Clinical Trials Unit efficient studies projects

These are the reports from 2022 projects, along with their lead units:

• Bristol TC - Development and validation of an online version of a new generic modular resource-use measure for RCTs
• Leeds  CTRU - IDEAL-S: Statistical Development of the IDEAL Framework
• Leeds  CTRU - An online resource to guide trialists, research staff and patient contributors in how best to prepare for and manage clinical trial participation changes
• Newcastle - CTU ROBust INterims for adaptive designs (ROBIN): developing best practice for high-quality and speedy interim analyses in Phase II-IV trials
• Nottingham - CTU Flourishing As Clinical Trial Staff (FACTS)
• OCTRU - EXPLAIN initiative
• Pragmatic CTRU - Development of Resources to promote best practice for the Analysis of Harm outcomes in RCTs (DoRAH)
• York - TU Supporting, developing and coordinating the Trial Forge SWAT Network

These are the reports from 2021 projects, along with their lead units:

• Norwich CTU - The development of guidance to implementing e-consent in REDCap and other similar Electronic Data Capture (EDC) systems
• Liverpool CTC - Development and prototype testing of a method to quantify the carbon footprint of current clinical trials to inform future lower carbon clinical trials design
• Sheffield CTRU - Recording HArms in Behavioural change Intervention Trials (RHABIT)
• Pragmatic CTU - Promoting INCLUsivity through improving the practice and anD utility of Ethnicity Data collection in trials (INCLUDED)
• Nottingham CTU - REcruitment in Mental health trials; broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND study)
• Norwich CTU - Screening LOg Guidelines (SLOG): A standardised model for screening data: who should be included and which data should be collected?
• Sheffield CTRU - A collaborative study between CTU's to identify the activity and resource needed to improve representation of of under-served groups in trials
• OCTRU - Participant Information PortalS - The PIPS Initiative
• Keele CTU - A WebApp for Sample Size calculation and evaluation of PROGRESSion criteria in pilot and feasibility studies (SS-Progress)

These are the reports from 2020 projects, along with their lead units:

• Bristol TC (1) - Development of an electronic study management system
• Bristol TC (2) - "How to run a good Trial Steering Committee”: an online workshop for TSC Chairs of new trials
• Leeds CTRU - Developing and piloting a template communication to improve information and help elicit preferences in people who stop trial participation early
• Norwich CTU (2) - Automated record linkage to support the efficient use of pseudonymised routine health record data in clinical trials
• Nottingham CTU - Blinding of the trial statistician in clinical trials
• Sheffield CTRU - Learning from COVID-19 related trial adaptations to inform efficient trial design - a sequential mixed methods study
• York CTU - Supporting the implementation of recruitment and retention SWATs

These are the reports from 2019 projects, along with their lead units:

• Birmingham CTU - Development of Guidance for Statistical Analysis Plans for Early Phase Clinical Trials
• Newcastle CTU - Costing Adaptive Trials (CAT): developing best practice costing guidance for CTUs supporting adaptive trials
• Southampton CTU - Presenting the evidence about digital tools for improving RCT recruitment and retention in online training packages to increase their uptake and the
  evidence base
• Sheffield CTRU - Value-based Adaptive Clinical Trial Designs for Efficient Delivery of NIHR Research
• Liverpool CTC - Implementing CDSIC standards into CTUs to increase efficiency and allow improvements for data sharing
• Liverpool CTC - Trial Activity Attributions and costs in Clinical Trials Units
• Manchester CTU - REDCap Cloud adoption and implementation toolkit
• Keele CTU - Supporting Effective and Efficient Initiation and Delivery of Individual Participant Data Meta-analyses (SEED: IPD Meta-analysis)

These are the reports from 2018 projects, along with their lead units:

• Sheffield CTRU - Updating the App SampSize for the Estimation of Sample Sizes for Clinical Trials - A Practical Adaptive Designs Toolkit
• Sheffield CTRU - A Practical Adaptive and Novel Designs Toolkit (PANDA)
• Liverpool TC - Adding value to Information Systems across CTUs
• Liverpool TC - The UK IBD Registry as a platform to support an efficient randomised clinical trial of e-Health interventions to enhance the monitoring of long term biological therapy
• Bristol Collaboration - Feasibility of an efficient study of surgical management of pressure ulcers
• Leeds CTRU - GSP: Good Statistical Practice (GCP for Statisticians)
• Birmingham CTU - Developing Expertise of CTU Staff through Massive Online Resource (MOOC's)
• Cambridge CTU - Eudract Safety Data Input Software Tool

These are the reports from 2017 projects, along with their lead units:

• Liverpool Trials Collaborative - Making requests to NHS Digital Easier for Clinical Trials
• Pragmatic CTU - PROMiSE – Patient Reported Outcome MeasureS using Electronic informed consent and data capture: developing methods and infrastructure
• Southampton CTU - User-focused research to identify the benefits of innovative digital recruitment and retention tools for more efficient conduct of randomised trials
• Imperial CTU - Feasibility evaluation to implement a multi-centre RCT to evaluate a digital tool utilising routine electronic data collection in a Hospital setting
• Sheffield CTRU - Outcome Measures for Emergency Care after a Seizure (OMECS)
• Oxford NPEU - Using electronic health record or disease registry data for clinical trials - a framework practice
• Sheffield CTRU - The SampSize App to assist in the calculation of sample sizes for clinical trials

These are the reports from 2015 projects, along with their lead units:

• Bristol CTEU - Scope the CTUs' requirements for a system to manage the IMP and efficiently develop a secure web-based application to meet requirements in CTU-managed CTIMPs
• ICNARC - Inefficiencies in the current delivery of adult critical care research studies (randomised and non-randomised) from duplication of data collection burden and for retrospective data linkage
• Sheffield CTRU - Development of CONSORT guidance for adaptive clinical trials
• Leeds CTRU - Unlock the potential of international collaboration to provide efficient, faster delivery of patient benefit (International Trials Toolkit)
• Liverpool TC - Validation of statistical programming: developing efficient regulatory compliant best practice
• Nottingham CTU - Improve conduct & efficiency of trials with a standardised set of performance metrics for monitoring & reporting of site performance in trials (developing a standardised tool for presenting metrics)