Johan Mackenbach Department of Public Health Erasmus MC

Size: px
Start display at page:

Download "Johan Mackenbach Department of Public Health Erasmus MC"

Transcription

1 Johan Mackenbach Department of Public Health Erasmus MC

2 Improved population health

3 Improved population health Reliable and relevant information

4 Improved population health Reliable and relevant information Proper scientific practices

5 Enormous advances in population health, but: Little progress in some underfunded areas (e.g., neglected tropical diseases ) Modest progress at high costs in some wellfunded areas (e.g., cancer) Progress sometimes comes with large-scale iatrogenic harm (e.g., drug side effects)

6 Enormous increase of available information, but: There is no evidence for most of what we do in medicine Most published research findings are false (Ioannides 2005) Increased skepticism about the claims of evidence-based medicine

7 Enormous increase of quantity and quality of medical and health research, but: Dissatisfaction with emphasis on publication and citation counts Conflicts of interest are omnipresent financial, personal, ideological, Discovery of breaches of scientific integrity suggests dysfunctioning systems

8 Improved population health Reliable and relevant information Proper scientific practices

9 Improved population health Reliable and relevant information Proper scientific practices

10 Improved population health Reliable and relevant information Proper scientific practices

11 Large-scale iatrogenic harm Suppression of research results Financial interests

12 Modest progress at high costs Overemphasis on positive findings Personal interests

13 Because the prior probability of claims being true is usually low Because many studies are biased and underpowered Because there is selective reporting and publishing of positive effects Ioannides 2005

14 Study publication bias arises when studies are published or not depending on their results - Positive results bias : authors are more likely to submit, and editors accept, positive than null results - Filedrawer effect : authors conduct many more studies than they finally report, and do not submit studies with null results Pipeline bias arises when studies without statistically significant results take longer to get published Within-study selective reporting bias arises when only a subset of the original outcome variables are reported Dwan et al. 2008

15 No progress in population health Publication bias Improper scientific practices

16 Artificial discrepancy between supply of study results and volume of high-impact journals ( winner s curse ) Lack of understanding among scientists of links between their practices and research outcomes Dependence of scientists careers, group grant incomes, and institutions reputations on positive results

17 Remove artificial scarcity of publication outlets by creating new, open journals Change editorial policies, e.g., prioritize papers for quality not relevance Obligatory registration of study protocols, and reporting of protocol-based analyses only Awareness raising, research training, codes of conduct, reporting checklists,. Less emphasis on publication and citation counts, wider range of science evaluation criteria Reduce dependence on industry sponsoring, increase public spending on research

18 Remove artificial scarcity of publication outlets by creating new, open journals Change editorial policies, e.g., prioritize papers for quality not relevance Obligatory registration of study protocols, and reporting of protocol-based analyses only Awareness raising, research training, codes of conduct, reporting checklists,. Less emphasis on publication and citation counts, wider range of science evaluation criteria Reduce dependence on industry sponsoring, increase public spending on research

19 Remove artificial scarcity of publication outlets by creating new, open journals Change editorial policies, e.g., prioritize papers for quality not relevance Obligatory registration of study protocols, and reporting of protocol-based analyses only Awareness raising, research training, codes of conduct, reporting checklists,. Less emphasis on publication and citation counts, wider range of science evaluation criteria Reduce dependence on industry sponsoring, increase public spending on research

20 Medical research has contributed and is still contributing to enormous advances in population health We can probably do even better better priorities, better study quality, better reporting, more integrity, Reducing publication bias is important Erasmus MC can contribute by raising research standards and avoiding perverse incentives Academic institutions should join forces to improve publication practices and reduce conflicts of interest

21 Current publication practices have contributed and are still contributing to enormous advances in population health We can probably do even better better priorities, better study quality, better reporting, more integrity, Erasmus MC can contribute to reducing publication bias by raising research standards and avoiding perverse incentives More importantly, academic institutions should join forces to improve publication practices and reduce conflicts of interest

