Hints and tips for carrying out clinical research in practice
22 May 2024
Are you interested in carrying out your own clinical research in practice but don’t know where to start or how feasible it might be?
During the PetSavers’ Progressive Care stream at this year’s BSAVA Congress, Clare Rusbridge, Professor in Veterinary Neurology at University of Surrey and Senior Neurologist at Wear Referrals, and Karen Humm, Associate Professor in Transfusion Medicine and ECC at the RVC, gave advice on designing a clinical research study, meeting ethical approval and how to avoid common pitfalls in research.
Why do clinical research?
Firstly, why should you do clinical research? As well as satisfying your natural curiosity, it can increase job satisfaction, it gives a sense of personal accomplishment and has been shown to reduce the risk of professional burnout. Research is valuable for career development, as having a research publication puts you above other candidates. It also allows you to critically review other people’s results and develop new strategies.
How to design your study
When designing your study, it starts with a question. This could be related to aetiology (identify and understand the cause of a disease or condition); prevention (identify risk factors for diseases and early screening techniques); a diagnostic test (is there a biomarker that could better diagnose a condition, or could the specificity or sensitivity of an existing test be improved?); therapy (can we improve treatments, consider the associated risks, benefits and costs?); and prognosis (can we give a better prognosis to patients?). The question should be something that interests you and that will be useful to others.
Using the FINER approach
To develop your research question, you can use the FINER approach.
Is the study idea Feasible?
- The research needs to be integrated into your day-to-day practice, otherwise it won’t get completed. If you or your colleagues are collecting data or samples, it needs to be as quick and easy as possible (e.g. print instructions and put them on every consulting room door).
- Consider your sample size and time frame. How many cases of the condition you’re interested in do you see per year and how much of a difference do you expect to see with the treatment you’re investigating? Use a sample size calculator such as ClinCalc to determine the minimum number of animals you will need for study power.
- Who will pay for the study, including the drugs needed, your time and follow-up time for analysis?
- Is it possible to organise randomisation of treatments? This is particularly difficult with ECC cases.
Is it Interesting?
Is it going to be relevant to other practitioners and lead to further studies? Will it be interesting enough to attract funding, if it’s needed?
It is Novel?
A study doesn’t need to be completely novel, but it’s good to approach a problem or question in a slightly different way to what has previously been done. Being novel can also help to secure funding. It should be an area of study that has visible gaps in knowledge, and not be easily answerable by a quick Google search. Doing preliminary research and reading the existing literature will help to develop your question.
Is it Ethical?
All clinical research should be subject to ethics review by the RCVS (RCVS will give ethical approval for veterinary staff working in practice) and most journals will require ethical approval for papers submitted for publication. Completing an Ethics Review Panel research proposal application helps you plan the study and makes you think about potential issues in advance. Informed consent is required from owners.
Check that the procedures or techniques you’ll be using for your study are outside ASPA legislation – these can be thought of as the routine, established procedures undertaken in the course of veterinary surgeons’ or veterinary nurses’ professional duties. Techniques classed as not routine include new surgeries, more invasive delivery (e.g. intrathecal) and new drugs. Defer to the RCVS Routine Veterinary Practice Subcommittee for advice.
An Animal Test Certificate (ATC) is required in the case of a veterinary clinical trial of a veterinary medical product.
Is it Relevant?
Will the study findings affect practice and attract funding?
Creating SMART objectives
As well as using the FINER approach, it’s also useful to create SMART objectives:
Specific (and strategic): be precise about what you want to achieve and identify outcome measures. Focusing early on a specific question means you can avoid a lack of focus and specificity, which are common pitfalls in research. Decide who will carry out the study.
Measurable: how much change would you expect to see as a result of the intervention in your study and how will you measure it?
Achievable: can you answer the question in the time and resources you have available within your practice? Set an achievable goal, such as presenting a Clinical Research Abstract of the results at your society meeting or BSAVA Congress.
Relevant: is the objective of the study actually answering the study question?
Time-bound: can you answer the question given your own time constraints and your case numbers per month or year?
Find a mentor who has experience of clinical research to help you design your study and be realistic about what you’re likely to achieve. There are lots of people out there who are able to help – this could either be practice colleagues or approaching someone you meet at a CPD event. The BSAVA has several resources to help support clinical veterinary research projects, especially in the practice setting (see below).
Further resources on carrying out clinical research
Help for clinical research – BSAVA library collection https://www.bsavalibrary.com/content/help-for-clinical-research
Everything you ever wanted to know about research but were afraid to ask – Congress lecture (2016) https://www.bsavalibrary.com/content/chapter/10.22233/9781910443446.ch73sec37
How to get ethical review if you don’t work at a University – Congress lecture (2016) https://www.bsavalibrary.com/content/chapter/10.22233/9781910443446.ch73sec36
Publishing does not have to be difficult – Congress lecture (2023) https://www.bsavalibrary.com/content/chapter/10.22233/9781913859152.Ch86
PetSavers funding
Practitioners can apply for a Clinical Research Projects grant for small-scale clinical research projects in companion animals, with the ultimate objective of advancing understanding of the causes and/or management of a clinical disorder. Funding is available for up to £20,000 to cover a project lasting 1–3 years. Find out more.