Once the analysis is complete, interpretation of the data should involve the full trial team including all stakeholders. Involving patient and public involvement groups will help ensure a patient perspective in interpretation of the data.
Visit the managing clinical trials page of the NCBI website for further information on clinical trials management. The NIHR expects patients and the public to be actively involved in all stages of the research process from project design to disseminating the findings in any research it funds. Whilst all of us are actual, former or indeed potential users of health and social care services, there is an important distinction to be made between the perspectives of the public and the perspectives of people who have a professional role in health and social care services.
To help you plan and undertake public involvement in your research we suggest you consider the following points:. Guidance for patient and public involvement can be found at the NIHR public involvement briefing notes for researchers. In deciding who best to involve it is important to think about the knowledge and perspective that you are looking for from members of the public, and what support you are able to give to people who you plan to involve.
Even if your research is about informing practitioners about approaches to practice, the end user of the research will be the person receiving the practice. In some research projects you will want to consider involving both practitioners and members of the public.
Once you have considered who you would like to involve, you then need to think about how to make contact with them. Speak with colleagues and members of the public and ask for their views on how to find the people you want to involve. Allow time to make contact with organisations and individuals as finding people will nearly always take longer than you think.
CTUs are specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological and other methodological advice and coordination to undertake successful clinical trials.
In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials. Units awarded UKCRC Registration are required to provide evidence to an international panel of experts of their capability to centrally coordinate multi-centre clinical trials i.
CTUs collaborate with you to play a key role in providing the dedicated expertise and support necessary for the design, development, management, analysis and publication of high quality clinical trials. You are able to search for CTUs that are interested in supporting fellowships and other research training award applications and also search based on the disease area, study type and methodological expertise of the CTU.
If you are interested in working with a CTU, you should contact them as early as possible in the process. Ideally, this should be at least three months before a research grant application deadline although many units prefer longer than this for open calls in order to provide adequate time to schedule the work required and ensure the CTU is able to offer the full benefit of its experience and knowledge from the initial stages of study development.
You will need to provide the CTU with information about your study and your requirements. Some CTUs will have their own collaboration request form. You can view a short video outlining the support a CTU can provide.
Excess treatment costs arise when the new treatment being trialled is more expensive than standard care. The difference between the treatment costs of the new intervention and standard care is classed as the excess treatment costs. Of course the new intervention may be cheaper than standard care in which case a saving in treatment costs to the NHS will be observed.
All NIHR application forms are accompanied by extensive guidance notes which detail what costs can and cannot be included in a particular application. Again this is another area where expert advice must be sought.
The Research Design Service RDS supports research teams to develop and submit high quality applied health and social care grant applications to NIHR and other national peer-reviewed funding programmes.
Please direct all queries academy nihr. Read Time: minutes. Version: 1. Print this document. Introduction Clinical trials, compared to observational studies, are considered by many to be the gold standard method for evaluation of healthcare interventions.
Where do I start? What is generally involved in conducting a clinical trial? How will I know whether or not a clinical trial is appropriate for my research? What would be a realistic timescale for a clinical trial and does this differ at all? How many projects should I become involved in? What pitfalls should I be aware of in general? The following simple checklist may help you decide whether a clinical trial is appropriate for your research: Step 1 — establish whether a relevant systematic review already exists If yes, and this resolves the clinical uncertainty — stop; If yes, and it demonstrates continued uncertainty — continue to design and justify your trial, using information from the systematic review as part of your justification; If yes, but the review is out of date, or of poor quality — consider updating the review; If no — consider doing a systematic review.
Step 2 — establish whether relevant clinical trials exist Are there already clinical trials that address your research question; If no, continue to design and justify your trial If yes, but there is clearly insufficient evidence to answer the clinical question robustly e.
Useful places to search: You can find examples of completed systematic reviews at the Cochrane Library and University of York Centre for Reviews and Dissemination. What aspects of a clinical trial can realistically be included within a Fellowship application to NIHR? Does this change depending on the level of award I apply for? Applicants do need to consider: the type e. UK Clinical trials for medicines: manage your authorisation, report safety issues in respect of CTIMPs Applicants should also ensure it is commensurate with the level of award and experience of the applicant.
How do I move from hypothesis-generating to clinical trials hypothesis-testing under an NIHR funded career pathway? What parts do I need to seek approvals for in my research? Where do I obtain approval from? Is there a pathway I can follow in order to obtain regulatory approval? Where can I find out information on trial governance?
How much monitoring should I be doing? How do I, and can I, publish the protocol for a clinical trial? Further information on approvals and when they will be required can be found by using the Clinical Trials Toolkit Designs, Types and Planning What are the different types of trials? Studies should ideally be registered prospectively before recruitment starts. Register your study Update your record Report your results.
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