RKI workshop, Evidence based immunisation. Evidence-based methods for public health

RKI workshop, Evidence based immunisation. Evidence-based methods for public health RKI workshop, Evidence based immunisation Evidence-based methods for public health ECDC report Evidence-based methods for public health How to assess the best available evidence when time is limited and

More information

National Cancer Institute

National Cancer Institute National Cancer Institute Taking Part in Cancer Treatment Research Studies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Taking Part in Cancer Treatment Research Studies If

More information

Comment Form: WHO Statement on Public Disclosure of Clinical Trial Results. Suggested Amendment

Comment Form: WHO Statement on Public Disclosure of Clinical Trial Results. Suggested Amendment Form: WHO Statement on Public Disclosure of Clinical Trial Results Page 1 of 6 as individual or on behalf of agency or institution?: Institution er's Name in Full, Title, Institution, City, Country, Tel.,

More information

PROPOSAL by Bangladesh, Barbados, Bolivia and Suriname. Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines

PROPOSAL by Bangladesh, Barbados, Bolivia and Suriname. Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines PROPOSAL by Bangladesh, Barbados, Bolivia and Suriname Chagas Disease Prize Fund for the Development of New Treatments, Diagnostics and Vaccines Executive Summary Date: 09.04.15 In resolution WHA 61.21,

More information

Sharing public health data: a code of conduct

Sharing public health data: a code of conduct 1 Sharing public health data: a code of conduct In this information age, science is advancing by leaps and bounds. What is driving the exponential growth in knowledge in areas such as genetics, astrophysics,

More information

Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility

Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility Report of a meeting organized by the Wellcome Trust and held on 14 15 January 2003 at Fort Lauderdale,

More information

Time for Computer Science to Grow Up

Time for Computer Science to Grow Up Time for Computer Science to Grow Up Lance Fortnow Northwestern University Abstract Unlike every other academic field, Computer Science uses conferences rather than journals as the main publication venue.

More information

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES

TAKING PART IN CANCER TREATMENT RESEARCH STUDIES For more infomation about Cancer Clinical Trials at Upstate Cancer Center please call Upstate Connect 1.800.464.8668 TAKING PART IN CANCER TREATMENT RESEARCH STUDIES Information provided by: National Cancer

More information

Narrowing the Gap. Clinical Development and Regulatory Pathways for Medical Technologies for Neglected Diseases. Tom Bollyky

Narrowing the Gap. Clinical Development and Regulatory Pathways for Medical Technologies for Neglected Diseases. Tom Bollyky Narrowing the Gap Clinical Development and Regulatory Pathways for Medical Technologies for Neglected Diseases Tom Bollyky Stanford Law School Drug Development and International Access Conference April

More information

Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman

Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman Centre for Statistics in Medicine University of Oxford Whatever the outcome of a study, it is really hard for the

More information

Is it time for a new drug development paradigm?

Is it time for a new drug development paradigm? Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and

More information

University of Cincinnati College of Medicine

University of Cincinnati College of Medicine University of Cincinnati College of Medicine Policy Policy and Guidelines for Industry Relationships Policy and Guidelines for Industry Relationships FAQ Date Updated Page 5/14/2008 2 -- 8 NB: The Institute

More information

The Coalition s Policy to Protect and Streamline Health and Medical Research Funding

The Coalition s Policy to Protect and Streamline Health and Medical Research Funding 1 Our Plan Real Solutions for all Australians The direction, values and policy priorities of the next Coalition Government. The Coalition s Policy to Protect and Streamline Health and Medical Research

More information

Strong support. Remaining concerns

Strong support. Remaining concerns EORTC opinion on the proposal for an EU Regulation on clinical trials on medicinal products for human use and the 7 th of June ENVI report on this proposal It is clear that the Commission and appointed

More information

AUSTRALIAN INSTITUTE OF HEALTH INNOVATION Faculty of Medicine and Health Sciences. Translating research into medical practice

