real-world data (RWD) Archives - https://hitconsultant.net/tag/real-world-data-rwd/ Wed, 17 Apr 2024 17:35:58 +0000 en-US hourly 1 COTA & Sanofi Partner to Leverage Real-World Data and AI to Accelerate Cancer Trials https://hitconsultant.net/2024/04/17/cota-sanofi-partner-to-leverage-real-world-data-and-ai-to-accelerate-cancer-trials/ https://hitconsultant.net/2024/04/17/cota-sanofi-partner-to-leverage-real-world-data-and-ai-to-accelerate-cancer-trials/#respond Wed, 17 Apr 2024 17:35:53 +0000 https://hitconsultant.net/?p=78862 ... Read More]]> FDA Extends RCA With COTA to Explore COVID's Effect on Cancer

What You Should Know: 

COTA, a leading real-world data (RWD) and analytics company in oncology, has announced a new collaboration with Sanofi

– The strategic partnership aims to leverage RWD and artificial intelligence (AI) to accelerate clinical trials specifically focused on multiple myeloma, a cancer affecting white blood cells. The findings from this partnership have the potential to significantly impact future clinical trial designs for multiple myeloma.

Unlocking Insights with Real-World Data

COTA’s expertise in RWD analysis will be instrumental in this initiative. Their comprehensive datasets offer valuable insights into real-world treatment pathways for cancer patients. This data will provide Sanofi with crucial context about key patient populations battling multiple myeloma.

Focus on Multiple Myeloma

The initial project will center around multiple myeloma, a complex blood cancer. By analyzing RWD, the collaborators aim to:

  • Unravel the Treatment Landscape: Gain a clearer understanding of the evolving treatment options for multiple myeloma.
  • Inform Future Trials: The insights gleaned from RWD analysis will be used to design more efficient and targeted clinical studies in the future.
  • Interpret Ongoing Trials: RWD can provide valuable context for interpreting the results of ongoing and future multiple myeloma trials, ensuring their relevance to real-world treatment practices.

Guiding Trial Interpretation

Additionally, the collaboration’s insights can aid in interpreting the results of ongoing and future clinical trials. By understanding how new treatments compare to existing standards of care for multiple myeloma patients, researchers can make more informed decisions about their therapeutic potential.

“Our collaboration with Sanofi has the potential to enable more patients and their families to benefit from breakthrough treatments in an expedited time frame,” said Dr. C.K. Wang, an oncologist and COTA’s chief medical officer. “We are providing high-quality RWD enabled by new AI-based tools to accelerate pharmaceutical research and improve patient care.”

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Flatiron Health, NCCN Collaborate to Advance Cancer Care with Real-World Data https://hitconsultant.net/2024/04/11/flatiron-health-nccn-collaborate-to-advance-cancer-care-with-real-world-data/ https://hitconsultant.net/2024/04/11/flatiron-health-nccn-collaborate-to-advance-cancer-care-with-real-world-data/#respond Thu, 11 Apr 2024 14:00:32 +0000 https://hitconsultant.net/?p=78758 ... Read More]]> Flatiron Health, NCCN Collaborate to Advance Cancer Care with Real-World Data

What You Should Know: 

Flatiron Health, a provider of real-world data (RWD) for cancer care, and the National Comprehensive Cancer Network® (NCCN®), an alliance of top cancer centers, have announced a renewal of their long-standing collaboration. 

– This decade-long partnership, dating back to 2014, focuses on leveraging RWD to improve cancer care and research.

The Power of Real-World Data in Cancer Care

Real-world data offers a valuable window into the realities of cancer care beyond clinical trials. By analyzing data from real-world settings, researchers and healthcare providers can gain a deeper understanding of treatment effectiveness, identify potential disparities in care, and ultimately improve patient outcomes.

Collaboration for Better Cancer Care with RWD

The renewed collaboration signifies a continued commitment to leveraging RWD for positive impact. This will involve several key initiatives:

  • Expanding Real-World Data Research: Flatiron and NCCN will work together to enable further research using RWD. This research will provide valuable insights into real-world treatment patterns and patient outcomes.
  • Improving Cancer Care Nationwide: Cancer centers across the country will benefit from access to Flatiron’s high-quality, curated datasets. This data can be used to benchmark performance, identify areas for improvement, and ultimately deliver better care for patients.
  • Enhancing Quality of Care: Flatiron and NCCN will continue collaborating on quality improvement initiatives for NCCN Member Institutions. This includes developing new metrics and benchmarks to assess and measure the quality of care provided.

“We strive to ensure that everyone, everywhere, is able to access high-quality cancer care based on the latest evidence and expert consensus,” said Crystal S. Denlinger, MD, Chief Executive Officer, NCCN. “This ongoing collaboration with Flatiron will help us leverage data in pursuit of that goal. We are happy to renew our commitment to work together to help people with cancer live better lives.”

