CancerLinQ aims to harness big data to improve cancer care by learning from every patient. It faces challenges of integrating diverse data types from genomics to behaviors. Its goals are precision, personalized medicine through molecular profiling of individual cancers. As clinical trials enroll few patients, CancerLinQ would provide real-world data from electronic health records to uncover new insights. When deployed, it will analyze de-identified patient records to uncover care patterns, allow comparing care to guidelines and peers, and provide evidence-based guidance. This has the potential to improve outcomes for patients and quality for providers and researchers.
SITIST 2015 Dev - Turning big data into presicion medicine real life examplessitist
油
Big data in healthcare comes from a variety of sources and formats including clinical trials, patient records, medical literature, genomic data, and medical imaging. This large volume of data presents challenges to make it accessible and usable. SAP offers platforms and solutions to unlock the value in healthcare big data by enabling precision medicine through analyzing diverse clinical and genomic data sources. Examples include SAP's partnership with ASCO on the CancerLinQ project to link oncology data and improve cancer treatment, and SAP Medical Research Insights deployed at the National Center for Tumor Diseases in Heidelberg, Germany.
AMCCBS Virtual2021 Conference Takeaways Part 1Carevive
油
Takeaways from Carevive's March 2nd presentation featuring Ethan Basch, Madelyn Trupkin Herzfeld, Bruno Lempernesse, and Nadia Still DNP, RN.
Learn more about Carevive's breakthrough cancer care platform:
https://bit.ly/3bJ5H1z
Pistoia Alliance US Conference 2015 - 1.1.3 Innovation in Pharma - Robert BolandPistoia Alliance
油
Janssen is exploring opportunities to use digital biomarkers and sensor technologies to create new services and improve patient engagement and treatment effectiveness. This involves cross-disciplinary teams researching how streaming data from consumer devices can be collected and assessed meaningfully. There are challenges around data quality from consumer devices, lack of standardization among devices and manufacturers, and evaluating which devices to select. The document outlines several potential use cases for digital patient technologies across the healthcare continuum, from early disease detection to clinical trials to consumer health.
Tomasz Sablinski from Transparency Life Sciences showed at the DayOne Expert event - Next Generation Clinical Trials ways to virtualize clinical trials or parts of them.
The document discusses the CDC's LabHIT program which aims to facilitate laboratory test ordering and reporting in electronic health records. The program develops and disseminates standardized terminology and code sets to support clinical data capture and interoperability. It also works with various stakeholders to engage in terminology development, promote semantic interoperability, and ensure usability and patient safety. The long-term goal is a single national reference database for recommended vocabulary sets to achieve full-scale interoperability for laboratory data.
This document provides information about an upcoming conference on oncology endpoints and quality of life assessments taking place in November 2015 in Philadelphia. Attendees will learn about (1) selecting clinical trial endpoints and interpreting quality of life measures to satisfy regulatory requirements, (2) understanding patient needs when designing trials and assessing oncology endpoints, and (3) developing patient-reported outcome tools to evaluate the benefits and risks of treatments. Featured speakers will provide insights and case studies on rapidly changing practices for endpoint selection and validation in oncology trials.
This presentation described features of a custom OR information system used to ensure timely administration of the correct antibiotics prior to surgery. The custom software (John Galt Systems) has since been replaced by an off-the-shelf product (Epic).
Patient Centricity: EHR Pillars to Patient CentricityDayOne
油
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
油
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
油
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
At the DayOne Experts even - Next Generation Clinical Trials, Lars G. Hemkens from University Hospital Basel shared his experience on how integrating data, that has been collected on a routine basis, into clinical trials will make a difference.
Accelerating Patient Care with Real World EvidenceCitiusTech
油
Life sciences and pharma companies are evolving their strategies to utilize Real World Data (RWD) to demonstrate value of pharmaceutical and medical device innovations. Technology advancements at the point of care and improvements in data collection strategies have led to a significant increase in the availability of RWD in healthcare
Real World Evidence (RWE) can provide actionable patient insights and accelerates time to market of new medical products in order to gain competitive advantage
With the emergence of wearable technologies, Internet of Things (IOT), Cognitive Computing, Genomics, Blockchain, etc., future RWE data sources will become more diverse and extensive. This document introduces the concept of Real World Evidence studies in healthcare, describes the various data sources for performing real world analytics and illustrates the role of RWE in better patient care. It then summarizes challenges faced while performing RWE analytics with respect to regulatory compliance, data accessibility and sharing, analysis reporting, costs etc.