AUSTRALIAN INSTITUTE OF HEALTH INNOVATION Faculty of Medicine and Health Sciences. Translating research into medical practice AUSTRALIAN INSTITUTE OF HEALTH INNOVATION Faculty of Medicine and Health Sciences Translating research into medical practice 2 Translating research into medical practice Techniques and treatments are improving

More information

A Guide to Clinical Trials

A Guide to Clinical Trials A Guide to Clinical Trials For young people with cancer and their parents Children s Cancer and Leukaemia Group www.cclg.org.uk Original booklet produced in conjunction with the CCLG Patient Advocacy Committee.

More information

WHY THE FDA SHOULD REGULATE TOBACCO PRODUCTS

WHY THE FDA SHOULD REGULATE TOBACCO PRODUCTS WHY THE FDA SHOULD REGULATE TOBACCO PRODUCTS WHAT IF a product consumed by nearly 50 million Americans every day killed one-third of those who became regular users and one-half of those who use it for

More information

Issues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit?

Issues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit? ELLEN PURÉ, Ph.D. Issues Does the academe have as a goal or an obligation, the development of its discoveries for human benefit? Can the academic review process support individual career development in

More information

Managing Research Compliance Risks

Managing Research Compliance Risks Managing Research Compliance Risks James Moran, J.D., CPA Executive Director of Compliance, University of Pennsylvania School of Medicine Rick Rohrbach, MBA, CPA Senior Manager, Healthcare Consulting Practice

More information

CHALLENGES AND BARRIERS ALONG THE IN-COUNTRY SUPPLY CHAIN

CHALLENGES AND BARRIERS ALONG THE IN-COUNTRY SUPPLY CHAIN UN Commission on Life-Saving Commodities for Women and Children CHALLENGES AND BARRIERS ALONG THE IN-COUNTRY SUPPLY CHAIN To increase access to life-saving commodities for women and children, barriers

More information

ADVANCING POPULATION HEALTH: NEW MODELS AND THE ROLE OF RESEARCH

ADVANCING POPULATION HEALTH: NEW MODELS AND THE ROLE OF RESEARCH 22 nd Annual Health Care Systems Research Network (HCSRN) Conference (formerly HMO Research Network Conference) ADVANCING POPULATION HEALTH: NEW MODELS AND THE ROLE OF RESEARCH Hosted by: Marshfield Clinic

More information

University of Central Florida College of Medicine Industry Relations Policy and Guidelines. Table of Contents

University of Central Florida College of Medicine Industry Relations Policy and Guidelines. Table of Contents University of Central Florida College of Medicine Industry Relations Policy and Guidelines 1. Introduction and Scope of Policy 2. Statement of Policy Table of Contents 3. Gifts and Individual Financial

More information

Paris, 15 June 2013 Response to a public consultation

Paris, 15 June 2013 Response to a public consultation Paris, 15 June 2013 Response to a public consultation Revision of the World Medical Association Helsinki Declaration: - transparency of clinical trial results must be enhanced (articles 23, 24 & 26) -

More information

Guidance for Peer Reviewers. The Journal of the American Osteopathic Association (JAOA)

Guidance for Peer Reviewers. The Journal of the American Osteopathic Association (JAOA) Guidance for Peer Reviewers The Journal of the American Osteopathic Association (JAOA) JAOA Editorial Staff This module is available online at http://jaoa.org/documentlibrary/prmodule.pdf Guidance for

More information

Neal Rouzier responds to the JAMA article on Men and Testosterone

Neal Rouzier responds to the JAMA article on Men and Testosterone Neal Rouzier responds to the JAMA article on Men and Testosterone On the first day the JAMA article was released I received 500 emails from physicians and patients requesting my opinion of the article

More information

HOT TOPICS IN IN HEALTH CARE REFORM

HOT TOPICS IN IN HEALTH CARE REFORM By Felicia Fuller Publications Manager, DAC Patient Recruitment Services The Patient Protection and Affordable Care Act (ACA), colloquially known as Obamacare, is in full effect and its impact is palpable

More information

Publication Bias in medical research: issues and communities

Publication Bias in medical research: issues and communities Publication Bias in medical research: issues and communities Edgar Schiebel and Maria Elisabeth Züger edgar.schiebel@ait.ac.at, maria-elisabeth.zueger@ait.ac.at AIT Austrian Institute of Technology GmbH,

More information

Marshall University Joan C. Edwards School of Medicine Conflict of Interest Policy. Introduction

Marshall University Joan C. Edwards School of Medicine Conflict of Interest Policy. Introduction Marshall University Joan C. Edwards School of Medicine Conflict of Interest Policy Introduction The faculty 1 and medical students of the Joan C. Edwards School of Medicine (SOM) have responsibilities

More information

Corresponding Author: Daniel Pucheril (email: dpucheril@gmail.com)

Corresponding Author: Daniel Pucheril (email: dpucheril@gmail.com) PRISMA-P 2015 CHECKLIST ADMINISTRATIVE INFORMATION Title: An updated systematic review of complications following Robotic-Assisted Laparoscopic Radical Prostatectomy: A guide to avoiding and managing complications

More information

FORM ENTRY INSTRUCTIONS FOR THE RESEARCH SEMINARS AND EVENTS WEB PAGE

FORM ENTRY INSTRUCTIONS FOR THE RESEARCH SEMINARS AND EVENTS WEB PAGE FORM ENTRY INSTRUCTIONS FOR THE RESEARCH SEMINARS AND EVENTS WEB PAGE ABOUT THE RESEARCH SEMINARS AND EVENTS WEB PAGE The RESEARCH SEMINARS AND EVENTS web page was created to provide a one stop internet

More information

Big Data Analysis & Data Mining

Big Data Analysis & Data Mining 2 nd International Conference on Big Data Analysis & Data Mining San Antonio, USA Nov 30-Dec 02, 2015 Brochure Conference Secretariat 2360 Corporate Circle, Suite 400, Henderson, NV 89074-7722, USA Ph:

More information

Past, present and future issues for the US Preventive Services Task Force. Ned Calonge, M.D., M.P.H. Chair, U.S. Preventive Services Task Force

Past, present and future issues for the US Preventive Services Task Force. Ned Calonge, M.D., M.P.H. Chair, U.S. Preventive Services Task Force Past, present and future issues for the US Preventive Services Task Force Ned Calonge, M.D., M.P.H. Chair, U.S. Preventive Services Task Force USPSTF history * USPSTF I: 1984 1989» Followed first report

More information

(1) Cancer drug means a prescription drug that is used to treat cancer or the side effects of cancer.

(1) Cancer drug means a prescription drug that is used to treat cancer or the side effects of cancer. DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Health Promotion and Disease Prevention Services CANCER DRUG REPOSITORY PROGRAM 6 CCR 1015-10 [Editor s Notes follow the text of the rules at the end of this

More information

Requirements for Drug Information Centres

Requirements for Drug Information Centres FIP Pharmacy Information Section Requirements for Drug Information Centres Summary All countries should provide drug information services either independently or as part of a regional network. The service

More information

Big Data Analysis & Data Mining

Big Data Analysis & Data Mining International Conference on Big Data Analysis & Data Mining Brochure Lexington, USA May 04-06, 2015 Conference Secretariat 5716 Corsa Ave., Suite 110, West Lake, Los Angeles, CA 91362-7354, USA Ph: +1-650-268-9744,

More information

16- Master s Degree in Public Health and Public Health Sciences (Majoring Health Management, Planning and Policy)

16- Master s Degree in Public Health and Public Health Sciences (Majoring Health Management, Planning and Policy) 16- Master s Degree in Public Health and Public Health Sciences (Majoring Health Management, Planning and Policy) Students should fulfill a total of 38 credit hours: 1- Basic requirements: 10 credit hours.

