We were thrilled to host The Future Leaders in Innovation, Enterprise, and Research (FLIER) program at Aparito in April of 2023. The visit was a part of the FLIERs Immersion Day, which aims to foster collaboration and interdisciplinary work across academia, industry, the NHS, and government to drive innovation in the life sciences sector.
Putting patient engagement at the forefront
We kicked off the day with Dr Elisa Ferrer Mallol and Navdeep Sahota discussing Aparito’s Patient Group Accelerator Program (PGAP), which aims to revolutionise the rare disease research world. Our approach puts patient engagement first, ensuring that those with lived experience of rare diseases have a voice.
PGAP is Aparito’s way of shaking things up in the rare disease research world, putting patient engagement at the forefront. In the quest for solutions to these often-neglected conditions, we give those who know them best – the patients – a seat at the table.
By tapping into their invaluable expertise, we can identify overlooked aspects of their illnesses and create more reliable outcomes for clinical trials.
Wearables, hardware and data
Next, Sandra Komarzynski, Jonathan Bullock and Christian Weaves shared our exciting work with Garmin Health’s wearable devices in clinical trials. The data we receive via Garmin Health’s SDK provides a rich tapestry of accelerations, activity count, step count, distance, activity type, and activity intensities. We also have access to data from light sensors and intervals between each reading, oxygen saturation, respiration rate, and sleep data.
Sandra and Christian then detailed a pioneering program with Yumen Bionics to transform raw data from hardware into insight-rich analyses using the Atom5TM platform as part of the DT4RD initiative. Through DT4RD, we aim to develop non-invasive tools for measuring mobility in rare disease patients using wearable sensors integrated with Atom5TM and at-home video assessments to capture physiological and psychosocial parameters.
Our team believes in the power of wearable devices not only to accelerate study timelines and reduce participant burden but also to generate novel insights and improve clinical decision-making based on high-quality data.
Dr Aziza shared how our video capture capabilities have been deployed for a variety of use cases including gait analysis, assessing strength, and investigating facial feature dynamics.
She demonstrated how video capture can provide new clinical endpoints through at-home assessments and how Aparito can time each section of a task separately and run more advanced analyses like measuring the angle of the knee and arm swing to see differences in the walking patterns.
The FLIER Immersion Day was a fantastic opportunity to share our work and collaborate with others in the life sciences sector. We look forward to continuing to drive innovation and put patients at the forefront of rare disease research.
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In the world of digital endpoint design, taking a two-pronged approach is key, and Dr Joe Newman, a clinical researcher at the University of Cambridge, has some insights to share in a recent Garmin Health Research webinar.
He discussed his approach to working with Aparito and Garmin Health to conceptualise digital endpoints for clinical trials with a focus on both the patient and research perspectives.
Engaging with patients
What really sets this approach apart is the emphasis on engaging patients early in the process.
As Joe explained, the questions researchers ask are different from those patients ask. Researchers focus on technical aspects like validity, test-retest repeatability, and responsiveness to change. Patients, on the other hand, care more about usability, engagement / long-term use over time, and safety. By designing endpoints in parallel and cross-talking between both perspectives, Joe believes we can create digital tools that patients will actually use.
This is especially relevant to Joe’s area of interest: pulmonary arterial hypertension. This rare disease is characterised by increased resistance and pressure in the blood vessels in the lungs, leading to symptoms like breathlessness. While there are treatments available, the prognosis remains poor. Current endpoints are largely hospital-based, but Joe and his team have developed patient-reported outcome measures that can be administered remotely. They’ve also partnered with a company called Thriva to test whether blood tests from finger prick capillary samples can be used in the home setting to measure a cardiac biomarker called NT-proBNP in relation to pulmonary hypertension.
The approach started with the patients themselves. Through a collaboration with the Pulmonary Hypertension Association (PHA UK), a patient advocacy group in the UK, he conducted focus groups and an online survey.
The results were promising: 95% of patients in the UK have a smartphone, and 87% are confident in using apps. Even more encouraging, 93% of patients who don’t currently use a wearable device would be willing to do so to measure their activity most of the day if it was provided for free as part of a clinical trial.
The Digital 6MWT
But the real focus of Joe’s talk was on exercise capacity testing. The most familiar test in this field is the 6-Minute Walk Test, where patients walk up and down a corridor for 6 minutes while their physiological parameters are measured. This test is used in many different types of diseases, and Joe believes it can be adapted for remote use.
With digital tools such as the Aparito Atom5TM platform and Garmin® smartwatches, patients could perform this test at home and make clinical trials more accessible and convenient*.
