Patients will help document treatment efficacy in innovative, decentralised trials project

Patients will help document treatment efficacy in innovative, decentralised trials project

In collaboration with leading researchers and the pharmaceutical industry, the PhaseV innovation project will set new standards for how the effects of treatment can be documented so that patients are offered the right treatment. Patients and healthcare professionals will thus provide data that can help shed light on whether the treatment is working when Monsenso’s digital platform is used to support decentralised trials in the project.

To date, medical treatments have been tested primarily in long-term, randomised clinical trials to determine treatment effects and side-effects, with limited measurement of long-term effects when treatment is provided in clinical practice.

Often, drug trials take 6-15 years before a new drug can be released on the market, and 80 percent of trials fail to recruit and retain a sufficient number of patients in the trials within the set timeframe. This means that the benefits for patients and healthcare systems are often delayed. However, with digital developments, it is possible for clinics, hospitals, and patients alike to play a more active role in documenting the impact of treatments.

The new PhaseV (Phase five) innovation project, in which Innovation Fund Denmark is investing DKK 24 million (of which DKK 8,3 million goes to Monsenso), aims to develop and validate a scalable digital platform for efficient, decentralised patient recruitment, patient data collection and study execution. This is done by engaging patients and clinicians in the monitoring of treatment effects over longer periods of time based on patients’ own feedback, digital biomarkers from smartphones and wearables, as well as registry data.

With this project, we want to show that it is possible to engage and motivate patients and healthcare professionals to collect continuous data from patients over time. PhaseV will set new standards for how the efficacy and safety of new treatments can be documented in a scalable way in the future, so that patients are offered the right treatment“, says Thomas Lethenborg, CEO of Monsenso.

Digitizing the effect of patient treatments can be of decisive importance for our insight into the effects of the treatment of severely overweight people as well as for future clinical studies, where the goal is to make it easier for both patients and healthcare personnel to participate“, says Daniel Vega Møller, Vice President Medical & Science Obesity, NASH and Devices Novo Nordisk A/S.

Country Manager for Novartis in Denmark, Peter Drøidal, also sees great potential in the PhaseV project: “The healthcare system lacks resources and therefore we all need to think in new ways. This project’s combination of public and private partners offers unique opportunities to develop new digital solutions that can help improve patient care and free up personnel time“.

Severe obesity, urticaria and diabetic foot ulcers
The PhaseV project will develop a platform with three apps to collect data on patients with severe obesity, diabetic foot ulcers and urticaria – all of which are costly chronic conditions. For example, annual treatment costs for severe obesity alone are estimated to exceed DKK 15 billion for Danish municipalities and regions.

More than 800,000 Danes live with severe obesity, and associated diseases are very common. As severe obesity causes both direct and indirect costs to society, there is a significant need for good and well-documented weight loss treatments“, says Jens Meldgaard Bruun, clinical professor at Aarhus University and Steno Diabetes Center Aarhus and part of PhaseV.

Urticaria affects 15-20 percent of the population, and in about 1 percent it occurs chronically and causes a severely reduced quality of life.

Thorough monitoring and efficient data collection on symptom development are crucial for correct and effective future treatment“, says Simon Francis Thomsen, Professor and Chief Physician at Bispebjerg Hospital.

22.000 Danes live with diabetic foot ulcers and treatment costs society more than DKK 5 billion annually.

For a patient with diabetes, a foot ulcer can become critical within days, and in exceptional cases amputation may be necessary. Hence, time is of the essence, and we want to prevent serious complications“, says Klaus Kirketerp-Møller, senior physician at Bispebjerg Hospital and Steno Diabetes Center Copenhagen.

The PhaseV project is expected to bring value to patients, regions, and municipalities, as well as to the institutions and companies involved.

Attractive new market opportunity for Monsenso
“We are further developing Monsenso’s digital health platform to improve the support of decentralised trials across chronic conditions, where behaviour and ongoing follow-up play a major role in patients’ quality of life. We see both the development work and the partnerships as very interesting for Monsenso, because it opens up a new, attractive market opportunity“, says the CEO of Monsenso, Thomas Lethenborg.

