FasterCures' Margaret Anderson presents at the 2009 BioEconomy Summit Healthcare Policy Session 2: Affordability and Access. Presents new business models to accelerate research.
This document discusses potential solutions to address bias in the NIH federal funding process. It finds that NIH review panels have disproportionate representation from top 50 funded institutions, and these institutions receive more funding. Solutions proposed include multi-stage blind reviews, public review sessions, regulating indirect costs, limiting panelist terms, and rotating Scientific Review Officers. The conclusions are based on analyses of reviewer connections, funding distributions, and H-indices that find bias toward top institutions exists.
The Clinical and Translational Science Awards (CTSA) Program: What can it do ...CTSciNet .org
The Clinical and Translational Science Awards (CTSA) Program aims to transform clinical and translational research. It establishes a national consortium of academic health centers to break down barriers between disciplines. The program's goals are to build research capabilities, train scientists, enhance collaboration, improve community health, and advance translational research. Each CTSA institution provides resources like training, mentoring, informatics tools, and community partnerships to researchers to improve efficiency and quality of clinical research.
The current system for evidence assessment in the United States is uncoordinated, with no single agency setting priorities and different organizations having varying objectives. Several initiatives have evolved to fill needs, such as the Drug Effectiveness Review Project which conducts reviews for state Medicaid programs. Prioritizing topics for systematic reviews is important due to scarce resources but major increases in funding and capacity may diminish the importance of prioritization in the future. The measure of success for any prioritization scheme is its usefulness to its intended audience.
Difference between cohort, cross sectional and case control study - Scientifi...Pubrica
This document compares and contrasts four types of observational studies: cross-sectional studies, cohort studies, retrospective cohort studies, and case-control studies. Cross-sectional studies determine disease prevalence at a single point in time. Cohort studies compare exposed and non-exposed groups over time. Retrospective cohort studies use existing data to follow groups retrospectively. Case-control studies compare people with a disease to controls without the disease.
Key Issues on the Economics of Precision MedicineHEHTAslides
Paula Lorgelly gave a presentation on the key issues in the economics of precision medicine. She discussed how a decade ago, genome sequencing was very expensive and personalized medicine seemed unlikely. Now, testing is much cheaper and more widely used. However, challenges remain around valuing new elements of precision medicine, paying for value, and generating evidence of value. She argued that new ways of measuring value beyond QALYs may be needed, and that current systems incentivize pharmaceutical companies more than diagnostic innovation. Real-world data will also be important to address economic questions as vast amounts of clinical data are now available.
Data Reproducibility in Preclinical Discovery, Is It a Real Problem? 09/17/15CTSI at UCSF
On Sep 17th Catalyst brought a panel of academic and industry thought leaders for a lively discussion on the issue of data reproducibility in academic research. Moderated by Cathy Tralau-Stewart, head of the Therapeutics track of the Catalyst Awards, the panel explored causes and potential solutions for a problem that has been receiving national attention in both scientific and popular media.
Panelists included Keith Yamamoto, Vice Chancellor for Research at UCSF; Larry Tabak, Principle Deputy Director, NIH; John Ioannidis, Professor of Health Research Policy at Stanford School of Medicine; Elizabeth Iorns, Co-Founder, Science Exchange; Parker B. Antin, Board of Directors President, FASEB; Amanda Halford, MBA, VP of Research, Sigma-Aldrich.
http://ctsi.ucsf.edu/news/about-ctsi/data-reproducibility-preclinical-research-and-discovery
The document discusses an electronic clinical trial recruitment system that aims to address the problems of slow clinical research translation, labor-intensive and costly trial recruitment methods. It presents a solution of leveraging existing electronic medical record data across different healthcare systems and practices to more efficiently identify and enroll qualified patients for clinical trials in a networked system. The system could benefit research sponsors, investigators, medical practices, and patients by speeding recruitment times and lowering costs while improving clinical care engagement and outcomes. It analyzes the potential market opportunity and differentiation of this federated network approach to electronic clinical trial recruitment.
Potential benefits of public-private partnerships (PPPs) in healthcare include:
1) Leveraging cross-disciplinary expertise from multiple partners to solve complex health problems and maximize resources while sharing risks.
2) Advancing therapeutic areas like heart disease, diabetes, and cancer through new treatments that improve outcomes, survival rates, and disease management.
3) Addressing unmet needs in rare diseases and furthering pharmaceutical innovation to continue improving public health and life expectancy.
4) Overcoming hurdles in drug research and development like disease heterogeneity and lack of predictive biomarkers through collaborative efforts.
