On the ISRCTN registry, the term intervention refers to the treatment or action tested or observed in the study, which not only includes drugs, medical devices and vaccines but also supplements, surgical procedures and behavioral interventions. The registry accepts all types of interventions provided that the study evaluates biomedical or health-related outcomes in human participants. Studies can be interventional, like randomized controlled trials (RCTs), or observational, like cohort studies.

New interventions are being developed and tested in clinical trials all the time. In this blog post we look at some of the trends in interventions we have observed in the studies we have registered in 2024 that hold promise for 2025.

AI

It should come as no surprise that clinical studies using artificial intelligence (AI) have increased dramatically in recent years. Although the first reference to AI in an ISRCTN study record dates back to the Healthy Mind study of a stress management tool registered in 2014, there has been a significant increase in the number of studies referencing AI since then, with registrations leaping from single digits in 2016 to 2019 to an average of 22 per year from 2020 to 2024, predating the current trends in generative AI such as ChatGPT.

AI, particularly machine learning, is set to revolutionize cancer research and clinical care by speeding up research, improving diagnostics, and enabling personalized treatment plans. In the last year alone, there are studies aiming to improve the diagnosis of lung cancer from chest X-rays, sarcoma from pathology slides, and rectal cancer from MRI scans, sometimes by learning from existing medical scans and sometimes by improving the acquisition of new images. There have been promising results, for example as recently reported for breast cancer screening.

There are also studies of AI methods for assessing the risk of osteoporosis, coronary heart disease and sepsis, detecting newborn hip dysplasia on ultrasound scans, finding broken bones on x-rays,  triaging patients in general practice, monitoring patients after surgery, and improving antibiotic prescriptions.

Psychedelic medicines

While not on the same level as AI, studies of psychedelic medicines have also seen an unusual increase in recent years, reaching an all-time high of seven studies in 2024 from a previous average of two per year. These include early Phase I studies in healthy volunteers of psilocybin (‘magic mushrooms’) and N, N-dimethyltryptamine (DMT; ayahuasca), as well as studies examining their possible applications for generalized anxiety disorder, major depressive disorder and hazardous and harmful alcohol drinking.

Genetic interventions

Studies on genetic interventions are crucial in 2025, supported by the UK and devolved governments' efforts to include genomics in the NHS. Genomic medicine changes a person's DNA to customize their medical treatment, which could help treat genetic disorders, cancer, and viral infections. "Our Future Health", the UK's biggest health research program, wants to sign up 5 million volunteers to gather health data. Collecting this information will support research and get more people involved in studies, making genomic research more effective.

Gene therapy is a treatment option for diseases that don't have many other options, such as Duchenne muscular dystrophy (DMD). DMD is a serious muscle disease that mostly affects boys. It's caused by changes in a gene that makes a protein needed for muscles to work properly. This study recruited patients in England to investigate a new treatment for DMD which tries to fix the problem by adding a working copy of the dystrophin gene into muscle cells. The therapy is for people with a specific type of DMD. It aims to help the body make a shorter but still useful version of the dystrophin protein. Early results in boys with DMD look promising with program expansion expected in 2025.

Other studies are using genetic screening (The Generation Study) of the entire genetic sequence of newborn babies to find and treat rare conditions sooner. Every year in England, about 3,000 babies are born with treatable genetic conditions. The NHS tests for nine of these at birth, but there are many more that could be treated if found early. Gene editing is being used to test how safe and effective a new gene-editing drug is for treating a rare genetic condition in newborns called OTC Deficiency, which causes harmful ammonia buildup in the blood. The CHOICES study is part of a project to help people with cystic fibrosis (CF) who have very rare genetic mutations. These people can't use the usual CF drugs. The study uses tiny lab-grown intestines made from the patient's own tissue to test new drug combinations. These drugs aim to fix the problem in CF by working together to improve the function of a protein called CFTR. The goal is to see if these new drugs can help people with rare CF mutations.

Genetic treatments will be important in 2025, thanks to new technology and support from the UK government to include genomics in healthcare. This could really change how we treat genetic conditions and help a lot of people.

The microbiome leads the way

Microbiome testing is really important in healthcare interventions right now because it shows how bacteria can affect things like weight, mental health, and diseases. ISRCTN holds 28 studies registered in 2024 using microbiome analysis to figure out what kinds of tiny organisms live in a certain place and what they do. This analysis helps doctors create better treatments and prevention programs by understanding how these tiny organisms impact our health.

One example is using oral microbiome analysis to see how a program to keep teeth and gums healthy can help pregnant women with gum disease and their babies. Gum disease is common in pregnant women and can cause problems like high blood pressure, early birth, and low birth weight. During pregnancy, changes in the mouth can make gum disease worse, affecting both the mum and the baby. The study aims to improve oral health, reduce the spread of bad bacteria, and lower the risks related to pregnancy.

Another example is the TAKeOFF – Microbiome – GH study, which looks at a disease called filarial lymphedema. People with this disease get painful attacks with fever and swollen limbs caused by tiny worms from mosquito bites. The study uses advanced technology to analyze bacteria and other germs involved in these attacks by testing blood and skin samples.

Other studies are looking at the scalp microbiome comparing anti-dandruff shampoos, and how taking a dietary supplement affects the oral microbiome in older people.

Microbiome analysis can be used to inform microbiome-based interventions for serious diseases. In 2024, two important studies are looking at how to help people with serious gut problems. The first study is about using healthy people's poo to treat Crohn's disease. This is a way to help balance the bacteria in the gut and control the disease. The second study is about changing what people with ulcerative colitis eat. By cutting out certain foods, researchers want to see if they can improve symptoms and change the gut bacteria to make people feel better.

So, microbiome testing is super important because it helps doctors understand how tiny organisms affect our health. By studying these organisms, doctors can create better treatments and prevention programs. This research is helping pregnant women with gum disease, people with filarial lymphedema, and those with serious gut problems like Crohn's disease and ulcerative colitis. These studies are really important because they could lead to new ways to treat these tough diseases and help people live healthier lives.

Conclusion

 To further explore emerging trends on ISRCTN, read this blog’s companion piece, ‘Evolving Trends – Conditions to Watch’ which highlights the conditions we’ve seen more of over the past year.