Tick, tock. Tick, tock. Whether it’s on an email or at the research delivery meeting, we’re all more than familiar with the phrases, “How much longer do we have on the clock?”, or “Has the clock started yet?”, and “Pop the data onto EDGE to stop the clock”. But do we all know what the ‘clocks’ are? Do we know why the ‘clocks’ exist?
It’s really important that the NHS undertakes research to move our care, treatments and services forward, ensuring we do our best for our patients and families, understanding best practice and reducing waste. The research itself has also shown to be of benefit to those who take part, giving patients access to innovative treatments or services before they are available on the NHS, as well as close contact with a knowledgeable, dedicated health professional throughout their involvement in the research.
To make sure that the results of the research are meaningful and useful to the NHS, and therefore that the research is ethical, researchers need to set up their studies quickly and recruit a specific number of participants within a set time frame. The reality in the past was that research in the NHS was slow to set up, slow to complete and slow to analyse and publish findings, largely due to complexities with finance and bureaucracy. This meant that researchers often had to identify additional funding and resources to keep the research going or abandon the research altogether.
Speeding up how quickly the results of research are available to clinicians, patients and the public was a priority for the NHS. Over the last 10 years, the Department of Health has invested significantly in the infrastructure to support the ‘doing’ of research in the NHS, reducing some of the ‘red tape’ involved in setting up research and providing staff and resources to ensure that the people enrolled in research were safe and looked after.
To ensure that the investment is continuing to help research to get going and complete to plan, the Department of Health, through its NHS research arm, the National Institute of Health Research (NIHR), has set key targets that NHS organisations have to meet.
Here’s my guide to the key NIHR targets we have to meet at Solent and my tips for getting ahead of the clocks…
1. Study set up
There are several key steps involved in setting up a research study at Solent NHS Trust. These steps run in parallel to ethics and Health Research Authority (HRA) approvals.
The first step is being invited to be involved in the research. We might be asked to be involved by a group of external researchers, a pharmaceutical company, or it might be a ‘home-grown’ study being undertaken by a Solent employee. We can be invited just before or following submission for approval to ethics and the HRA.
At this point, we will be provided with a copy of the study protocol and maybe a Statement of Activities (or the Site Agreement) and Schedule of Events. These documents help us to assess whether the study is suitable for Solent. Working with clinicians, managers, patients and our partners, we look at whether the research would be suitable for our patients, whether it fits with our services, and whether the finances and resources are in place to support it.
The time it takes for us to complete this step is not monitored by the NIHR, however it is still important to try to complete this step as quickly as possible and keep the researchers up-to-date with progress. I recommend using this time well to investigate the feasibility of the study thoroughly to avoid issues with recruitment later.
Once the feasibility assessment is complete, the researchers will officially select Solent as a site and will send through a valid Local Information Pack. The study set up clock starts on the date the email with the pack is sent to us. The NIHR have set a 40 calendar day target for NHS organisations to complete this step. We use this time to arrange for the research to start, putting in place all the pieces of the jigsaw puzzle needed to get the research to work. We also negotiate with the researchers how many people they would like us to enrol into the study while it is open in Solent. My top tip here is to really understand the population that the researchers would like to involve; is the target they are suggesting achievable?
Once everything is in place for the study to start, Solent will be confirmed as a participating organisation by signing off the Statement of Activities. The study set up clock stops on the date the document is signed.
2. Recruiting the first participant
The signing of the Statement of Activities also starts the next clock: time taken to recruit the first participant. The NIHR have set a 30 calendar day target to achieve this. Here’s where the work you have undertaken during the study set-up will really come into fruition. If you’re well prepared, you will know exactly where to find the people the researchers would like to invite to take part in the study. This clock stops on the date the first participant is enrolled on the study.
3. Time taken to reach the agreed target
The final target the NIHR have set is ensuring that NHS organisations enrol the number of people the researchers would like within the time they have said they would. The NIHR call this Time to Target. This clock is important because it has a big impact on whether the research needs an extension, and therefore additional funding and resources, and whether the amount of data collected is powerful enough to provide meaningful results.
It’s important to quickly flag up any problems with finding people to take part so that strategies can be put in place to improve. This might mean the researchers amending their protocol or renegotiating the target for Solent.
Currently, Solent is doing really well with meeting the targets set by the NIHR. We publish the data for some of the research we undertake on this website. But we recognise that trying to keep ahead of the clocks can be more complicated than it sounds. Get in touch with our team to understand how the clocks apply to your project, and for advice on how to move your project forward.