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Verantos Bolsters Real-World Data Network with 7M Patient Records from CuriMeta https://hitconsultant.net/2024/03/28/verantos-bolsters-real-world-data-network-with-7m-patient-records-from-curimeta/ https://hitconsultant.net/2024/03/28/verantos-bolsters-real-world-data-network-with-7m-patient-records-from-curimeta/#respond Thu, 28 Mar 2024 05:41:18 +0000 https://hitconsultant.net/?p=78451 ... Read More]]> Verantos Bolsters Real-World Data Network with 7M Patient Records from CuriMeta

What You Should Know:

Verantos, the leader in high-quality real-world evidence (RWE) forms a strategic partnership with CuriMeta to expand Verantos’ Research Network with de-identified data from 7 million patients,

– The collaboration will enhance the depth and reach of real-world data (RWD) available to life science organizations.

Enhancing RWD Quality and Accessibility

The Verantos Research Network is a unique platform that gathers data from various sources, including academic institutions, community health systems, insurance claims, and disease registries. Their focus on high-quality data ensures researchers have access to the most reliable and comprehensive RWD available.

The two companies will collaborate across various therapeutic areas. CuriMeta’s data will directly support the development and expansion of Verantos’ disease-specific Pragmatic Registries, ultimately leading to more effective treatments and improved patient outcomes.

“The Verantos Evidence Platform uses artificial intelligence (AI) to generate unique disease-specific insights. It is critical that AI models are trained using high-quality patient care data,” said Anand Shroff, President of Verantos. “CuriMeta’s participation will enable us to enhance our disease-specific Pragmatic Registries that are used to accelerate life sciences research.”

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Tempus Donates Over 3,000 Cancer Patient Profiles to Fuel National Cancer Institute Research https://hitconsultant.net/2024/03/14/tempus-donates-over-3000-cancer-patient-profiles-to-fuel-national-cancer-institute-research/ https://hitconsultant.net/2024/03/14/tempus-donates-over-3000-cancer-patient-profiles-to-fuel-national-cancer-institute-research/#respond Thu, 14 Mar 2024 20:06:30 +0000 https://hitconsultant.net/?p=78081 ... Read More]]>

What You Should Know:

Tempus, a leader in artificial intelligence and precision medicine, announced a groundbreaking data contribution to the National Cancer Institute (NCI) today.

– The first-of-its-kind contribution will significantly enhance the NCI’s planned Data Enclave, a secure repository designed to accelerate cancer research.

Unlocking Insights from 3,000 Cancer Diagnoses

Tempus is donating de-identified tumor profiles with limited associated clinical information from over 3,000 cancer diagnoses. These anonymized data sets, derived from patients sequenced with Tempus’ xT assay, will build upon the foundation established by The Cancer Genome Atlas (TCGA) sequencing project.

Empowering Researchers with Secure Data Access

Researchers will be able to securely access and query this valuable data through the NCI Data Enclave. This innovative system utilizes an Application Programming Interface (API) to receive user queries and return anonymized, cohort-level summary results. These findings will be openly accessible to the entire cancer research community.

“Data contributions allow the cancer research community to continue to learn and advance our knowledge in cancer thereby fulfilling NCI’s mission,” said Jill Barnholtz-Sloan, PhD, Associate Director for the Informatics and Data Science Program in NCI’s Center for Biomedical Informatics and Information Technology and Senior Investigator in the NCI Division of Cancer Epidemiology and Genetics. “This data will greatly expand the genomic data resources available to the cancer research community.  Datasets of this magnitude are desperately needed to have the statistical power to study rare cancers and rare subtypes of common cancers.”

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MUSC Hollings Cancer Center and Flatiron Health Partner to Deliver Advanced Cancer Care https://hitconsultant.net/2024/03/13/musc-hollings-cancer-center-and-flatiron-health-partnerhip/ https://hitconsultant.net/2024/03/13/musc-hollings-cancer-center-and-flatiron-health-partnerhip/#respond Wed, 13 Mar 2024 13:23:59 +0000 https://hitconsultant.net/?p=78036 ... Read More]]>

What You Should Know:

The Medical University of South Carolina (MUSC) Hollings Cancer Center and Flatiron Health, a leading oncology-focused healthtech company, today announced a collaboration to bring Flatiron Assist™ to MUSC’s oncology care clinicians.

– The strategic collaboration equips clinicians at MUSC Hollings Cancer Center with Flatiron Assist, a unique clinical decision support platform designed specifically for oncology.  Flatiron Assist prioritizes the latest evidence-based medicine, promotes adherence to site-preferred treatment pathways, and streamlines access to relevant clinical trials – all readily available at the point of care.

