Guidance released by NICE earlier this year considers how people living with Parkinson’s Disease and their carers could benefit from remote device technologies, and the clinical and cost effectiveness of the use of the technologies. Remote monitoring devices provide Parkinson’s Disease (PD) symptom data that enables clinicians to make better informed decisions about the care they provide, which in turn supports patients with improved symptom management and quality of life.

The guidance highlights the currently insufficient evidence surrounding the impact of using these devices in the NHS on quality of life of Parkinson’s patients and their carers, and a lack of clarity about how these devices affect NHS resources.  Therefore, NICE recommends that more evidence is generated whilst these technologies are being used in the NHS.

To support this, NICE has released an evidence generation plan which outlines the evidence gaps and what real-world data needs to be collected for a review of the technologies again in the future. 

uMed’s AccessPD Cohort is referred to in this document as a valuable resource for setting up research studies.

AccessPD: A Unique Approach to Evidence Generation

AccessPD is a novel decentralised registry and integrated clinical research platform that provides researchers with access to evidence that doesn’t exist in other databases.

NICE highlights AccessPD as a valuable data source to address the evidence gaps that exist with the use of these technologies in the NHS. 

Within the context of the outlined plan, AccessPD provides opportunities to immediately commence a longitudinal parallel cohort study, for the ongoing collection of data on the use of these technologies, from a pre-consented cohort of patients with a diagnosis of Parkinson’s Disease.

AccessPD allows:

• Data beyond that routinely available: Participants within AccessPD are actively contributing data from their Electronic Medical Records (EMR), genetic tests, wearable devices used at-home and patient-reported outcome surveys. This provides access to a rich source of regulatory grade data which can then be augmented with the collection of additional custom data as required to answer specific research questions.

• Immediate data collection: The AccessPD master protocol is ethics approved, so researchers can begin collecting data immediately.

• Population-wide patient access: AccessPD comprises nearly 1000 pre-consented participants with a diagnosis of Parksinson’s Disease. The cohort is powered by uMed’s ACCESS Research Platform which is embedded across a vast network of healthcare institutions across the UK. This enables rapid and targeted identification of patients via their health record data, and engagement on behalf of their healthcare institution.

• Dedicated Patient support: For Parkinson’s Disease patients, communication and technology may be a barrier to participation. AccessPD provides a dedicated patient support team that can help participants and carers through the study process. This leads to improved participation, and representation of a wider patient population.

• Pre-consented, research ready patients: Upon invitation to the cohort, patients provide their consent to be re-contacted for the collection of additional data or participate in additional research studies. This means we can rapidly contact patients to collect additional data, without having to restart the recruitment and/or consent process from scratch.

• Alleviate pressure on study budget and staff resource: uMed facilitates device delivery and remote training, as well as data collection and aggregation, which would otherwise need to be factored into resource and study budgets.

If you’d like to discuss how uMed’s AccessPD can provide access to the evidence required for your research project please contact our team at hello@umed.io.

uMed have announced the successful enrollment of 1000 participants into their AccessCMD Cardiometabolic Disease Cohort, just 2 months after the study launched in the UK.

The growth of AccessCMD within this time frame highlights the capability of uMed’s unique approach of patient identification and tailored engagement to rapidly build a database of pre-consented patients within specific disease areas.

AccessCMD provides researchers access to custom data and insights based on specific research criteria.

Unlike traditional registries that are static and do not allow for the collection of customised data, AccessCMD combines routinely collected EMR with outcomes collected directly from patients at-home including genetic tests, wearable device data and clinically validated scales.

This provides researchers with a rich source of regulatory grade data that can be further augmented with the collection of custom endpoints. Furthermore, AccessCMD enables the running of standalone studies within the infrastructure of the existing cohort.

The alarming rise in global prevalence of cardiometabolic disease, and the resulting economic and healthcare burdens associated with managing these chronic conditions, has prompted a surge of research into developing effective preventative and therapeutic measures.

In particular, the effectiveness of the GLP-1 receptor agonists has been hitting the headlines, with recent research highlighting the benefits of these drugs to significantly lower the risk of cardiovascular events.[1]

With these cardiometabolic disorders affecting an increasingly large proportion of the global population, there is demand for wide-scale research with groups that are representative of the entire population, allowing for a true understanding of these diseases and the impact of therapies and treatments. The challenge for researchers is finding a large enough group of patients that meet the very specific criteria to conduct robust studies.

uMed’s ACCESS Research Platform and AccessCMD protocol is embedded across a vast network of healthcare providers across the UK, providing access to a wide patient population and allowing for rapid identification of those with a diagnosis of cardiometabolic disease. Patients are sent tailored engagements, on behalf of their trusted healthcare provider, inviting them to participate in the Cohort, and are asked for their consent to be recontacted for additional research opportunities.

This unique approach, combined with fully remote data collection, mitigates biases that often arise in research due to factors such as patient location, socioeconomic circumstances, race, gender, and age. The result is the development of a diverse cohort of patients that can be rapidly and repeatedly contacted to collect additional data points as required.

AccessCMD continues to be offered to patients via their healthcare providers in the UK, and aims to launch in the US in by the end of 2024.

[1] https://www.clinicaltrials.gov/study/NCT03574597

• uMed launches pioneering AccessCMD patient cohort facilitating access to custom data and insights to help accelerate cardiometabolic disease research
• Cardiometabolic disease is now the leading cause of mortality globally and is placing a huge financial burden on healthcare systems and the economy
• uMed have already recruited over 500 patients into the cohort, achieving over 15% consent rate from the first patient engagements sent, with significant potential for expansion across UK and US healthcare networks 

uMed has announced the successful enrollment of the first 500 UK participants into their groundbreaking AccessCMD cohort of patients with cardiometabolic disease.

AccessCMD will provide researchers with unique tools to access custom data and insights based on specific research criteria, to accelerate research and understanding across this group of conditions.

Cardiometabolic Disease encompasses a range of conditions including type 2 diabetes, stroke, hypertension, and congestive heart failure. It is now the number one cause of mortality across the globe, accounting for 31% of global deaths. [1] 

In the UK the NHS spends around £10 billion a year on type 2 diabetes, approximately 10% of its entire budget,[2] and it is estimated that £7.4 billion is being spent on healthcare related to CVD, with an annual cost to the wider economy of £15.8 billion.[3]

With the prevalence of cardiometabolic diseases on a sharp incline globally, research into this group of diseases is on the rise. 

Following the success of initial engagements sent to patients, which resulted in a 15% consent rate, uMed is now rolling out further engagements via their extensive UK healthcare provider network. 

uMed’s unique approach to patient identification, outreach, and consent, combined with fully decentralised data collection, mitigates biases that often arise in research due to factors such as patient location, socioeconomic circumstances, race, gender, and age.

‘The conversion rate we achieved from our first engagements is compelling; if we extrapolate this rate to the eligible patient population covered by our healthcare provider network in the UK, we’ll be able to offer thousands of patients the opportunity to participate in research and very quickly build a unique and rich source of information in Cardiometabolic Disease” commented Anil S. Jina, MD, Chief Medical Officer & President North America, at uMed.

Unlike traditional registries that are static and do not easily allow for the generation of custom data, AccessCMD enables re-engagement with patients that have already consented to participate in additional studies. This allows for the rapid collection of custom data that holds the answer to specific research questions, in the form of electronic health records, clinical outcomes, patient-reported outcomes and biosamples. 

Dr Mark Toshner, Consultant Respiratory Physician at the University of Cambridge, and AccesssPD Principal Investigator, commented “The potential that AccessCMD holds for research is extensive. The prevalence of these diseases has grown at a substantial rate over the past 20 years and the consequence is a huge burden on the populations’ health and our healthcare systems,  so there is much research to be done to understand the mechanisms contributing to these poor health outcomes.

“Conducting research at a large-scale with patient groups that represent the entire population is essential for developing a true understanding of the disease and underlying burden or unmet needs. The challenge for researchers is finding enough patients that meet the very specific criteria to conduct robust studies.’

“AccessCMD provides researchers with access to custom data to answer their key research questions, as and when required, and even enables the running of standalone studies within the infrastructure of the existing cohort. This will significantly expedite the development of understandings and treatments to reduce the burden of these diseases.”

The launch of AccessCMD follows the success of uMed’s inaugural AccessPD cohort study, which has so far recruited over 500 patients diagnosed with Parkinson’s Disease in the UK, 

Additionally, the company has recently begun the roll-out of engagements to patients with Interstitial Lung Disease, with nearly 100 patients in the UK now consented into their AccessILD cohort.

The swift succession of AccessCMD underscores the popularity of uMed’s Cohort Platform Studies amongst both patients and healthcare providers, highlighting the value for researchers within cardiometabolic disease and many more disease areas. 

Plans are underway to launch AccessPD, AccessILD and AccessCMD in the USA in 2024.

[1] https://www.roche.com/solutions/focus-areas/cardiometabolic

[2] https://www.england.nhs.uk/2022/03/nhs-prevention-programme-cuts-chances-of-type-2-diabetes-for-thousands/

[3] https://www.gov.uk/government/publications/health-matters-preventing-cardiovascular-disease/health-matters-preventing-cardiovascular-disease#:~:text=Yearly%20healthcare%20costs%20in%20England,economy%20of%20%C2%A315.8%20billion.