Navigating the innovation roadmap: from discovery to patient impact

In the context of cancer, the word ‘innovation’ can mean a lot of things: a new diagnostic test or treatment, a new technology, or a new method of delivering a service. All innovations start out as an idea – often from a researcher – that is built out into something usable and impactful.

Before they can make a difference for people affected by cancer, these discoveries must make their way along the innovation roadmap. This journey is made up of many activities that can vary depending on the type of innovation and that don’t always happen step-by-step. This can be complicated for people to get their heads around, including innovators and policymakers.

Our new Innovation Roadmap tool helps explain the innovation roadmap. It explains why the process can be difficult to navigate and gives some recommendations to health and research decision makers on how routes to adoption can be streamlined. As an example of how an innovation might move along the roadmap, we also follow a drug called loncastuximab tesirine (Zynlonta) that Cancer Research UK’s innovation wing, Cancer Research Horizons, helped to develop.

But first, why is this roadmap important to cancer patients and Cancer Research UK?

Every new innovation makes its way along the roadmap and could be the thing that transforms someone’s life. We want everyone across the UK affected by or at risk of cancer to have access to the best care and life-changing, proven interventions, without delays. As the evidence grows for more and more exciting innovations like personalised treatments, the bumps in the foundations of the roadmap must be addressed so patients can benefit as soon as possible.

At Cancer Research UK, we have invested £4bn into cancer research over the past decade. We have experience in every aspect of the roadmap – from funding discovery research in our institutions and research centres, to developing spin-outs in our commercial wing, Cancer Research Horizons, to working with health systems, the civil service, and government to help advance patient access to high-quality, evidence-based innovations. By using our expertise to explain the complexities of the innovation roadmap, we want to help government, health, and research sector decision-makers make change that simplifies these processes so more patients can have timely access to transformational new tests and treatments.

What does the roadmap look like?

We can split the roadmap into seven distinct activities.

It all starts with Discovery. Discovery research explores ideas that build our understanding of health and disease. These ideas are explored theoretically or through experimentation and can uncover new opportunities to alter the status quo of healthcare. Cancer Research UK provides grant funding for this research across the UK and has four institutes that bring scientists together to tackle the fundamentals of cancer.

When a promising finding is made at the discovery stage, it can be further explored through Early translation. Here, the idea is assessed to see if it has a potential real-world use. This can include undertaking experiments that produce evidence to demonstrate potential.

Some academics who have sufficiently developed a new discovery may begin the process of spinning out a company, seeking investment, finding lab space, and hiring scientists and other staff to commercialise their work. Others may license their discovery to a larger firm.

Early translation often happens alongside Validation and Development. This is where the idea is refined, evolved and scaled up into an innovation that is ready for market. This also includes intense pre-clinical checks on human tissue and in model systems to remove any risks before the innovation is tested on humans.

To be used in practice, most innovations must be tested on humans through Clinical trials. Clinical trials have a sponsor who is responsible for running and reporting on the trial – this could be a commercial sponsor, like a pharmaceutical company, or a non-commercial sponsor like a health service, university or charity like Cancer Research UK. Patients eligible to take part in a clinical trial are usually identified by their clinician, or sometimes through data-driven recruitment that allows researchers to identify potential participants from a database.

Usually, the evidence collated through clinical trials is then brought for Evidence Review and Approval. The Medical Health Regulatory Agency (MHRA) assesses this evidence for safety, quality, and efficacy and will decide whether to grant ‘market authorisation’ for the innovation to be licensed for sale in the UK. Some innovations must also undergo a Health Technology Assessment (HTA) – an examination of clinical and cost effectiveness. In England, this is the responsibility of the National Institute for Health and Care Excellence (NICE), who also give recommendations for the innovation’s use in the health system.

For a proven innovation to reach patients, innovators must go through Commissioning and Adoption. Decisions about which innovations are commissioned for use happen differently across the UK; some happen locally and some at a national level. Sometimes an innovation is piloted in a small, local setting to build evidence for commissioners by showing how effective the new option is compared to current practice. When innovations are then adopted into a particular setting, there is a process of testing, refinement and evaluation to make sure they are working as effectively as possible.