Integration with Existing Systems for Seamless Workflow

Through Flatiron’s integration with MUSC’s existing Epic electronic health record system, Flatiron Assist seamlessly integrates into existing workflows. Clinicians can leverage the platform to:

  • Identify and promote site-preferred treatment pathways – These pathways represent the center’s most effective treatment approaches for various cancers.
  • Gain real-time access to open clinical trials – Patients can be efficiently matched to potentially life-saving research opportunities.
  • Ensure adherence to NCCN Guidelines – Flatiron Assist integrates seamlessly with the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®), promoting standardized and high-quality care.

“Partnering with the Medical University of South Carolina’s Hollings Cancer Center, a market-leading cancer care provider, is an incredible opportunity to accelerate our shared vision for the delivery of more standardized, efficient, and effective cancer care.” said James Hamrick, MD, Vice President of Clinical Oncology at Flatiron Health. “Flatiron Assist, tailor made for oncology, offers a clinical decision support platform that places emphasis on the latest evidence based medicine, aiming to reduce care variation while increasing access to clinical trials and novel therapies, ensuring patients at MUSC and beyond receive the highest quality of care.”

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Trilliant Health Launches Network Explorer: An Application To Improve Network Performance With Real-World Data https://hitconsultant.net/2024/02/21/trilliant-health-launches-network-explorer-an-application-to-improve-network-performance-with-real-world-data/ https://hitconsultant.net/2024/02/21/trilliant-health-launches-network-explorer-an-application-to-improve-network-performance-with-real-world-data/#respond Wed, 21 Feb 2024 14:01:00 +0000 https://hitconsultant.net/?p=77486 ... Read More]]>

What You Should Know:

  • Trilliant Health, the leading provider of data-driven strategy analytics for the health economy, announced the launch of Network Explorer, a point-and-click application to manage network performance.
  • Network Explorer enables stakeholders across the health economy to form evidence-based strategies to improve their network performance. Limited to their own data, no health economy stakeholder has a full picture of the scope of physician-patient interactions, leaving them exposed to unknown and, therefore, unaddressable network misalignment.

Empowering Stakeholders: Leveraging the Network Explorer Tool for Enhanced Health Economy Alignment

Stakeholders in the health economy are subject to unknown and, therefore, unaddressable network misalignment since they are limited to their own data and do not have a complete picture of the spectrum of physician-patient interactions. Physician decisions have a direct impact on the financial performance of a wide range of stakeholders, for which the Network Explorer tool is intended to enable use cases. Using Network Explorer, users can: 

1. Boost Provider Alignment: Monitor referrals both inside and outside of a network to spot potential for partnerships with independent organisations and misalignment with affiliated providers.

2. Find Gaps in the Network: To guide long-term growth goals, examine how network alignment varies throughout specialties, procedure codes, health plans, and treatments.

3. Benchmark Against Rivals: Examine competing networks’ volumes and referral trends to find tactical openings for successful competition.

“Every physician-patient interaction affects the network performance of every health economy stakeholder, whether they know it,” said Hal Andrews, Chief Executive Officer for Trilliant Health. “Referrals to other providers are made, or not. Referrals are made ‘in-network,’ or not. The U.S. health economy is simply the aggregation of millions of small decisions that are made, or not, every day. Every health economy stakeholder’s network performance depends on how many of those decisions were favorable to their business, or not.”

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CDC Awards Truveta Real-World Data Contract to Study COVID, Maternal Health, Pediatric Care https://hitconsultant.net/2024/01/23/truveta-partners-with-cdc-to-power-public-health-research/ https://hitconsultant.net/2024/01/23/truveta-partners-with-cdc-to-power-public-health-research/#respond Tue, 23 Jan 2024 09:39:51 +0000 https://hitconsultant.net/?p=76889 ... Read More]]>
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What You Should Know:

Truveta, a consortium of 30 health systems united in “Saving Lives with Data,” has secured a significant partnership with the U.S. Centers for Disease Control and Prevention (CDC).

– This collaboration will leverage Truveta’s vast repository of real-world healthcare data to empower CDC researchers in tackling pressing public health challenges, including COVID-19, maternal health, and pediatric care.

Unprecedented Data Access for COVID-19 Insights

Truveta will provide the CDC with access to anonymized electronic health record (EHR) data from over 100 million patients, offering a comprehensive and timely snapshot of real-world healthcare experiences. This unprecedented access will equip CDC researchers with novel insights into:

  • SARS-CoV-2 variants: Understanding the spread and impact of new variants is crucial for informing public health measures and vaccine strategies.
  • Vaccinations and testing: Truveta’s data can reveal the effectiveness of vaccination and testing programs, helping optimize resource allocation and improve public health outcomes.
  • Re-infection and long-term effects: Studying re-infection patterns and long-term health impacts of COVID-19 will be vital for developing effective treatment strategies and managing long-term consequences.

