digital following final application submission. This concluded in May 2020. Prior to application submission, significant time and effort was needed particularly in relation to the PATCH trial where negotiations over consent and data linkage took many years. Conclusions Our experience demonstrates that data access can be a prolonged and complex process. This is compounded if multiple data sources are required for the same project. This needs to be factored in when planning to use EHR within RCTs and is best considered prior to conception of the trial. Data holders and researchers are endeavouring to simplify and streamline the application process so that the potential of EHR can be realised for clinical trials.

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Access to routinely collected health data for clinical trials – review of successful data requests to UK registries

10.1101/2020.04.08.20033373 ◽

2020 ◽

Author(s):

Sarah Lensen ◽

Archie Macnair ◽

Sharon B Love ◽

Victoria Yorke-Edwards ◽

Nurulamin M Noor ◽

...

Keyword(s):

Clinical Trials ◽

Data Extraction ◽

Health Data ◽

Lack Of Information ◽

Routinely Collected Health Data ◽

Long Term Follow Up ◽

Randomised Controlled ◽

The Uk

ABSTRACTBackgroundClinical trials generally each collect their own data despite routinely-collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.MethodsWe conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013-2018, for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction was undertaken between Jan-2019 and May-2019.ResultsWe identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (approximately 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.ConclusionsIn the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined up thinking between the registries and the regulatory authorities.RegistrationPROSPERO CRD42019123088

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Stroke Prevention in Non-Valvular Atrial Fibrillation

Hämostaseologie ◽

10.1055/s-0038-1659985 ◽

1997 ◽

Vol 17 (03) ◽

pp. 166-169

Author(s):

Judith O’Brien ◽

Wendy Klittich ◽

J. Jaime Caro

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Care Home ◽

Relevant Literature ◽

Clinical Trial Data ◽

Outcome Data ◽

Sensitivity Analyses ◽

Bleeding Events ◽

Discharge Data ◽

The Cost

SummaryDespite evidence from 6 major clinical trials that warfarin effectively prevents strokes in atrial fibrillation, clinicians and health care managers may remain reluctant to support anticoagulant prophylaxis because of its perceived costs. Yet, doing nothing also has a price. To assess this, we carried out a pharmacoe-conomic analysis of warfarin use in atrial fibrillation. The course of the disease, including the occurrence of cerebral and systemic emboli, intracranial and other major bleeding events, was modeled and a meta-analysis of the clinical trials and other relevant literature was carried out to estimate the required probabilities with and without warfarin use. The cost of managing each event, including acute and subsequent care, home care equipment and MD costs, was derived by estimating the cost per resource unit, the proportion consuming each resource and the volume of use. Unit costs and volumes of use were determined from established US government databases, all charges were adjusted using cost-to-charge ratios, and a 3% discount rate was applied to costs incurred beyond the first year. The proportions of patients consuming each resource were estimated by fitting a joint distribution to the clinical trial data, stroke outcome data from a recent Swedish study and aggregate ICD-9 specific, Massachusetts discharge data. If nothing is done, 3.2% more patients will suffer serious emboli annually and the expected annual cost of managing a patient will increase by DM 2,544 (1996 German Marks), from DM 4,366 to DM 6,910. Extensive multiway sensitivity analyses revealed that the higher price of doing nothing persists except for very extreme combinations of inputs unsupported by literature or clinical standards. The price of doing nothing is thus so high, both in health and economic terms, that cost-consciousness as well as clinical considerations mandate warfarin prophylaxis in atrial fibrillation.

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Correction: Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2019-216118corr1 ◽

2020 ◽

Vol 79 (6) ◽

pp. e75-e75

Keyword(s):

Clinical Trials ◽

Axial Spondyloarthritis ◽

Efficacy And Safety ◽

Controlled Clinical Trials ◽

Phase 3 ◽

Two Phase ◽

Randomised Controlled

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Saving cognitive outcome data in Alzheimer's disease clinical trials during the COVID‐19 pandemic: Commentary on the virtual administration of the ADAS‐Cog

Alzheimer s & Dementia Translational Research & Clinical Interventions ◽

10.1002/trc2.12081 ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Nadine A. Schwab ◽

Libby A. DesRuisseaux ◽

Marc S. Weinberg ◽

Steven E. Arnold

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Clinical Trials ◽

Outcome Data ◽

Cognitive Outcome

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Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-043370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043370

Author(s):

Ainsley Matthewson ◽

Olena Bereznyakova ◽

Brian Dewar ◽

Alexandra Davis ◽

Mark Fedyk ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Randomised Controlled Trials ◽

Standard Of Care ◽

Standards Of Care ◽

Controlled Trials ◽

Theory Approach ◽

Reference Centre ◽

Cochrane Database ◽

Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

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