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Expert opinion

Five reasons why medical research can be a long process

In this blog, we answer your questions about the medical research pipeline and why developing new treatments takes time.
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Josie Clarkson 6 February 2024

A photo of a researcher standing beside a microscope showing an image on a monitor beside it on a lab bench.

We all want a cure for type 1 diabetes as soon as possible, but we need to make sure any new treatments are safe and reliable. So, the journey from scientific discovery to a new medical treatment, known as the research pipeline, involves a complex and time-consuming process.

We’ve received a lot of questions on social media about why research can be a slow process, so we hope this blog helps explain some of the challenges that our researchers navigate to bring us new treatments for type 1.

1. Our bodies are complicated systems

Medical conditions, such as type 1 diabetes, are incredibly complex. As people with type 1 know all too well, so many things influence the working relationship between insulin and glucose, from your stress levels to the weather outside.

Type 1 diabetes primarily involves the insulin-producing beta cells and the immune cells that attack them. But these cells don’t exist in isolation. We have roughly 20,500 genes for around 400 different types of cells totalling 17 trillion cells in children and up to 37 trillion in adults. Our cells and the chemicals they release have intricate interactions and relationships with each other. So, our researchers have so much more than just the beta cells to consider when trying to replace, regrow or protect them.

Due to this complicated biology, researchers often face unexpected challenges and setbacks that require revisiting and refining their ideas and approaches or sometimes starting from scratch.

2. Rigorous testing and validation: the research pipeline

Before doctors can give new treatments for type 1, researchers need to thoroughly test them to make sure they are safe and effective. This extensive development and testing process is called the research pipeline and involves distinct phases.

A diagram of the research pipeline.

A diagram of the research pipeline.

The drug discovery stage is when the exploratory lab work takes place, with researchers investigating new ways to prevent, treat and cure conditions like type 1. Promising ideas move forward to preclinical trials, in which researchers test new therapies using cells in petri dishes and lab animals. Treatments that prove safe and effective in animals progress to clinical trials in humans.

New treatments must undergo three phases of clinical trials. Phase I trials involve a small number of people to check the treatment isn’t toxic for humans and to find the best dose. Following this, the trial moves to phase II, recruiting more people to investigate side effects and whether the treatment works. Then, in phase III even more participants are involved to compare the new treatment to an existing therapy or a placebo. A trial can fail and be terminated at any of these three stages.

Each stage of the research pipeline involves time-consuming processes, including planning experimental methods, applying for ethical approval and writing and reviewing scientific papers, and getting those papers published in journals. Many individual research projects occur within every stage to repeat the experiments to ensure results are reproducible and to tweak methods to improve the outcomes. Only five in 10,000 prospective drugs reach clinical trials, and just one progresses all the way to securing regulatory approval.

3. Securing regulatory approval

Evidence gathered from research studies is used to apply for approval for new technologies and treatments from government regulatory bodies. Each country has their own organisation that carefully evaluates the data to ensure that the benefits outweigh any risks before granting licences for new medicines. In the UK, we have the Medicines and Healthcare products Regulatory Agency (MHRA). This step is crucial for patient safety but can add a significant amount of time to the overall process. For example, the MHRA can request more evidence of a treatment’s safety and effectiveness, so researchers must run more clinical trials.

4. From approval to prescription

Even once the MHRA approves a treatment, this approval doesn’t mean it becomes automatically available for patients. The next stage to get medications and technology into the hands of people who need them is an agreement between the manufacturers, government bodies and healthcare providers.

For example, the first hybrid closed loop (HCL) system was licensed in 2020. In the UK, this HCL technology was approved by the National Institute for Health and Care Excellence (NICE) for most people with type 1 in 2024. The approval process involved extended negotiations between five medical technology companies, the NHS, healthcare professionals and patient advocacy groups including JDRF to agree who can receive the funding. These consultations are sometimes lengthy to ensure that treatments are provided to the people who need them most.

5. Funding challenges

Medical research is a hugely expensive endeavor, and it is extremely important that the available money is used wisely. Therefore, researchers often face lengthy review processes to secure funding for their projects. Competition for grants, limited resources, and the need for long-term financial support can all slow down the progress of research.

That’s why our supporters are so vital, and we are so grateful to you all for helping us boost the pace of research by funding so many incredible type 1 diabetes research projects. Without your donations, we wouldn’t be able to fund our pioneering research, and we’d be a lot further from a cure than we are now.

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