This document discusses potential solutions to address bias in the NIH federal funding process. It finds that NIH review panels have disproportionate representation from top 50 funded institutions, and these institutions receive more funding. Solutions proposed include multi-stage blind reviews, public review sessions, regulating indirect costs, limiting panelist terms, and rotating Scientific Review Officers. The conclusions are based on analyses of reviewer connections, funding distributions, and H-indices that find bias toward top institutions exists.
The Clinical and Translational Science Awards (CTSA) Program: What can it do ...CTSciNet .org
The Clinical and Translational Science Awards (CTSA) Program aims to transform clinical and translational research. It establishes a national consortium of academic health centers to break down barriers between disciplines. The program's goals are to build research capabilities, train scientists, enhance collaboration, improve community health, and advance translational research. Each CTSA institution provides resources like training, mentoring, informatics tools, and community partnerships to researchers to improve efficiency and quality of clinical research.
The current system for evidence assessment in the United States is uncoordinated, with no single agency setting priorities and different organizations having varying objectives. Several initiatives have evolved to fill needs, such as the Drug Effectiveness Review Project which conducts reviews for state Medicaid programs. Prioritizing topics for systematic reviews is important due to scarce resources but major increases in funding and capacity may diminish the importance of prioritization in the future. The measure of success for any prioritization scheme is its usefulness to its intended audience.
Difference between cohort, cross sectional and case control study - Scientifi...Pubrica
This document compares and contrasts four types of observational studies: cross-sectional studies, cohort studies, retrospective cohort studies, and case-control studies. Cross-sectional studies determine disease prevalence at a single point in time. Cohort studies compare exposed and non-exposed groups over time. Retrospective cohort studies use existing data to follow groups retrospectively. Case-control studies compare people with a disease to controls without the disease.
Key Issues on the Economics of Precision MedicineHEHTAslides
Paula Lorgelly gave a presentation on the key issues in the economics of precision medicine. She discussed how a decade ago, genome sequencing was very expensive and personalized medicine seemed unlikely. Now, testing is much cheaper and more widely used. However, challenges remain around valuing new elements of precision medicine, paying for value, and generating evidence of value. She argued that new ways of measuring value beyond QALYs may be needed, and that current systems incentivize pharmaceutical companies more than diagnostic innovation. Real-world data will also be important to address economic questions as vast amounts of clinical data are now available.
Data Reproducibility in Preclinical Discovery, Is It a Real Problem? 09/17/15CTSI at UCSF
On Sep 17th Catalyst brought a panel of academic and industry thought leaders for a lively discussion on the issue of data reproducibility in academic research. Moderated by Cathy Tralau-Stewart, head of the Therapeutics track of the Catalyst Awards, the panel explored causes and potential solutions for a problem that has been receiving national attention in both scientific and popular media.
Panelists included Keith Yamamoto, Vice Chancellor for Research at UCSF; Larry Tabak, Principle Deputy Director, NIH; John Ioannidis, Professor of Health Research Policy at Stanford School of Medicine; Elizabeth Iorns, Co-Founder, Science Exchange; Parker B. Antin, Board of Directors President, FASEB; Amanda Halford, MBA, VP of Research, Sigma-Aldrich.
http://ctsi.ucsf.edu/news/about-ctsi/data-reproducibility-preclinical-research-and-discovery
The document discusses an electronic clinical trial recruitment system that aims to address the problems of slow clinical research translation, labor-intensive and costly trial recruitment methods. It presents a solution of leveraging existing electronic medical record data across different healthcare systems and practices to more efficiently identify and enroll qualified patients for clinical trials in a networked system. The system could benefit research sponsors, investigators, medical practices, and patients by speeding recruitment times and lowering costs while improving clinical care engagement and outcomes. It analyzes the potential market opportunity and differentiation of this federated network approach to electronic clinical trial recruitment.
Potential benefits of public-private partnerships (PPPs) in healthcare include:
1) Leveraging cross-disciplinary expertise from multiple partners to solve complex health problems and maximize resources while sharing risks.
2) Advancing therapeutic areas like heart disease, diabetes, and cancer through new treatments that improve outcomes, survival rates, and disease management.
3) Addressing unmet needs in rare diseases and furthering pharmaceutical innovation to continue improving public health and life expectancy.
4) Overcoming hurdles in drug research and development like disease heterogeneity and lack of predictive biomarkers through collaborative efforts.
'Sick or Treat: eCancer by Dr Nick Chapman Sick or Treat SessionsRareCancersAustralia
This document compares global investment in different areas of health research and development. It finds that while cancer receives $15 billion annually, rare cancers receive around $3 billion and neglected diseases receive only $3.2 billion despite addressing major health issues. It outlines approaches that have helped increase the pipeline of treatments for neglected diseases, such as public and philanthropic funding, product development partnerships, and incentive programs. However, it notes the pipeline remains concentrated on only a few diseases and that an access gap remains for developing treatments for the most neglected health issues.
