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The Clinical Trials Unit (CTU)

The Clinical Trials Unit (CTU)

World renowned centre of excellence in the design, conduct, analysis and reporting of clinical trials.

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About us
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About - CTU paragraph
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The Clinical Trials Unit (CTU) at the London School of Hygiene & Tropical Medicine is a world renowned centre of excellence in the design, conduct, analysis and reporting of clinical trials of and is fully registered with the UK Clinical Research Collaboration (UKCRC). Additionally, we have extensive knowledge and practical experience of dissemination of results, conducting systematic reviews and research into trial methodological issues. Our team consist of expert clinical trialists, methodologists, statisticians, trial management and data management teams, trial administrators and IT systems operators. The Cochrane Eye, Heart and Injuries Groups are an integral part of our team. As our CTU is based within the largest school of public health in Europe, we have an extensive body of expertise on which we can draw, with senior academics in a range of disciplines including epidemiology, medical statistics, health economics, decision analytic modelling, and social sciences. Our CTU will only consider trials which are of high quality and methodologically sound in which we have academic input. 

An important element to the success of our trials is the involvement of participants. INVOLVE is a national NHS advisory group that supports public involvement in health and social care research, they asked people what they think public involvement in research is for. Follow the link to find out more: INVOLVE

This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.

Our team
Team CTU
Management group

Haleema
Shakur-Still

Associate Professor

Liam
Smeeth

Professor

Tim
Clayton

Associate Professor

Hakim Miah

IT Systems Manager

Courtenay Howe

Clinical Trials Unit Administrator
Trialists

Phil
Edwards

Associate Professor

Katharine Ker

Lecturer

Haleema
Shakur-Still

Associate Professor

Liam
Smeeth

Professor
Statisticians

Tim
Clayton

Associate Professor

Phil
Edwards

Associate Professor

Tom
Godec

Research Degree Student

Miland Joshi

Statistician

Jennifer
Nicholas

Assistant Professor
Trial Managers

Monica Arribas

Assistant Trial Manager

Eni Balogun

Trial Manager

Kieran Brack

Danielle Beaumont

Trial Manager

Lauren Frimley

Assistant Trial Manager

David I'Anson

Assistant Trial Manager

Bernard Ndungu

Assistant Trial Manager

Alexander
Perkins

Trial Manager

Kimberley Potter

Assistant Trial Manager

Joanna Sturgess

Rebecca Swinson

Laura VanDyck

Trial/Data Manager
Data team

Madeleine Cargill

Data Assistant

Matthew Dodd

Data Manager

Carolyn Hughes

Data Assistant

Tracey Pepple

Data Manager

Danielle Prowse

Assistant Data Manager

Steven
Robertson

Data Manager

Andrew Thayne

Laura VanDyck

Trial/Data Manager
Administration

Josenir
Astarci

Trial Assistant

Collette Barrow

Trial Administrator

Myriam Benyahia

Imogen Brooks

Rebecca Chu

Catherine Gilliam

Trial Administrator

Lauren Jerome

Trial Assistant

Courtenay Howe

Clinical Trials Unit Administrator

Lauren Jerome

Trial Assistant

Mia Reid

Clerical Assistant
IT Management

Sergey Kostrov

IT Systems Officer

Hakim Miah

Our Trials

The Clinical Trials Unit at London School of Hygiene & Tropical Medicine specialises in the conduct of large scale UK and international multicentre trials. Our current trials are listed below.

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Current trials
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AIMS

A prospective, randomised, placebo-controlled double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome.

CRASH-3

CRASH-3 is a large, international, randomised, placebo controlled trial, to quantify the safety and effect on mortality and morbidity of the administration of tranexamic acid in patients with TBI.

ERIC-PPCI

ERIC-PCCI is a multicentre randomised controlled clinical trial to determine whether remote ischaemic conditioning (RIC) improves clinical outcomes in STEMI patients undergoing PPCI.

First Steps

A randomised controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) programme compared to routine care in improving outcomes for high-risk mothers and preventing abuse.

HALT-IT

HALT-IT is a a large, international trial assessing whether early administration of tranexamic acid in people with acute gastrointestinal bleeding can reduce their risk of dying in the hospital.

INCLUSIVE

Initiating change locally in bullying and aggression through the school environment.

PREVENTT

PREVENTT is a randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery.

REVIVED

REVIVED is a multicentre prospective randomised open controlled trial to evaluate the efficacy and safety of percutaneous coronary intervention compared to optimal medical therapy alone for ischaemic left ventricular dysfunction. 

Safetxt

Safetxt is a randomised controlled trial of an intervention delivered by mobile phone messaging to reduce sexually transmitted infections (STI) by increasing sexual health precaution behaviours in young people.

StatinWISE

StatinWISE is a trial designed to find out whether the muscle symptoms experienced during statin use are caused by statins. 

 

Where we work
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The London School of Hygiene & Tropical Medicine is a world leading centre for research and postgraduate education in public and global health. The School now has more than 3,500 students and 1,200 staff working in 100 countries worldwide. An introduction to the School is on our website, with our 2012-17 Strategy.  The most recently published data on student numbers, financial information and staff lists are available in the School’s latest Annual Report.

Below are a list of the countries that we have worked in along with the trials and work carried out:

Afghanistan CRASH-3
Albania CRASHCRASH-2CRASH-3,  WOMAN
Argentina CRASHCRASH-2CRASH-3
Australia CRASHCRASH-2
Austria CRASHCRASH-2
Azernaijan CRASH-3
Bangladesh CRASH-2WOMANCRASH-3
Belgium: BRAIN TrialCRASHCRASH-2REPAIR
Brazil CRASH
Burkina Faso WOMAN
Cambodia CRASH-3
Cameroon CRASH-2CRASH-3WOMAN
Canada CRASH-2CRASH-3
Chile CRASH
China CRASHCRASH-2
Colombia BRAIN TrialCRASHCRASH-2CRASH-3WOMAN
Costa Rica CRASH
Cuba CRASHCRASH-2
Czech Republic BRAIN TrialCRASHCRASH-2
Democratic Republic of Congo WOMAN
Dominican Republic CRASH-3
Ecuador CRASHCRASH-2CRASH-3
Estonia BRAIN Trial
Egypt CRASHCRASH-2CRASH-3HALT-IT WOMAN
El Salvador CRASH-2CRASH-3
Ethiopia WOMAN
France REPAIRCRASH-3
Georgia CRASHCRASH-2CRASH-3HALT-IT
Germany CRASH
Ghana CRASHCRASH-2WOMAN
Greece CRASHCRASH-3
India BRAIN TrialCRASHCRASH-2CRASH-3
Indonesia CRASHCRASH-2CRASH-3WOMAN
Iran CRASHCRASH-2
Iraq CRASH-2
Ireland CRASHCRASH-3
Italy CRASHCRASH-2CRASH-3
Ivory Coast CRASH
Jamaica CRASH-2CRASH-3,  WOMAN
Japan CRASH-2CRASH-3
Kenya CRASHCRASH-2CRASH-3WOMAN
Malaysia CRASHCRASH-2CRASH-3HALT-IT
Mexico CRASHCRASH-3
Myanmar CRASH-3
Nepal WOMANCRASH-3
New Zealand CRASH
Nigeria CRASHCRASH-2CRASH-3,  WOMANHALT-IT
Pakistan CRASHWOMANCRASH-3HALT-IT
Panama CRASH
Papua New Guinea HALT-IT
Paraguay CRASH
Peru CRASHCRASH-2CRASH-3
Poland CRASH-2
Portugal CRASH
Romania BRAIN TrialCRASHCRASH-3HALT-IT
Saudi Arabia CRASHCRASH-2
Serbia & Montenegro CRASHCRASH-2
Singapore CRASHCRASH-2
Slovakia CRASHCRASH-2
South Africa BRAIN TrialCRASHCRASH-2
Spain BRAIN TrialCRASHCRASH-2CRASH-3
Sri Lanka CRASHCRASH-2CRASH-3
Sudan WOMAN
Switzerland CRASH
Tanzania CRASH-2CRASH-3WOMAN
Thailand CRASHCRASH-2WOMAN
The Netherlands REPAIR
Tunisia CRASHCRASH-2CRASH-3
Turkey CRASH
Uganda CRASHCRASH-3WOMAN
United Arab Emirates CRASH-3
United Kingdom
Vietnam CRASH
Zambia CRASH-2WOMANCRASH-3
Zimbabwe WOMAN
Working with us
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Working with the CTU
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We are fully registered as a UK Clinical Research Collaboration (UKCRC) Clinical Trials Unit. This means that we have capabilities required to provide a full spectrum of expertise required to deliver high quality clinical research to the highest standards.

In order to obtain full registration status we needed to demonstrate: 

  • Track record and experience of coordinating multi-centre randomised controlled trials or other well designed studies 
  • Presence of a core team of expert staff to develop studies 
  • Presence of robust quality assurance systems and processes to meet appropriate regulations and legislation (e.g. the principles of Good Clinical Practice, the NHS Research Governance Framework, the Data Protection Act and the UK regulations implementing the EU Directive for Clinical Trials) 
  • Evidence of longer term viability of capacity for trials coordination and the development/maintenance of a trials portfolio, including core funding or evidence of a rolling programme of grants, with evidence of commitment from the host institution.

Working with our CTU

We welcome enquiries from external agencies seeking opportunities to conduct clinical research which fits with our aims.

