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Strict regulations needed to address commercial health self-test concerns

Written by Louise Stanley on . Posted in Uncategorized.

Far greater regulation is needed for off-the-shelf health tests, due to considerable concerns over both suitability of the tests for the public, and accuracy of claims made on-package.

In a series of papers published by The BMJ, researchers from BHP founder-member the University of Birmingham funded by the NIHR Birmingham Biomedical Research Centre reviewed a range of commercially-available health tests bought in shops. The work was carried out due to concerns that directions for use, usability of equipment, and incorrect interpretation of results could cause harm.

Thirty self-test kits were purchased from major supermarkets, pharmacies and health and wellbeing shops, including tests for vitamin deficiency, blood cholesterol, menopause and bowel cancer. Accuracy claims were made for 24 of the tests, and most (14/24; 58%) claimed a performance of at least 98% accuracy, sensitivity or specificity. However, evidence supporting these accuracy claims was largely unavailable or didn’t provide sufficient information for the likely end users of such tests.

Where information about the methods used to estimate test accuracy was available in instruction leaflets (17/30 tests), the accuracy of five tests (5/17; 29%) was evaluated against a similar test rather than a more reliable and accurate test. In addition, the descriptions of participants involved in these studies was mostly lacking, preventing an assessment of the relevance of accuracy estimates to the general public.

The study also highlights issues with the usability and safety of tests, with 18 self-tests being identified as having potential to give an erroneous result or action. The team also identified:

  • 11 tests with problems in the equipment
  • 10 with problems in the sampling process
  • 15 with problems in the instructions or the interpretation of the results

Researchers involved in the study are now calling for better regulation and guidance for manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.

Professor Jon Deeks at the University of Birmingham and corresponding author of the study said: “A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.

“Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves. In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.

“Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”

Dr Clare Davenport, Clinical Associate Professor at the University of Birmingham and co-author of the study said: “The wide range of off-the-shelf tests now available to the public are not endorsed by the NHS and evidence for their benefit is lacking. This is in contrast to well-established self-tests, such as pregnancy tests.

“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.”

New medicines or interventions must undergo a stringent regulatory process, including clinical trials and registration with the MHRA. In contrast, medical self-test devices are subject to less stringent checks by Notified Bodies, and this has allowed certain self-tests to be sold in the UK, despite them raising concerns.

New regulatory standards should ensure better reporting of studies of self-tests to support transparency of test claims, according to the research team. The researchers also assert that more emphasis should be placed on ensuring the clinical studies of self-tests are conducted appropriately. In particular, self-tests should not only be tested in laboratories, but they should also be evaluated by the people and for the purposes for which they are intended to be used.

Dr Clare Davenport said: “The same consideration given to pharmaceuticals should be given to self-testing where some, such as pregnancy tests, could be sold over the counter and others that carry greater risk of misuse are sold only with the support of a pharmacist. These latest studies have also shown that information and data that support claims of accuracy, specificity or sensitivity needs to be available to the public.”

Professor Jon Deeks said: “Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers. Several of the self-test manufacturers refused to provide us with reports of their studies, which support their claims, stating that they were “commercially confidential”. Legally, they do not need to share this information. However, for all matters of our health, it really is important that the evidence upon which health decisions are made is available and can be scrutinised.”

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BHP People – “the ultimate goal is to make research more accessible”

Written by Louise Stanley on . Posted in BHP People, Birmingham Health Partners, Uncategorized.

Pardeep Janjua, Research Data and Systems Officer at Sandwell and West Birmingham Hospitals, is the Trust’s first recipient of the BHP People recognition award.

We spoke to Pardeep about transitioning from pharmacy to data management, and the challenges and opportunities of scaling his work from SWB across the region more widely.

Q: Can you briefly run us through your career so far and how you came to work at SWB?

PJ: I began my career in clinical trials back in 2012, when I moved from main pharmacy into clinical trials pharmacy. At first, I wasn’t quite sure – clinical trials is a niche field – but after speaking with the team, I really liked the idea of being at the forefront of new medical treatments and I’ve never really looked back. The role provided a fantastic environment to build strong governance skills and develop a solid understanding of clinical trials, especially CTIMPs. Over the years, we started thinking about how to better monitor our performance and evolve our working practices. That led to the development of KPI monitoring and reporting tools, and eventually, Power BI dashboards.