Beyond COVID-19: Maternal and Pediatric Health Research

The collaboration extends beyond COVID-19, providing valuable data for research on critical areas like maternal and pediatric health. This includes:

  • Maternal health: Truveta’s data can shed light on pregnancy and childbirth complications, leading to improved prenatal care and maternal health outcomes.
  • Pediatric care: Studying childhood illnesses and healthcare utilization through Truveta’s data can inform preventive measures and optimize pediatric care delivery.

“As the coronavirus pandemic began ravaging our country and the world, Truveta was formed in 2020 to bring together data that would enable faster answers and better care,” said Truveta CEO Terry Myerson. “This is a full-circle moment for Truveta to provide the CDC with regulatory-grade data and powerful analytics to enable scientifically rigorous research on COVID and other major public health concerns that improves care for us all. We are honored that our unique data will help the CDC advance its mission of working 24/7 to save lives and protect people.” 

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Leveraging RWD & Tech: Diversifying Clinical Research for Real-World Impact https://hitconsultant.net/2024/01/18/leveraging-rwd-tech-diversifying-clinical-research-for-real-world-impact/ https://hitconsultant.net/2024/01/18/leveraging-rwd-tech-diversifying-clinical-research-for-real-world-impact/#respond Thu, 18 Jan 2024 09:00:00 +0000 https://hitconsultant.net/?p=76798 ... Read More]]>
James Coutcher, Sr.Director and Global Head of Emerging Methods and Solutions for IQVIA

In today’s complex healthcare landscape, real-world data (RWD) is increasingly valued for its information regarding diverse patient populations. Clinical research sites are an essential part of the RWD collection process, which increasingly leverages advanced technologies that enhance data collection, analysis and informed decision-making. 

RWD can accelerate development timelines and augment clinical trial insights with key observational results from a wider and more diverse range of patients. However, clinical research sites face numerous challenges beyond the collection of RWD, such as managing overburdened staff, constrained budgets and the imperative to maintain high-quality patient care.

Diversity adds tangible value

Diversifying RWD in terms of population and data sources is crucial for generating real-world evidence (RWE) with far-reaching implications. RWD includes information from electronic health records (EHRs), claims data and patient-reported outcomes (PROs), which can provide a more complete picture of patient’s medical histories, healthcare usage and treatment experiences. The value of RWD resides in its many applications, such as treatment strategy documentation, individualized treatment planning and treatment efficacy and safety assessment in real-world populations.

Integrated technology solutions can augment the potential of clinical trial sites to realize the benefits of RWD collection. For example, technology can enable the extraction and curation of unstructured relevant data from patient records. These can provide additional and valuable insights into treatment rationale or assist in more precise in-patient identification for clinical trial participation. This data can also be used to study the differences in patient journeys for a given disease to advise quicker, more informed decisions and assess therapies for broader patient populations. This inclusivity extends to assessing treatments for different socioeconomic groups, gender-based variations and age-specific considerations. It also permits the evaluation of treatment effects in populations frequently excluded from traditional clinical trials, such as pregnant women.

Together, sites and technology facilitate swift advancements in research and the development of life-saving therapies. 

Challenges in collecting real-world data

Collecting RWD for clinical research presents several challenges in several areas. For example, there are budget constraints that often limit the time allocated for research, meaning that staff can be overburdened as HCPs must prioritize patient care. When resources are available for research, the collection of observational data tends to be deprioritized in favor of clinical trials for novel therapies.

Moreover, there can be concerns relating to data completeness. Often, a patient’s data is siloed across various providers, which hinders the ability to create a comprehensive and coherent picture of a patient’s healthcare record. 

Another challenge includes data integration and linkage. Integrating RWD from disparate sources requires robust data linkage methods to ensure patient identifiers are accurate and consistent across datasets. This is crucial for identifying and tracking individuals throughout their patient care journey. As RWD is often collected from diverse sources, such as EHRs, claims data, patient-reported outcomes and wearable devices, this heterogeneity can lead to inconsistencies in data formats, coding practices and missing values, which can complicate data analysis and interpretation. A lack of standardization in data collection and coding practices can hinder data comparability and analysis. 

Patient diversity in data availability is another challenge. Clinical trials have traditionally been out of reach for many, particularly those in rural areas and low-income communities, which may be due to transportation hurdles, language barriers and site research capabilities. Even awareness of clinical trials can be a challenge, especially for underserved populations, which may not have equal access to information.

Technology fatigue is an increasing issue for clinical sites. Individual technological solutions are not always integrated with each other, resulting in increased site burden for technology training, excessive log-in requirements and handling updates. These challenges highlight the necessity for advanced integrated technological solutions to streamline processes and enhance the quality of data collected and analyzed in clinical research and open clinical trials to more representative populations and democratize clinical trial access.

