CPTU Services

CPTU services

The CPTU team possess extensive experience in designing, running and overseeing clinical trials in cancer prevention and screening. We also provide training, mentoring and management for trial-specific staff. 

CPTU services include:

  • Statistical design and analysis 
  • Protocol development 
  • Trial teams’ recruitment and supervision 
  • Management of day-to-day trial operations 
  • Maintenance of a quality management system, that includes standard operating procedures (SOPs) to ensure compliance
  • Advice on information governance advice 
  • Patient and public involvement 
  • Behavioural science research 
  • Use of REDCap data and electronic data capture infrastructure
  • Data safe haven for storage and processing of sensitive data, including personal information 
  • IT network and Data Security and Protection (DSP) Toolkit 
  • Monitoring and auditing of clinical trials and CPTU processes
  • Coordination of passive, long-term follow-up of patients via NHS Digital 
  • Training and continuous professional development 

Novel Methodologies

The CPTU aims to use NHS DigiTrials and other providers such as iPlato to invite participants to participate to their epidemiology studies due to the large number of participants required. This is a new and exciting way to work with NHS Digital, and we are  involved in a proof-of-concept project that may inform how other units handle recruitment in future. 

To study outcomes for several years after the treatment or screening period, we continue to pioneer the use of electronic health records to study outcomes extended follow-up. The CPTU works with NHS Digital and other data providers to allow more efficient approaches to long-term follow-up. In both the GRAIL (NHS-Galleri) and YORKSURe projects, we utilise health registry data collection to meet study objectives, minimising the need for duplicate data collections in secondary care. 

We study novel paradigms to enable smaller trials involving multiple treatment arms and derive and implement novel methods to preserve randomised  comparisons in the presence of non-compliance or opportunistic cross-over. 

  • In YorkSure, we use a conceal-reveal design increases statistical power and use of a reciprocal design makes it more acceptable ethically. 
  • In Finesse, a pragmatic study utilises open-label using pharmacy stock to deliver the study at a fraction of the cost of a double blind trial. 


We promote the use of electronic patient records and computer applications (apps) for recruitment and management of participants, whenever possible. The CPTU Behavioural Scientist conducted in depth PPI interviews with individuals in target communities for the YorkSure bladder cancer project to determine acceptability of novel data collection methods (such as the mobile phone application and web-based systems). 

In cluster randomised controlled trials that do not require individual-level consent, we use aggregated data (or securely linked encrypted individual level data). 

Leadership for the clinical research community 

  • Peter Sasieni is a member of the CRUK Prevention and Population Research Committee. He presented at the CRUK’s Tesco Board engagement visit (to The Crick) in January 2020 where he highlighted how Tesco’s support for CRUK has enabled CRUK to fund the CTU and conduct practice changing research in breast cancer prevention, cervical screening, electronic cigarettes and oesophageal cancer screening and prevention. 


  • To disseminate the BEST3 trial results, the CPTU has developed the best3event.com engagement website. 


  • The CPTU has presented and promoted its services to NCRI’s Screening Prevention and Early Diagnosis Group (SPED). Senior members of CPTU have presented trial proposals to several NCRI Clinical Study Groups. 


  • CPTU has strong collaborative links with the Alliance for Cancer Early Detection (ACED) at the University of Cambridge and serves as their CTU.  Peter Sasieni has shared his expertise and knowledge by participating in the faculty for ACED summer school for the last few years. 


  • PPI: Through membership of the CRUK PPI task and finish group, the CPTU behavioural scientist will be able to share some of her experience and expertise more widely through the network. 


  • The CPTU Senior Clinical Trials Application Developer has successfully implemented and chairs the KCL REDCap forum with approximately 25 members representing research groups across a broad range of faculties including: Cancer, Psychiatry, Health Services & Population, Education & Research Solutions, Life Sciences & Medicine and Biostatistics & Health Informatics. The aim of the forum is deliver a high-quality REDCap Service by pooling together strengths and insights. 

 


King’s CPTU REDCap Service 


The Research Electronic Data Capture (REDCap) is a secure, web-based software application developed by Vanderbilt University for designing and managing online databases and collecting scientific research data. 

The CPTU REDCap supports multiple study types including: 

  • Surveys and qualitative studies 
  • Cross-sectional projects using data collection forms for one-time use 
  • Complex and longitudinal studies that re-use forms at multiple time points 

Functions & Features

The CPTU REDCap service provides detailed information on key REDCap functions and features in the CPTU REDCap functions summary 

Data Safe Haven 

All data in the CRUK Cancer Prevention Trials Unit (CPTU) at Queen Mary University London REDCap is stored in a Data Safe Haven (DSH) provided by AIMES, a government-approved web-based cloud infrastructure provider based in Liverpool, United Kingdom. AIMES has ISO27001:2013 and Cyber Essentials Plus accreditation and assessment under the NHS Digital Data Security and Protection Toolkit. 


Projects

You can find examples of CPTU REDCap projects in the following presentation.


Eligibility

To use CPTU REDCap services please complete the following Database Requirements Survey to provide information on your project's database needs. 

Cost

For cost information, please contact cptu_dm@kcl.ac.uk

Contact us

If you have any questions about REDCap features, functions, pricing, or anything else our team is ready to answer your questions.

 

Please email us on cptu_dm@kcl.ac.uk 

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