Clinical innovation
What is clinical innovation?
Clinical trials are the cornerstone of delivering the next wave of life-changing medicines. However, healthcare environments are becoming increasingly complex, creating new challenges for clinical trial research. Recently, the upsurge in digital healthcare has catalysed and accelerated changes in clinical trial recruitment and participation, adding further complexity. Furthermore, the transition towards next-generation therapeutics is necessitating changes to the design and delivery of clinical trials. To meet these demands for clinical innovation, we are pioneering new approaches to how we engage with patients, trial teams and healthcare providers, in the clinic and beyond.
Clinical innovation means we are constantly thinking about how we can design and deliver patient-centric clinical trials that improve the experience of patients and site teams, and how we can use data, digital and AI to improve patient outcomes and health equity.
Clinical trial transparency
We have a long-standing commitment to make information about our clinical research publicly available. We believe that being transparent about our research and development, including our clinical trials, is serving the best interests of patients, their relatives, caregivers, healthcare professionals, researchers and the public.
The aim of our clinical trial website is to increase knowledge and awareness of clinical trials including what it means to participate and to increase access to relevant clinical trials for patients.
Using data and digital health solutions to improve experience and patient outcomes
We have the opportunity to integrate digital health solutions across clinical trials and help patients achieve better health outcomes. Digital health technologies have the potential to enable a broader group of people to participate and reduce patients’ need to travel to the clinic.
Digital technologies are also allowing us to collect data using devices patients can use at home. This enables healthcare providers to monitor symptoms and vital signs in real-time, giving clinicians and study teams a better understanding of how an investigational medicine impacts a disease and how it interacts with an individual’s overall health and quality of life. By leveraging digital technology, we are also reducing the time needed to develop life-changing medicines for patients who need them most.
Explore examples of innovative use of data and digital technology in our clinical trials
Improving experience
We developed Unify, a clinical trial support tool. Unify aims to reduce the complexity of clinical trials for patients and sites by integrating the clinical trial experience into a single mobile application for patients and a web-based portal for site teams.
Co-developed with patients and healthcare professionals, Unify is designed to enhance the participant experience before, during and after a trial; this includes simplifying and optimising several components of clinical trials, such as virtual consultations, medication reminders and patient-reported outcomes.
Optimising enrolment
When enrolling for trials, it is important to include diverse groups of patients that represent the broader population of the focus disease area.
To help inform of our approach to enrolment, we have partnered with Tempus, a technology company leading in AI and precision medicine. This gives us access to one of the world’s largest libraries of anonymised data, so we can identify and provide sites in the United States with data of consenting oncology patients whose disease profiles match a specific trial – and who could potentially benefit from an experimental medicine. We also support patients with study locators to help them find suitable trials.
Screening and detection
Innovative screening and detection methods are enabling earlier diagnosis, giving a higher chance of treatment success.
In Oncology, novel biomarkers increasingly guide patient selection. These biomarkers are based on detecting circulating tumour DNA (ctDNA), small DNA fragments leaking from cancer cells into the bloodstream – unlocking opportunities for detection, treatment, and monitoring for recurrence, faster than traditional methods.
We collaborate with GRAIL, a biotechnology company in early cancer screening, to adopt ctDNA biomarkers in more trials and identify high-risk patients with early-stage disease who could benefit most from our medicines.
Assessing outcome events
Clinical trial events like ‘cardiovascular death’ need to be examined by an independent adjudication committee to qualify whether they were caused by a cardiovascular issue or another condition. This can take up to five months.
To accelerate drug development, we worked with regulators to develop AIDA (Automating Identification Detection Adjudication). AIDA uses AI and machine learning to assess the certainty of the adjudication, and has demonstrated a high degree of consistency with human expert adjudication. If ‘uncertain’, AIDA escalates to a human; in future, this could shorten timelines of studies significantly.
Remote patient monitoring
Digital therapeutics are where health and technology merge to improve on traditional medicines alone.
These scientifically validated apps and devices – which are often prescribed by a healthcare provider alongside traditional medicine – deliver software-generated therapeutic interventions. We currently have several digital therapeutics in development across our therapy areas.