Advanced technologies mitigate challenges

Technology is already being leveraged in several beneficial ways. For example, EMR data can be fed directly into an Electronic Data Capture (EDC) system. This means that when running a clinical trial or study requiring case report forms, technology can automatically pre-populate fields within those forms using relevant data from the EMR. All that remains for the site is to confirm the accuracy of the data and fill in any missing information. This streamlines the process by leveraging secondary data, ultimately alleviating site burden in observational studies.

Increasingly, the role of modern clinical technologies, like artificial intelligence (AI), in overcoming RWD collection challenges, enhancing patient and disease diversity in clinical research and improving patient care is becoming pivotal in several important ways:

Enabling interoperability: A lack of interoperability between health information systems reduces the quality of care provided to patients and wastes resources. Technology, including AI, may be able to support healthcare interoperability by addressing the challenges of fragmented data and disparate systems, such as data standardization and harmonization, data matching and linking and real-time data sharing and access. Addressing data fragmentation and data exchange can empower healthcare providers to deliver more coordinated, efficient and patient-centered care.

Enhanced patient recruitment for diverse populations: AI-embedded digital platforms are helping sites identify patient populations through optimal channels, such as social media and telehealth, enhancing patient recruitment for clinical studies and helping them reach broader, more diverse patient populations. 

Expanding scope to encompass underdiagnosed diseases: By collecting and analyzing large RWD sets, AI can pinpoint diseases that are underdiagnosed, like non-alcoholic steatohepatitis and idiopathic pulmonary fibrosis. It can also help rare disease sites recruit patients by identifying those at risk or who should be screened but have not been diagnosed, thus enhancing recruitment. 

Streamlining patient experiences: Smart technologies are simplifying patient experiences and improving clinical research involvement by enabling remote participation and minimizing the need for physical presence at research sites. It is also enabling the prediction of personalized therapies and diagnostics through large dataset analysis, leading to more effective, individualized treatments. Wearable devices, such as Fitbits and glucose monitoring devices, can, for example, collect real-time patient data, making clinical research more accessible and easier for patients. Furthermore, telemedicine visits allow those with limited mobility or living in rural areas to take part, supporting increased patient diversity.

Deeper insights into advancing patient therapies: Modern AI technologies enable deeper insights into the effectiveness of potential therapies across diverse patient populations by collecting and analyzing large datasets. 

The future of technology in real world data collection

Diversifying available data hubs has a pivotal role in unlocking the full potential of RWD and generating impactful RWE that benefits a diverse range of patient groups. Developing standardized data collection practices, harmonizing data elements and implementing robust data governance frameworks can ensure the quality, reliability and validity of RWD for clinical trials, leading to more informed treatment decisions and improved patient outcomes.

Various technologies can streamline RWD collection and analysis, reduce costs, enhance patient recruitment and enable deeper insights into advancing patient therapies. These capabilities must be integrated to minimize site fatigue from technology overload. However, by embracing the transformative power of technology, organizations can revolutionize clinical research and usher in a new era of personalized and equitable healthcare. 


About James Coutcher
James Coutcher is a seasoned industry expert and currently serves as the Senior Director and Global Head of Emerging Methods and Solutions, Real World Solutions at IQVIA. Prior to his role at IQVIA, James held executive positions including Vice President, Commercial Solutions at CorEvitas, LLC (formerly Corrona), and Global Head of Healthcare at GlobalData. James earned his Bachelor of Arts in Chemistry from Boston University, further complementing his expertise with an MBA from Quantic School of Business and Technology.

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ConcertAI Acquires CancerLinQ to Expand Real-World Data and AI Solutions for Cancer Care https://hitconsultant.net/2023/12/11/concertai-acquires-cancerlinq/ https://hitconsultant.net/2023/12/11/concertai-acquires-cancerlinq/#respond Mon, 11 Dec 2023 16:43:07 +0000 https://hitconsultant.net/?p=76111 ... Read More]]>

What You Should Know:

ConcertAI, a developer of AI-powered healthcare solutions, announced today the acquisition of CancerLinQ, a subsidiary of the American Society of Clinical Oncology (ASCO).

– This strategic move will significantly enhance and expand CancerLinQ’s capabilities, unlocking the potential of real-world data and next-generation AI to revolutionize cancer care and accelerate clinical research.

CancerLinQ Background

CancerLinQ represents one of the largest oncology real-world data and quality of care technology services entities in the world. With access to data from nearly seven million patients across a network of over 100 cancer centers and oncology practices, CancerLinQ empowers healthcare professionals with data-driven insights to improve care delivery and research outcomes.

CancerLinQ Acquisition Benefits

Building on CancerLinQ’s existing strengths, the acquisition will:

– Expand CancerLinQ’s real-world data platform: ConcertAI will invest more than $250 million over the next few years to integrate additional data sources into the platform, providing a broader and deeper understanding of cancer patients and their care.

