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Pragmatic Clinical Trials Unit


Pilot and Feasibility Studies mini webinar series

This resource includes information on pilot trial:

Workshop on Pilot and Feasibility Studies 

A workshop on Pilot and Feasibility Studies will be held from 2-5pm on Monday Oct 3rd in Harrogate.  Please see for further information.



The PCTU are making clinical trials and other well designed studies on COVID-19 a priority.

Dr Clare Relton and colleagues are developing new tools (Virus-Health And Wellbeing checKer), methods (Trials using Cohorts/ TwiCs) and structures (COVIDENCE, UK National Health Study) for efficient population health research in the COVID era and beyond.

For more information please contact


12 May 2020: Professor Rupert Pearse speaks on BBC Radio 4 programme

Intensive Care Consultant and QMUL Professor of Intensive Care Madicine, Rupert Pearse recently appeared on BBC Radio 4's File On 4 programme 'Coronavirus - stories from behind the mask'.

'We've coped - but only just. In fact, at one point it was very close. And as NHS staff I think we're just a little bit broken' 

Listen to the the full broadcast at


8 May 2020: Blizard Institute Professor of Surgery and Barts Health NHS Trust Consultant Surgeon, Professor Charles Knowles, has written and recorded a ballad in memory of all NHS staff and other key workers who have lost their lives in the fight against the coronavirus pandemic.

The ballad, titled Rainbow’s End, aims to raise money for families of those who have died or been incapacitated by coronavirus. The ballad has so far raised almost £11,000 through donations at the time of writing.

Professor Knowles said: "First and foremost, I want listeners to recognise the risk that healthcare workers and other key workers are taking on behalf of the nation, as an increasing number are giving their
lives in this task.

“This is close to home for me. People are dying, and it’s a reality that I don’t think even we as doctors are used to.”

The single is available on all major platforms. You can listen to the ballad on Youtube and can donate on the Just Giving page






19 September 2019: New PCTU supported CTIMP exploring the use of cladribine to halt deterioration in people with advanced multiple sclerosis: #CHARIOT-MS

Work has begun on an exciting new PCTU supported CTIMP study exploring the safety and effectiveness of a drug called cladribine.

Lead by Chief Investigator Dr Klaus Schmierer and a team of expert co-applicants, #CHARIOT-MS will explore the role of the drug in preserving or improving upper limb performance in people with advanced multiple sclerosis (MS).

#CHARIOT-MS will be one of the first studies to explore disease modifying treatments for people experiencing disability associated with advanced MS. Whilst major strides have been made in the treatment of early MS, the study team identified an evident need for more effective treatments for people with progressive MS who are largely or entirely dependent on a wheelchair to mobilise.

Working closely with people with advanced MS and the larger MS community, the trial team established that maintaining upper limb function is an important priority for people who have lost mobility in their lower limbs as a result of their MS.

This will be the first study to use upper limb function as the primary indicator of the effectiveness of the treatment. 

#CHARIOT-MS will use the 9-Hole Peg Test, part of the standard assessment for monitoring arm and hand function in MS and clinical trials. 

Recruitment for this multi-site trial will take place across 20 neuroscience centres across the UK. #CHARIOT-MS will be managed centrally by the PCTU.


We look forward to the launch of this important and exciting study.

Visit the Barts MS Blog to find out more about the study and the important work being carried out in this area.


18 September 2019: PCTU Data Security and Protection (DSP) Toolkit submission – Standards met!

The Data Security and Protection Toolkit replaced the Information Governance in April 2018, providing a self-assessment tool that enables organisations to measure their performance against the ten data security standards that arose from the National Data Guardian for Health and Care’s 2016 Review of Data Security, Consent and Opt-Outs.

As the PCTU is an organisation that has access to NHS patient data, we complete the toolkit to provide assurance that we practice good data security and that all data, in particular personal, confidential data is handled appropriately, securely and lawfully.

The PCTU achieved an overall, ‘standards met’ for the DSPT submission in March 2019. This confirms that evidence was provided to fulfil all of the mandatory requirements set out by the toolkit.

You can view the published outcome via the Data Security and Protection Toolkit website here: PCTU organisational outcome 2018-19

An action plan for next year’s submission is currently being drafted which aims to build on the evidence provided for last year’s submission and to gather evidence to support newly introduced requirements, including compliance with NHS data opt-outs, a policy on data quality and guidance for delivering Data Protection Impact Assessments.


2 July 2019: Research findings published: Short-term increase in step-count leads to long term health benefits

The outcomes of a PCTU supported study have now been published.  The research aimed to evaluate the long-term health outcomes of the 12-week walking programme introduced to participants in the 2011-2013 PACE-UP and PACE-Lift studies.  This 4-year follow up used routine primary care date to calculate new health events for the study participants in the intervening years to establish the long-term trial outcomes.

The findings have now been published in PLOS: Medicine.

You can read more about the study and its findings on the QMUL News site.


16 January 2019: BBC news report on the PCTU's CHILL study

BBC news has reported on PCTU's current study CHILL which is exploring whether reducing air pollution from traffic improves lunch growth and respiratory health in primary school children.

The news segment appeared on BBC News at Six and BBC News at Ten and reported: "A new study with 3,000 primary school children in London and Luton will see if new initiatives to reduce air pollution, such as London’s new Ultra Low Emission Zone, can provide health benefits. Children are especially vulnerable to damage caused by air pollution, which can stunt lung growth and affect other organs".

Watch the BBC News report by visiting their website: Clean air: Do low emission schemes improve children's lungs?

Find out more about CHILL by visiting the dedicated study site: CHILL (Children's Health in London and Luton)


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