From there, things really took off. During COVID, as many trials stopped, we took the opportunity to review our processes and developed innovative ways of reporting finance, which we showcased regionally and nationally. The natural next step for me was to expand that work beyond pharmacy and I briefly moved to Clinical Trials Facilitator, managing study set up.

However, my passion remained in systems and data to drive improvement. An opportunity came up to join SWB as the Research Systems and Data Officer, and it felt like a perfect fit – the role has given me the freedom to continue innovating, building real-time, practical tools to monitor and manage research activity. Ultimately, the aim is to help deliver research more effectively and efficiently, providing more opportunities for patients to access cutting-edge treatments and therapies.

Q: In your current role, what are some of the tasks and duties you’re involved in most frequently?

PJ: My core focus is on developing and maintaining data systems that support clinical research delivery. Building Power BI dashboards, working with data from EDGE, and transforming raw data into meaningful, real-time insights. These dashboards support a wide range of functions: monitoring study set-up; amendment workflows; tracking recruitment; governance; and research finance. Working with all teams engaged in research helps to ensure the data reflects their real-world processes and supports evidence-based decision making.

I am also currently leading a Black Country-wide initiative to scale our reporting platform across all local Trusts. I engage and support different teams across the patch – delivering training, understanding their unique working practices, and helping them embed use of the interactive reports they require. I’m also developing a shared governance framework for research data and reporting. Over the past eight months, we’ve made significant progress, developing a range of reports and working closely with stakeholders to create new processes, working instructions, and reporting methods where none previously existed. Much of this effort involves starting from scratch, which makes it a substantial undertaking.

The idea is that by sharing core elements across trusts, we can expand beyond the project’s initial scope to share best practice and continually evolve how we work. I’ve recently been asked to contribute to the national RDN working group on this.

Everything I do, whether locally at Sandwell or across the region, is geared toward building more efficient, transparent, and responsive systems improving how we deliver research. The ultimate goal is to make research more effective and accessible, offering more opportunities for patients to participate. This not only enhances patient care but also facilitates access to cutting-edge medical technologies, advancements, and treatments through research.

Q: Have you experienced any particular challenges in your role, and how have you overcome them?

PJ: One of the key challenges I’ve faced has been trying to implement new process and embed new systems approach. Whenever you’re introducing or integrating something new, it’s often difficult to showcase the benefits clearly.

Working across the wider region adds another layer of complexity as each Trust and site has its own nuances. The difficult part has been identifying how we develop a shared understanding of each process, how we can standardise core elements, and then how we embed that into working practice. I think we’ve made great strides – we’ve collaboratively identified where there are similarities in how we work and in key areas like finance, we’ve managed to create one shared core process.

Finally, ensuring our datasets are complete and accurate remains vital. We monitor data quality closely with a dedicated report and empower teams to manage their own data queries in real time, which helps spread workload and prevents data issues from building up.

Overall, data management in research is challenging, but through clear communication, collaboration, governance, and technical rigor, we are making meaningful progress, which is very rewarding.

Q: Collaboration seems central to your approach – how have you worked with clinicians, researchers and other colleagues to ensure your datasets and reports meet their needs?

PJ: Collaboration is key to all of the work we’ve done. We work closely with a wide range of stakeholders including clinicians, researchers, governance teams, delivery teams, support services, to develop systems and processes that enable them to carry out their usual working practices without adding extra burdens. The aim is to embed data collection naturally into their workflow so they don’t have to do additional data entry, while still providing relevant reports that deliver the insights they need in a format relevant to them.

Much of this work is done through close one-to-one collaboration – preferably in person because that’s how I truly understand what teams want and need. Regionally, across the Black Country, I engage regularly with governance facilitators, lead nurses, heads of research, finance teams, IT, BI teams, and information governance. For example, some reports have necessitated the need for submission of Data Protection Impact Assessments (DPIAs), so I ensure that all necessary teams are involved to support the longevity and smooth implementation of our project work. Embedding these processes at the trust level alongside other core services is crucial.

Take the finance teams, for example: we have worked closely with them on implementing a finance tool, uploading costing templates, recording finance data, and reporting it. The process is iterative, we develop the process, collect the data, produce the report, then refine it until it meets their needs.

I also attend specialty lead meetings when possible, providing report demos and updates, sharing the vision, and offering open access to certain principal investigators. Their feedback is invaluable and helps evolve the reports to deliver quicker and more relevant insights.