Informing future R&D
With patients’ consent, our research teams can utilise data and human biological samples (HBS) collected during trials to help inform the next wave of drug discovery, novel target identification and research and development. Reusing and combining data and HBS enables better design of our drug development strategies and programmes, in a sustainable way. This can help us design smarter clinical trials, strengthen our scientific discoveries, and ultimately has the potential to help patients receive the right treatments at the right time.
The opportunity for digital health to improve human health and transform patient outcomes is starting to be realised. We are at the forefront of this healthcare revolution, powered by scientific evidence, digital, longitudinal multiomics health data, and AI.
Designing and delivering patient-centric clinical trials
Clinical trials are necessary to drive innovation, yet only a small percentage of eligible patients choose or are able to join a trial. To enable more patients to participate, we are focusing on making them more accessible, providing simpler information and designing our trials so they are easier and more flexible for patients to fit around their routine care.
Learning from the patient experience
We work with patients and caregivers as partners to bring their voice into our trials. For patients with rare diseases, Alexion’s Rare Disease Patient Friction Coefficient assesses the burden of clinical trials on patients and their families and allows us to utilise these insights to inform and improve our trial designs and protocols. Across other disease areas, we have surveyed more than 1,400 patients about the burdens they face during clinical trials. When designing new studies, we use Merlin, a tool that proactively calculates a score to help our study teams evaluate how burdensome a trial might be for patients. Based on these data, our research teams can make informed decisions to reduce these potentially burdensome aspects of a trial.
Designing patient-centric trial endpoints
Designing better trial endpoints is one way to support clinical decision-making and capture the whole disease burden and trial journey of patients. A trial endpoint is an event or outcome that can be objectively measured to determine whether the intervention or treatment being studied is beneficial. For several of our asthma and COPD clinical trials, we have developed novel composite endpoints that help us to reduce the size and duration of our clinical trials. Moreover, we piloted the use of at-home spirometry measurements and virtual coaching to enable the remote collection of data for this endpoint, reducing the need for in-person visits by 50% and the need for patients to travel.
Delivering patient-centred and innovative clinical trial designs
Where possible, we are introducing the innovative clinical trial designs that could reduce patient burden, accelerate timelines and increase efficiency.
We are increasingly utilising platform studies for our early clinical trials that compare multiple potential drugs for a single disease. For example, patients can be enrolled to a platform study in cardiovascular disease based on results of biomarker tests for different sub-types of their specific disease. Depending on the response to the initial treatment, patients can then potentially switch to other drugs on the platform trial, as indicated by their disease biomarkers.
By designing patient-centric trials, improving the patient experience, and using digital technology, we are continually expanding our ability to reach diverse patient populations.
Delivering sustainable clinical trials for the health of society and the planet
Improving inclusion and diversity in our clinical trials
We are committed to designing clinical programmes with equity at the forefront – from idea inception to patient care. Our approach includes increasing the diversity of clinical trial participants, so trials better reflect the patients who may use our medicines, which ensures we have a robust and reliable body of evidence.
Prioritising diversity in our clinical trials is key to meeting the needs of our patients and of regulators – it is also simply ‘good science’
Reducing the environmental impact of our trials
We focus on running our trials sustainably, to reduce greenhouse gas emissions and environmental impact, helping create a healthy future for society and the planet. We are using a multitude of operational and digital health solutions throughout the clinical trial process – from study design to data analysis. Our operational innovations include decreasing face-to-face meetings and clinic visits for patients, reducing the number of wasted lab kits by better predicting where they are needed, diverting unused kits to other healthcare facilities and cutting back on single-use plastic.
Who could benefit from innovation in clinical trials?
The benefits of clinical trial innovation are significant and can have a positive impact across the entire ecosystem. These include:
Patients
Increased access to clinical trials and less burdensome clinical trial experience
Caregivers
Less burdensome clinical trial experience
Site teams
More streamlined processes to increase efficiency
Health care professionals
Better patient connections enabling enhanced insights
Researchers
Faster access to robust and actionable data
Regulators
Reduced timelines and trial populations that better reflect clinical practice
Our objective is to run our trials more efficiently and get potential new medicines to patients more quickly – through innovation we’re reducing the time commitment for patients and investigators and improving the trial experience to benefit all involved.
Latest updates in clinical innovation
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Veeva ID: Z4-56718
Date of preparation: July 2023