– Develop innovative clinical trial solutions: By leveraging ConcertAI’s Digital Access to Clinical Trial (DACT) platform, CancerLinQ will facilitate patient participation in clinical trials, making it more accessible and less burdensome.

– Enhance clinical decision support tools: The combined expertise of ConcertAI and ASCO will lead to the development of more robust clinical decision support tools within the SmartLinQ™ platform, empowering physicians to make informed treatment decisions.

– Streamline data integration: Automated EMR integration will be implemented, seamlessly incorporating SmartLinQ into existing practice workflows.

This collaboration is expected to deliver significant benefits for various stakeholders:

– Oncology practices: Enhanced SmartLinQ™ platform, improved access to clinical trials, and streamlined data integration.

– Patients: Better access to treatment options, improved care quality, and more personalized treatment plans.

– Researchers: Faster development of new drugs and therapies through access to a vast and diverse pool of real-world data.

“We believe this agreement will provide the resources to fulfill and amplify CancerLinQ’s impact,” said Dr. Clifford A. Hudis, MD, FACP, FASCO, Chief Executive Officer of ASCO. “We expect CancerLinQ to be an important avenue for practices to achieve certification under ASCO’s recently launched ASCO Certified program.”

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Syapse and FDA OCE Collaborate to Advance Real-World Evidence in Oncology https://hitconsultant.net/2023/12/05/syapse-and-fda-oce-collaborate-to-advance-real-world-evidence-in-oncology/ https://hitconsultant.net/2023/12/05/syapse-and-fda-oce-collaborate-to-advance-real-world-evidence-in-oncology/#respond Tue, 05 Dec 2023 19:18:29 +0000 https://hitconsultant.net/?p=76003 ... Read More]]>

What You Should Know:

Syapse®, a leading real-world evidence (RWE) company dedicated to extinguishing the fear and burden of serious diseases, and the FDA Oncology Center of Excellence (OCE) today announced the renewal of their four-year collaboration agreement.

– This expanded strategic partnership aims to collaboratively develop and implement research projects that advance the use of real-world data (RWD) and explore the potential of RWE to inform regulatory decisions in oncology.

Harnessing the Power of Real-World Data

This strategic partnership aims to address the evolving landscape of oncology care by leveraging the vast potential of RWD and RWE. The collaboration will focus on evaluating RWD study designs and analytic methods, developing clinically meaningful research questions regarding cancer patient care, treatment, and outcomes, and facilitating the use of novel oncology data sources.

Key objectives of the renewed partnership include:

Exploring RWD Study Designs and Analytic Methods: The partners will investigate and evaluate various RWD study designs and analytic methods to ensure the validity and reliability of RWE generated from RWD sources.

Developing Clinically Meaningful Research Questions: Syapse and the OCE will collaborate to identify and prioritize clinically relevant research questions that can be addressed using RWD and RWE, with a focus on improving patient care and outcomes.

Analyzing Syapse Learning Health Network (LHN) Data: The LHN, a vast repository of real-world oncology data, will serve as a valuable source for conducting observational studies and generating RWE.

Evaluating Novel Oncology Data Sources: The collaboration will explore the potential of emerging oncology data sources, such as electronic health records and genomic data, to further enhance RWE generation.

Building Upon Early Success

The renewed partnership builds upon the successful collaboration between Syapse and the OCE, which has yielded valuable insights into safety and health disparities in oncology care. The partners have previously conducted studies on immune-checkpoint inhibitor-related pneumonitis in lung cancer and the impact of COVID-19 on cancer patients.

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Veradigm Invests $30M in Behavioral Health Co. Holmusk https://hitconsultant.net/2023/10/03/veradigm-invests-30m-in-behavioral-health-co-holmusk/ https://hitconsultant.net/2023/10/03/veradigm-invests-30m-in-behavioral-health-co-holmusk/#respond Tue, 03 Oct 2023 04:00:00 +0000 https://hitconsultant.net/?p=74583 ... Read More]]>

What You Should Know: 

Veradigm Inc. (NASDAQ: MDRX), a  provider of healthcare data and technology solutions, announced it has made a $30M strategic investment in Holmusk, a global behavioral  health real-world evidence company. The strategic investment builds on the strengths of each company to fuel innovation in behavioral health and create the evidence needed to move the field forward. 

– In this new phase of the collaboration, cohorts of millions of behavioral health patients and related de-identified clinical data from Veradigm will be added to Holmusk’s NeuroBlu Database, a source for real-world data (RWD) that shows how behavioral healthcare is delivered. The NeuroBlu Database will now be able to power even more research and address challenging behavioral health questions that require the creation of targeted research cohorts.