Without input from all stakeholders, the process simply couldn’t continue. Everyone plays a vital role in making the reports more relevant and ensuring we gain the insights needed for better evidence-based decisions.

Q: What advice would you give to someone weighing up their career options within clinical research?

PJ: For anyone looking to get into clinical research, I’d say it’s an amazing and exciting field. You’re truly at the cutting edge of medical technologies and treatments, contributing to innovations that can make a real difference in patient care.

That said, it’s also hard work. There’s a lot of vital work happening behind the scenes, teams working tirelessly to maintain studies, manage workloads, and keep everything running smoothly. But despite the challenges, it’s incredibly rewarding to be part of a culture and a team that’s driving advancements in healthcare.

Ultimately, the goal is to improve the experience and outcomes for patients across our trusts. Being able to contribute to that mission and see the tangible impact of your work is what makes clinical research so fulfilling.

Back to BHP People

The BHP Starter Fellowship – Anna’s story

Written by Louise Stanley on . Posted in Uncategorized.

Anna Price

Dr Anna Price, ST3 in Renal Medicine at the Queen Elizabeth Hospital Birmingham, undertook a Birmingham Health Partners Starter Fellowship in 2015-2016 and is currently undertaking a PhD at University of Birmingham. We spoke to Anna about her thoughts on her fellowship experience.

What attracted you to the BHP Starter Fellowship?

During my undergraduate intercalation I became involved in cardio renal research. I thoroughly enjoyed it and knew from that point on I wanted to do a PhD. After completing an Academic Foundation Programme I was unsuccessful obtaining an Academic Clinical Fellowship. In Core Medical Training the clinical workload was naturally busy and the MRCP and medical curriculum became all consuming. Research projects became squeezed into early mornings and late nights. I was fortunate enough to meet my current supervisor in my cardiology rotation and we made an application to the British Heart Foundation but unfortunately this was unsuccessful.

I applied for speciality training in Renal Medicine but felt like the opportunities to do research were dwindling away. I became resigned to a career without research when the BHP fellowship flyer was emailed to me. The fellowship was a unique opportunity to gain independent funding to complete a PhD on a topic of my choosing. It gave me the break I had been waiting for.

What were the benefits of the Fellowship?

The BHP fellowship gave me dedicated time to make several funding applications and successfully fund my study consumables and time out of programme for three years. Within my BHP fellowship year I was awarded three grants including a personal British Heart Foundation Clinical Training Fellowship totalling £249,000. I have had the time to set up my study protocol, gain ethical approval, buy equipment and learn the skills required to hit the ground running.

Were there any challenges during the fellowship?

This was my golden opportunity to achieve ongoing funding so there was some pressure, this was the biggest hurdle. Most of my colleagues already had funding and were well on their way with a project. It can be frustrating at times waiting for news on grant applications!

How much clinical work did you do while undertaking the fellowship?

During the fellowship I took up half a slot on the on call Renal registrar rota at the Queen Elizabeth Hospital Birmingham. All of my on call commitments are outside of normal working hours i.e. lates, nights and weekends so they don’t interfere with patient recruitment. It does allow me to keep up my clinical skills and in the long run I know it will be much less daunting when I return to training.

Did the fellowship help with your clinical practice?

The fellowship has taught me perseverance and persistence. My confidence has grown and I have more self-belief that I can work through challenges and find my own solutions. I approach research papers in a completely different way now. I am more critical of the methodology used and I don’t take findings at face value.

Do you feel the fellowship has helped with your career development and aspirations?

It has reaffirmed my desire to have a career in Academic Medicine. Completing a PhD is the first step in achieving that goal. Being involved in an established research group has given me experience in clinical trials and multi-centre studies. I have been lucky enough to work with some of the best academics in their field. I have really enjoyed aspects of research that I didn’t think I would such as statistics. I have also been able to explore sub specialities such as hypertension which I hadn’t considered before.

What advice would you give to a prospective applicant?

  1. Identify a supervisor who shares your academic interests and will support you during your research. Someone you can develop a good rapport with is important as you will be working with them closely for a number of years.
  2. Review potential funders early and be aware of grant deadlines (there may only be one application cycle per year).
  3. Develop your project proposal as much as you can. Use existing funding application forms to guide you.