Clinical trials serve as the mechanism that translates research into standards of care.

However, even though the number of trials has increased exponentially in the past few decades, fewer than 4% of cancer patients worldwide enrol in clinical trials. Higher enrolment in clinical trials has been shown to produce advances in treatment of cancer populations at a faster rate. Furthermore, patients who participate in research are more likely to report positive patient experiences.

Matching patients to trials is a lengthy and complicated process that varies among hospitals and clinicians. With Navify Clinical Trial Match app on the Navify platform, we give clinicians a tool that allows a faster, more standardised and personalised search for trials.

During a tumour board meeting or in preparation for it, multidisciplinary team members can initiate a search with the Navify Clinical Trial Match app based on an individual patient’s data. The app is sponsor-agnostic, integrated with Navify Tumor Board and returns current clinical trials – typically within seconds – from ClinicalTrials.gov, European Medicine Agency, other international trial registries and private institutions; results can be filtered by location.

Using non-identifiable information, patients are matched with trials for which they meet inclusion requirements and have no exclusion conflicts, and local trials are ranked high to encourage enrolment.

The app, therefore, may help raise awareness of relevant clinical trials with the potential to increase participation. By integrating clinical trial match functionality into Navify Tumor Board, clinicians are armed with additional options for patients and time is saved for oncology care teams.

First, it is important for healthcare providers and patients alike that they get unbiased results. Therefore, the Navify Clinical Trial Match app provides sponsor-agnostic search results. Second, often there may be no suitable trials for a particular patient within the institution or close vicinity. To provide global coverage, Clinical Trial Match queries 11 worldwide registries for clinical trials. Third, to optimise the matching given the complexity of trial inclusion and exclusion criteria, the Navify Clinical Trial Match app uses parameters such as age, gender, biomarkers, tumour type, location and stage. Last but not least, to address the increasing number of umbrella and basket trials, the Navify Clinical Trial Match app can search trial databases based on genomic alterations, where applicable.

The Navify Clinical Trial Match is one of the first two clinical decision support apps launched as part of the Navify Decision Support portfolio, a cloud-based platform that hosts workflow products and applications. Further apps from Roche, partners and third parties are to follow and add to the Navify apps eco-system. Currently we offer digital solutions for the oncology space.

The plan is to add workflow products and clinical decision support apps for other clinical fields. A sufficient number of trial registries could be the foundation for a clinical trial matching tool in that respective field.

The content of the Navify Clinical Trial Match apps is provided by MolecularMatch, a clinical informatics company with expertise in precision oncology, immunotherapy and bioinformatics combined with clinical insights. The app leverages MolecularMatch’s KnowledgeBase platform and search engine to globally search clinical trial registries — ClinicalTrials.gov [US], EUCTR [European Union], ANZCTR [Australia] and DRKS [Germany], to name a few.

The solution’s natural language processing [NLP] function recognises 36 million search terms from structured, semi-structured and unstructured clinical data and matches it with unstructured and structured data from thousands of clinical trials in more than 100 countries.

We have involved external clinical collaboration partners throughout the design and development of all of our products, including our apps. It is important to note that key aspects of the user experience – the search and return of results all take place within the Navify Tumor Board, creating an efficient user experience.

Dealing with digital data in healthcare always prompts four questions. How structured is the data? Do you have an unambiguous data model? What’s the quality of the data? How is data secured and kept private?

To address these questions, we partnered with MolecularMatch. MolecularMatch curates and validates clinical trial data and applies machine learning and NLP to improve the matching results. MolecularMatch’s curation process occurs more frequently than the registries on their own. No personally identifiable information is used to match patients to potential clinical trials.

Matching the right patient with the right trial is becoming more and more complex.

Patients trust their healthcare providers to get the most up-to-date information on available therapy options, including clinical trials.

Digital solutions like Navify Tumor Board and Navify Clinical Trial Match are designed to improve transparency to all possible treatment options to personalise treatment to the patient. Having said that, this is a multi-faceted topic. There will always be trials that have difficulty recruiting patients for other reasons.

Artificial intelligence encompasses NLP and machine learning. Navify Clinical Trial Match is on the leading edge of data interpretation and text mining. But we anticipate the growing sophistication of these tools will inform clinical trial development, ensuring not only higher enrolments but refining the objectives of trials so they collect the right information from the right patients at the right time to drive personalised healthcare and improved patient outcomes in an era of value-based care.

Despite being one of the most prevalent diseases in the world, diabetes, and particularly type 2 diabetes, remains a challenge for drug developers, and has pushed them to become increasingly innovative in creating therapies for the condition.

One therapeutic approach being studied and trialled by the pharma industry involves taking advantage of the mechanism of action of incretins glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1).

Despite success for some patients with GLP-1 receptor agonists, the industry is beginning to investigate if combining the two incretins into one medication can better treat type 2 diabetes.

Eli Lilly recently demonstrated superior clinical benefit from its combination of the two incretins compared to both placebo and GLP-1 receptor agonists.

According to data from the International Diabetes Federation, globally 425 million people had diabetes in 2017, which represents 8.8% of the world’s population, and type 2 diabetes accounts for 90% of all cases.

Although the condition is massively prevalent on a global scale, prompting no small investment in drug development, there are many aspects of type 2 diabetes that remain a challenge to pharmaceutical companies.

There are some issues with sustaining glycaemic control. GlobalData managing healthcare analyst Dr Jesus Cuaron says: “All currently available treatments for type 2 diabetes are initially effective and reduce complication rates, but they lack the ability to maintain glycaemic control in the long term because of the progressive nature of pancreatic β-cell dysfunction. None of these agents has been shown to alter the natural history of the disease.”

He says there is a need for “treatments that bring sustained improvement in glycaemic control, with a focus on decreasing insulin resistance and preserving β-cell function”.

This challenge is not helped by suboptimal adherence to therapies, linked to the cost of drugs and the fact they are usually injectable rather than oral.

Diabetes UK research communications officer Dr Faye Riley also notes the importance of the industry using research to “better understand the underlying biology of type 2 diabetes”.

She adds: “It’s also vital that new drugs for type 2 diabetes do more than just lower blood glucose levels if they are to genuinely improve the lives of people living with the condition.

“They should, for example, take into account ease of use for people living with type 2 diabetes, how they affect people’s weight management and carry low risk of hypoglycaemia.”

GLP-1 receptor agonists such as Eli Lilly’s Trulicity and AstraZeneca’s Byetta represent a common treatment option for type 2 diabetes.

This treatment approach has a long history. In the early 20^th century, researchers discovered gut hormones called incretins, which work by stimulating insulin secretion in a glucose-dependent manner from pancreatic ß cells; type 2 diabetics do not produce sufficient amounts of them.

The first incretin to be discovered was GIP and attempts were made to correct the low quantity in diabetics by providing them with naturally occurring doses of the hormone.

However, this approach failed to increase insulin secretion in patients, primarily because the hormone is rapidly metabolised by endoprotease dipeptidyl peptidase IV, and led to the search for a second incretin and the discovery of GLP-1, which acts more directly on islets in the ß cells.

At this point scientists began to develop analogue versions of the incretins, in which one amino acid was different. For GLP-1 receptor agonists, analogues are primarily superior to pure forms because they do not need to be administered through subcutaneous infusion.

Over time GIP has lost most of its insulinotropic effect in type 2 diabetes patients, but GLP-1 receptor agonists remain effective at stimulating insulin secretion.

Cuaron notes that combination therapies within one drug class have become popular in the type 2 diabetes field, which has led to investigation into whether a combined GIP and GLP-1 treatment could improve on the clinical benefits of GLP-1 receptor agonists.

Eli Lilly has been developing a dual GIP and GLP-1 receptor agonist called LY3298176 and, at the European Association for the Study of Diabetes’ 54^th annual meeting, the company announced improvement across different endpoints in a Phase II trial compared to its GLP-1 receptor agonist Trulicity and placebo.

The trial specifically recruited patients whose type 2 diabetes was inadequately controlled by diet or stable treatment with metaformin.

National Research Institute president and principal investigator Juan P. Frias said: "The next wave of innovation in the study of incretins for treating type 2 diabetes is fascinating. We're taking the already proven benefits of GLP-1 receptor agonists and looking at a new molecule that integrates GIP action to see what additional benefits are possible."

At six months, primary analysis using statistical approaches showed an average reduction in Haemoglobin A1c (HbA1c) levels, a measure of glycaemic control, of 2.4% and an average weight reduction of 12.7% across the three doses of LY3298176.

The study also found that 69.1% of those taking 5mg, 90% of those taking 10mg and 77.4% of those taking 15mg of combination therapy achieved the recommended HbA1c target of 7% or less.

Unsurprisingly, the most significant reductions in HbA1c levels were observed for higher doses; 30% of those who received 15mg of the combination therapy and 18% of those who took 10mg achieved HbA1c levels of less than 5.7%, which is the normal range for people without diabetes.

HbA1c reduction for placebo was 0.1% and for Trulicity was 1.1%. Only 51.4% of those who took the latter achieved the 7% HbA1c target.

The safety profile of LY3298176 was similar to Trulicity and no participants experienced severe hypoglycaemia.

Frias continued: "These phase 2b clinical trial results for GIP/GLP-1 RA are unprecedented, and the impressive blood glucose and weight reductions seen may lead to a new treatment option for people with type 2 diabetes."

Lilly Diabetes vice president of product development Jeff Emmick said: “We're excited to continue studying GIP/GLP-1 RA and hope to add it to our wide range of therapies for people with diabetes."

The company plans to further evaluate the safety and efficacy of the combination therapy in a larger Phase III study.

Although this data has shown efficacy compared to GLP-1 receptor agonist alone, Cuaron sounds a note of caution: “Late-stage trial data is still required in order to cement this claim, and also to provide information on which subset of T2D patients may benefit most from this therapy.”