Clinical trials are the lifeblood of pharmaceutical R&D, but the experimental therapies of the future aren’t necessarily an easy sell for patients. It’s widely acknowledged that recruiting patients on to trials has become a bottleneck in many areas of clinical research. There’s no shortage of factors stacking the deck against trials looking to secure a patient group, from the complexities of raising awareness among clinicians and potential subjects to the time-consuming process of patient screening and the score of potential objections that could make patients hesitant to enrol.
Added to this is the transition towards more personalised treatments, particularly in oncology research, meaning that drug candidates are increasingly being targeted at specific biomarkers and with a wider range of exclusion criteria, further cutting down the eligible patient population for a given trial. The result is that recruitment and retention issues represent one of the biggest causes of failed trials in pharma R&D, and major research sites like the Memorial Sloan Kettering Cancer Center are warning of “a crisis in cancer research and discovery” if the low enrolment trend continues.
While the industry works on innumerable strategies to address the many problem areas in clinical trial recruitment, matching the right patients to the right trials – thereby maximising the eligible patient population for a study – is fundamental. It’s also an area with massive scope for improvement by applying the data-crunching digital innovations of the last decade.
In September, pharma giant Roche launched its attempt to do just that – the Clinical Trial Match App. The software is being released as one of the two first apps in the company’s Navify decision support portfolio, or as Roche put it, “the start of the Navify apps eco-system”. The app is intended to work alongside the Navify Tumor Board, a software product designed to improve oncology teams’ treatment decisions, and gives users a way to match patient-specific data such as age, biomarkers and tumour information to appropriate clinical trials.
Here, Roche’s global head of diagnostic information solutions Tim Jaeger discusses getting the Clinical Trial Match app, Roche’s growing decision-support services and the role of digital technologies in giving trials access to the patients they need to develop the life-saving treatments of tomorrow.
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Chris Lo: Navify Clinical Trial Match is one of the first apps launched on Roche’s Navify Tumor Board. Why did you choose clinical trial matching as an initial focus?
Tim Jaeger: 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.
CL: How does the Clinical Trial Match app work?
TJ: 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.
CL: How is the app designed to optimise the matching of patients to oncology trials specifically?
TJ: 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.
CL: Are you aiming to expand the app, or launch new apps, to target patient matching for trials in other therapy areas?
TJ: 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.
CL: Which organisations have you worked with to ensure a sufficiently wide range of patient data for trial matching purposes?
TJ: 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 recognizes 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.
CL: What work has been done on the design of the app to present trial matching data in an intuitive and simple way for users?
TJ: 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.
CL: What are the biggest challenges involved in using digital data to boost recruitment in clinical trials?
TJ: 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.
CL: Do you think digital technologies will ultimately prove to be the key to minimising enrolment issues and reducing the number of trials that fail due to problems with patient recruitment?
TJ: 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.
CL: With advanced technologies such as artificial intelligence, machine learning and blockchain maturing rapidly, how do you think digital trial enrolment and patient matching methods will evolve in years to come?
TJ: 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.