Thinking about your research idea
Assessment of the risks and benefits of a new treatment/intervention needs to be based on reliable evidence. The most reliable evidence is best obtained by carrying out randomised controlled trials (RCTs) to compare outcomes of similar groups of participants who receive either the new intervention or the current standard intervention or, if there is no current standard, a placebo (or no active treatment).
A randomised control trial (RCT) is the best research method to determine whether there is a link between an intervention and an outcome. To look at the safety and effectiveness of an intervention, the evidence a RCT will provide, is the way to go. The most important thing an RCT will do, is reduce bias when testing the effectiveness of a new treatment. Participants will be randomly allocated in a group, either an intervention/experimental group where they will receive what is being assessed or a control group where they will get no intervention (or a placebo). A comparison will then be made between the two groups. Along with testing the effectiveness of a medical intervention, a RCT can also provide information, such as the effects a drug can have.
When designing an RCT you need to consider your research question. PICO is a focused clinical research question that consists of the following concepts;
P - population, patient, problem. Who are the patients you want to investigate?
I - intervention or exposure. What will be provided to the population?, e.g. surgery or services
C - the comparison or control. What can we compare the intervention with?
O - the outcome. What do you want to change or measure?
The trial protocol is the document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and integrity of the data collected.
Come and talk to us about your trial idea and we can work with you on protocol design to make your trial work for you.
“The HRA was established in 2011 with the strategic goal of making the UK a global leader in health research. In order to do this the HRA has various work-themes which cover streamlining research, transparency in research, patient and public engagement in research and working with the devolved nations. In practical terms, the HRA leads on a number of key projects which have an impact on clinical trial delivery, for example, implementation of HRA approval which aligns the Research Ethics Committee (REC) approvals’ process with NHS R&D approvals to reduce duplication and create a single ‘HRA assessment’ and hosting the integrated research application system (IRAS). HRA is also responsible for issuing guidance for research in England, taking over from the Research Governance Framework (RGF). The HRA regularly issues consultations and calls for good practice or evidence in relation to clinical trial conduct and past consultations have included protocol guidance and a template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP), model Non-Commercial Agreement (mNCA) revisions and seeking informed consent for simple and efficient trials in the NHS.”
UKTMN, 2018. The Guide to Efficient Trial Management. Sixth Edition: 2018 © UKTMN www.tmn.ac.uk
The HRA (Health Research Authority) website provides up to date information on at: www.hra.nhs.uk
Keele CTU have a strong track record of successful regulatory approvals. At the NHS Research & Development Forum in 2017, our presentation to explain our approach to this was awarded a prize!
In the past we've conducted research studies and then thought about implementation afterwards, waiting for the scientific papers to be in the public domain. Consideration of real-world implementation is now very much at the forefront. Increasingly we're getting requests from researchers (and funders) to design the foundations for future implementation (pathways to impact) in new studies and as research is active and ongoing, rather than delivering a standard academic dissemination plan at the end. It’s about looking for the learning within your research study that will signal how your innovation moves beyond the research and becomes sustainable.
Our Impact Accelerator Unit (IAU) in the School of Primary, Community and Social Care, Keele University, has a leading role in closing the evidence-to-practice gap by accelerating the uptake and impact of best evidence through implementation of the best health research. We have four main priorities: stakeholder engagement, implementation activities, applied health research, and impact. See this fun brief clip to illustrate the role of the IAU:
Our overarching objective is to have a positive and sustained impact by supporting the timely movement of our research into practice. We do this by providing influence and support throughout the entire research cycle using knowledge mobilisation theory and practice. We encourage researchers to think of not just the value and feasibility of their research to healthcare but the feasibility of implementing this research into practice, to support the timely translation of evidence into healthcare treatment. We also maintain an active portfolio of implementation projects with international reach and significance.
The PROMPPT trial here at Keele is a study of people using opioids for long-term pain, which is currently in design. Find out more information here.