The consortium behind the project, which is supported by the Innovation Fund, includes Novo Nordisk, Novartis, Aarhus University, the Research Unit for General Practice, Aarhus Municipality, Bispebjerg Hospital, the Danish Technological Institute, the Danish Life Science Cluster, Steno Diabetes Center Aarhus, the Copenhagen Institute for Future Studies and Monsenso.

Financial expectations
The project does not change Monsenso’s financial expectations for H2 2022 but is expected to contribute to increased growth in 2023 and beyond.

Facts
Innovation Fund investment: DKK 24.3 million (of which DKK 8.3 million is for Monsenso).
Total project budget: DKK 48.2 million.
Duration: 3 years
Official title: PhaseV

Further information
CEO, Monsenso
Thomas Lethenborg
Tel. +45 21 29 88 27
E-mail: lethenborg@monsenso.com

Chairman of the board, Monsenso
Peter Mørch Eriksen
Tel. +45 29 00 35
E-mail: petermorcheriksen@outlook.com

Certified Adviser, Monsenso
Norden CEF A/S
John Norden
Tel. +45 20 72 02 00
E-mail: jn@nordencef.dk
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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence and behavioural data. It connects individuals, carers and health care providers to enable personalised treatment, remote care and early intervention. We collaborate with health and social care, pharmaceuticals and leading researcher worldwide in our endeavours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com

 
Digitalization could help tackle the issue of lacking resources in mental health services

Digitalization could help tackle the issue of lacking resources in mental health services

Did you know that over 500.000 Danish citizens currently live with one or multiple mental health disorders [1] and that approximately half of the Danish population will suffer from a mental illness at least once in their lifetime [2]?

Mental health is declining in Denmark [2]. However, treatments and services offered to people with mental disorders often lack quality compared to those offered to people with physical disorders [2]. One of the reasons is a clear shortage of resources. 

Lack of resources as a challenge in Danish mental health services
Recruiting and retaining mental health professionals, in social psychiatry, regional psychiatry, and specialised social services focusing on children and youths [2] has been a significant struggle in recent years.

In Region South, for example, only 8 out of 21 open job positions for psychologists could be filled at the beginning of the year. In Region Zealand, it was even less: 11 applicants for 22 advertised positions, and 6 suitable candidates hired [3].

There are several assumptions for why it is so challenging to recruit mental health professionals. One of them is that we are currently experiencing a generational shift, with many healthcare professionals retiring at the same time [3].

The insufficient capacity and availability led many individuals suffering from mental illness to not receive the right treatment at the right time [2]. The average waiting time to see a psychologist in Denmark is around 16 weeks – but in many cases, patients easily wait up to 20 weeks before their first treatment [4]. 

This limited capacity also reduces the possibility of early detection and interventions. Insufficient preventive measures are a major cause of high mortality rates amongst individuals suffering from severe mental illnesses in Denmark [2].

Approaches to improve mental health services in Denmark
In order to make the quality and availability of mental health services a top priority, the Danish government decided to initiate working on a 10-year plan for the development of psychiatry in 2020, setting aside 600 million Danish Kroner annually for the improvement of mental health care in Denmark. [2].

Recommendations for the long-term plan include the expansion of easily accessible offers for mental health services in Danish municipalities (including improved offers for children and young adolescents), increased country-wide mental health promotion, and better early detection of mental illness [2]. 

None of these goals will be properly implemented if Denmark is still facing a lack of resources. But while the need to hire more trained professionals is undoubtedly critical to improve mental health services, this may also be an opportunity for scalable technologies to improve the reach of the current workforce to serve the needs of patients waiting to receive care.

Digitalization as the key to improved mental health services?
A large study by Elsevier Health (2022) shows that 77% of international clinicians expect tech companies to become “key stakeholders in managing healthcare systems in 10 years”, and that the majority of clinicians (70%) believe an increased use of digital technologies will transform healthcare positively [5].

Many healthcare professionals therefore expect that digital technologies and remote monitoring tools could help them to handle the growing patient data volumes they are currently feeling overwhelmed with [5]. 

The current recommendations for the psychiatric 10-year plan acknowledge that digital solutions can facilitate making better use of resources available in the future, and ensure the capacity meets the growing demand for mental health services. The use of digital technology offers the potential to address challenges in Danish mental health services. In particular, the use of digital platforms for remote patient monitoring and health assessment could improve access and speed to care, and real-time patient analytics could enable personalised treatment and improved quality of care [5]. 