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Atropos Health Partners, Janssen Partner to Accelerate Clinical Trials with RWD https://hitconsultant.net/2023/09/27/atropos-health-partners-janssen-partner-to-accelerate-clinical-trials-with-rwd/ https://hitconsultant.net/2023/09/27/atropos-health-partners-janssen-partner-to-accelerate-clinical-trials-with-rwd/#respond Wed, 27 Sep 2023 13:01:00 +0000 https://hitconsultant.net/?p=74492 ... Read More]]>

What You Should Know:

  • Atropos Health, a pioneer in evidence-based healthcare known for its Green Button Clinical Informatics Consult Service, today announced an agreement with Janssen Research & Development, LLC (Janssen), a Johnson & Johnson company, to help accelerate clinical development with real-world data analysis.
  • Building upon an existing collaboration, under the new agreement, Atropos and Janssen data scientists will utilize Atropos’s software platform to interrogate Janssen’s in-house real-world data sets to inform clinical development strategies, including optimizing trial design, understanding patient natural histories and assessing outcomes in real-world patient populations. The collaboration will span a broad portfolio of therapeutic areas.

Data-Driven Analysis to Accelerate Clinical Development

“Atropos Health’s core mission is to close the evidence gap for patients worldwide,” said Dr. Brigham Hyde, CEO and Co-Founder of Atropos Health. “We are thrilled to collaborate with Janssen R&D’s world-class data scientists to support efforts to generate insights that could help optimize and accelerate clinical trials.” 

As a leader in rapid, rigorous evidence generation across the spectrum of research and clinical use, Atropos Health builds technology to help accelerate clinical development and shorten time to value. Atropos Evidence Platform combines the Green Button Clinical Informatics Consult Service with cloud-based data integration within life science companies’ technology stack to generate evidence in 48 hours in a private library. Life science companies use this unique blend of software and clinical expert services to maximize their real-world data assets for iterative hypothesis testing, protocol feasibility, cohort analysis, treatment pathways, patient journeys, unmet need, and more.

Evidence may be produced from customers’ cloud-based in-house data platforms behind their firewall, adding to the value of their existing infrastructure investments, or from external data via Atropos Evidence™ Network, offering a secure mechanism for greater information access and study capabilities. All network evidence contains a Real World Fitness Score (RWFS™) that shows the fitness of the underlying data for that study. It helps life science companies quickly identify “fit-for-purpose” data – a new capability that is shifting paradigms in data strategy. Life Science companies use it for faster analyses that can be validated with clinical perspectives – tackling many of the greatest challenges to evidence generation.

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COTA Launches EHR Dataset to Advance Generative AI Models for Cancer Care https://hitconsultant.net/2023/09/26/cota-launches-ehr-dataset-to-advance-generative-ai-models-for-cancer-care/ https://hitconsultant.net/2023/09/26/cota-launches-ehr-dataset-to-advance-generative-ai-models-for-cancer-care/#respond Tue, 26 Sep 2023 16:47:03 +0000 https://hitconsultant.net/?p=74476 ... Read More]]>

What You Should Know:

– COTA, a real-world oncology data and analytics company announced the launch of Vista, a large-scale automated EHR dataset to accelerate cancer research and the deployment of trusted generative AI in cancer care.

– Vista will provide biopharmaceutical companies with timely insights from real-world data sources to bring life-saving therapies to market faster. Vista uses automated data abstraction techniques, machine learning algorithms, and medical expert oversight to glean clinically relevant information from electronic medical records at scale.

How Vista Works

Unreliable data is the single largest barrier to unlocking generative AI as a breakthrough tool to transform cancer therapy for millions of patients. Vista sources data directly from the electronic medical record and COTA oncologists provide programmatic oversight of the data to ensure the information is clinically precise and relevant. This transparency is critical to power trustworthy AI tools. That information provides better insights into the holistic journey of cancer patient populations, with the goal of not only powering retrospective analyses but also enabling patient matching into clinical trials.

“Real-world data that tells a more complete story of a patient has accelerated our understanding of cancer and the development of lifesaving and life-extending therapies,” said Miruna Sasu, CEO of COTA. “Generative AI has even more potential to advance treatment options for millions of people if we can build trusted large language models for oncology. That means first curating and validating data at a fundamentally different pace and scale. That’s what we are doing with Vista.”

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Atropos Health Goes Global With New Funding from Samsung, Presido Ventures https://hitconsultant.net/2023/09/21/atropos-health-goes-global-with-new-funding-from-samsung-presido-ventures/ https://hitconsultant.net/2023/09/21/atropos-health-goes-global-with-new-funding-from-samsung-presido-ventures/#respond Thu, 21 Sep 2023 14:15:50 +0000 https://hitconsultant.net/?p=74387 ... Read More]]>

What You Should Know:

  • Atropos Health, a pioneer in evidence-based healthcare known for its Green Button Clinical Informatics Consult Service, today announced that it has completed strategic financing from Presidio Ventures, the venture arm of Sumitomo Corporation, Samsung Next, a venture arm of Samsung Electronics, Gaingels, and others.
  • The funding enables Atropos Health to accelerate commercial and development opportunities outside the U.S., using its proprietary technology and approach. The initial focus centers on key customers in Japan and Brazil.

