We are fully registered as a UK Clinical Research Collaboration (UKCRC) Clinical Trials Unit
We have capabilities required to provide a full spectrum of expertise required to deliver high quality clinical research to the highest standards
HOW WE CAN SUPPORT YOU
Our unit is home to a wide range of expertise
Researchers
Our experts offer advice on clinical requirements when designing studies, dissemination of results, conducting systematic reviews and research into research clinical methodological issues
Trial Managment
Our team is comprised of Trial Managers, Trial Administrators, Trial Assistant Managers, Trials Assistants. Our team has extensive knowledge in managing every stage of a trial life cycle
Data Management
Our expert team can provide a range of data management services, enable the systems creation for a successful infrastructure for research projects
Statistics and Health Economics Support
Our team of statisticians, health economists and IT specialists can provide guidance on the design, feasibility, conduct, analysis and reporting of studies
INTERESTED IN WORKING WITH US?
1. COLLABORATION ENQUIRY (Expression of Interest Stage)
- Enquiries to be submitted prior to the funding application stage
- Responses to enquiries will be made within 14 working days of submission
- All progressed enquiries must undergo the LSHTM CTU Review Process for outline and full applications
Proposal must include a member of LSHTM CTU Management Group as a co-applicant
2. LSHTM CTU REVIEW PROCESS
There are 2 stages to the LSHTM CTU Review Process for all progressed enquiries:
- Outline Stage for LSHTM CTU Provisional Approval
- Full Stage for LSHTM CTU Adoption
Each stage should allow at least 14 working days for review
OUR ASSESSMENT CRITERIA
Clear demonstration from the evidence base (including a formal review of relevant Randomised Controlled Trials) that the research is needed
The trial must address a question that is clinically important (such as areas of crucial evidence gaps, or areas of controversy or high variation in clinical care)
Must be relevant to the population – particular interest in trials of global importance
To ensure trials progress in line with expectations, in particular recruitment and retainment of participants, the research team will be assessed for an appropriate blend of experience and clinical credibility
The assumptions behind the study will 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
The optimal scientific design, with the best and most appropriate analysis, with suitable methods of managing and conducting the trial will be required, along with trial registration and a full commitment to publish the results in peer reviewed journals
LSHTM CTU involvement in a study must be appropriately financed. Staffing and consumable costs will be reviewed to ensure the trial is adequately funded and deliverable in the proposed timelines
Trial should enhance and confirm LSHTM CTU reputation as the world renowned of excellence in delivering high quality, clinically relevant, methodologically excellent Randomised Controlled Trials
The risks and benefits have been considered, awareness that there is a need for high ethical standards in research
Although some trials may be successful on all of the above criteria, if the LSHTM CTU does not have capacity to take on the responsibilities, it will not be adopted
THE COCHRANE INJURIES GROUP
Anti-Fibrinolytics Trialists Collaboration
The Anti-fibrinolytics Trialists Collaboration (ATC) is an international collaboration to conduct individual patient data meta-analyses of results from randomised trials of anti-fibrinolytics versus placebo.
The lead investigators of all completed and ongoing high quality trials of anti-fibrinolytics that involve 500 or more patients are invited to join the collaboration and contribute individual patient data.
The ATC has been set up to address important clinical questions regarding the effects of anti-fibrinolytics that cannot be answered by individual trials or by standard meta-analyses based on aggregate data.
The ATC is co-ordinated from Clinical Trials Unit at the London School of Hygiene & Tropical Medicine