This approach to digital endpoint design is refreshing in its patient-centeredness. By engaging patients early and often, Joe believes we can create digital tools that will make clinical trials more efficient and inclusive. Patient-reported outcome measures, blood tests from finger prick capillary samples, and exercise capacity testing can all be delivered from the comfort of patients’ homes. With this approach, patients can stay engaged, comfortable, and safe, making it easier to ensure the success of a clinical trial.
But the question remains: what does it take to accelerate the acceptance of these digital solutions?
According to Joe, it all comes down to acceptance. Patients need to be willing to use the technology that’s designed for them, and providers need to trust in its accuracy and clinical relevance. So what’s needed to make this happen?
For patients, Joe emphasises the importance of usability and simplicity. This means designing interfaces that are aesthetically pleasing, minimising button clicks, and gathering extensive feedback from patients to optimize the technology’s design. Patients also need to see the value in the data being collected, which is where providing digital diaries and progress tracking comes in handy. And perhaps most importantly, patients need reassurance that their data is being used and governed responsibly.
But what about providers? For them, Joe stresses the importance of trust in the data being collected and its clinical relevance. To achieve this, it’s important to work closely with patients and optimize the signal-to-noise ratio to filter out irrelevant data. Ultimately, the technology needs to make healthcare providers’ lives easier, not harder, by reducing workloads.
And when it comes to using wearables in clinical research, Joe believes that patients should not incur the costs themselves.
After all, we don’t want to create health inequality between those who can afford the technology and those who can’t, or those who have the digital literacy skills to use it and those who don’t.
Watch the webinar on-demand
Want to know more about Dr Joe Newman’s work with Aparito and Garmin? Watch the Garmin Health webinar on-demand here.
Garmin Health provides custom enterprise business solutions that leverage Garmin’s extensive wearable portfolio and high-quality sensor data for applications in the corporate wellness, population health, and patient monitoring markets. As part of a global company that designs, manufactures and ships products worldwide, Garmin Health supports its customers’ commerce and logistics needs, allowing enterprises to scale with a single, trusted partner.
Following HSBC UK’s purchase of Silicon Valley Bank UK (SVB UK) the leadership team at Aparito are pleased to see decisive action taken following a petition by UK startup leaders to the UK chancellor.
Dr Elin Haf Davies was amongst 334 CEOs and Founders representing £5.4B of investment and more than 16,000 employees in the UK who signed a letter to escalate the fallout of SVB UK to the highest echelons of government, and with good reason: nearly half of U.S. venture-backed technology and life science companies bank with SVB.
According to the Bank of England, SVB UK had a total balance sheet size of around 8.8 billion GBP, with a deposit base of around 6.7 billion GBP and approximately 3,300 UK clients from startups to venture-backed growth companies in the tech and life sciences sectors.
Despite Aparito having limited liabilities with the bank, we are relieved that HSBC stepped in to save SVB UK to ensure access to working capital for founders. SVB UK remains important to high-growth companies like ours and we are pleased that collective action led to a swift resolution without resorting to a taxpayer bailout.
“It has been an extremely stressful weekend for everyone involved in the life science and tech sectors,” said Aparito CEO, Dr Elin Haf Davies. “We are relieved and eager to make Aparito a success whatever the economy throws at us. Our resilience to headwinds such as this is a testament to our diverse portfolio of global pharma and biotech customers who share our aim of digitising clinical trials for patients all over the world.”
Aparito digitises clinical trials for rare disease studies and unlocks real-world data through mobile apps, video assessments & wearable devices via Atom5™, our iOS & Android-compatible web and mobile app platform.
The Atom5™ platform integrates clinical & regulatory expertise to capture patient data and develop digital endpoints to streamline the drug development process.
There is always more to be done but we are proud of our commitment to furthering equal representation of women in STEM, and not just because greater female representation at senior levels within businesses makes those businesses more profitable and more socially responsible, but because it’s the right thing to do to create a more equitable society.
Five women who paved the way in STEM
Aparito stands on the shoulders of giants when it comes to innovating in STEM and so we celebrate five women whose contributions to the world made our work possible.
1. Elizabeth Garrett Anderson
The first English female doctor; Elizabeth Garrett Anderson (1836 – 1917) was an astounding and resilient woman whose plight and determination enabled other women to also achieve greatness.
Having been inspired by successful women such as Elizabeth Blackwell, the first female doctor in the US, Elizabeth Garrett Anderson opted to contradict the submissive life she was expected to lead and become a doctor. Denied entry to any medical school, she was forced to study nursing alongside male peers whose objections led to her dismissal.