Everyone deserves access to mental healthcare. The integration of digital solutions in healthcare bears huge potential, and it needs to happen timely. There is never a better time to act.
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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. We collaborate with health and social care, pharmaceuticals, and leading researcher worldwide in our endeavours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com.

References:

[1] EN AF OS (n.d.). About EN AF OS. Sundhedsstyrelsen.
http://www.en-af-os.dk/da/English/About-us#:~:text=Statistically%2C%201%20in%205%20Danes,they%20will%20get%20well%20again.

[2] Sundhedsstyrelsen (2022). Fagligt oplæg til en 10-årsplan.
https://www.sst.dk/da/Udgivelser/2022/Fagligt-oplaeg-til-en-10-aarsplan

[3] Kofoed (2022). Der er mangel på psykologer over hele landet – og det kan især gå ud over unge. DR.
https://www.dr.dk/nyheder/indland/der-er-mangel-paa-psykologer-over-hele-landet-og-det-kan-isaer-gaa-ud-over-unge

[4] Kofoed et al. (2022). Millioner til psykologhjælp forbliver ubrugte trods rekordlange ventetider. DR.
https://www.dr.dk/nyheder/politik/kommunalvalg/millioner-til-psykologhjaelp-forbliver-ubrugte-trods-rekordlange

[5] Elsevier Health (2022). Clinician of the Future Report 2022.
https://www.elsevier.com/connect/clinician-of-the-future

Monsenso expands to Israel as part of a real-world evidence project in pharma

Monsenso expands to Israel as part of a real-world evidence project in pharma

Monsenso is translating its digital health app to Hebrew and Russian as part of a real-world evidence project with a pharmaceutical customer in Israel.

Monsenso’s digital health solution is translated to Hebrew and Russian and will be implemented in Israel as part of a project, where it will be used to collect real-world patient-reported health data and data from connected wearables to support evidence generation for a specific drug.

With these recent additions, Monsenso’s digital health solution is now available in 19 countries and 12 languages.

The project is a great example of the relevance of Monsenso’s solution to help pharmaceuticals generate the evidence necessary to support regulatory approval and reimbursement dialogues. It helps pave the way to provide Monsenso’s solution internationally to customers wishing to collect valuable, longitudinal patient data via daily self-reports, periodic clinical questionnaires as well as sensor data from phones and connected wearables to support studies and clinical practice.

CEO Thomas Lethenborg says: “We are excited to continue our success in the pharmaceutical market and offer our digital health solution in more languages and countries going forward, thus enabling even more individuals globally to better take care of their mental health”.

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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. We collaborate with health and social care, pharmaceuticals, and leading researcher worldwide in our endeavours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com.

Monsenso will be working with Australian mental health clinic

Monsenso will be working with Australian mental health clinic

Monsenso will be working with the mental health clinic Aware Family Wellness in Australia.

Aware Family Wellness focuses on providing outpatient treatment to individuals in all age groups across a broad range of mental disorders, such as depression and perinatal depression, anxiety, eating disorders, complex trauma, and others.

Patients will be offered the Monsenso digital health solution as part of the treatment at the clinic, with the overall aim to better prepare patients for consultations, enhance the probability of correct and timely diagnosis and treatment, and thereby reduce the number of admissions and the probability of serious illness.

Founder and Accredited Mental Health Social Worker, Amy Ware says: “We are looking forward to using the Monsenso digital health solution to support our patients even more actively, and offering them a solution that provides them with self-help tools and psychoeducational material, enabling them to take better care of their mental health outside of treatment sessions”.

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About Monsenso
Monsenso is an innovative technology company offering a digital health solution used for decentralised trials, remote patient monitoring and treatment support. Our mission is to contribute to improved health for more people at lower costs by supporting treatment digitally and leveraging patient-reported outcomes data. Our solution helps optimise the treatment and gives a detailed overview of an individual’s health through the collection of outcome, adherence, and behavioural data. It connects individuals, carers, and health care providers to enable personalised treatment, remote care, and early intervention. We collaborate with health and social care, pharmaceuticals, and leading researcher worldwide in our endeavours to deliver solutions that fit into the life of patients and health care professionals. To learn more visit  www.monsenso.com.