Caris Life Sciences provides comprehensive molecular profiling services to help guide cancer treatment decisions. They have a large laboratory campus in Arizona that offers multiple technology platforms to analyze tumor biology. Caris also has a network of cancer centers that collaborate to profile patients, track outcomes, publish research, and establish guidelines for integrating molecular testing into care. The goal is to illuminate treatment options and match patients to therapies or clinical trials through their molecular intelligence reports.
Genome sequencing technology available today can accurately sequence a whole genome from an individuals test sample for a surprisingly low cost.
As a result, the adoption of this technology is rapidly expanding as medical centers around the world embrace its utility in informing healthcare decisionsan emerging reality of personalized medicine.
Tools to Drive Enrollment OCT Arena-Boston-2015Dan Diaz
油
The 4th Annual Clinical Operations in Oncology Trials East Coast was an amazing hit. Over 25 speakers challenged the 200 attendees on how- "WE" as an industry can use new tools and strategies to better our Clinical Trial Execution and Patient Enrollment.
With only 3% of the patients in the USA participating in Cancer Trials- we have to do a better job finding ways to educate them about the benefits of clinical studies.
The following tools are some of the new enhancements for better site and physician selection which can help find better results.
Real-Time Data. Real-World Impact. Info sheet Covance
油
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Cracking the Code: When and How to Validate ICD Algorithms for RWEInsideScientific
油
The availability of real world (e.g., routinely collected) data has allowed researchers to generate massive amounts of evidence on epidemiology, natural history, disease burden, and drug efficacy. However, very few studies conducted with these data use validated code algorithms to identify the study cohort, exposure, or control variables. Even when algorithms are validated, their performance is often suboptimal. Several research groups and government agencies have offered recommendations for when and how algorithms should be validated and how the results should be reported.
Key learning objectives:
- The majority of studies performed with real world data lack adequate algorithm validation.
- Exposures and outcomes algorithms are often more important to validate than population identification algorithms.
- Positive predictive value, while the most often reported validation statistic, may not be the most useful or important one
- Validation of algorithms for rare conditions requires a different approach than for common ones.
- Medical record review remains the only reliable validation method in most cases and cannot be reliably performed with artificial intelligence techniques.
- Validation of code algorithms using accepted methods improves study quality and increases chance of publication acceptance at higher impact journals.
Real-world Evidence A Saudi Regulatory PerspectiveUN SPHS
油
By Mr. Turki A. Al-Thunian, Bpharm, MClinPharm, MSc.Epi, PhD, Acting Director of the Research Informatics Department, Saudi Food and Drug Authority (SFDA), delivered at the Global Forum 2020 Drug Safety and Supply Chains session.
Smart phone-based herd health management tool ILRI
油
Poster prepared by Solomon Gizaw, Crawford Revie, Gennaro Imperatore, Dagim Berhanu and Barbara Wieland for the Virtual Livestock CRP Planning Meeting, 8-17 June 2020. Nairobi, Kenya: ILRI.
Sucessful Healthcare Organizations will be Data DrivenMichelle Blackmer
油
The document discusses how healthcare organizations are becoming increasingly data-driven. It notes that there is an estimated 50 petabytes of healthcare data, much of which is unstructured, and stored across hundreds of different sources like medical images and lab results. Integrating medical devices with electronic health records could save over $30 billion per year while improving patient care. However, only a third of hospitals currently integrate devices with EHRs. The large amount of data from various sources presents challenges around data quality, fragmentation, accuracy, and security. Healthcare organizations are increasingly relying on data and analytics to support population health, deliver best practices, increase patient engagement, and move from volume-based to value-based care. Clean, connected, and secure data
This document summarizes the Cortellis Clinical Trials Intelligence product. It provides access to over 130,000 clinical trials from around the world across various therapeutic areas. Users can access the data through a web portal or integrate it with other systems using APIs. The platform offers powerful search and filtering capabilities along with dynamic visualizations to analyze trial findings and competitive intelligence. It aims to help users accelerate strategic clinical development decisions and advance personalized medicine.
This document provides an overview of developments in clinical trial design, with a focus on adaptive designs. It discusses how adaptive designs allow trials to be modified based on accumulating data to make trials more efficient. The number of adaptive design trials has been growing annually by an average of 11.5%. Various types of adaptive designs are described, including exploratory, confirmatory, seamless, and enrichment designs. Specific examples highlight how adaptive designs can help drop ineffective treatments earlier and identify more promising treatments. Regulatory progress on adaptive designs and remaining hurdles are also discussed.
The document summarizes ChathamHealthLink, a health information exchange program in Chatham County, Georgia. It was formed by the Chatham County Safety Net Planning Council in 2004 to improve access to and quality of healthcare for uninsured county residents. The program allows different healthcare providers using separate electronic medical record systems to securely share patient information through a central database. This reduces duplication of services, improves care coordination, and allows providers and the Council to track health outcomes and service trends across the safety net system. The goal is for ChathamHealthLink to eventually connect all area providers, hospitals, and behavioral health organizations using interoperable electronic records.
The Plantwise program aims to improve global food security and reduce poverty by supporting smallholder farmers. It does this through a network of local plant clinics staffed by plant doctors who provide free advice on pest and disease management. Data collected from clinic visits is compiled in an open access knowledge bank, along with information from other sources, to generate predictive maps and insights on emerging threats. The goal is to help farmers lose less of their crops to pests and diseases, allowing them to feed more people globally.
David Haggstrom Regenstrief Conference 際際滷sShawnHoke
油
The document discusses approaches to measuring and improving cancer care quality through health information technology and data sharing. It proposes:
1) Measuring quality using longitudinal data from sources like cancer registries to track entire patient populations.
2) Implementing health information exchange and clinical decision support systems to provide real-time quality data and reminders to guide screening and follow-up care.
3) Addressing accountability for follow-up care through approaches like assigning responsibility to larger provider groups or enabling data sharing through personal health records.
- The document discusses the Total Cancer Care (TCC) approach at Moffitt Cancer Center, which aims to provide personalized cancer care through comprehensive data collection and analysis.
- TCC collects extensive clinical, genomic, treatment and outcomes data from over 78,000 consented patients to power research studies and clinical trials matching. Molecular profiling has been conducted on over 14,000 tumor samples.
- The TCC data is housed in a large integrated database and used by researchers for studies in areas like radiochemotherapy response, exome sequencing, immunology biomarkers, and cancer epidemiology.
- The database also helps clinicians identify eligible patients for clinical trials and develop evidence-based treatment pathways. The goal is to transform cancer
This presentation described features of a custom OR information system used to ensure timely administration of the correct antibiotics prior to surgery. The custom software (John Galt Systems) has since been replaced by an off-the-shelf product (Epic).
Patient Centricity: EHR Pillars to Patient CentricityDayOne
油
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
What Happens After Your Device is Approved? Collecting Data in the Real WorldMedpace
油
In this workshop, Medpace will discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research. To listen to this presentation, visit https://vimeo.com/168768256
From Edge Case to Main Case, Michelle Longmire of Medable_mHealth IsraelLevi Shapiro
油
Presentation by Michelle Longmire, CEO of Medable, April 20, 2021, for mHealth Israel. During CoVID, as physical access to clinics was limited, Medable enabled patients to continue participating in critical research efforts. Medable Supporting over 100 Studies Across a Diverse Array of Therapeutic Areas. Medable provides a platform for seamless evidence
generation, across the entire patient journey. Connecting patients globally for community, care, and research. Improve patient experience and retention. Reduce site burden. Data Cloud & Platform should be flexible and modular to enable protocol-fit digital. Medable Digitome, for data driven decentralized trials and a new era of understanding patients, therapies, and conditions. Clinical research is a small component of the broader healthcare journey. Enable health data and evidence generation from clinical to commercial, from day one. Continuous health data & evidence from clinical to commercial and beyond. The Digitome can provide a
primary observational protocol that collects large scale baseline data in a framework that enables streamlined recruitment, enrollment, and participation into interventional clinical substudies.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
This document provides an overview of clinical research, including what clinical research is, the clinical research process, types of organizations involved, and the steps involved in clinical trials. It then discusses KSR Clinical Research, a consulting firm that places clinical research professionals with pharmaceutical, biotech, and medical device companies as well as research facilities. KSR provides recruitment, project management support, and competencies across various clinical research functions and therapeutic areas.
At the DayOne Experts even - Next Generation Clinical Trials, Lars G. Hemkens from University Hospital Basel shared his experience on how integrating data, that has been collected on a routine basis, into clinical trials will make a difference.
Accelerating Patient Care with Real World EvidenceCitiusTech
油
Life sciences and pharma companies are evolving their strategies to utilize Real World Data (RWD) to demonstrate value of pharmaceutical and medical device innovations. Technology advancements at the point of care and improvements in data collection strategies have led to a significant increase in the availability of RWD in healthcare
Real World Evidence (RWE) can provide actionable patient insights and accelerates time to market of new medical products in order to gain competitive advantage
With the emergence of wearable technologies, Internet of Things (IOT), Cognitive Computing, Genomics, Blockchain, etc., future RWE data sources will become more diverse and extensive. This document introduces the concept of Real World Evidence studies in healthcare, describes the various data sources for performing real world analytics and illustrates the role of RWE in better patient care. It then summarizes challenges faced while performing RWE analytics with respect to regulatory compliance, data accessibility and sharing, analysis reporting, costs etc.
Caris Life Sciences provides comprehensive molecular profiling services to help guide cancer treatment decisions. They have a large laboratory campus in Arizona that offers multiple technology platforms to analyze tumor biology. Caris also has a network of cancer centers that collaborate to profile patients, track outcomes, publish research, and establish guidelines for integrating molecular testing into care. The goal is to illuminate treatment options and match patients to therapies or clinical trials through their molecular intelligence reports.
Genome sequencing technology available today can accurately sequence a whole genome from an individuals test sample for a surprisingly low cost.
As a result, the adoption of this technology is rapidly expanding as medical centers around the world embrace its utility in informing healthcare decisionsan emerging reality of personalized medicine.
Tools to Drive Enrollment OCT Arena-Boston-2015Dan Diaz
油
The 4th Annual Clinical Operations in Oncology Trials East Coast was an amazing hit. Over 25 speakers challenged the 200 attendees on how- "WE" as an industry can use new tools and strategies to better our Clinical Trial Execution and Patient Enrollment.
With only 3% of the patients in the USA participating in Cancer Trials- we have to do a better job finding ways to educate them about the benefits of clinical studies.
The following tools are some of the new enhancements for better site and physician selection which can help find better results.
Real-Time Data. Real-World Impact. Info sheet Covance
油
Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies.
Cracking the Code: When and How to Validate ICD Algorithms for RWEInsideScientific
油
The availability of real world (e.g., routinely collected) data has allowed researchers to generate massive amounts of evidence on epidemiology, natural history, disease burden, and drug efficacy. However, very few studies conducted with these data use validated code algorithms to identify the study cohort, exposure, or control variables. Even when algorithms are validated, their performance is often suboptimal. Several research groups and government agencies have offered recommendations for when and how algorithms should be validated and how the results should be reported.
Key learning objectives:
- The majority of studies performed with real world data lack adequate algorithm validation.
- Exposures and outcomes algorithms are often more important to validate than population identification algorithms.
- Positive predictive value, while the most often reported validation statistic, may not be the most useful or important one
- Validation of algorithms for rare conditions requires a different approach than for common ones.
- Medical record review remains the only reliable validation method in most cases and cannot be reliably performed with artificial intelligence techniques.
- Validation of code algorithms using accepted methods improves study quality and increases chance of publication acceptance at higher impact journals.
Real-world Evidence A Saudi Regulatory PerspectiveUN SPHS
油
By Mr. Turki A. Al-Thunian, Bpharm, MClinPharm, MSc.Epi, PhD, Acting Director of the Research Informatics Department, Saudi Food and Drug Authority (SFDA), delivered at the Global Forum 2020 Drug Safety and Supply Chains session.
Smart phone-based herd health management tool ILRI
油
Poster prepared by Solomon Gizaw, Crawford Revie, Gennaro Imperatore, Dagim Berhanu and Barbara Wieland for the Virtual Livestock CRP Planning Meeting, 8-17 June 2020. Nairobi, Kenya: ILRI.
Sucessful Healthcare Organizations will be Data DrivenMichelle Blackmer
油
The document discusses how healthcare organizations are becoming increasingly data-driven. It notes that there is an estimated 50 petabytes of healthcare data, much of which is unstructured, and stored across hundreds of different sources like medical images and lab results. Integrating medical devices with electronic health records could save over $30 billion per year while improving patient care. However, only a third of hospitals currently integrate devices with EHRs. The large amount of data from various sources presents challenges around data quality, fragmentation, accuracy, and security. Healthcare organizations are increasingly relying on data and analytics to support population health, deliver best practices, increase patient engagement, and move from volume-based to value-based care. Clean, connected, and secure data
This document summarizes the Cortellis Clinical Trials Intelligence product. It provides access to over 130,000 clinical trials from around the world across various therapeutic areas. Users can access the data through a web portal or integrate it with other systems using APIs. The platform offers powerful search and filtering capabilities along with dynamic visualizations to analyze trial findings and competitive intelligence. It aims to help users accelerate strategic clinical development decisions and advance personalized medicine.
This document provides an overview of developments in clinical trial design, with a focus on adaptive designs. It discusses how adaptive designs allow trials to be modified based on accumulating data to make trials more efficient. The number of adaptive design trials has been growing annually by an average of 11.5%. Various types of adaptive designs are described, including exploratory, confirmatory, seamless, and enrichment designs. Specific examples highlight how adaptive designs can help drop ineffective treatments earlier and identify more promising treatments. Regulatory progress on adaptive designs and remaining hurdles are also discussed.
The document summarizes ChathamHealthLink, a health information exchange program in Chatham County, Georgia. It was formed by the Chatham County Safety Net Planning Council in 2004 to improve access to and quality of healthcare for uninsured county residents. The program allows different healthcare providers using separate electronic medical record systems to securely share patient information through a central database. This reduces duplication of services, improves care coordination, and allows providers and the Council to track health outcomes and service trends across the safety net system. The goal is for ChathamHealthLink to eventually connect all area providers, hospitals, and behavioral health organizations using interoperable electronic records.
The Plantwise program aims to improve global food security and reduce poverty by supporting smallholder farmers. It does this through a network of local plant clinics staffed by plant doctors who provide free advice on pest and disease management. Data collected from clinic visits is compiled in an open access knowledge bank, along with information from other sources, to generate predictive maps and insights on emerging threats. The goal is to help farmers lose less of their crops to pests and diseases, allowing them to feed more people globally.
David Haggstrom Regenstrief Conference 際際滷sShawnHoke
油
The document discusses approaches to measuring and improving cancer care quality through health information technology and data sharing. It proposes:
1) Measuring quality using longitudinal data from sources like cancer registries to track entire patient populations.
2) Implementing health information exchange and clinical decision support systems to provide real-time quality data and reminders to guide screening and follow-up care.
3) Addressing accountability for follow-up care through approaches like assigning responsibility to larger provider groups or enabling data sharing through personal health records.
- The document discusses the Total Cancer Care (TCC) approach at Moffitt Cancer Center, which aims to provide personalized cancer care through comprehensive data collection and analysis.
- TCC collects extensive clinical, genomic, treatment and outcomes data from over 78,000 consented patients to power research studies and clinical trials matching. Molecular profiling has been conducted on over 14,000 tumor samples.
- The TCC data is housed in a large integrated database and used by researchers for studies in areas like radiochemotherapy response, exome sequencing, immunology biomarkers, and cancer epidemiology.
- The database also helps clinicians identify eligible patients for clinical trials and develop evidence-based treatment pathways. The goal is to transform cancer
This document discusses Moffitt Cancer Center's Total Cancer Care program which aims to transform cancer care through a personalized approach. It involves collecting extensive clinical, molecular, and biospecimen data from patients over their lifetime to power research. The goals are to improve outcomes through early detection, personalized treatment, and clinical trials matching. Moffitt has established an extensive biorepository and informatics platform to integrate data from over 78,000 consented patients to enable precision oncology research.
This document discusses using data from the Veterans Affairs (VA) healthcare system to conduct precision oncology research. It describes extracting data from the VA Corporate Data Warehouse, including clinical records from cancer registries and records of patients who received tumor sequencing and immunotherapy. The author builds a cohort of 330 non-small cell lung cancer patients who received immunotherapy before 2018 and had their cancer verified in the registry to study outcomes like the impact of PD-L1 expression on response to treatment. Challenges include lag times in cancer registry reporting and building a large enough cohort to draw powerful conclusions from retrospective analyses.
Data in precision oncology SAMSI Precision Medicine Meeting mar 2019Warren Kibbe
油
Talk at the March 14-15 2019 SAMSI Advances in Precision and Personalized Medicine held as part of the Program on Statistical, Mathematical, and Computational Methods for Precision Medicine (PMED) at NCSU, Raleigh, NC
Electronic Medical Records: From Clinical Decision Support to Precision MedicineKent State University
油
This document discusses the transition from traditional clinical decision support using electronic medical records to precision medicine. It provides examples of how Cleveland Clinic has used electronic medical records to create registries for conditions like chronic kidney disease, develop predictive models, and power algorithms for precision treatment recommendations. The document envisions precision medicine relying on vast amounts of molecular, genomic, and patient-reported data integrated into clinical decision support.
Cancer principles & practice of oncologySAMANTHA Lopez
油
This chapter provides an overview of cancer genetic counseling. Cancer genetic counseling is a communication process that assesses an individual's cancer risk based on their family history of cancer. The goals are to provide clients with an understanding of their risk, emotional support, and determine if cancers in the family could be due to a hereditary cancer syndrome. There are over 30 hereditary cancer syndromes that can be caused by mutations in different genes, so genetic testing for these syndromes can be complex. The chapter emphasizes that accurate cancer risk assessment and counseling requires specialized training.
Real world Evidence and Precision medicine bridging the gapClinosolIndia
油
Real-world evidence and precision medicine represent complementary forces reshaping the healthcare landscape. The synergy between these realms offers a pathway to more personalized, effective, and patient-centered care. As technology, data analytics, and collaborative initiatives advance, the integration of real-world evidence into precision medicine practices holds the promise of revolutionizing how healthcare is delivered, ensuring that treatments are not only scientifically sound but also tailored to the unique characteristics and experiences of individual patients.
Dr. Dennis Wang discusses possible ways to enable ML methods to be more powerful for discovery and to reduce ambiguity within translational medicine, allowing data-informed decision-making to deliver the next generation of diagnostics and therapeutics to patients quicker, at lowered costs, and at scale.
The talk by Dr. Dennis Wang was followed by a panel discussion with Mr. Albert Wang, M. Eng., Head, IT Business Partner, Translational Research & Technologies, Bristol-Myers Squibb.
Day 2 Big Data panel at the NIH BD2K All Hands 2016 meetingWarren Kibbe
油
Big data in oncology and implications for open data, open science, rapid innovation, data reuse, reproducibility and data sharing. Cancer Moonshot, Precisions Medicine Initiative (PMI), the Genomic Data Commons, NCI Cloud Pilots, NCI-DOE Pilots, and the Cancer Research Data Ecosystem.
Are we ready for disruption in Translational Research through Digital Medicine?Ashish Atreja, MD, MPH
油
This is the slide deck that was presented at Translational Science 2016. Touches upon evidence generation as one of the most desired but expensive process in medical science. Provides examples of how Social Media, medical apps, quantified self movement are leading to patient generated data that can disrupt evidence generation process.
Patient engagement in clinical trials Martin Kelly
油
The document discusses improving patient engagement in clinical trials through digital methods. Only 2-5% of cancer patients currently participate in clinical trials. The top 3 solutions identified to engage patients were: 1) a clinical trial finder for patients to inform them of available trials, 2) virtual clinical trials conducted entirely online, and 3) tools to personalize clinical trials to individual patient needs/preferences. The document reviews several companies providing these types of solutions and proposes an experiment partnering with a CRO to test if a digital intervention increases patient enrollment and retention in a clinical trial compared to a control group without a digital intervention.
Precision Medicine in Oncology InformaticsWarren Kibbe
油
Precision medicine in oncology aims to provide targeted cancer treatments based on a patient's individual tumor characteristics. The presentation discusses precision oncology initiatives including NCI-MATCH clinical trials which assign cancer therapies based on a tumor's molecular abnormalities rather than location. It outlines plans to expand genomically-based cancer trials, understand and overcome treatment resistance through molecular analysis, and establish a national cancer database integrating genomic and clinical data to accelerate cancer research. Cloud computing platforms are being developed to provide researchers access to large cancer genomic and clinical datasets. The goal is to advance precision cancer treatment by incorporating individual patient genetics and biomarkers into therapeutic decision making.
Martha Schmidt has over 20 years of experience in clinical research, drug development, and the medical field. She has worked for several large pharmaceutical companies, managing clinical trials and ensuring regulatory compliance. She is knowledgeable about all phases of drug development and has experience in clinical oncology. Schmidt has extensive expertise in clinical data review and analysis. She is passionate about assisting with product liability and medical malpractice litigation through case review and serving as an expert witness.
How to Use Data to Improve Patient Safety: A Two-Part DiscussionHealth Catalyst
油
As healthcare organizations continue to experience expenses growing faster than revenues, value based care, and consumer transparency of costs and quality, patient safety will be an important determinant of success. This session will describe the sociotechnical attributes of a safe system, the challenges, the barriers and opportunities, and how to use data and your culture of safety as a powerful tool to drive down adverse events.
Attendees will learn:
Why patient safety and quality are important.
How data can help improve patient safety.
The history of patient safety and where we are today.
What components make up a safety analytics culture.
How the internal safety culture directly impacts patient safety metrics.
To describe basic guidelines for improving a safety culture with analytics.
On July 7, 2014, the Green Park Collaborative (GPC) of the Center for Medical Technology Policy (CMTP) and the Institute for Clinical and Economic Review (ICER) co-hosted a web conference to explore the evidence needed to demonstrate the effectiveness and value of new drugs to treat chronic hepatitis C (HCV) infection. Representatives from various stakeholder groups, including payers, patients, pharmaceutical industry, health technology assessment organizations, and regulatory bodies, presented and discussed this issue with a particular focus on:
1. The evidence generated for regulatory approval;
2. The evidence preferences of post-approval decision makers; and
3. Strategies to efficiently generate the additional evidence.
Each of the invited speakers gave a brief presentation followed by a question and answer session at the end of the presentations. Audience members had an opportunity to submit questions through a chat feature. The conference was moderated by Dr. Sean Tunis, Founder
and CEO of CMTP. More than 200 participants, including a variety of subject matter experts and stakeholder representatives, attended the web conference.
Video and webinar summary available here: http://www.cmtpnet.org/featured-projects/green-park-collaborative/gpc-usa-meetings/webinars/hepatitis-c-drugs-evidence-to-demonstrate-effectiveness-value
To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-fighting-neurodegenerative-diseases/
Evelyn Pyper, MPH discusses how a patient-centered approach to real-world data collection and evidence generation can transform research in neurodegeneration. Neurodegenerative diseases often affect both motor and cognitive function, produce emotional and social changes, and require significant caregiver support, all while stretching across a fragmented healthcare ecosystem. Participatory research that directly obtains patient consent, empowers patients, and simplifies the task of linking multiple data sources, can lead to a more comprehensive capture of medical histories. This presentation briefly explores ways in which patient-centered research can improve understanding of disease diagnoses, symptomatology, and progression.
Observational research can impact clinical decision making for cancer treatment by providing real-world evidence to complement randomized controlled trials, which have limitations. Observational studies capture long-term outcomes of various treatments in everyday practice. However, their findings are more susceptible to bias. To strengthen observational research, standards are needed for electronic health data collection and reporting, while prioritizing patient privacy and rigorous methodologies. With these improvements, observational data can better inform estimates of cancer progression and treatment effects.
OSU Medical Center CEO Steven Gabbe, MD delivers a talk on facilitating learning healthcare systems: Focus on approaches to leverage Health IT investments for advancements in research and personalized healthcare and learning from every patient.
This session will focus on the usages of HIT to learn from every patient so that this knowledge can be used to further the practice of medicine. The discussion will address the implications for research, privacy, and HIT to change the paradigm of advancing healthcare discoveries so that it is a continuous process driven through every patient interaction.
5. One disease 7 molecular driversand more
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Lung cancer: from one cancer to many
KRAS
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6. Evolution in Complex Disease
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1
vs
and everyday patients tend to be
less healthyolder and more diverse
than clinical trial patients.
1. Lewis JH, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol. 2003;21:1383-1389. http://jco.ascopubs.org/content/21/7/1383.full.pdf.
2. Mitchell AP, et al. Clinical trial subjects compared to "real world" patients: generalizability of renal cell carcinoma trials. J Clin Oncol. 2014;32(suppl):6510.
3. Taking action to diversify clinical cancer research. National Cancer Institute Web site. http://www.cancer.gov/ncicancerbulletin/051810/page7. Accessed July 23, 2014.
16. INFORMED: Framework
Transformation*
Formal submission
Data exported for
analysis
Data exchange/visualization
dashboard*
Sponsor
Transformation* as needed
*R&D and software development
Real world data
working group
Clinical
Knowledge
Base
17. When Deployed CancerLinQ Will:
Unlock, assemble, and analyze
de-identified cancer patient medical
records
Uncover patterns that can improve
patient care
Allow doctors to compare their care
against guidelines and the care of their
peers
Provide guidance by identifying the
best evidence-based course of care
18. 20
Improving Quality for Patients, Providers, Researchers
CancerLinQ improving QUALITY of care and enhancing outcomes; additional
benefits:
Patients
Improved outcomes
Clinical trial matching
Safety monitoring
Real-time side effect
management
Patient-reported
outcomes
Evidence based care
Providers
Real-time second
opinions
Observational and
guideline-driven clinical
decision support
Real-time access to
resources at the point of
care
Quality reporting and
benchmarking
Research/Public Health
Mining big data for
correlations and new
insights
Comparative effectiveness
research
Hypothesis-generating
exploration of data
Identifying early signals for
adverse events and
effectiveness in off label
use
20. SAP Foundation for Health
Providing breakthrough capabilities for healthcare and life sciences applications
from SAP and its partners, while reducing time to value and the total cost of ownership.
Support for any device
Partner apps for healthcare
and life sciences
SAP Medical Research
Insights
Health engagement
SAP Foundation for Health based on SAP HANA
Integration services
Spatial
Business
function library
Search Text mining
Predictive
analysis library
Database
services
Stored procedure & data models
Planning
engine
Rules engine
Application and user
interface services
Genomics
Healthcare integration services
#4: But to do that, we face two key challenges:
We need to learn from many more patients than we do today in fact, we need to learn from all of them; and
We have to harness data in powerful new ways
#5: As you can see here, the left represents an individuals genomic make-up.
And the right are clinical data that reflect a patients unique environment, behaviors and preferences.
To make a meaningful impact on cancer care, we cant take either of these in isolation.
#6: Take lung cancer for example soon, every cancer will be a rare cancer, defined by unique molecular characteristics
Brings vast increase in number of possibilities and the information physicians have to make sense of
Only way to do this is through powerful new data analytic tools
#7: Precision medicine also adds a new level of complexity to cancer care, creating the need for information management
#8: Right now, we essentially only learn from 3 percent of patients those who participate in clinical trials
#9: These clinical trial patients rarely reflect the real-world patients we see in clinics
The only way to keep pace with expanding scientific possibilities is to expand the number and diversity of the patients we can learn from
#10: This is the cancer data architecture in the inner circle, you have various sources of health data including data from EHRs, and clinical and genomic data that are critically important to patient care.
But these data are all housed in different places in their own information systems and data repositories.
We have to figure out how we can capture, move and share this information.
We need to understand how these data are structured, map that to a common model, move the data around from one warehouse to another, create information exchanges, and establish standards to transmit data. If we do that we achieve interoperability and have data liquidity.
And this is where SAP comes in because SAPs HANA technology can move massive amounts of data, precisely, and in real time.
#11: [Dr. Yu this is an adaptation of your slide on data to learning, to show how raw data can be transformed to what CancerLinQ aims to get at, increasing the understanding and real-world applicability of information. Please let us know if we captured it correctly or if you would like to revise]
#12: [Dr. Yu we took the next few slides from the slides you shared with us; let us know if your talking points for these slides fit with what comes before and after this section]
#14: Each stage of CancerLinQ will deliver successively more powerful tools and insights to physicians, researchers, patients and others in the cancer community.
The first version, being rolled out later this year, features several core components of the CancerLinQ system.
#15: First, doctors will have powerful new ways to visualize data from their electronic health records.
For example Theyll be able to view a visual, longitudinal record of any given patients care over time as you see here. 油
In effect, CancerLinQ gives them in an instant the story of that patients characteristics, the care theyve received, and the outcomes theyve experienced.
Until now, most physicians have had no simple way of constructing something like this.
#16: Doctors can dig down into any part of that story to:
Better understand why their patient might be experiencing some new health problem
See if any opportunities have been missed油
#17: Second, the physician will have a new way to see the quality of care theyre delivering at any moment.
油
And not just that theyll see if there are specific patients who are currently in need of an intervention to meet standards of care.
Example of a physician who is meeting a given quality measure 80 percent of the time.
CancerLinQ will identify what we call an actionable patient flagging a patient that requires follow-up care. So if shes not already scheduled for that care, the practice can reach out and ask her to come in to discuss.
The big shift here is from measuring quality retrospectively after the fact to intervening in real time to ensure that quality is achieved.
#21: Primary goal is QUALITY. This will deliver benefits for multiple audiences.
Educate and empower patients by linking them to their cancer care teams and providing personalized treatment information at their fingertips.
Improve personalized treatment decisions by cancer care teams by capturing patient information in real time at the point of care; providing real-time decision support tailored to each patient and his or her cancer; and automatically reporting on the quality of care compared with clinical guidelines and the outcomes of other patients.
Create a powerful new de-identified data source for use in real-world quality and comparative effectiveness studies, and to generate new ideas for clinical research.