uMed’s AccessPD Interactive Parkinson’s Registry Surpasses 1000 Participants

uMed has announced that its pioneering AccessPD Parkinson’s Disease Interactive registry has surpassed 1,000 participants. This milestone marks a significant step forward in advancing research in Parkinson’s Disease by providing life science companies and researchers with access to a large, diverse cohort of patients who are ready to participate in research opportunities.

Enriching Real-World Evidence

AccessPD offers a unique approach to evidence generation, providing access to data beyond what is routinely available. The interactive registry is designed to enrich real-world evidence with patient experiences, motivations, and outcome assessments that extend beyond traditional clinical efficacy. 

Participants contribute data from multiple sources, including their Electronic Health Records (EHRs), genetic tests, wearable devices, 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.

Rapid data collection from research-ready participants

Upon invitation to AccessPD, patients provide their consent to be re-contacted for the collection of additional data or to participate in further research opportunities. This means uMed can rapidly re-contact patients to collect specific data, without having to restart the recruitment and/or consent process from scratch.

In addition, the AccessPD master protocol is ethics-approved so researchers are able to immediately commence observational studies from a pre-consented cohort of patients with a diagnosis of Parkinson’s Disease.

Breaking Down Barriers to Participation

Recruiting and retaining patients for neurodegenerative disease studies, including Parkinson’s Disease, has long been a challenge due to barriers such as travel requirements, communication issues and limited digital access among older populations. AccessPD is uniquely positioned to overcome these hurdles by implementing innovative, patient-centric strategies including:

  • Provider-led identification: Patients are identified via their electronic health records which allows for the accurate identification of clinically diagnosed patients. This approach leads to increased engagement and consent rates.
  • Multi-Channel engagement: Patients are invited to attend AccessPD on behalf of their healthcare provider via SMS, email and letters, ensuring inclusivity regardless of digital proficiency or technology access.  
  • Delegated Consent: Accredited nurses are available to guide patients through the consent process via telephone and can provide delegated consent on their behalf, simplifying participation.
  • Remote participation:  AccessPD provides the opportunity for patients to participate in research from the comfort of their own homes; removing any financial or geographic barriers to taking part.

The success of AccessPD highlights the potential of combining technology with patient-focused engagement methods to address the unique challenges of neurodegenerative disease research.

For more information about AccessPD or to inquire about collaboration opportunities, please contact gabriel.koslover@umed.io

Decisive Consulting and uMed Announce Partnership to Drive Data-Driven Market Access Success in Cardiometabolic and Parkinson’s Disease Research

New collaboration launches at ISPOR 2024, offering pharmaceutical and biotech companies rapid access to unique, customizable data and expert guidance to bridge HTA evidence gaps.

London, UK, 18 November 2024 – Leading Market Access consultancy Decisive Consulting and, uMed, a pioneering healthcare evidence-generation and technology company, have announced a strategic partnership aimed at accelerating market access initially for therapies targeting Cardiometabolic Disease (CMD) and Parkinson’s Disease (PD). 

Combining uMed’s cutting-edge data collection and linkage capabilities within these disease areas, with Decisive Consulting’s extensive expertise in navigating healthcare technology assessments (HTAs) and evolving evidence needs worldwide, this collaboration promises to address key challenges that hinder therapies from reaching patients. 

Launching officially at ISPOR Europe 2024 in November, the partnership offers a unique consultancy service that empowers pharmaceutical, biotechnology and medical device companies with fast, efficient access to both retrospective and prospective patient data, alongside expert-driven strategic recommendations. This approach is designed to identify and address critical evidence gaps, helping customers shape their market access strategies and ultimately prove value to HTA bodies. 

As the healthcare industry faces increasing pressure to prove the value of high-cost treatments, and medicines with uncertain long-term benefits, this partnership will directly address several key industry challenges. 

HTA decisions rely on comprehensive and high-quality clinical data, but real-world evidence is often lacking or incomplete. uMed’s platform links real-world, clinical and patient-generated data to provide a dynamic, customisable dataset that can be smartly adapted to meet specific HTA needs, unlike traditional static databases.  

Furthermore uMed’s direct-to-patient data collection captures outcomes that are difficult to quantify, such as quality of life and patient satisfaction, providing a clearer picture of treatment impact. 

With access to pre-consented patient cohorts, organizations will be able to rapidly gather insights that enable quicker decisions on strategic positioning and evidence requirements, providing competitive advantage in a fast-moving market.  

By aligning this unique, patient-generated data with comprehensive evaluations of evidence gaps from experienced HTA consultants who understand both the scientific and economic landscape, the partnership enables companies to mitigate gaps in their evidence base, ultimately enhancing their ability to meet HTA criteria for clinical and cost-effectiveness. Customers can also expect to receive full support for the publication of evidence, helping to translate data into actionable insights for HTA submissions. 