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

Patient Voice in RWE: generating evidence that will impact payer and HTA decision-making

With the rise of patient-centered medicine and accelerated approvals, health technology assessment (HTA) bodies and payers are looking to real-world evidence (RWE) to strengthen evidence packages and reduce uncertainties at the time of launch.

Increasingly, stakeholders are recognizing the importance of RWE that incorporates patients’ real-world experiences in understanding what treatments work, and for whom, in clinical practice.

Real-world evidence is generated through applying data science to real-world data (RWD), or data “relating to patient health status or the delivery of healthcare routinely collected from EHRs, claims, registries, patient-reported outcomes, devices/applications, etc.” Decision-makers are exploring how this evidence can supplement clinical trials and provide additional context on the effectiveness of therapies.

There is some overlap between patient experience data, which provides information about a patient’s experience with a disease or condition, and real-world data (RWD), however, they are not one and the same. For example, patient-reported outcomes (PROs) collected in an electronic health record (EHR) would be considered both RWD and patient experience data, however, lab test results in the medical record would be considered only RWD. As personalized medicine continues to gain traction, decision-makers like ICER, FDA, NPC, EMA, EUNetHTA, and EHDEN are calling for patients’ voices to be included in the drug development and assessment process. Such information – direct input from patients on how they feel and function is often lacking from RWD sources, and FDA and EMA identified such missing data as problematic for interpretation.

We spoke with Ashley Jaksa MPH, Scientific Partnerships Lead, Aetion and Chung Yen Looi, DPhil Partnerships Director, Monsenso, about the evolving landscape of patient experience data and how biopharma organizations can incorporate the patient voice into their RWD and RWE programs.

Q: Ashley, can you tell our readers a little more about what Aetion does? 

AJ: Aetion is a healthcare technology company that uses routinely collected health care data to generate RWE on the safety and effectiveness of medical treatments and technologies. We were founded by Harvard epidemiologists to develop a way to conduct scalable and transparent RWD analyses at the highest level of scientific rigour. Our RWE analytics platform helps biopharma organizations, regulators, HTAs, payers, and other researchers generate RWE to inform decisions on the safety, effectiveness, and value of medical interventions across the product lifecycle. Our platform is data fluent, meaning it can analyze almost any type of RWD, and we often work with our customers and partners to identify the most fit-for-purpose data set for their research question.

Q: Why is the patient experience important for biopharma to understand, and where in the drug development lifecycle is it most important to integrate patients’ voices? 

CL: I think we can all agree that pharma and its stakeholders want to develop safe and effective drugs and bring them to market, to improve patients’ lives. As such, asking patients directly about how a drug impacts their lives is critical. Without the patient voice, we will never know how patients experience therapies in the real world, and how medical interventions could make a meaningful difference to their lives. Capturing and incorporating the patient voice across the product lifecycle can help biopharma companies to better understand the real-world impact of their drug, treatment responders, and meaningful endpoints based on a wider, representative population, in a quick and cost-effective way. 

AJ: Similar to RWE, patient experience data is important in almost all stages of the product lifecycle—not just as a post-marketing exercise. For example, understanding the treatment pathways and patient experiences on first-line therapies can help shape what comparators and outcomes should be captured in future randomized controlled trials to differentiate the drug in the market.

Q: How can incorporating the patient voice improve market access?

CL: Patient voice is a powerful way to demonstrate the impact of a drug on patients’ quality of life to payers and HTA bodies, particularly for cost-effectiveness evaluations. Some biopharma organizations have used PRO measures on daily functioning and health-related quality of life as their primary and secondary endpoints in clinical and real-world studies, while others have directly linked PROs to their drug reimbursement contracts. Patient voice contributions can help biopharma companies differentiate their product from similar drugs for coverage, especially for payers who are tying reimbursement to the value to patients based on outcomes and have longer-term responsibilities for their populations.  Some of the common myths are that “payers don’t care about PRO evidence, PROs only matter if they make it to the label, and that PROs should only be collected in Phase IV.” The facts are that not all payers are alike. Some pay a lot of attention to PRO evidence. Payers will consider all data from pivotal trials, whether or not it is on the package insert, and coverage decisions will be made on pivotal trials, so waiting until Phase IV to collect PROs would be too late.