After Elizabeth qualified as a doctor through the Society of Apothecaries, they immediately implemented a ban on female entrants. The sexism and adversity Elizabeth faced only fuelled her strength and resolve.
Having taught herself French in order to study at the University of Paris, Elizabeth finally earned her medical degree. However, this was still not enough to allow her onto the British Medical Register, so she established the New Hospital for Women, which was to become the London School of Medicine for Women.
Her vocal campaign efforts eventually paid off and in 1876 female entry into the profession of medicine was legalised.
Even once she had retired from medicine, Dr Anderson was still grinding down the patriarchy, becoming the first female mayor in England. She was influential in the suffragette movement and inspired her daughter, alongside many other intrepid women, to follow in her esteemed footsteps and strive toward gender equality.
2. Betsi Cadwaladr
Betsi Cadwaladr (1789 – 1860) was one of 16 children from Bala in North Wales. When Betsi grew up she became a traveller of note. She travelled around the world extensively in an age when most working-class men hardly ever moved outside the area they were born. Betsi was not officially a nurse but her various jobs involved her in nursing duties and she was convinced of the need for cleanliness as an aid to recovery from disease and illness.
In 1854, the Crimean War broke out and a total lack of care for the wounded and dying soldiers became evident. Betsi applied to join Florence Nightingale’s group of nurses to go out to help, when she arrived she demanded to be sent to the front, Nightingale thought that Betsi was argumentative and wanted nothing more to do with her. Betsi lived and worked just behind the front line where she cared for wounded and injured soldiers. She nursed for up to 20 hours a day and usually slept on the floor with seven other nurses by which time she was over 70 years of age.
When Nightingale visited the battlefront and saw what amazing work Betsi had done, she changed her mind about a woman whom she had only previously considered as being irritating. She begged Betsi to stay on, but Betsi knew she had reached her limit by then and returned home.
Her heroic efforts in the field of healthcare were not acknowledged during her lifetime, however, she did gain some degree of recognition in 2009 when the Betsi Cadwaladr Health Board was created to include the six local health boards along the North Wales coast.
3. Ada Lovelace
Ada Lovelace (1815-1852) was unquestionably one of the most important women in science history. She was born in 1815, the daughter to Lord Byron and Lady Byron. Lady Byron believed that if she could tame Ada’s imagination, this would prevent Ada from going down the line of imaginative self-indulgence that Byron himself had.
She set out to use mathematics as the method of taming Ada’s imagination, figuring that if she could arrange for Ada to be educated in mathematics. When Ada was only 17 years old, and on the evening of 5 June 1833, she met a man who would become arguably her most important friend.
His name was Charles Babbage. He was 24 years older than her, and she quickly became fascinated, after talking to him, with his plans for building a calculating machine called a ‘Difference Engine’. The purpose of this, although Babbage never managed to complete it, was to calculate mathematical tables automatically without error.
Babbage eventually abandoned the Difference Engine in favour of the Analytical Engine: the world’s first digital computer, with a store, a processor, a memory, a sub-routing function and all the other essential features of a modern digital computer.
It is Lovelace’s work on the Analytical Engine that has led to her being known as the first computer programmer.
4. Katherine Johnson
Katherine Johnson (1918 – 2020) was a mathematician who worked on NASA’s early space missions and was portrayed by Taraji P Henson in the film ‘Hidden Figures‘.
She was one of the “computers” who solved equations by hand during NASA’s early years and those of its precursor organisation, the National Advisory Committee for Aeronautics. Johnson and other black women initially worked in a racially segregated computing unit in Hampton, Virginia, that was not officially dissolved until NACA became NASA in 1958. Signs had dictated which toilets the women could use.
She focused on planes and other research at first. But her work at NASA’s Langley Research Centre eventually shifted to Project Mercury, the nation’s first human space programme.
She and her co-workers had been relatively unsung heroes of America’s ‘Space Race But in 2015, President Barack Obama awarded Johnson (then 97 years old) the Presidential Medal of Freedom, the nation’s highest civilian honour.
5. Barbara McClintock
We live in an age where we have mapped the human genome and developed tools such as CRISPR, but all of this was possible thanks to the dedication and lifelong study into genetics by Barbara McClintock (1902 –1992) She spent her entire career analysing maize, and in the 1930s developed a staining technique that allowed her to identify, examine and describe its individual chromosomes.
Armed with her research, she was able to determine the existence of jumping genes, which are sequences of DNA that move between the genome. Jumping genes were considered junk DNA by much of the scientific community at the time. Still, McClintock pressed on and suggested they might in fact determine which of the genes in cells are switched on – vital in creating differences between cell types.
It was not until 1983, when she was awarded The Nobel Prize in Physiology or Medicine, that the scientific community began to recognise not only just how important these jumping genes are, but how much of the genome they make up – some estimates suggest they make up 40 per cent of the human genome.
McClintock also was the first to suggest the idea of epigenetics, where genes alter their activity in response to external factors, some 40 years before it was formally studied.
Clinical research is often site-centric, adhering to schedules largely driven by tradition and operational convenience rather than the natural history of diseases, and the diversity of target populations.1 It stands to reason therefore that the patients recruited to clinical trials do not always reflect real-world clinical presentations, which in turn can bias the findings and limit their applicability to real-world settings. However, in reality, few studies are totally site-centric with treatment often self-administered at home, between study-site visits; some data capture may also occur between site visits—for example, patient-reported outcomes (PROs).
Restrictions on movement imposed during the COVID-19 pandemic, disrupted many site-centric clinical trials and accelerated the interest in and growth of digitally enabled clinical research including trials.2 3 Challenges previously perceived as insurmountable were overcome in weeks as ethics committees, regulators, study sponsors, clinicians and patients alike, embraced new approaches like digitally enabled screening, recruitment, remote consent and data capture that were able to provide assurances that rigour and patient safety would not be compromised.
The US Food and Drugs Administration (FDA) defines decentralised clinical trials as trials executed through telemedicine and mobile or local healthcare providers, using procedures that vary from the traditional clinical trial model.4 Patient recruitment, delivery and administration of study medication, and collection of study outcomes data occur without in-person contact between the study team and patients in fully decentralised trials.2 This definition could be expanded to encompass non-trial clinical research. In this article, we explain these innovations and limitations.
Harnessing the power of patients: Developing and validating the Neuronopathic Gaucher Disease Patient Reported Outcomes (nGD-PRO) and Observer Reported Outcomes (nGD-ObsRO) to measure HRQoL in patients with Gaucher Disease Type 2 and Type 3 documents over three and a half years of research to develop and assess the content validity ofnGD-specific patient-reported outcomes (PRO) and observer-reported outcomes (ObsRO) measure in partnership with patients, caregivers, and other stakeholders as part of the GARDIAN project with the International Gaucher Alliance and Cerner Enviza.
Dr Clare Matthews and Dr Rabia Aziza’s poster presentation at the Child Health Technology Conference 2022 showcased a fascinating project that Aparito have worked on with University College London to explore “Feasibility of facial expression analysis as an objective palatability assessment of paediatric medicine”.
This project utilised Aparito’s innovative video capture & analysis technology via the Atom5™ clinical trial platform to enable study participants to upload videos capturing their responses to taste. The videos were analysed by our data science team and their findings were disseminated via the poster.
The University of Cardiff investigated sleep in adult-onset idiopathic focal cervical dystonia (AOIFCD). Sleep disturbances are an important component of the phenotypic profile of adult-onset idiopathic focal cervical dystonia (AOIFCD), reported in up to 70% of patients. Given the chronic nature of dystonia, greater understanding of potential sleep disturbances would require minimally intrusive monitoring and minimal input from the patients themselves.
Created in conjunction with the University of Birmingham‘s CPROR team, this poster details how the team set out to develop and assess the feasibility of an electronic patient-reported outcome measure (ePROM) system for inclusion within routine clinical care & traumatic brain injury (TBI) research.
Selecting only two webinars from our 2022 highlight reel was a challenge!
We chose these webinars not just because they were the most popular, but because they also showcase the technical capabilities of Atom5™ alongside our collaboration with patients and academic partners to co-create novel digital biomarkers.
Co-creation with patients is vital for effective clinical trial design and this webinar explores how Aparito’s Patient Group Accelerator Programme enables patients to co-create alongside sponsors & CROs.
Our panel discussed:
how we designed a study to evaluate engagement with physiotherapy using mobile health technology
how to involve patients early in the design phase of clinical trials
Aparito are delighted to announce our latest Patient Group Accelerator Programme partnership with PHA UK and welcome them into Aparito’s Patient Group Accelerator Programme to develop endpoints for patients with pulmonary hypertension!
Pulmonary hypertension (PH) is defined by PHA UK as “a rare condition that causes high blood pressure in the blood vessels connecting the heart and lungs (the pulmonary arteries). When a person develops PH, the walls of the pulmonary arteries become stiff and thickened, or blocked by blood clots.”
Patient Group Accelerator Programme
The Accelerator is designed to understand and fulfil patient needs by working closely with patient organisations and finding new endpoints that are relevant to their specific conditions.
By developing technological solutions, novel endpoints and digital biomarkers designed with patients, the objective is to show the feasibility of a potential new solution as a starting point for future validation and use in clinical trials.
The first stage of the Accelerator explored the unmet needs of PH patients regarding digital outcomes measures through a co-creation approach in partnership with PHA UK. We are privileged to be joined by clinical specialists from the University of Cambridge for this project, and the learnings will inform the design of future PH clinical research!
To date, we have digitised and tested a PH-specific PRO, which was developed by the PH community, and intend to commence a second round to test a digital walk test of functional capacity in January 2023.
We are excited to partner with Aparito to further assist the PH community, by co-developing new digital endpoints for clinical trials that could be collected in a real-life environment. We hope this will help PH patients participating in clinical trials to improve their trial experience and measure outcomes that better reflect how PH affects their day-to-day life.
Shaun Clayton, Director of Membership Support at PHA UK
We are very excited to launch this new partnership with PHA UK as part of the Accelerator Programme. This is an excellent opportunity to co-develop patient-driven solutions to support the PH patient community.
The Patient Group Accelerator is a critical part of Aparito’s DNA and vision for a patient-centric solution to conveying what’s important to them. As the Accelerator goes from strength to strength, we are thrilled to partner with PHA UK and see this as an exciting addition to the partnerships that we have with ALS Belgium, Duchenne UK and PCD Support UK.
We are the only charity in the UK dedicated to supporting people affected by the rare disease pulmonary hypertension (PH).
Our national support network helps patients, their family and carers and NHS professionals too – and we are committed to our values of integrity, hope and influence.
From its launch in the year 2000, the PHA UK has now grown to almost 4,500 members. Our community is like no other; a unique group of people committed to supporting each other and raising awareness of this serious condition in the hope of one day, finding a cure.
Patients living with life-limiting rare diseases need access to clinical trials and innovative treatments.
Aparito digitises clinical trials to provide that access, wherever patients are.
We unlock real-world data through mobile apps, video assessments & wearable devices via Atom5™, our iOS & Android-compatible web and mobile app platform.
Available in 193 countries and 125 languages, the Atom5™ platform integrates clinical & regulatory expertise to capture patient data and develop digital endpoints for hybrid and decentralized clinical trials to streamline the drug development process.
Learn more about Aparito’s Patient Group Accelerator Programme here.
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Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study
A UK-wide trial, led by Addenbrooke’s Hospital and the University of Cambridge utilising the Aparito Atom5™ platform, has found that a drug used to reduce the risk of blood clots does not help patients recovering from moderate and severe Covid – despite this approach being offered to patients.
The HEAL-COVID trial (Helping to Alleviate the Longer-term consequences of Covid-19) is funded by the National Institute for Health and Care Research (NIHR) and the Cambridge NIHR Biomedical Research Centre. To date, more than a thousand NHS patients hospitalised with Covid have taken part in HEAL-COVID, a platform trial that is aiming to find treatments to reduce the number who die or are readmitted following their time in hospital. HEAL-COVID enrols patients when they are discharged from hospital, following their first admission for Covid-19. They are randomised to a treatment and their progress tracked.
In these first results from HEAL-COVID, it’s been shown that prescribing the oral anticoagulant Apixaban does not stop Covid patients from later dying or being readmitted to hospital over the following year (Apixaban 29.1%, versus standard care 30.8%).
As well as not being beneficial, anticoagulant therapy has known serious side effects, and these were experienced by participants in the trial with a small number of the 402 participants receiving Apixaban having major bleeding that required them to discontinue the treatment.
There was also no benefit from Apixaban in terms of the number of days alive and out of hospital at day 60 after randomisation (Apixaban 59 days, versus standard care 59 days).
Following these results, the trial will continue to test another drug called Atorvastatin, a widely used lipid-lowering drug (‘a statin’) that acts on other mechanisms of disease that are thought to be important in Covid.
“This is a significant milestone for HEAL-COVID”, said Aparito CEO, Dr Elin Haf Davies. “These results demonstrate the importance of conducting this study and further research of other interventions for patients who have been hospitalised with Covid-19.”
The trial is being led by Cambridge University Hospitals NHS Foundation Trust (CUH) and University of Cambridge, in collaboration with Liverpool Clinical Trials Centre (University of Liverpool) and Aparito.