William J Cragg
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View article: Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project
Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project Open
Background/Aims: Existing regulatory and ethical guidance does not address real-life complexities in how clinical trial participants’ level of participation may change. If these complexities are inappropriately managed, there may be negati…
View article: Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study
Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study Open
Background Giving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about…
View article: Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study.
Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study. Open
Background Giving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about…
View article: How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration
How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration Open
Background Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participant…
View article: How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration
How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration Open
Background Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participant…
View article: Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit
Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit Open
Background Use of electronic methods to support informed consent (‘eConsent’) is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from …
View article: Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial Open
Background/Aims Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing…
View article: Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2)
Developing an online, searchable database to systematically map and organise current literature on retention research (ORRCA2) Open
Background Addressing recruitment and retention challenges in trials is a key priority for methods research, but navigating the literature is difficult and time-consuming. In 2016, ORRCA ( www.orrca.org.uk ) launched a free, searchable dat…
View article: Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial
Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial Open
Background Sharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation…
View article: Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey
Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey Open
BackgroundEligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to partici…
View article: Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review
Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: A scoping review Open
Background/Aims It is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have recently encouraged more risk-based monitoring. Risk assessment should take pl…
View article: Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitoring study
Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitoring study Open
Background/Aims: Clinical trials should be designed and managed to minimise important errors with potential to compromise patient safety or data integrity, employ monitoring practices that detect and correct important errors quickly, and t…
View article: Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: further analyses of findings from the prospective TEMPER triggered monitoring study
Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: further analyses of findings from the prospective TEMPER triggered monitoring study Open
Background/Aims Clinical trials should be designed and managed to minimise important errors with potential to compromise patient safety or data integrity, employ monitoring practices that detect and correct important errors quickly, and ta…
View article: Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review
Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review Open
Background/Aims It is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have in recent years encouraged more risk-based monitoring. Risk assessment should …
View article: A third trial oversight committee: Functions, benefits and issues
A third trial oversight committee: Functions, benefits and issues Open
Background/aims: Clinical trial oversight is central to the safety of participants and production of robust data. The United Kingdom Medical Research Council originally set out an oversight structure comprising three committees in 1998. Th…
View article: Proposals on Kaplan–Meier plots in medical research and a survey of stakeholder views: KMunicate
Proposals on Kaplan–Meier plots in medical research and a survey of stakeholder views: KMunicate Open
Objectives To examine reactions to the proposed improvements to standard Kaplan–Meier plots, the standard way to present time-to-event data, and to understand which (if any) facilitated better depiction of (1) the state of patients over ti…
View article: Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms
Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms Open
Our results constitute preliminary effectiveness evidence for novel methods in monitoring and managing data return rates in randomised controlled trials. We encourage other researchers to work on generating better evidence-based methods in…
View article: Development of an online resource for recruitment research in clinical trials to organise and map current literature
Development of an online resource for recruitment research in clinical trials to organise and map current literature Open
Background Recruiting the target number of participants within the pre-specified time frame agreed with funders remains a common challenge in the completion of a successful clinical trial and addressing this is an important methodological …
View article: Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study
Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study Open
Background/aims In multi-site clinical trials, where trial data and conduct are scrutinised centrally with pre-specified triggers for visits to sites, targeted monitoring may be an efficient way to prioritise on-site monitoring. This appro…