Once an innovation has proven its use in one setting, it can be rolled out to more locations. This is called Spread. The NHS wants innovators to think about how to make their innovation applicable to a variety of settings so more patients can access new methods of cancer diagnosis and treatment.

Where can there be challenges for innovators?

Each activity that makes up the roadmap has its own challenges. The combination of these makes the whole topic particularly complex and delays patient access to potentially life-changing innovations. Some of the big challenges include: funding discovery and early-stage research, setting up clinical trials and the lack of clear and standardised routes to approval and adoption. We go through these challenges and more in detail in our Innovation Roadmap tool.

Funding discovery and early-stage research

A lot of research happens in universities, and many are facing financial difficulties. On top of this, around 62% of funding for cancer research in the UK comes from the charity sector. This makes cancer research very vulnerable to changes in the external environment, as seen when charity incomes dropped during the COVID-19 pandemic. There is also a gap in funding dedicated to early translational research. This is known as the ‘valley of death’, where researchers have an invention that’s not quite developed enough for others to want to invest.

Setting up clinical trials

Researchers often face unnecessary bureaucratic barriers when setting up clinical trials. These can lead to delayed approvals and bottlenecks.

It can also be difficult to recruit people for clinical trials. This may be because clinicians don’t have enough time to engage with research and find opportunities for their patients to take part, because data-driven recruitment is not widespread yet, or because the patients signing up for clinical trials don’t always reflect the diversity of the general public.

The lack of clear and standardised routes to approval and adoption.

When it comes to regulation and assessments of an innovation’s safety and effectiveness, there are different options open to innovators, some of which vary for different types of innovation. The information about who needs to take part in different regulatory steps is often very unclear, and if an innovator needs to provide evidence for their innovation as part of these activities, it can be difficult to work out what evidence and how much. This is particularly muddy for non-medicine products and technologies – for example, in England, all medicines are required to have HTA approval from NICE, but not all other innovations are.

The steps to get an approved innovation adopted into the health system aren’t much clearer. There is no standardised route for innovators to take their product from approval to commissioning and no single way for providers to find out which options are emerging and available to them. Differences in commissioning approaches across the UK can result in unwarranted variation in the uptake of innovations.

Why does the roadmap matter now? And what do we want to see change?

It’s a really exciting time for change around innovation in the UK. As set out in their health and growth ‘missions’, the UK Government has committed to modernising the NHS by shifting from “analogue to digital” and to driving forward the UK’s excellence in life sciences.

The UK Government has also been asking lots of questions about how they can streamline the development, approval and adoption of innovations through the 10-Year Health Plan, Life Sciences Sector Plan, and National Cancer Plan. At Cancer Research UK, as part of our response to the consultations for each of these plans, we have included insight and recommendations on how the innovation roadmap can be improved to the benefit of people affected by cancer and for cancer research in the UK.

In the Innovation Roadmap tool, for each activity we go through some of our policy recommendations for decision makers in government and the health and research sectors. These consider where positive changes can be made to alleviate some of the barriers innovators face, make the UK’s life sciences sector more attractive for researchers and investors, and speed up patient access to high-quality, proven innovations.

These recommendations include calls for:

The UK Government to work with industry, research funders and research charities to set out a plan to create a more resilient funding environment for cancer research.
The UK Government to deliver and sustainably fund the announced Health Data Research Service
UK health systems to develop a faster and less bureaucratic process for non-commercial trials, including mandating a single negotiation and sign-off process for costing and contracting trials within the NHS
DHSC, MHRA, NICE, and devolved equivalents, to clearly define routes to adoption from pre-market authorisation to commissioning for emerging innovations, including AI applications, digital technologies and diagnostic tests.
DHSC to routinely conduct targeted horizon scanning to identify the most impactful cancer interventions that must be prioritised for national roll-out, working closely with national and local delivery teams for screening and cancer care, Cancer Alliances, Health Innovation Networks, clinicians, researchers and Cancer Research UK.

The Innovation Roadmap can be found here

Read more of our policy work on innovation and supporting science: