Jan Geissler, EUPATI: Presentation at workshop "Patient involvement in medicines development - paradigm shift towards true patient impact in regulatory science?" at the University of Copenhagen on 6 May 2015
Partnering with Patients: Designing, Participating in and Reporting Health Ou...patvocates
Partnering with Patients: Designing, Participating in and Reporting Health Outcomes - presented by Jan Geissler at ISPOR 19th ANNUAL CONGRESS in Dublin on 6 Nov 2013
Master highyield pointofcare ultrasound applications that are targeted specifically to answer questions that arise commonly in the outpatient clinic! Written for primary care providers in  Family Medicine Pediatrics and Internal Medicine Ultrasound for Primary Care is a practical easytoread guide.  Learn to incorporate ultrasound to augment your physical exam for evaluation of thyroid nodules enlarged lymph nodes pericardial effusion chronic kidney disease and a host of musculoskeletal issues and much more.  Additionally included are chapters on ultrasound for guidance of procedures including joint injections lumbar puncture and needle biopsy to name a few. Wellillustrated and highly templated this unique title helps you expand the scope of your practice and provide more effective patient care.Puts key concepts in the perspective of common questions that arise in primary car
TreatmentMAP™
TreatmentMAP supports physicians in optimizing their treatment decisions, even for cancer patients in advanced stages of cancer, or when all of the standard treatment options for a patient have been exhausted.
Clinical trials are used to test whether new medical treatments work effectively and actually treat a disease. Conducting and designing clinical trials today can take years and cost millions of dollars. A workshop was held with clinical trial experts to discuss challenges in conducting clinical trials and ways to improve efficiency while maintaining high standards. The workshop focused on cardiovascular disease, depression, cancer, and diabetes and gained insights into differences in clinical trials by disease that could help overall improvement. Future work will further analyze regulatory, administrative, and financial barriers to effective clinical trials and develop a vision for a sustainable clinical research infrastructure in the United States.
1) Drug development involves multiple phases of clinical trials in humans (phases I-IV) to test dosing, safety and efficacy in an increasing number of patients before regulatory approval and market access.
2) Patient involvement in clinical research is important to ensure trials address patient priorities and perspectives on risk/benefit, endpoints, and trial design elements like inclusion criteria.
3) Key elements of a clinical trial protocol include type of comparisons, randomization, blinding, endpoints, inclusion/exclusion criteria, schedule of events, informed consent process, and patient reported outcomes.
HXR 2016: Tracking the Body: Devices, Consumer Genomics, and Sensors- Niall O...HxRefactored
As tracking has become more mainstream, consumers who were once only curious about their heart rate at the gym are now interested in diving deeper and learning more. This session takes a look at the technical side of the latest in telehealth solutions, genomic platforms, and hacks in the world of sensors and devices.
The document discusses the emerging field of precision medicine and how it represents a shift from symptom-based to evidence-based to personalized medicine. Precision medicine utilizes large datasets including multi-omics data, imaging, and other clinical data combined with machine learning algorithms and reference databases to generate personalized molecular profiles and enable targeted prevention and treatment. Key to realizing precision medicine's potential is establishing standards, processes, and reference databases to facilitate large-scale data analysis and ensure results can be reproduced.
Partnering with Patients: Designing, Participating in and Reporting Health Ou...patvocates
Partnering with Patients: Designing, Participating in and Reporting Health Outcomes - presented by Jan Geissler at ISPOR 19th ANNUAL CONGRESS in Dublin on 6 Nov 2013
Master highyield pointofcare ultrasound applications that are targeted specifically to answer questions that arise commonly in the outpatient clinic! Written for primary care providers in  Family Medicine Pediatrics and Internal Medicine Ultrasound for Primary Care is a practical easytoread guide.  Learn to incorporate ultrasound to augment your physical exam for evaluation of thyroid nodules enlarged lymph nodes pericardial effusion chronic kidney disease and a host of musculoskeletal issues and much more.  Additionally included are chapters on ultrasound for guidance of procedures including joint injections lumbar puncture and needle biopsy to name a few. Wellillustrated and highly templated this unique title helps you expand the scope of your practice and provide more effective patient care.Puts key concepts in the perspective of common questions that arise in primary car
TreatmentMAP™
TreatmentMAP supports physicians in optimizing their treatment decisions, even for cancer patients in advanced stages of cancer, or when all of the standard treatment options for a patient have been exhausted.
Clinical trials are used to test whether new medical treatments work effectively and actually treat a disease. Conducting and designing clinical trials today can take years and cost millions of dollars. A workshop was held with clinical trial experts to discuss challenges in conducting clinical trials and ways to improve efficiency while maintaining high standards. The workshop focused on cardiovascular disease, depression, cancer, and diabetes and gained insights into differences in clinical trials by disease that could help overall improvement. Future work will further analyze regulatory, administrative, and financial barriers to effective clinical trials and develop a vision for a sustainable clinical research infrastructure in the United States.
1) Drug development involves multiple phases of clinical trials in humans (phases I-IV) to test dosing, safety and efficacy in an increasing number of patients before regulatory approval and market access.
2) Patient involvement in clinical research is important to ensure trials address patient priorities and perspectives on risk/benefit, endpoints, and trial design elements like inclusion criteria.
3) Key elements of a clinical trial protocol include type of comparisons, randomization, blinding, endpoints, inclusion/exclusion criteria, schedule of events, informed consent process, and patient reported outcomes.
HXR 2016: Tracking the Body: Devices, Consumer Genomics, and Sensors- Niall O...HxRefactored
As tracking has become more mainstream, consumers who were once only curious about their heart rate at the gym are now interested in diving deeper and learning more. This session takes a look at the technical side of the latest in telehealth solutions, genomic platforms, and hacks in the world of sensors and devices.
The document discusses the emerging field of precision medicine and how it represents a shift from symptom-based to evidence-based to personalized medicine. Precision medicine utilizes large datasets including multi-omics data, imaging, and other clinical data combined with machine learning algorithms and reference databases to generate personalized molecular profiles and enable targeted prevention and treatment. Key to realizing precision medicine's potential is establishing standards, processes, and reference databases to facilitate large-scale data analysis and ensure results can be reproduced.
Could this change how radiology residents record their clinical output?Apparao Mukkamala
Radiology residents around the world typically record experiential learning (EL) in a clinical logbook, but according to a new study published in the Journal of Digital Imaging, modern PACS and RIS technology could very well be used to build the EL portfolios of the future. https://www.radiologybusiness.com/topics/imaging-informatics/pacs-ris-radiology-residents-clinical-output
Precision medicine represents a shift from symptom-based and intuition-based medicine of the past to a data-driven approach using an individual's molecular and genomic data to guide prevention, diagnosis, and treatment decisions. By applying rules, algorithms and reference databases to integrate multiple types of data such as molecular fingerprints, imaging, and non-molecular content, precision medicine enables actionable clinical decision support and precise, efficient care tailored to each individual.
A new generic approach for scoping HTA. Iris Pasternack.HTAi Bilbao 2012
This document describes a new generic approach for scoping health technology assessments (HTAs) using the HTA Core Model. The Core Model provides methodological guidance on questions an HTA should answer and a structure for reporting results. It addresses domains like safety, clinical effectiveness, and costs. The document gives examples of how to scope pilot HTA projects using a PICO framework and discusses expanding the framework to include elements like intended use, population details, and outcomes. It also describes an online tool for the HTA Core Model and concludes that carefully expanding the scoping frame does not necessarily imply deviating from the scope.
The document discusses how patients can find, select, and shape clinical trials in order to identify research that is most beneficial. It emphasizes that patients should: understand their treatment options and scientific landscape; carefully evaluate trial design and motivations; and recognize that various stakeholders have competing interests. The goal is not just increasing the number of trials, but improving trial quality so they answer patients' needs. Patients are encouraged to engage with research groups long-term to help guide trial design toward options that offer meaningful benefit.
Precision Medicine is now a funded NIH initiative and an organic movement in the clinic and at the research institute. Based on work with Genomics England, multiple large pharmaceutical firms, and research hospitals, attendees will learn about the best practices for epidemiology, signal detection, research, and the clinical diagnostics associated with Precision Medicine, including the development of high-scale bio-repositories that link traditional patient data with genomic information. Come hear about how leadership, collaboration, consent, and compute can lead to success or failure in your Precision Medicine initiative, and how to bring your stakeholders together for an aligned mission response.
InnVentis provides precision medicine through analyzing personal molecular profiles derived from multi-omics data and the internet of things to recommend diets and supplements personalized to each individual's daily schedule.
This document discusses using large amounts of publicly available biomedical data to discover new drugs and diagnostics. Over 1.7 million gene expression microarrays are publicly available, doubling every 2-3 years. The author describes several examples where their team analyzed public data to design new diagnostics for preeclampsia and identify potential drug repurposing opportunities, like using an anti-seizure drug for inflammatory bowel disease. Validation methods are becoming standardized. The author advocates using open data to ask new scientific questions and foster collaborations between academia and industry.
The document discusses key considerations for big data aspects of precision medicine. It outlines 10 points regarding potential disparities in data capture, the importance of active participant involvement, ensuring enough statistical power through validation studies, exploiting network effects to connect multiple data sets while maintaining privacy, the need for third party access and usability of data, allowing imperfect initial data release, keeping data fresh over time, and leaving open questions for other researchers.
The Uneven Future of Evidence-Based MedicineIda Sim
An Apple ResearchKit study enrolled 22,000 people in five days. A
study claims that Twitter can be used to identify depressed patients. A computer program crunches genomic data, the published literature, and electronic health record data to guide cancer treatment. The pace, the data sources, and the methods for generating medical evidence are changing radically. What will — what should — evidence-based medicine look like in a faster, personalized, data-dense tomorrow?
- Presented as the 3rd Annual Cochrane Lecture, October 2015 in Vienna, Austria.
The Nicholas Conor Institute aims to improve treatments for pediatric cancer by developing personalized therapies tailored to each child's unique cancer characteristics. It plans to do this through translating medical discoveries into integrated treatment programs, developing predictive tests to guide therapy, and bringing new child-friendly treatments to clinics. The Institute was founded in memory of Nicholas "Conor" Boddy to address the lack of treatment options and high costs faced by children with cancer.
EMR as a highly powerful European RWD sourceIMSHealthRWES
This document discusses leveraging electronic medical record (EMR) data from multiple countries in Europe to improve clinical trial design and patient recruitment for a cardiovascular drug trial. Specifically:
EMR data from France, UK, Italy, Germany and Spain was used to 1) characterize and quantify the number of potential patients meeting the inclusion criteria, and 2) identify and pre-select high-potential clinical trial sites. This approach helped clarify the definition of "statin-intolerant patients" and ensured the number of required trial sites would be sufficient. Using real-world data in this way enhanced the clinical trial strategy and avoided potential delays or additional costs associated with insufficient patient recruitment.
Assessing the appropriateness of CT scans among pediatric ortho patientsImage gently
The article discusses assessing the appropriate use of CT scans among pediatric orthopedic patients to minimize radiation exposure. It notes that while CT scans can be necessary, other imaging options should be considered whenever possible. The authors conducted a review of studies on radiation doses from various imaging technologies used for pediatric orthopedic injuries. Their findings suggest current practices need reexamination based on nationally accepted best practices to balance imaging needs with minimizing radiation exposure.
Transctriptional Science aims to re-evaluate existing data in the context of the translational sciences paradim in order to secure reliability and validity of data used for hypothesis generation, project design and decision making at a highest possible level of confidence
While clinical trials represent leading cancer research, less than 5% of cancer patients enroll due to a lack of awareness and resources. Physicians have little time to enroll patients, and patients and doctors have misconceptions about clinical trials. Molecular targeted trials, based on genetic markers, require less patients than traditional trials to produce meaningful results. Unlike traditional trials, targeted trials do not use placebos and allow switching to tested drugs if beneficial. While complex genetic profiling is required for targeted trials, they provide more personalized treatment with fewer side effects than chemotherapy. Focusing clinical trial searches on predefined molecular markers can help patients find more suitable targeted trials.
This document discusses major advancements in precision oncology and immuno-oncology, including increasing the number of targeted drugs and biomarkers to expand rational treatment approaches. It also addresses combining therapies like PD1/PD-L1 inhibitors with chemotherapy or novel immune modulators to increase efficacy. As biomarkers proliferate, challenges arise around conducting clinical trials in fragmented populations and relying on liquid biopsies. Ongoing questions center on balancing earlier access to treatments with stronger evidence requirements in regulatory approval.
This document provides an overview of clinical trial accrual challenges and discusses how social media could potentially help address some of these challenges. It summarizes the National Clinical Trials Network (NCTN) and reviews major accrual barriers experienced by institutions, investigators, and patients. These include a lack of trial awareness, preference for standard care over trials, and concerns about side effects. The document then describes NCI's use of Twitter to promote NCTN trials and poses questions about how social media could enhance awareness of cancer clinical trials.
The document discusses engaging decision makers in comparative effectiveness research (CER). It outlines calls for a National Institute of CER and defines CER. It describes how CER differs from traditional research by being more politically insulated and transparent. The document emphasizes that CER evidence enterprises must be designed around decision makers' needs and that they must be meaningfully engaged at all stages for limited success. It provides examples of organizations that have meaningfully engaged decision makers and outlines strategies for doing so, including selecting smart, energetic participants and valuing different perspectives.
The benefits of patient involvement in research and development (RE:ACT Congr...jangeissler
This document discusses the benefits of patient involvement in health research and development. It notes that innovation is transforming lives but more breakthroughs are still needed. Patients can provide unique perspectives to improve trial design and address unmet needs. However, public distrust and lack of knowledge limit patient participation in research. The document advocates for greater patient involvement at all stages of research, from setting priorities to disseminating results. It highlights the EUPATI initiative which aims to educate patients and the public about medicines research through training courses, educational tools, and national platforms. The goal is empowering patients as partners in research.
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Could this change how radiology residents record their clinical output?Apparao Mukkamala
Radiology residents around the world typically record experiential learning (EL) in a clinical logbook, but according to a new study published in the Journal of Digital Imaging, modern PACS and RIS technology could very well be used to build the EL portfolios of the future. https://www.radiologybusiness.com/topics/imaging-informatics/pacs-ris-radiology-residents-clinical-output
Precision medicine represents a shift from symptom-based and intuition-based medicine of the past to a data-driven approach using an individual's molecular and genomic data to guide prevention, diagnosis, and treatment decisions. By applying rules, algorithms and reference databases to integrate multiple types of data such as molecular fingerprints, imaging, and non-molecular content, precision medicine enables actionable clinical decision support and precise, efficient care tailored to each individual.
A new generic approach for scoping HTA. Iris Pasternack.HTAi Bilbao 2012
This document describes a new generic approach for scoping health technology assessments (HTAs) using the HTA Core Model. The Core Model provides methodological guidance on questions an HTA should answer and a structure for reporting results. It addresses domains like safety, clinical effectiveness, and costs. The document gives examples of how to scope pilot HTA projects using a PICO framework and discusses expanding the framework to include elements like intended use, population details, and outcomes. It also describes an online tool for the HTA Core Model and concludes that carefully expanding the scoping frame does not necessarily imply deviating from the scope.
The document discusses how patients can find, select, and shape clinical trials in order to identify research that is most beneficial. It emphasizes that patients should: understand their treatment options and scientific landscape; carefully evaluate trial design and motivations; and recognize that various stakeholders have competing interests. The goal is not just increasing the number of trials, but improving trial quality so they answer patients' needs. Patients are encouraged to engage with research groups long-term to help guide trial design toward options that offer meaningful benefit.
Precision Medicine is now a funded NIH initiative and an organic movement in the clinic and at the research institute. Based on work with Genomics England, multiple large pharmaceutical firms, and research hospitals, attendees will learn about the best practices for epidemiology, signal detection, research, and the clinical diagnostics associated with Precision Medicine, including the development of high-scale bio-repositories that link traditional patient data with genomic information. Come hear about how leadership, collaboration, consent, and compute can lead to success or failure in your Precision Medicine initiative, and how to bring your stakeholders together for an aligned mission response.
InnVentis provides precision medicine through analyzing personal molecular profiles derived from multi-omics data and the internet of things to recommend diets and supplements personalized to each individual's daily schedule.
This document discusses using large amounts of publicly available biomedical data to discover new drugs and diagnostics. Over 1.7 million gene expression microarrays are publicly available, doubling every 2-3 years. The author describes several examples where their team analyzed public data to design new diagnostics for preeclampsia and identify potential drug repurposing opportunities, like using an anti-seizure drug for inflammatory bowel disease. Validation methods are becoming standardized. The author advocates using open data to ask new scientific questions and foster collaborations between academia and industry.
The document discusses key considerations for big data aspects of precision medicine. It outlines 10 points regarding potential disparities in data capture, the importance of active participant involvement, ensuring enough statistical power through validation studies, exploiting network effects to connect multiple data sets while maintaining privacy, the need for third party access and usability of data, allowing imperfect initial data release, keeping data fresh over time, and leaving open questions for other researchers.
The Uneven Future of Evidence-Based MedicineIda Sim
An Apple ResearchKit study enrolled 22,000 people in five days. A
study claims that Twitter can be used to identify depressed patients. A computer program crunches genomic data, the published literature, and electronic health record data to guide cancer treatment. The pace, the data sources, and the methods for generating medical evidence are changing radically. What will — what should — evidence-based medicine look like in a faster, personalized, data-dense tomorrow?
- Presented as the 3rd Annual Cochrane Lecture, October 2015 in Vienna, Austria.
The Nicholas Conor Institute aims to improve treatments for pediatric cancer by developing personalized therapies tailored to each child's unique cancer characteristics. It plans to do this through translating medical discoveries into integrated treatment programs, developing predictive tests to guide therapy, and bringing new child-friendly treatments to clinics. The Institute was founded in memory of Nicholas "Conor" Boddy to address the lack of treatment options and high costs faced by children with cancer.
EMR as a highly powerful European RWD sourceIMSHealthRWES
This document discusses leveraging electronic medical record (EMR) data from multiple countries in Europe to improve clinical trial design and patient recruitment for a cardiovascular drug trial. Specifically:
EMR data from France, UK, Italy, Germany and Spain was used to 1) characterize and quantify the number of potential patients meeting the inclusion criteria, and 2) identify and pre-select high-potential clinical trial sites. This approach helped clarify the definition of "statin-intolerant patients" and ensured the number of required trial sites would be sufficient. Using real-world data in this way enhanced the clinical trial strategy and avoided potential delays or additional costs associated with insufficient patient recruitment.
Assessing the appropriateness of CT scans among pediatric ortho patientsImage gently
The article discusses assessing the appropriate use of CT scans among pediatric orthopedic patients to minimize radiation exposure. It notes that while CT scans can be necessary, other imaging options should be considered whenever possible. The authors conducted a review of studies on radiation doses from various imaging technologies used for pediatric orthopedic injuries. Their findings suggest current practices need reexamination based on nationally accepted best practices to balance imaging needs with minimizing radiation exposure.
Transctriptional Science aims to re-evaluate existing data in the context of the translational sciences paradim in order to secure reliability and validity of data used for hypothesis generation, project design and decision making at a highest possible level of confidence
While clinical trials represent leading cancer research, less than 5% of cancer patients enroll due to a lack of awareness and resources. Physicians have little time to enroll patients, and patients and doctors have misconceptions about clinical trials. Molecular targeted trials, based on genetic markers, require less patients than traditional trials to produce meaningful results. Unlike traditional trials, targeted trials do not use placebos and allow switching to tested drugs if beneficial. While complex genetic profiling is required for targeted trials, they provide more personalized treatment with fewer side effects than chemotherapy. Focusing clinical trial searches on predefined molecular markers can help patients find more suitable targeted trials.
This document discusses major advancements in precision oncology and immuno-oncology, including increasing the number of targeted drugs and biomarkers to expand rational treatment approaches. It also addresses combining therapies like PD1/PD-L1 inhibitors with chemotherapy or novel immune modulators to increase efficacy. As biomarkers proliferate, challenges arise around conducting clinical trials in fragmented populations and relying on liquid biopsies. Ongoing questions center on balancing earlier access to treatments with stronger evidence requirements in regulatory approval.
This document provides an overview of clinical trial accrual challenges and discusses how social media could potentially help address some of these challenges. It summarizes the National Clinical Trials Network (NCTN) and reviews major accrual barriers experienced by institutions, investigators, and patients. These include a lack of trial awareness, preference for standard care over trials, and concerns about side effects. The document then describes NCI's use of Twitter to promote NCTN trials and poses questions about how social media could enhance awareness of cancer clinical trials.
The document discusses engaging decision makers in comparative effectiveness research (CER). It outlines calls for a National Institute of CER and defines CER. It describes how CER differs from traditional research by being more politically insulated and transparent. The document emphasizes that CER evidence enterprises must be designed around decision makers' needs and that they must be meaningfully engaged at all stages for limited success. It provides examples of organizations that have meaningfully engaged decision makers and outlines strategies for doing so, including selecting smart, energetic participants and valuing different perspectives.
The benefits of patient involvement in research and development (RE:ACT Congr...jangeissler
This document discusses the benefits of patient involvement in health research and development. It notes that innovation is transforming lives but more breakthroughs are still needed. Patients can provide unique perspectives to improve trial design and address unmet needs. However, public distrust and lack of knowledge limit patient participation in research. The document advocates for greater patient involvement at all stages of research, from setting priorities to disseminating results. It highlights the EUPATI initiative which aims to educate patients and the public about medicines research through training courses, educational tools, and national platforms. The goal is empowering patients as partners in research.
The role of patients and healthcare providers in translational medicinejangeissler
The role of patients and healthcare providers in translational medicine, presented by Jan Geissler at the European Commission's Personalized Medicine Conference 2016 on 1 June 2016 in Brussels
Patient Advocates in Cancer Research: European Patients’ Perspective - Jan ...patvocates
Patient Advocates in Cancer Research: European Patients’ Perspective, presented by Jan Geissler (Twitter @jangeissler) at ISOQOL 19th Annual Conference, Budapast, 26 Oct 2012
The e-patient: empowered or overwhelmed? Patient's perspective on new technol...jangeissler
"The e-patient: empowered or overwhelmed? Patient's perspective on new technologies", presented by Jan Geissler at EFGCP Annual Conference 2013 on "Virtual Future: Ethical dimensions of emerging technologies in clinical trials and research" on 29 January 2013 in Brussels
2013-04-17: The Promise, Current State, And Future of Personalized MedicineBaltimore Lean Startup
Jeffrey M. Otto discusses the promise, current state, and future of personalized medicine in a presentation. He begins with definitions of key terms like personalized medicine and biomarkers. He then reviews the early promises of personalized medicine in improving diagnoses, drug development, and treatment effectiveness. However, he notes the field has faced challenges in fully achieving these promises. Currently, the Center for Translational Research is taking an integrated approach using electronic health records, biospecimen samples, and statistical analysis to develop predictive signatures to advance personalized medicine. Their goal is to translate scientific discoveries into clinical applications to improve patient outcomes.
Aysun Karatas MedicReS World Congress 2015 MedicReS
A Non-Profit Sponsor Organisation for Investigator Initiated Oncologic Trials in Germany and Europe Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York by Dr. Aysun Karatas
Meeting healthcare challenges: what are the challenges and what is the role o...Mohammad Al-Ubaydli
The document discusses the challenges facing healthcare systems and the role that e-health can play in addressing these challenges. The major challenges are quality and safety, access, responsiveness, and affordability. E-health can help by providing access to electronic patient records, reducing complexity, optimizing information processing, and increasing efficiency. It can also help with navigation through the healthcare system and engaging patients in their own health. The document advocates for free access to research information and using data to identify at-risk patients in need of care.
This document discusses using big data to advance personalized medicine in oncology. It notes that clinical studies and registries contain data from hundreds of cancer patients but it is fragmented across different organizations. The IMI2 HARMONY project aims to address this by creating a single big data platform to harmonize hematological malignancy data from over 45,000 patients across various clinical trials and registries. This will allow researchers to better understand patient subgroups and predictors of outcomes. The document outlines some of HARMONY's research projects and efforts to involve patients to help overcome challenges to large-scale data sharing and utilization.
The document discusses the Hereditary Neuropathy Foundation's (HNF) efforts to accelerate research for treatments for Charcot-Marie-Tooth (CMT) disease and related inherited neuropathies. Some key points:
- HNF submitted a large proposal to the NIH for $1.25M per year over 5 years to fund clinical trials and research to help translate existing preclinical research into therapies more quickly.
- Currently there are no effective treatments for CMT despite the discovery of the causal genes over 20 years ago. HNF's TRIAD program aims to increase collaboration between advocacy groups, academia, and industry to speed development of therapies.
- HNF is conducting studies to develop better
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.
14 technologies that will shape the future of cancer careMpower Medical Inc
The document discusses 14 technologies that will shape the future of cancer care, including fluid biopsy, which extracts cancer cells from blood samples; real-time cancer diagnostics using devices like the "iKnife" surgical tool; and artificial intelligence to design personalized therapy based on a patient's genetic profile and other factors. It also covers precision surgery using robotic tools, embedded sensors to remotely monitor patients, and social networks to help patients cope with treatment side effects. These technologies aim to revolutionize cancer prevention, diagnosis, treatment, and long-term patient care and support.
This year's 3rd Annual TCGC: The Clinical Genome Conference, held June 10-12, 2014 in San Francisco, is a three-day event that weaves together the science of sequencing and the business of implementing genomics in the clinic. It uniquely illustrates the mutual influence of those areas and the need to therefore consider the needs, challenges and opportunities of both - from next-generation sequencing and variant interpretation to insurance reimbursement and electronic health records - throughout the entire research process.Learn more at http://www.clinicalgenomeconference.com
Presentation "The Impact of All Data on Healthcare"
Keith Perry
Associate VP & Deputy CIO
UT MD Anderson Cancer Center
With continuing advancement in both technology and medicine, the drive is on to make all data meaningful to drive medical discovery and create actionable outcomes. With tools and capabilities to capture more data than ever before, the challenge becomes linking existing structured and unstructured clinical data with genomic data to increase the industry’s analytical footprint.
Learning Objectives:
∙ Discuss the need to make all data meaningful in order to speed discovery of new knowledge
∙ Provide examples of an analytical direction that supports evolution in medicine
∙ Expose the challenges facing the industry with respect to ~omits
This document discusses developing a "cardiac moonshot" initiative using precision medicine approaches to more effectively treat heart disease. It outlines how precision medicine considers individual genetic and lifestyle factors. The initiative would leverage technologies like remote monitoring, wearables, and electronic health records to integrate diverse health data. This would allow more personalized treatment and risk prediction. Challenges include standardizing large data collection and educating medical professionals on complex multi-omic data analysis.
Access to treatment, care and clinical trials by patients with rare cancers...patvocates
"Access to treatment, care and clinical trials by patients with rare cancers", presented by Jan Geissler (Twitter @jangeissler) at ESMO congress in Vienna, 30 Sept 2012
This document discusses patient-reported outcome measures (PROMs) and their importance in drug development and clinical trials for Duchenne muscular dystrophy (DMD). It outlines how multistakeholder meetings including patients, regulators, industry, researchers, and clinicians can provide input to help develop DMD-specific PROMs and guidelines. It also describes the development of the Performance of Upper Limb module, a DMD-specific PROM created with input from DMD patients to measure important functional outcomes.
CORD Rare Drug Conference June 8-9, 2022
Global, International, and National Rare Disease Networks
Rare Disease Research Network and National Children’s Hospital - Marshall
Summar, Rare Disease Institute
Translational medicine aims to expedite the discovery of new diagnostic tools and treatments through a multidisciplinary collaborative approach. It is a bidirectional process that encourages information flow from the laboratory to the clinic and vice versa. This allows for bench-to-bedside factors that test new therapies in clinical trials as well as bedside-to-bench factors that provide feedback to improve treatments. The examples given show how translational medicine has led to repurposing an existing drug to treat Marfan syndrome and developing more sensitive MRI techniques to detect early-stage prostate cancer.
Don't just talk about patient centricity - put meaningful patient engagement ...jangeissler
"Don't just talk about patient centricity - put meaningful patient engagement into the design of your cancer research", presented by Jan Geissler at Meet2Win on 7/5/2021
CML: A tiger in the cage? A (European) perspective on CML disease managementjangeissler
CML: A tiger in the cage? A (European) perspective on CML disease management, presented by Jan Geissler, co-founder CML Advocates Network, at the 5th Friends of Max Leadership Summit in (virtual) India on 21 Feb 2021, Session "Beyond Borders"
Sicht der Patienten auf Real World Data, Register und Versorgungsdatenjangeissler
Sicht der Patienten auf Real World Data, Register und Versorgungsdaten. Präsentation von Jan Geissler beim FACHSYMPOSIUM ONKOLOGIE am 28.10.2020 im Rahmen der Sitzung "Daten aus der klinischen Versorgung - was leisten RWD, Register und versorgungsnahe klinische Studien in der Onkologie?"
Überblick der Aktivitäten von Leukämie-Online und CML Advocates Networkjangeissler
Präsentation von Jan Geissler und Cornelia Borowczak über die Aktivitäten von Leukämie-Online und CML Advocates Network, präsentiert beim Leukämie-Online-Patiententreffen am 22/23.9.2019 in Fulda
Umfrage zur Therapiefreien Remission (TFR) der CML-Patientengemeinschaftjangeissler
Präsentation der vorläufigen deutschen Ergebnisse der Umfrage der CML-Patientengemeinschaft zur den Erfahrungen, Ängsten und Erwartungen im Kontext der Therapiefreien Remission (TFR), präsentiert von Jan Geissler am 30.3.2019 beim Jahrestreffen der Deutschen CML-Allianz in Weimar
Bericht LeukaNET / leukaemie-online.de und CML Advocates Networkjangeissler
Bericht über die Aktivitäten von Leukaemie-Online.de / LeukaNET e.V. und CML Advocates Network, präsentiert auf dem Leukämie-Online-Treffen am 23/23. September 2018
How to get the most of the EHA congress as a CML patient advocatejangeissler
The European Hematology Association's (EHA) annual congress will start on 14 June 2018 in Stockholm. The co-founder of the CML Advocates Network and member of the EHA European Affairs Committee, Jan Geissler, on behalf of the EuroBloodNET ePAG, presents this webinar on how to get the most of EHA as a CML patient advocate.
Through the webinar you will be able to know more about topics as:
- Types of sessions at EHA and their relevance for a CML patient advocate
- How to set your priorities attending this huge congress.
- How to find and engage with key opinion leaders at the EHA Posters Sessions.
- More about EHA Abstracts: how to find them and how to read them.
European Patient Perspective on Access and Innovation with Multiplex Genomic ...jangeissler
European Patient Perspective on Access and Innovation with Multiplex Genomic Testing, presented by Jan Geissler at ASCO 2018 in Chicago, USA, on 3 June 2018
European Cancer Patient Advocacy: Introduction to the community, key stakehol...jangeissler
Overview of the European cancer patient advocacy community, key stakeholder interfaces and key initiatives and projects in evidence-based advocacy and capacity building. Presented by Jan Geissler, Patvocates, at European School of Oncology Masterclass, 23 Feb 2019, Lisbon, Portugal
Häufige Fragen von CML-Patienten und Welt-CML-Tag 2017jangeissler
"Häufige Fragen von CML-Patienten - und was am Welt-CML-Tag 2017 am 22.9.2017 los war", präsentiert von Jan Geissler im Symposium der Deutschen CML-Allianz beim Jahrestreffen der Deutschen Gesellschaft für Hämatologie und Onkologie (DGHO) am 29.9.2017 in Stuttgart
How to get the most of EHA as a patient advocatejangeissler
"How to get the most of EHA as a patient advocate", presented by Jan Geissler at the EHA / EuroBloodNet Capacity Building Meeting for Patient Advocates on 22 June 2017, Madrid
The Networked Patient Group: How technology changes the face of patient advocacyjangeissler
"The Networked Patient Group: How technology changes the face of patient advocacy", presented by Jan Geissler (@jangeissler) at European Patient Innovation Summit on 4 Oct 2016
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
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Patient involvement in R&D - setting the scene, current status and future plans: A Patient Perspective (Jan Geissler)
1. Setting the scene, current
status and future plans:
a Patient Perspective
Jan Geissler
Copenhagen, 6 May 2015
Director, European Patients‘ Academy (EUPATI)
Vice President, Leukemia Patient Advocates Foundation
jan@patientsacademy.eu, Twitter @jangeissler
2. Patients need innovation –
Medical landscape is changing at a fast pace
2
Molecular targets/pathways
Genome sequencing
Translational research
Personalized medicine
• Small trial populations
• Biomarkers, companion diagnostics
Need for post-marketing data
Health Technology Assessment,
QoL, endpoints, comparators
BUT long term pressure on health
budgets – here to stay…
Window of
opportunity
New
collaboration
models
3. We need more „magic bullets“:
Not yet there for most patients
We are excited about what happens in
CML, Melanoma, NSC Lung Cancer, …
“Success stories” only for small
populations and “best ages” yet
Patients need both
incremental
& breakthrough
innovation
RareCare (Gatta et al, 2012)
4. How to address >200 cancers, >5.200 rare diseases
in times of decreasing medical R&D productivity?
Structure
of DNA
Restriction
enzymes
DNA
sequencing
Recombinant
DNA
Human
insulin
Dolly
the sheep
Human
genome v1milestones
Source: Nature – How to improve R&D productivity: the pharmaceutical industry's grand challenge
5. Over 30% of trial
interventions not
sufficiently described
Over 50% of planned
study outcomes not
reported
Most new research not
interpreted in the
context of systematic
assessment of other
relevant evidence
Unbiased and
usable report?
85% research waste = over $85 billion / year
“Avoidable waste in the production and reporting
of research evidence”
Low priority
questions
addressed
Important outcomes
not assessed
Clinicians and
patients not
involved in setting
research agendas
Questions
relevant
to clinicians &
patients?
Over 50% studies
designed without
reference to
systematic reviews of
existing evidence
Over 50% of studies fail
to take adequate steps
to reduce biases, e.g.
unconcealed treatment
allocation
Appropriate
design and
methods?
Over 50% of studies
never published in full
Biased under-reporting
of studies with
disappointing results
Accessible
full publication?
Iain Chalmers, Paul Glasziou, The Lancet, 15 June 2009, doi:10.1016/S0140-6736(09)60329-9
6. Patients have a unique perspective on symptoms and
side effects – may differ from HCP’s
Detecting Myeloma, ways to shortening an often painful and tedious patient odyssey: results from an international
survey. Myeloma Euronet (2009). 314 physicians & nurses, 260 patients & carers, 43 countries
7. “We need to do the right things,
not just doing things right.”
Bettina Ryll,
European Melanoma Patient
Advocate, 28 Feb 2014
http://is.gd/bettinaryll
8. Early involvement may create highest impact,
but involvement today is mostly at late phase
Courtesy of B. Ryll (2014)
9. Practical “Roadmap” on patient involvement in R&D:
Research design
and Planning
Design of Protocol:
Informed Consent Study reporting
Post-study
communication
Patient Info
Leaflet
Trial steering committee
Investigators Meeting:
Level of expertise in the disease area required:
mediumhigh
Data Monitoring CommitteePractical
con-
siderations
Health Technology
Assessment
Protocol
Synopsis:
design,
comparators
Research
priorities
Setting
research
priorities:
Fundraising
Information to
trial participants
Research conduct and
operations
Source: Geissler, Ryll,
EPALCO (2014, unpublished)
Regulatory affairs
Dissemination,
communication,
post-approval
10. Public
Research Ethics
Committees
Competent
authorities
Policy makers
/Research Policy
HTA agencies
& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical
Research
Patients have a key role in all aspects of
health-related research
Trial protocol design,
informed consent, ethical
review, marketing
authorization, value
assessment, health policy
11. Education is key to increase the number
of empowered patient advocates in R&D
Launched Feb ’12, runs for 5 years,
30 consortium members,
Funded by Innovative Medicines Initiative
Patient-led public private partnership of
patients, academia, NGOs and industry
will build competencies
& expert capacity to facilitate patient
involvement in R&D to collaborate in
academic research, industry research,
authorities and ethics committees
First 50 patients in training, 50 more next
year, educational material in 7 languages
rolled out end of 2015 www.patientsacademy.eu
12. No research about us
without us!
Jan Geißler
jan@patientsacademy.eu
Twitter @jangeissler