Types of support provided by our CTU: 

  • Protocol development
  • Funding applications
  • Setup of oversight bodies
  • Research ethics committee, Regulatory and Local NHS Trust R&D applications
  • Trial management and coordination
  • GCP training
  • Participant recruitment
  • Quality control procedures
  • Case report forms (CRFs)
  • Database design, development and management
  • Data management
  • Design and management of trial websites
  • Statistical analyses
  • Health economic evaluation
  • Report writing and publication
  • Dissemination of trial results

Getting help and support from our CTU

  1. Collaboration Enquiry 
    We advise early contact to the London School of Hygiene & Tropical Medicine CTU, even before submitting an outline grant application. The initial information we require is contained within the CTU Collaboration Enquiry Form; the proposal will be assessed by the Management Team. Here is the supporting criteria for your guidance. Collaboration Enquiry Form
  2. Full application stage
    When your project is at the full application stage, the CTU require detailed information about your study and the processes you would expect the CTU to perform before full adoption. Collaboration Request Form.

Our role

Our CTU will only engage in high quality trials where we also have academic input. A member of the CTU Management Group must be a co-investigator. 

The following criteria will be used to assess whether or not a trial is adopted by our CTU:

  • Importance of the research question. The trial must address a question that is clinically important (e.g. areas of crucial evidence gaps, or areas of controversy or high variation in clinical care)
  • Need for the research. Clear demonstration from the evidence base (including a formal review of relevant RCTs) that the research is needed. We can assist with the formal review of evidence if required.
  • Relevance. Must be relevant to the population. We are particularly interested to be involved in trials that are of global importance. 
  • Feasible. Many RCTs fail to proceed in line with expectations, in particular failing to recruit and retain the required number of participants. The research team will be assessed for the correct blend of talent, enthusiasm, experience and clinical credibility. The assumptions behind the study would be critically reviewed, with evidence sought upfront that these assumptions are reasonable. If such reassurance is not obtained, then it will be sought from a pilot study or early returns as the study commences. 
  • Methodologically sound. The optimal scientific design, with the best and most appropriate analyses, with suitable methods of managing and conducting the trial, including procedures for early termination for safety or efficacy reasons, will be required, along with trial registration and a full commitment to publish the results in peer reviewed journals. 
  • Financially viable. Our involvement with a study must be appropriately funded, with a minimum expectation that we recover the true cost of our engagement in terms of staff cost and consumables. 
  • Fits in with the aims of our CTU. We will carefully assess our engagement in a trial on the basis that the trial should enhance and confirm our reputation as the deliverer of high quality, clinically relevant, methodologically excellent RCTs. 
  • Ethically sound. The risks and benefits will have been considered; awareness of a need for high ethical standards in research.
  • Quality assured. All trials conducted as part of the CTU must adhere to relevant Standard Operating Procedures already in place.

Full application stage

Once your project is through to the full application stage, you will need to submit the Collaboration Request Form. This will give us more detailed information about your study. Item 13 of the form lists potential cost items of a clinical trial and will help you ensure that your budget includes all necessary costs. This is where you should specify which of those processes you would expect our CTU to perform. We aim to review and respond to a proposal within four weeks of receiving a completed application.

For enquiries please email ctu@lshtm.ac.uk

Publications
Publications CTU

Below is a list of publications published in 2017 relating to CTU work. Details of further publications by the CTU team can be found on the individual academic profile pages.

Publications
Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms.
Roberts, I; Edwards, P; Prieto, D; Joshi, M; Mahmood, A; Ker, K; Shakur, H; (2017)
Trials, 18 (1). p. 48. ISSN 1745-6215 DOI: 10.1186/s13063-016-1750-1
Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.
WOMAN Trial Collaborators; , COLLABORATORS; Shakur, H; Roberts, I; Fawole, B; Chaudhri, R; El-Sheikh, M; Akintan, A; Qureshi, Z; Kidanto, H; +485 more... (2017)
Lancet. ISSN 0140-6736 DOI: 10.1016/S0140-6736(17)30638-4
The role of general practice in surgical trials.
Butcher, A; Swinson, R; VanDyck, L; Collier, T; Richards, T; (2017)
The British journal of general practice , 67 (657). pp. 157-158. ISSN 0960-1643 DOI: 10.3399/bjgp17X690137
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.
Bonell, C; Mathiot, A; Allen, E; Bevilacqua, L; Christie, D; Elbourne, D; Fletcher, A; Grieve, R; Legood, R; Scott, S; Warren, E; Wiggins, M; Viner, RM; (2017)
Trials, 18 (1). p. 238. ISSN 1745-6215 DOI: 10.1186/s13063-017-1984-6
Data sharing
CTU Data sharing