Dr. Matt Wilson, CEO & Founder of uMed, commented: “This partnership enables us to become an essential partner to our customers by extending our services beyond the provision of custom datasets, to now also offer meaningful insights that substantiate value propositions and improve chances of market success. This is especially timely as we see the exponential development of innovative therapies for obesity and associated cardiometabolic conditions.” 

Esther Nzenza, CEO & Founder of Decisive Consulting, added:  “This strategic collaboration enhances our shared capabilities beyond evidence strategy and into evidence action, allowing identification of gaps and rapid delivery of targeted insights to support a range of different needs. In fast-evolving fields such as CVM, addressing these gaps is often crucial for market access and HTA success. Together, we empower clients to find and proactively address evidence shortfalls, strengthen their value propositions, and improve their ability to navigate complex market access requirements” 

Dr. Matt Wilson, CEO & Founder of uMed, commented: “This partnership enables us to become an essential partner to our customers by extending our services beyond the provision of custom datasets, to now also offer meaningful insights that substantiate value propositions and improve chances of market success. This is especially timely as we see the exponential development of innovative therapies for obesity and associated cardiometabolic conditions.” 

Esther Nzenza, CEO & Founder of Decisive Consulting, added:  “This strategic collaboration enhances our shared capabilities beyond evidence strategy and into evidence action, allowing identification of gaps and rapid delivery of targeted insights to support a range of different needs. In fast-evolving fields such as CVM, addressing these gaps is often crucial for market access and HTA success. Together, we empower clients to find and proactively address evidence shortfalls, strengthen their value propositions, and improve their ability to navigate complex market access requirements” 

 

About uMed  

uMed is a leading health data platform that combines real-world evidence with patient-generated data, bridging critical evidence gaps in life science research. With a pre-consented patient cohort, uMed accelerates the collection of high-quality, customizable  data for clinical and real-world studies. 

 

About Decisive Consulting  

Decisive Consulting is a global market access consultancy with a proven track record of successfully supporting the launch of innovative medicines and technologies. Decisive specialises in helping clients anticipate requirements and navigate complexity, ensuring products meet the clinical and cost-effectiveness criteria set by HTA bodies and other decision makers. 

 

For media inquiries, please contact: 

Lucy White 

Communications Manager, uMed 

lucy.white@umed.io 

 

Samantha Shannon

Partnerships Manager, Decisive Consulting

samantha.shannon@decisiveconsulting.co.uk

The Future of Obesity Pharmacology: Bridging Evidence Gaps with a New Model for Clinical Registries

In this article with Pharmaceutical Executive, uMed CEO & Founder, Dr Matt Wilson, discusses the need for robust evidence that goes beyond just routinely collected data and that accurately reflects the diverse patient populations affected by obesity.

By leveraging advanced data collection methods, including patient-reported outcomes and digital health tools, the healthcare industry can build stronger evidence, enhancing the personalization and effectiveness of obesity treatments for broader populations. This shift promises to bridge gaps in clinical research and support better decision-making across the pharmaceutical and healthcare sectors.

Read the full article here.

 

Poster: The role of e-registries in advancing Interstitial Lung Disease research

View the poster here.

ILD is a group of rare, heterogeneous conditions causing lung fibrosis and inflammation. Different trajectories across the ILD spectrum call for better disease characterization. The rarity of ILD and other, physical, geographical or financial constraints are key barriers in studying cohorts or registries which are representative of the true spectrum of the ILD population.

In this poster, presented at ICLAF 2024, we share insights from AccessILD, fully remote registry that allows in-depth ILD stratification by combining Electronic Health Records (EHR) and electronic Patient Reported Outcomes (ePRO) data.

Poster: AccessPD Registry Update: Accelerating Parkinson’s Disease Research Through Integrated Digital Solutions

Launched in September 2022, AccessPD aims to address the challenges of PD research by leveraging electronic health records and electronic patient-reported outcomes within a fully remote, integrated platform. This poster provides an update on AccessPD’s progress, emphasizing the growth in patient recruitment, data integration, and the preliminary analysis aimed at advancing Parkinson’s disease (PD) research.

View the poster here

Poster: Enhancing Cardiometabolic Disease Research through AccessCMD

A Novel Approach to Patient Recruitment and Data Collection

The burden of cardiometabolic diseases (CMD) such as diabetes, heart disease, and stroke, along with associated risk factors like obesity, hypertension, and hyperlipidemia, represents a global health crisis that significantly impacts life expectancy, quality of life, and healthcare costs.

To address this challenge, the AccessCMD project aims to create a comprehensive registry with recall capacity for CMD and multimorbidity.

This initiative leverages electronic health records (EHR) to identify potential participants, enhancing our understanding of CMD through robust data collection and participant engagement strategies.

View the poster here.

uMed Extends Role in HARMONIE RSV Study with Collection of Wheeze Data

uMed has announced its continued involvement in the HARMONIE infant RSV Study, contributing to the delivery of a study extension designed to support further regulatory submission.

