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
- 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
- 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 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 email@example.com