Author: Lucy White

Lucy White

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.

 

Lucy White

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.

Lucy White

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

Lucy White

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.

Lucy White

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. 

Lucy White

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.

Lucy White

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.

Lucy White

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.

Lucy White

uMed partners with the Global Parkinson’s Genetics Program (GP2) to address emerging research demands in Parkinson’s Disease

  • Genetic samples remotely collected as part of uMed’s AccessPD Cohort to contribute to the international GP2 Program. 
  • Analyses of samples will be linked back to the AccessPD Core clinical dataset (combining electronic health record data and patient reported outcomes), providing PD researchers with comprehensive resources.
  • AccessPD supports GP2’s mission to expand sample collection from groups traditionally  under-represented in PD genetics studies.

Cambridge, MA, June 18 – Healthcare evidence-generation and technology company uMed today announced they have entered into a partnership with the Global Parkinson’s Genetics Program (GP2) to support expansion of the international genetic initiative. uMed will be providing access to genetic samples collected as part of their AccessPD Cohort Study. 

The Aligning Science Across Parkinson’s (ASAP) initiative launched GP2 in 2019, building on previous funding efforts from The Michael J Fox Foundation for Parkinson’s Research (MJFF).  ASAP is a coordinated research initiative to advance targeted basic research for Parkinson’s disease (PD). ASAP is devoted to accelerating the pace of discovery and informing the path to a cure for PD through collaboration, research-enabling resources, and data sharing.  

AccessPD is a unique Cohort Study of patients diagnosed with PD, that remotely collects data from pre-consented patients at home and links with EMR and clinical data to build a comprehensive regulatory grade dataset that can be further augmented with custom endpoints. 

Under the announced agreement, uMed will be contributing anonymized genetic samples, remotely collected from consented participants within AccessPD.

GP2 will perform genetic analyses of the samples to feed into the program, and results will also be linked back to additional endpoints within the AccessPD clinical dataset including ePROs, eClinROs, EHR and device data.  

The ongoing collection of genetic samples is part of the AccessPD protocol. uMed observes on average a 72% completion rate of the saliva-based genetic tests sent to patients within the cohort, highlighting the formidable engagement of participants, and the strength of uMed’s ACCESS Cohort model to build patient communities and encourage participation and retention.

Dr Matt Wilson, CEO & Founder at uMed commented “We’re delighted to be contributing to the GP2 program and excited about the impact that this partnership will have on AccessPD and the future of Parkinson’s research. AccessPD already provides researchers with a comprehensive picture of the patient, and this partnership with GP2 allows us to expedite the expansion of this rich dataset.  It’s programs like AccessPD and GP2 that will be game changing to research in the future, and we are proud to be part of the process!”

In alignment with GP2’s mission to expand global genetics studies to include populations underrepresented in research, AccessPD’s unique decentralized approach will maximise the involvement of these populations in the program.

AccessPD is underpinned by uMed’s ACCESS Research Platform which is embedded across an expansive network of healthcare institutions across the US and UK, and allows for engagement with patients on behalf of the healthcare provider.  Combined with the remote collection of data from patients at home, this approach provides access to large patient populations, including those that would normally face economic, geographical and disease-related barriers.

Press release on prweb.com

Find out more about AccessPD here, or chat to our team to discover how AccessPD can support your research goals.

Lucy White

Hot topics from IAPRD 2024

Advancements in Deep Brain Stimulation, advances in genetic analysis, and a requirement for refocus on non-motor symptoms

At the end of May our team attended the World Congress on Parkinson’s Disease and Related Disorders (IAPRD) in Lisbon. This annual event brings together researchers, clinicians, and other healthcare professionals with an interest in Parkinson’s Disease and other neurodegenerative disorders, and offers three days of clinically-relevant disease and treatment overviews and updates.

We’ve compiled some key insights gathered from the congress sessions and discussions, and explored how our AccessPD Cohort program has the potential to support these advancements moving forward.

 

Key takeaway 1:

Significant advancements in Deep Brain Stimulation (DBS) are moving towards adaptive and personalized approaches. 

uMed’s AccessPD Patient Cohort provides researchers with access to a database of nearly 1000 Parkinson’s Disease patients that can be rapidly re-contacted and invited to ‘sub-studies’ without the need to set-up recruitment from scratch.

Our technology allows for the quick identification of patients within the cohort that match specific study criteria and that have already consented to be re-contacted for additional study opportunities. This enables rapid engagement and recruitment of pre-screened patients for interventional studies such as those focusing on DBS.

 

Key takeaway 2:

Genetic analysis is unveiling numerous variants associated with Parkinson’s Disease, enhancing our understanding of its pathogenesis and uncovering new potential treatment targets. 

Programs such as the Global Parkinson’s Genetics Program (GP2) are pivotal in improving genetics knowledge to accelerate the development and deployment of therapeutic strategies for PD.

uMed has recently partnered with GP2 (keep an eye out for more news!) to support expansion of this international initiative through the provision of access to genetic samples collected as part of our AccessPD Cohort Study. GP2 will perform genetic analyses of the samples to feed into the program, and results will also be linked back to additional endpoints within the AccessPD clinical dataset including ePROs, electronic Clinician Reported Outcomes (eClinROs), EHR and device data.  

This partnership will significantly contribute to developments in genetic analysis, as well as provide researchers with access to enriched data collected within AccessPD.

 

Key takeaway 3:

While much research focuses on motor symptoms, non-motor symptoms significantly impact patients’ quality of life and deserve more attention. 

AccessPD enables the remote collection of longitudinal data on symptoms via surveys, allowing for continuous monitoring of patients over time. This method facilitates the identification of patterns and trends in symptom progression, enabling more accurate patient stratification. By distinguishing between different subgroups of patients based on their symptom profiles, targeted interventions can be developed and implemented more effectively. 

 

The PD Movers Projects

We also had the pleasure of speaking with Alissa Pacheco, Clinical Research Manager at the Neurorehabilitation Research Laboratory, Columbia University, about the PD Movers project, an initiative started by a team of Columbia researchers to share the stories of Black and African Americans affected by PD.

Doctors and researchers at Columbia University Irving Medical Center (CUIMC) and Teachers College, Columbia University invited a group of Black and African American individuals with Parkinson’s Disease and their caregivers to come together to develop an educational guide for Parkinson’s disease (PD) designed specifically for the Black and African American community. 

Find out more at > https://www.neurology.columbia.edu/patient-care/specialties/movement-disorders/pd-movers-we-keep-moving-storybook

We believe AccessPD could learn from their success and implement similar strategies to boost diversity and inclusion within our own initiatives.

If you’d like to learn how AccessPD can support your research project please contact our team at hello@umed.io.