Q: What are the common barriers in generating high-quality, patient-centric RWE?

AJ: I think the common barriers to generating RWE and patient-centric RWE are very similar; researchers must ensure that the data exists, that the data is capturing the relevant underlying medical concept, and that it is generated in a way that limits bias and confounding. Traditional RWD sources, like claims and EHRs, often have limited patient-centric data. This is a challenge for researchers attempting to incorporate this information into their studies. However, groups like Friends of Cancer Research and data providers like Monsenso are working to ensure this information is being collected. Once it is collected, it is essential to validate that these data and algorithms are actually measuring what we are intending to measure. Finally, researchers must be cognizant of bias and confounding and control for this as much as possible through study design and analytic methods. 

CL: Adding to Ashley’s points, I think data privacy and security, patients’ burden of contributing to research, and standardized methodology to analysis and interpretation are common barriers. It may seem like a no-brainer to ensure that patient data is managed in a secure way, but a recent study showed that almost a third of health apps out there collect patient data without privacy policy, and about one in five data transmissions occurred on insecure communication protocols. Furthermore, as patients are already suffering from their disease or conditions, contributing to research could add to their burden, which is why data capture platforms should be designed in a way that is easy-to-use and that provides valuable insights to patients. Finally, there is a lack of standardization in analysis and interpretation—which is why companies like Aetion are important to ensure that critical questions are answered, data sets are relevant, and standards are followed to derive and present meaningful insights that will inform decision-making.

Q: How can biopharma generate high-quality, patient-centric RWE for decision-makers? 

AJ: In addition to addressing the common barriers mentioned above, we think it is important to follow a principled approach to study design and execution. The main reasons why decision-makers like regulators and HTAs/payers dismiss RWE are due to deficient data selection and insufficient methodology. Following principled epidemiologic methods of selecting fit-for-purpose data, avoiding common methodological mistakes, and ensuring the protocol and results are clearly communicated are essential to ensuring the decision-makers trust the evidence. This planning and execution of RWE studies is not easy; it takes forethought. Biopharma manufacturers should be considering RWE at every stage of the product lifecycle, and proactively planning for how RWE studies will be incorporated into each product’s launch. 

Q. What is the cost-benefit for biopharma of generating patient-centric RWE? 

CL: Relative to the costs of bringing a new drug to market – which could go up to billions of dollars and take over a decade, with limited success ratesthe costs associated with collecting patient-centric RWE is insignificant. In return, patient-centric evidence could provide significant savings and valuable insights as early as possible to ensure that new drugs are truly driven by patients’ unmet needs, that they impact outcomes that matter to patients, and, ultimately, that they have the greatest chance of reaching the market and making a meaningful difference to patients. 

AJ: RWE can provide value for biopharma organizations across the product lifecycle—from eliminating costs typically incurred during clinical trials to accelerating time to market. Using a validated RWE platform can take this a step further, allowing companies to run more efficient, credible studies and reach insights faster than they could with traditional line programming. By ensuring patient-centric outcomes are collected in clinical data sources, then incorporating patient-centric RWE across drug development and commercialization programs, biopharma organizations can unlock insights that deliver value not only for their company but for patients as well. 

Q: Lastly, for our readers who are not familiar with Monsenso, Looi can you kindly tell a little more about what Monsenso does? 

CL: of course, Monsenso is a digital health company that enables patient-centric care and research. We’re a spinout from the IT University of Copenhagen based on the groundbreaking research of Professor Lars Kessing and Dr. Mads Frost on bipolar disorder and depression. We were founded in 2013 and have been listed on Nasdaq First North in Denmark since 2020. Our solution enables pharma companies to collect self-reported and device-generated data directly from patients in a simple, scalable, secure, and cost-effective way. Our cloud-based platform connects patients and investigators via an app and a web portal, respectively, to collect data in real-time across clinical development, post-market studies, and clinical practice to inform decision-making. Our platform can integrate with wearable devices and sensors, and combine with other RWD sources to provide a more holistic view of the impact of a drug on patients’ lives.