The Company’s involvement in the HARMONIE extension project follows the successful enrollment of 735 infants into the HARMONIE Phase 3b study within just 5 months.

Supporting the extension project, uMed will collect wheeze data from the patients’ health records 24 months after their participation in the HARMONIE study

uMed’s ability to directly engage primary care practices and securely access and link health record data at speed, without the requirement to recontact participants will significantly reduce the burden on trial sites and expedite data collection. Where required, uMed will also collect secondary care data on behalf of the trial site.

Read more about uMed’s involvement in the HARMONIE Phase 3b study here

If you’d like to discuss how uMed can support data collection or patient recruitment for your study, please don’t hesitate to contact us. 

AccessCMD: Next-generation Cardiometabolic Cohort hits 2000 patient milestone in less than 4 months

Providing researchers with unparalleled opportunity to access novel endpoints

London, UK, July 10, 2024 – Healthcare evidence-generation and technology company uMed have announced the successful enrollment of over 2,000 participants into their AccessCMD Cardiometabolic Cohort less than 4 months after starting enrollment. 

The exponential growth of the cohort within this short time frame highlights the commitment of patients within this disease area to engage in research, and showcases the effectiveness of uMed’s unique model in providing research access that has previously been unavailable.

AccessCMD is a novel decentralised registry and integrated clinical research platform, ethics committee-approved under a master protocol framework. As with all uMed Cohorts, AccessCMD is powered by the Company’s ACCESS Research Platform which is partnered with a vast network of healthcare institutions in the UK and US. This enables rapid and targeted identification of patients via their health record data, and engagement via SMS, email, letter and phone, on behalf of their healthcare institution. 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. 

Participants within AccessCMD actively contribute data from their Electronic Medical Records (EMR), genetic tests, wearable devices and patient-reported outcome surveys, offering an unparalleled opportunity for researchers within this disease area to access novel endpoints.

“From the rapid growth we have seen with AccessCMD it is clear that patients are willing and eager to participate in research, they just need to be provided the opportunity to do so, and at uMed we are empowering this unique access.

We achieve this through a combination of tailored communication on behalf of the patients’ trusted healthcare provider, offering research opportunities that are highly relevant to the individual’s health circumstances, and allowing patients to participate from the comfort of their own home” commented Anil Jina, MD. Chief Medical Officer at uMed.

With the rise in global obesity and related diseases, cardiometabolic research is capturing the attention of research groups as they work towards the development of new therapies and tools to address this health crisis. 

The potential for these therapies to benefit such a large proportion of the population is evident, however a challenge for researchers at all stages of the therapy lifecycle is the ability to access the required data points from large enough representative sub-cohorts.

Cardiometabolic disease describes numerous conditions, each interacting through intricate pathways and mechanisms that vary among individuals, many of which remain incompletely understood. Therefore researchers are often faced with the obstacles of finding a sufficient number of patients that meet their very specific study criteria, and obtaining the necessary endpoints needed to answer their research questions. Available databases and registries are static, preventing the easy collection of custom data, and site-based research is time consuming and expensive to set-up. 

“We’ve seen the huge impact of recent therapeutic developments within cardiometabolics, and for the many researchers now entering this field,   accessibility and speed are key.” commented Dr Matt Wilson, CEO & Founder of uMed.  “uMed is bridging the evidence gaps that currently exist between static databases and site-based studies, enabling the rapid collection of custom datasets without the requirement to start studies from scratch. AccessCMD presents researchers with a large cohort of pre-consented patients that researchers can rapidly re-contact to access additional custom endpoints to augment the expanding baseline dataset. ” 

“The rate of growth of AccessCMD is compelling and the potential for further growth is exciting.  Over a quarter of the population in the UK have risk factors, such high BMI, for serious cardiometabolic diseases. uMed’s integration with healthcare institutions across the UK is providing access to a large number of these patients. If we extrapolate the rate of growth we are seeing in AccessCMD to these wider population numbers, we expect to be able to improve access for patients to relevant research studies and to present researchers with important opportunities to extend their research to groups who have been historically underserved.” commented Dr Mark Toshner, Chief Investigator of AccessCMD

AccessCMD is currently recruiting patients across the UK via uMed’s healthcare network, with plans to launch the Cohort in the US by the end of 2024.

AccessPD: a valuable tool to address evidence gaps in device remote monitoring of Parkinson’s disease

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.

Poster: Remote DNA Collection for Parkinson’s Research: Insights from AccessPD

Established in 2022, the AccessPD registry aims to create a comprehensive database integrating electronic health records, self-reported outcomes, and genetic data from Parkinson’s disease (PD) patients.

This report outlines our experiences with remotely collecting DNA samples to analyze genetic variants and risk factors associated with PD. View the poster here.