The document discusses the role of government science at Health Canada. It outlines four essential roles of government science including decision making, policy development, regulations, and economic and social development. It also discusses Health Canada's mission to help Canadians maintain and improve their health through science-based decision making, delivering on strategic objectives, and addressing health issues. Health Canada performs both internal research and partnerships with external organizations to access diverse scientific expertise needed to support its legislated mandate.
Patients Recruitment Forecast in Clinical TrialsCognizant
Patient recruitment is a crucial but challenging part of clinical trials. Accurately forecasting patient enrollment is important to remain on schedule and budget. However, recruitment is often underestimated, leading to delays and costs. This is due to uncertainties like site investigator overestimations, patient dropout rates, and variability in recruitment across sites. The document discusses stochastic and non-stochastic approaches to more accurately model recruitment, using statistical techniques like Monte Carlo simulation to account for uncertainties. Accurately predicting enrollment can improve clinical trial success and reduce costs.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
A new public health services and systems research agenda is being developed through a collaborative process involving the Robert Wood Johnson Foundation, CDC, and the National Coordinating Center for Public Health Services and Systems Research. The agenda will focus on four key areas: the public health workforce, organization and structure of public health systems, public health finance, and technologies, data and methods. Feedback is being gathered from researchers and practitioners to finalize the agenda and identify action steps. The final agenda will help guide future research to better understand and improve public health systems and services.
Using alternative scholarly metrics to showcase the impact of your research: ...SC CTSI at USC and CHLA
Date: Feb 7, 2018
Speaker: Caroline Muglia, Co-Associate Dean for Collections and Technical Services; and Head, Resource Sharing and Collection Assessment, USC Libraries
Overview: Scholarship is increasingly being created, disseminated, and measured on digital and social platforms. If Twitter exchanges, Facebook “saves,” and YouTube hits are the new metrics for tracking scholarship, how are we measuring societal and educational impact and outreach? How can researchers display their research impact using social media on promotion and tenure dossiers? This webinar will discuss altmetrics, alternative scholarly metrics that measure the impact and use of scholarship. We will focus on PlumX, the tool used at USC, which combines traditional and new metrics to paint a comprehensive portrait of your scholarly output and its reach in various communities and with different stakeholders.
Presentation by Dr Davina Ghersi, NHMRC, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.
F&I: Kathryn Graham - Business Intelligence II: Research ImpactCASRAI
The document discusses assessing the impact of health research and innovation from a systems perspective. It presents a Canadian framework that identifies five categories of research impact: advancing knowledge, capacity building, informing decision making, health benefits, and broad economic and social benefits. The framework includes a library of 66 impact indicators that can be measured at different levels. It also discusses promising tools for addressing needs across the system, including a common approach, language, and metrics to optimize measuring research impact in Canada. Building greater capacity for impact assessment using a collaborative approach is advocated.
The document discusses developing a pilot project for coverage with evidence development (CED) in the private sector. A stakeholder workgroup selected pharmacogenetic testing for estimating initial warfarin dosing as the topic. The workgroup discussed operational and study design issues, such as coverage models, communication with patients and providers, funding, and informed consent. Conducting private sector CED poses challenges but payers remain interested to generate better information for coverage decisions through this mechanism.
UCSF CER - What PCORI Wants (Symposium 2013)CTSI at UCSF
This document summarizes a presentation about the Patient-Centered Outcomes Research Institute (PCORI). PCORI is funding patient-centered comparative effectiveness research. The presentation highlights two award winning projects, discusses some projects that were not funded, and outlines PCORI's funding priorities and challenges. PCORI wants to advance research that engages stakeholders, reflects patient variability, and focuses on important health outcomes without using cost-effectiveness as a funding criterion. Opportunities for PCORI include supporting real-world evidence generation and incorporating diverse stakeholder perspectives, but challenges include stakeholder burnout and operating in the current fiscal environment.
UC Research Exchange (UC ReX) & Los Angeles Data Repository (LADR) UCLA CTSI
Learn more about the clinical data set tools, LADR and UC ReX available to UCLA CTSI, its partners and other UCs.
Marianne Zachariah
Administrator, Informatics Program
UCLA Clinical and Translational Science Institute
UCLA CTSI K Workshop - February 4, 2016
Mariko Ishimori, MD
Associate Health Sciences Clinical Professor of Medicine
Cedars-Sinai Medical Center CTSI Associate Leader UCLA Clinical & Translational Science Institute
ROLE OF LIBRARIAN IN HEALTH CARE INSTITUTIONSAnaivko
Librarians play an increasingly important role in healthcare institutions by searching relevant literature for clinicians. While clinicians can research themselves using online databases, many lack the skills, time or access to consistently find the best evidence. When librarians assisted with searches, they were able to solve 84% of clinicians' requests by accessing medical databases and selecting the most appropriate literature. While online information is abundant, clinicians require training on effective search strategies and using the best evidence in practice to provide successful patient treatment.
Clinical research informatics involves using informatics tools to support clinical research activities like managing clinical trials data and conducting secondary research using clinical data. It can help make clinical trials more efficient by facilitating study design, subject recruitment from electronic medical records and social media, data collection and management, and data analysis. National initiatives aim to develop informatics tools and networks to help researchers access data and accelerate clinical research.
UCLA CTSI K Workshop - February 4, 2016
Learn to navigate through the possible career development awards (CDAs) available to you and which you should target.
Carol M. Mangione, MD, MSPH
Barbara A. Levey MD & Gerald S. Levey MD Endowed Chair
Professor of Medicine and Public Health at UCLA
Associate Director, UCLA Clinical and Translational Science Institute
Leader, Research Education, Training and Career Development Program
UCLA CTSI K Workshop
Learn to navigate through the possible career development awards (CDAs) available to you and which you should target.
Carol M. Mangione, MD, MSPH
Barbara A. Levey MD & Gerald S. Levey MD Endowed Chair
Professor of Medicine and Public Health at UCLA
Associate Director, UCLA Clinical and Translational Science Institute
Leader, UCLA CTSI Workforce Development
Presentation date: February 09, 2017
From evidence to action when people disagree: societal values and provision o...Office of Health Economics
Koonal Shah presented findings from a review of 23 studies on societal preferences for end of life treatments. The review found mixed evidence - some studies showed support for an "end of life premium" where greater value is placed on health gains for end of life patients, while others found no such support. There was also significant heterogeneity in individual preferences both within and across studies. Overall the evidence does not provide a clear or unanimous indication of whether society supports additional weighting for end of life treatments.
This document provides guidance on funding options for clinical research. It discusses considering one's goals and interests to determine the appropriate funding. National Institutes of Health grants such as K-awards and R01 grants are recommended for spending significant time in academic investigation. Small internal grants can provide pilot data for larger grants. Industry-sponsored clinical trials are another option but require ensuring publication rights and managing conflicts of interest. The document stresses applying to multiple sources and being creative in finding support that aligns with one's research goals.
Adrian Towse's slides from a session will exploring how the benefits of antibiotics can best be captured in HTA, and how we should pay for them when their value may depend on restricting their use.
Author(s) and affiliation(s): Adrian Towse, Office of Health Economics
Conference/meeting: Health Technology Assessment International (HTAi) 2018
Location: Vancouver, Canada
Date: 03/06/2018
Collision Forces: Scientific Integrity Meets the Capital MarketsLindsay Meyer
The landscape for innovation in the life sciences requires substantial participation from the investment community to finance new ventures and support existing projects. As such, appropriate risk-adjusted returns are expected by investors. Gaining insight into the progress of important clinical trials has catalyzed an information asymmetry between direct participants in the scientific process and the investment community. Direct participants can gain materially by breaching confidentiality agreements or engaging in insider trading, unethical practices that compromise scientific integrity. This report explores the nature of conflicts that can arise from the unique relationships specific to entities developing human therapeutics and proposes three mechanisms for minimizing negative externalities of the research process: raising awareness of the problem, mandating professional organizations to adopt and enforce strict policies for sharing material information, and establishing project work teams to limit the number of individuals exposed to non-public information.
'Sick or Treat: eCancer by Dr Nick Chapman Sick or Treat SessionsRareCancersAustralia
This document compares global investment in different areas of health research and development. It finds that while cancer receives $15 billion annually, rare cancers receive around $3 billion and neglected diseases receive only $3.2 billion despite addressing major health issues. It outlines approaches that have helped increase the pipeline of treatments for neglected diseases, such as public and philanthropic funding, product development partnerships, and incentive programs. However, it notes the pipeline remains concentrated on only a few diseases and that an access gap remains for developing treatments for the most neglected health issues.
The document discusses the role of government science at Health Canada. It outlines four essential roles of government science including decision making, policy development, regulations, and economic and social development. It also discusses Health Canada's mission to help Canadians maintain and improve their health through science-based decision making, delivering on strategic objectives, and addressing health issues. Health Canada performs both internal research and partnerships with external organizations to access diverse scientific expertise needed to support its legislated mandate.
Patients Recruitment Forecast in Clinical TrialsCognizant
Patient recruitment is a crucial but challenging part of clinical trials. Accurately forecasting patient enrollment is important to remain on schedule and budget. However, recruitment is often underestimated, leading to delays and costs. This is due to uncertainties like site investigator overestimations, patient dropout rates, and variability in recruitment across sites. The document discusses stochastic and non-stochastic approaches to more accurately model recruitment, using statistical techniques like Monte Carlo simulation to account for uncertainties. Accurately predicting enrollment can improve clinical trial success and reduce costs.
A presentation showcasing some of the patient recruitment challenges that I encountered as a recruitment manager as well as some of the strategies -- DIGITAL ADVERTISING -- I used to overcome them.
A new public health services and systems research agenda is being developed through a collaborative process involving the Robert Wood Johnson Foundation, CDC, and the National Coordinating Center for Public Health Services and Systems Research. The agenda will focus on four key areas: the public health workforce, organization and structure of public health systems, public health finance, and technologies, data and methods. Feedback is being gathered from researchers and practitioners to finalize the agenda and identify action steps. The final agenda will help guide future research to better understand and improve public health systems and services.
Using alternative scholarly metrics to showcase the impact of your research: ...SC CTSI at USC and CHLA
Date: Feb 7, 2018
Speaker: Caroline Muglia, Co-Associate Dean for Collections and Technical Services; and Head, Resource Sharing and Collection Assessment, USC Libraries
Overview: Scholarship is increasingly being created, disseminated, and measured on digital and social platforms. If Twitter exchanges, Facebook “saves,” and YouTube hits are the new metrics for tracking scholarship, how are we measuring societal and educational impact and outreach? How can researchers display their research impact using social media on promotion and tenure dossiers? This webinar will discuss altmetrics, alternative scholarly metrics that measure the impact and use of scholarship. We will focus on PlumX, the tool used at USC, which combines traditional and new metrics to paint a comprehensive portrait of your scholarly output and its reach in various communities and with different stakeholders.
Presentation by Dr Davina Ghersi, NHMRC, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.
F&I: Kathryn Graham - Business Intelligence II: Research ImpactCASRAI
The document discusses assessing the impact of health research and innovation from a systems perspective. It presents a Canadian framework that identifies five categories of research impact: advancing knowledge, capacity building, informing decision making, health benefits, and broad economic and social benefits. The framework includes a library of 66 impact indicators that can be measured at different levels. It also discusses promising tools for addressing needs across the system, including a common approach, language, and metrics to optimize measuring research impact in Canada. Building greater capacity for impact assessment using a collaborative approach is advocated.
The document discusses developing a pilot project for coverage with evidence development (CED) in the private sector. A stakeholder workgroup selected pharmacogenetic testing for estimating initial warfarin dosing as the topic. The workgroup discussed operational and study design issues, such as coverage models, communication with patients and providers, funding, and informed consent. Conducting private sector CED poses challenges but payers remain interested to generate better information for coverage decisions through this mechanism.
UCSF CER - What PCORI Wants (Symposium 2013)CTSI at UCSF
This document summarizes a presentation about the Patient-Centered Outcomes Research Institute (PCORI). PCORI is funding patient-centered comparative effectiveness research. The presentation highlights two award winning projects, discusses some projects that were not funded, and outlines PCORI's funding priorities and challenges. PCORI wants to advance research that engages stakeholders, reflects patient variability, and focuses on important health outcomes without using cost-effectiveness as a funding criterion. Opportunities for PCORI include supporting real-world evidence generation and incorporating diverse stakeholder perspectives, but challenges include stakeholder burnout and operating in the current fiscal environment.
UC Research Exchange (UC ReX) & Los Angeles Data Repository (LADR) UCLA CTSI
Learn more about the clinical data set tools, LADR and UC ReX available to UCLA CTSI, its partners and other UCs.
Marianne Zachariah
Administrator, Informatics Program
UCLA Clinical and Translational Science Institute
UCLA CTSI K Workshop - February 4, 2016
Mariko Ishimori, MD
Associate Health Sciences Clinical Professor of Medicine
Cedars-Sinai Medical Center CTSI Associate Leader UCLA Clinical & Translational Science Institute
ROLE OF LIBRARIAN IN HEALTH CARE INSTITUTIONSAnaivko
Librarians play an increasingly important role in healthcare institutions by searching relevant literature for clinicians. While clinicians can research themselves using online databases, many lack the skills, time or access to consistently find the best evidence. When librarians assisted with searches, they were able to solve 84% of clinicians' requests by accessing medical databases and selecting the most appropriate literature. While online information is abundant, clinicians require training on effective search strategies and using the best evidence in practice to provide successful patient treatment.
Clinical research informatics involves using informatics tools to support clinical research activities like managing clinical trials data and conducting secondary research using clinical data. It can help make clinical trials more efficient by facilitating study design, subject recruitment from electronic medical records and social media, data collection and management, and data analysis. National initiatives aim to develop informatics tools and networks to help researchers access data and accelerate clinical research.
UCLA CTSI K Workshop - February 4, 2016
Learn to navigate through the possible career development awards (CDAs) available to you and which you should target.
Carol M. Mangione, MD, MSPH
Barbara A. Levey MD & Gerald S. Levey MD Endowed Chair
Professor of Medicine and Public Health at UCLA
Associate Director, UCLA Clinical and Translational Science Institute
Leader, Research Education, Training and Career Development Program
UCLA CTSI K Workshop
Learn to navigate through the possible career development awards (CDAs) available to you and which you should target.
Carol M. Mangione, MD, MSPH
Barbara A. Levey MD & Gerald S. Levey MD Endowed Chair
Professor of Medicine and Public Health at UCLA
Associate Director, UCLA Clinical and Translational Science Institute
Leader, UCLA CTSI Workforce Development
Presentation date: February 09, 2017
From evidence to action when people disagree: societal values and provision o...Office of Health Economics
Koonal Shah presented findings from a review of 23 studies on societal preferences for end of life treatments. The review found mixed evidence - some studies showed support for an "end of life premium" where greater value is placed on health gains for end of life patients, while others found no such support. There was also significant heterogeneity in individual preferences both within and across studies. Overall the evidence does not provide a clear or unanimous indication of whether society supports additional weighting for end of life treatments.
This document provides guidance on funding options for clinical research. It discusses considering one's goals and interests to determine the appropriate funding. National Institutes of Health grants such as K-awards and R01 grants are recommended for spending significant time in academic investigation. Small internal grants can provide pilot data for larger grants. Industry-sponsored clinical trials are another option but require ensuring publication rights and managing conflicts of interest. The document stresses applying to multiple sources and being creative in finding support that aligns with one's research goals.
Adrian Towse's slides from a session will exploring how the benefits of antibiotics can best be captured in HTA, and how we should pay for them when their value may depend on restricting their use.
Author(s) and affiliation(s): Adrian Towse, Office of Health Economics
Conference/meeting: Health Technology Assessment International (HTAi) 2018
Location: Vancouver, Canada
Date: 03/06/2018
Collision Forces: Scientific Integrity Meets the Capital MarketsLindsay Meyer
The landscape for innovation in the life sciences requires substantial participation from the investment community to finance new ventures and support existing projects. As such, appropriate risk-adjusted returns are expected by investors. Gaining insight into the progress of important clinical trials has catalyzed an information asymmetry between direct participants in the scientific process and the investment community. Direct participants can gain materially by breaching confidentiality agreements or engaging in insider trading, unethical practices that compromise scientific integrity. This report explores the nature of conflicts that can arise from the unique relationships specific to entities developing human therapeutics and proposes three mechanisms for minimizing negative externalities of the research process: raising awareness of the problem, mandating professional organizations to adopt and enforce strict policies for sharing material information, and establishing project work teams to limit the number of individuals exposed to non-public information.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
This document discusses knowledge transfer between researchers and policymakers. It begins with an overview of the knowledge cycle and evidence-based healthcare. It notes that while researchers seek truth and policymakers seek compromise, their common goal is improving public health. The document recommends establishing units to facilitate knowledge transfer and decision support. It also suggests training policymakers to identify how research can help and accessing evidence to inform decisions. The overall message is that researchers and policymakers must understand each other and work together toward their shared goal of improving health outcomes.
This document discusses how open innovation can transform the healthcare and life sciences industry. It argues that the traditional linear model of operations for these industries needs to change given rising costs, failing drug pipelines, and demands for improved outcomes. Open innovation enables collaboration across organizations through knowledge sharing. The document outlines a three step technology-driven agenda for healthcare and life sciences companies to become more open and patient-centric: 1) Transitioning R&D from silos to open environments, 2) Shifting marketing from one-way to co-creative, and 3) Adopting predictive clinical diagnosis. Technology plays a key role by facilitating knowledge exchange, collaboration, and analytics across organizations.
What's In An Idea-Chanda-UofT Life Science CoachDebra A. Chanda
The document discusses challenges and opportunities in the medical innovation process. It notes that while regulatory approval and reimbursement processes can be slow, improvements are being made. Medical device innovation requires collaboration between physicians, engineers, and industry. The future includes more implanted diagnostics to better manage diseases and promote wellness. Overall, the field remains promising for new technologies despite barriers that can be further addressed.
The Precision Medicine Initiative is a $215 million effort to revolutionize disease treatment through personalized care. It will create a voluntary national research cohort of over 1 million Americans to share health data to accelerate discoveries. The goals are to develop more effective cancer treatments through genetic testing and clinical trials, create an open research platform for the cohort to partner on studies, and ensure strong privacy protections for health information. The initiative aims to translate precision medicine successes into broader application through public-private partnerships and regulatory modernization.
Dr. Alan Bernstein, president of the Canadian Institutes of Health Research (CIHR), has set an ambitious goal to turn Canada's $20 billion annual healthcare spending into a research-driven enterprise to capture both health and economic benefits. Under Bernstein's leadership, the CIHR has increased funding for healthcare research significantly, focusing on areas like health services research and population health that have the potential to improve healthcare delivery and identify preventative strategies. The CIHR also aims to commercialize research discoveries in Canada in order to fund new research, reward scientists, and retain top talent in the country. Several examples are provided of research institutions and startups that have successfully commercialized healthcare technologies and therapies with support from the CIHR.
5 presentations on the challenges and options for science funding (health research) in Canada from a panel at the Canadian Science Policy Conference, 2013. Presenters: Christine Williams, Peter Goodhand, Jane Aubin, Phil Hieter and Jim Woodgett (chair).
From personalized medicine to personalized science - a new concept in biogero...Anna Ericsson
This document proposes a new model for patient-driven, goal-oriented biomedical research. The key aspects of the model are:
1) Patients with chronic conditions and no known cures would engage directly in research efforts by providing funding, samples, and project management expertise to a multidisciplinary research team.
2) Research organizations would assemble teams of scientists and physicians and announce specific research projects focused on patients' medical issues. Teams would be selected and funded by the interested patients.
3) The model is proposed to better integrate research and clinical practice by having patients directly involved in coordinating goal-oriented research projects aimed at their conditions.
This document discusses evidence-based public health (EBPH). It defines EBPH as the development, implementation, and evaluation of effective programs and policies through applying scientific reasoning principles. The key steps of EBPH include quantifying the public health issue, conducting a literature review, developing and prioritizing program options, creating an action plan, and evaluating programs and policies. EBPH relies on diverse sources of evidence, both quantitative and qualitative research. It differs from evidence-based medicine in its focus on populations rather than individuals and emphasis on environmental and social factors.
This document summarizes PCORI's efforts to engage patients in research and tool development. It discusses PCORI's priorities in comparative clinical effectiveness research and shared decision making. Examples are provided of pilot projects developing tools like a digital portal for multiple sclerosis patients and integrating patient-reported outcomes into arthritis care. PCORI's vision for a National Patient-Centered Clinical Research Network is outlined, with plans to fund Clinical Data Research Networks and Patient-Powered Research Networks through cooperative agreements.
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
This document summarizes evidence-informed health care for rare diseases. It discusses:
1) Progress in rare disease research including increasing genetic tests available and approved orphan drugs. Clinical interventions and systems of care are important.
2) Why studying systems of care is important to reduce the "effectiveness gap" between clinical trials and real-world outcomes. Translational research from efficacy to effectiveness and population impact is needed.
3) Challenges in studying rare disease care including limited knowledge, defining meaningful outcomes, and study feasibility with small patient numbers. International collaboration is key.
The document summarizes plans to develop a Clinical and Translational Science Award (CTSA) application for the University of Colorado. It discusses the goals of the CTSA program to improve translational research and the requirements for the application. Working groups are being formed across University of Colorado campuses and affiliated hospitals to develop the application components. The deadline for submission is October 24, 2007.
EuroBioForum 2013 - Day 1 | Etienne RicherEuroBioForum
EuroBioForum 2013 2nd Annual Conference
27-28 May 2013 - Hilton Munich City, Munich, Germany
http://www.eurobioforum.eu/2013
=======================================
# NATIONAL PERSPECTIVES #
Canada:
Personalised Medicine: A Canadian Collaborative Perspective'
Dr Étienne Richer, Assistant Director at CIHR Institute of Genetics
=======================================
http://www.eurobioforum.eu
The document discusses the importance of including African American ophthalmologists in clinical trials. It notes that while efforts are being made to recruit more minority patients, African American doctors are often left out. Barriers include perceptions of lack of time/resources, distrust of industry, and regulatory hurdles. Breaking down these barriers could help faster drug approval through more diverse enrollment and compliance. Measurable outcomes include increased minority exposure to research and education of both patients and doctors.
This document discusses issues with reproducibility in biomedical research and proposes solutions. It notes that an estimated $28 billion is spent annually in the USA on preclinical research that cannot be reproduced, and that over 50% of published bioscience research reports have flaws. The causes go beyond intentional fraud and include flawed research protocols, materials, and overzealous data interpretation. The system of incentives prioritizes novelty and impact over reproducibility, reliability, and reporting negative results. A series of reforms are proposed, including making raw data and protocols openly accessible, increasing funding for reproducibility studies, and updating standards for statistical analysis and experimental design.
The document discusses the Myelin Repair Foundation's (MRF) mission to accelerate the discovery of treatments for multiple sclerosis (MS) by establishing a new paradigm for medical research. It outlines some of the inefficiencies of the current academic research and drug discovery system. The MRF aims to coordinate disease-specific research, protect intellectual property, and transition promising targets to clinical candidates more efficiently through its Accelerated Research Collaboration model. It summarizes the MRF's research progress and plans over its first five years and outlines strategies to further translate its discoveries.
This document discusses the need for a paradigm shift in public understanding of medical research and development (R&D) to better meet patient needs. It notes that current "success stories" only help small numbers of patients, and that patients urgently need therapeutic innovation. It argues that innovation in areas like cancer, rare diseases, clinical trial design, and personalized medicine requires new approaches in R&D. It also emphasizes the important role patient organizations can play by providing insights into patient experiences and priorities to help drive research. Finally, it introduces the European Patients' Academy as an initiative aiming to train patient advocates and foster collaborative efforts to make drug development more effective.
Presentation on current state of pharmaceutical drug research and ideas for change. It addresses how the pharmaceutical industry, NIH, Government, HealthCare Law, OIG, Public Health
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Valley of Death Panel Slides at the Partnering for Cures Conference, December...TRAIN Central Station
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Amy Comstock Rick, Chief Executive Officer, Parkinson's Action Network
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FasterCures Presentation: Fostering innovation while delivering treatments and technologies to large markets
1. Margaret Anderson COO June 25, 2009 BioEconomy Summit Healthcare Policy Session 2: Affordability and Access Fostering innovation while delivering affordable treatments and technologies to large markets
7. Finding Big Ideas in Small Spaces: New Business Models to Accelerate Research
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9. Finding Big Ideas in Small Spaces The Redstone Acceleration and Innovation Network Passion Capital De-Risking Investments Patient Access Clinical Trial and Research Networks Intellectual Capacity Research Discipline Science Management Advocacy T he R edstone A cceleration and I nnovation N etwork
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12. Separating what we need to do in science and what we need to do in the culture of science to accelerate curing diseases
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14. Get involved with FasterCures Visit us online and get the latest FasterCures information, publications, podcasts, video clips, and other multimedia resources Stay informed, get relevant, up-to-date news stories in biomedical research delivered to you twice-weekly Track our progress through our quarterly newsletter featuring program developments and offerings Talk to us. Respond and comment on our blogs about the latest issues, trends, and findings that impact medical research and discovery Find and follow us
15. Partnering for Cures will bring together philanthropists, medical research foundations, and biopharmaceutical companies that can accelerate the development and approval of new therapies patients need.
Editor's Notes
Source: “ 2006 Investment in U.S. Health Research ”, Research!America, An Alliance for Discoveries in Health, 2007; Moses, H. et al, “ Financial Anatomy of Biomedical Research ,” Journal of American Medical Association, vol.294, No.11, September 21, 2005
Collaborative, mission-driven, results-oriented, and strategic in their use of capital, these groups are motivated solely by moving promising therapies from the laboratory bench to the patient’s bedside as rapidly as possible – even those that do not directly fund therapy development. For too long, our national research enterprise has been dominated by long-term investment in low-risk, low-yield, but reliable bonds. These new disease research organizations represent a diversification of our national research portfolio with a variety of high-risk, high-reward ventures. Nonprofit organizations can support alliances that typically would not be supported through public investments, such as with for-profit companies. They can bridge disciplines, institutions, and ideas when the opportunity arises and in record time. Because of their close relationships with the patient communities, their ability to move quickly to address emerging translational and clinical opportunities and their capacity to leverage public investment, these organizations can catalyze and jump-start innovation. Moreover, they can serve as a reliable source of funds for novel, high-risk research that might not be able to compete successfully for public funds. Because they are closer to the patients and therefore closer to the problems needing solutions, innovative nonprofit funders have heightened awareness of the importance of translational and clinical research programs. Increasingly, they are forming a unified advocacy front on key public policy issues affecting the pace of research, such as privacy regulations, intellectual property challenges, and the resolution of ethical issues.
Free of the pressures of publication and career advancement in academia and the bottomline imperatives of the private sector, nonprofit foundations are ideally positioned to make relatively high-risk investments that could significantly move a field of research forward and increase the likelihood that other parties also will invest.