London school of hygiene and tropical medicine CTU
Welcome to the London School of Hygiene & Tropical Medicine Clinical Trials Unit (CTU). We would like to introduce you to our CTU, our services and how to get help and support from us.
About our CTU
We are fully registered as a UK Clinical Research Collaboration (UKCRC) CTU. 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 that implement 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.
Our aim is to conduct research which improves outcomes relevant to people themselves, as promptly as possible, using the opportunity in all our trials to develop new methods to improve the design, conduct, analysis and dissemination of research studies.The Clinical Trials Unit at LSHTM was formed by combining the two main clinical trials groups in the Faculty of Epidemiology and Population Health: Trials Coordination Group at the Medical Statistics Department (MSD) and the Trials Coordinating Centre at the Department of Nutrition and Public Health Intervention Research (NPHIRU).
We have created a CTU which brings together key opinion leaders and the expertise required for conducting global clinical research in a wide variety of clinical specialties.
Working with our CTU
Research funders and research leaders believe that there is a need to involve CTUs in clinical research projects to ensure quality. Funders may not support a project unless a CTU is involved.
Collaboration with LSHTM Staff
Several groups within LSHTM conduct research both nationally and internationally. It is not mandatory to involve our CTU for all research being conducted at LSHTM. However, if you are applying for funding or collaborating on research where it is indicated that the LSHTM CTU is involved in your application or project, you will need to contact us well in advance to see if your work can be supported by our CTU. This support must not be assumed. LSHTM staff can also work with other CTUs with relevant expertise in conducting research in their specific area. The trials which were included in the original application for CTU registration are automatically included as part of the CTU portfolio following confirmation from the Quality Assurance Manager that all relevant standard operating procedures are in place for trial conduct.
We welcome enquiries from external agencies seeking opportunities to conduct clinical research which fits with our aims.
Getting help and support from our CTU
1. Early contact
We advise that you make contact with us as early as possible, even before submitting an outline grant application. In the first instance, please complete theCollaboration Enquiry Form and send by email to firstname.lastname@example.org. The Management Team will then assess your proposal.
2. 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 no such reassurance is possible, 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 analysis, 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 financed, with a minimum expectation that we recover the true cost of our engagement in a study (in terms of its expense of staff costs 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 have been considered, awareness that there is 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.
3. 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 all potential cost items of a clinical trial and should help you ensure that everything is covered in your budget. This is where you specify which of those processes you would expect our CTU to perform.
Types of support provided by our CTU
- Protocol development
- Funding applications
- Set-up of oversight bodies
- Research ethics committee, Regulatory and Local NHS Trust R&D applications
- Trial management and organisation
- GCP training
- Participant recruitment
- Trial quality control procedures
- Case record forms (CRFs)
- Database design, development and management
- Data management
- Design and management of trial websites
- Statistical analysis
- Health economic evaluation
- Report writing and publication
- Dissemination of trial results
We aim to review and respond to a proposal within four weeks of receiving a completed application.
CTU Management Team
- Ian Roberts – Co-director
- Haleema Shakur – Co-director
- Elizabeth Allen – Statistician, Clinical Trials
- Tim Clayton – Statistician, Clinical Trials
- Elizabeth Deadman – Business Administrator
- Diana Elbourne – Statistical leadership
- Patricia Henley – Quality Assurance Expert (represents LSHTM as Sponsor)
- Rosemary Knight – Senior Trials Manager
- Hakim Miah – Database and IT support systems
- Maria Ramos – Senior Project Administrator
For any enquiries please email ctu@Lshtm.ac.uk