Addressing the Global Evidence Gap in Markets Plagued by Tight Data Restrictions and Lack of Clinical Trial Diversity

“While the lack of representation in clinical trials creates an evidence gap for up to 70 percent of U.S patients, this effect is even more pronounced internationally. Lack of representation and relevant evidence on local populations leads to poorly informed treatment decisions and worse outcomes for patients around the world,” said Dr. Brigham Hyde, CEO and Co-Founder of Atropos Health. “The support from our new strategic investors, Presidio and Samsung Next, and international healthcare partners underscores the value we deliver on a global scale– to unlock real-world data for evidence-based medicine.”

Atropos Health offers the world’s first award-winning platform for faster data evaluation, evidence generation and Generative AI innovation of research and care. This platform is designed to meet the demands of health systems and life science companies working to solve increasingly global, diverse and data-intensive healthcare problems. Atropos Evidence Platform is federated, allowing for compliance with sovereign policies on data retention, security, and privacy – such as General Data Protection Regulation, the standard of EU privacy law. This critical infrastructure opens up global research opportunities to accelerate evidence generation and representation.

Atropos Health’s cloud-based platform is uniquely able to navigate the data restrictions faced in international markets, providing vital data and insights to frontline physicians and researchers abroad. This is happening at a time when life-saving medical research is increasingly multinational, with more than half of all clinical trials taking place outside the US. Diversity in clinical trials is essential to advancing innovation of the best treatments for the right patients. Atropos’ unique global offerings help life science leaders overcome this challenge. With the additional capital and in-market support provided by Presidio and Samsung Next, Atropos Health is commencing engagements with several, international customers who will both add global RWD to their Atropos Evidence Platform and drive new RWD in the Atropos Evidence Library. Providers and researchers outside the U.S. can begin to generate evidence-based insights through Atropos Green Button service. In addition to the strategic investment, Atropos Health has added partnerships with Analitica, Syndesis Health, DVX, and Project 360 LTD, to provide a critical footprint of in-market data integration support and channel distribution across Asia, South America and the Middle East.

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OM1 Launches Parkinson’s Disease Real-World Datasets for Neuroscience https://hitconsultant.net/2023/09/07/om1-launches-parkinsons-disease-real-world-datasets/ https://hitconsultant.net/2023/09/07/om1-launches-parkinsons-disease-real-world-datasets/#respond Thu, 07 Sep 2023 19:07:24 +0000 https://hitconsultant.net/?p=74103 ... Read More]]>

What You Should Know:

  • Today, OM1 announced the launch of its Parkinson’s Disease datasets, enhancing its Mental Health & Neuroscience Real-World Data Network.
  • OM1’s Mental Health & Neuroscience Real-World Data Network, which already includes robust datasets focused on Major Depressive Disorder, Multiple Sclerosis, Bipolar Disorder I and Schizophrenia, will further expand to include Alzheimer’s Disease in the coming months.

Parkinson’s Disease Premium Dataset

Nearly 1 million Americans are living with Parkinson’s Disease, but there’s currently no known cure and no interventions that help stop the progression of the disease. Understanding treatment options & disease progression in patients is critical in the next steps of care. The Parkinson’s Disease dataset includes more than 7,000 patients prospectively followed by neurologists in hundreds of clinics across all 50 states. To enrich the data, OM1 extracts relevant information from treating clinician notes using its unique artificial intelligence (AI) and language modeling capabilities. Data points include key symptoms, disease severity, treatments, longitudinal outcomes, and clinical response. In addition to the premium dataset, data from an additional 700,000 PD patients are available in the OM1 Real-World Data Cloud™ for modeling health economics outcomes, patient recruitment for clinical trials, prescriber trends, and other research needs.

The dataset combines real-world data sources, such as EMR, medical and pharmacy claims, mortality data and social determinants of health (SDoH), to provide deeper insights into Parkinson’s Disease patient journeys. The data can be leveraged to accelerate medical research and to support approvals and reimbursement, reducing the time to market and improving existing therapies.

“Understanding treatments and disease progression in patients suffering from this devastating illness with real-world data is critical for driving clinical advancements,” said Carl Marci, MD, Chief Psychiatrist and Managing Director of Mental Health and Neuroscience at OM1. “Among our goals is to break down barriers that impede access to deep clinical insights that otherwise would go unseen and unused to help develop personalized and targeted treatments for patients with Parkinson’s Disease.”

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