More information

May 17, 2015. Office of Extramural Research National Institutes of Health 9000 Rockville Pike Bethesda, Maryland 20892

May 17, 2015. Office of Extramural Research National Institutes of Health 9000 Rockville Pike Bethesda, Maryland 20892 Office of Extramural Research National Institutes of Health 9000 Rockville Pike Bethesda, Maryland 20892 RE: Request for Information (RFI): Optimizing Funding Policies and Other Strategies to Improve the

More information

Workshop on Establishing a Central Resource of Data from Genome Sequencing Projects

Workshop on Establishing a Central Resource of Data from Genome Sequencing Projects Report on the Workshop on Establishing a Central Resource of Data from Genome Sequencing Projects Background and Goals of the Workshop June 5 6, 2012 The use of genome sequencing in human research is growing

More information

EDITORIAL MINING FOR GOLD : CAPITALISING ON DATA TO TRANSFORM DRUG DEVELOPMENT. A Changing Industry. What Is Big Data?

EDITORIAL MINING FOR GOLD : CAPITALISING ON DATA TO TRANSFORM DRUG DEVELOPMENT. A Changing Industry. What Is Big Data? EDITORIAL : VOL 14 ISSUE 1 BSLR 3 Much has been written about the potential of data mining big data to transform drug development, reduce uncertainty, facilitate more targeted drug discovery and make more

More information

Stakeholder Guide 2014 www.effectivehealthcare.ahrq.gov

Stakeholder Guide 2014 www.effectivehealthcare.ahrq.gov Stakeholder Guide 2014 www.effectivehealthcare.ahrq.gov AHRQ Publication No. 14-EHC010-EF Replaces Publication No. 11-EHC069-EF February 2014 Effective Health Care Program Stakeholder Guide Contents Introduction...1

More information

Ethical Standards for Publication of Aeronautics and Astronautics Research

Ethical Standards for Publication of Aeronautics and Astronautics Research Ethical Standards for Publication of Aeronautics and Astronautics Research I. Preface/Introduction II. AIAA Ethical Standards A. Ethical Standards for AIAA Journals B. Ethical Standards for AIAA Books

More information

Evaluating New Cancer Treatments

Evaluating New Cancer Treatments Evaluating New Cancer Treatments You ve just heard about a possible new cancer treatment and you wonder if it might work for you. Your doctor hasn t mentioned it, but you want to find out more about this

More information

Welcome Address by the. State Secretary at the Federal Ministry of Education and Research. Dr Georg Schütte

Welcome Address by the. State Secretary at the Federal Ministry of Education and Research. Dr Georg Schütte Welcome Address by the State Secretary at the Federal Ministry of Education and Research Dr Georg Schütte at the "Systems Biology and Systems Medicine" session of the World Health Summit at the Federal

More information

Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY

Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials

More information

Elizabeth Wager & Sabine Kleinert. Contact details: liz@sideview.demon.co.uk sabine.kleinert@lancet.com

Elizabeth Wager & Sabine Kleinert. Contact details: liz@sideview.demon.co.uk sabine.kleinert@lancet.com Responsible research publication: international standards for authors A position statement developed at the 2 nd World Conference on Research Integrity, Singapore, July 22-24, 2010 Elizabeth Wager & Sabine

More information

Post-authorisation safety studies and the EU PAS Register

Post-authorisation safety studies and the EU PAS Register Post-authorisation safety studies and the EU PAS Register Xavier Kurz European Medicines Agency EMA, 11 October 2012 An agency of the European Union Content of the presentation 1. PASS: definition and

More information

The Changing Pharmaceutical Sales Landscape: Recommendations for Achieving Compliance and Sales Excellence

The Changing Pharmaceutical Sales Landscape: Recommendations for Achieving Compliance and Sales Excellence The Changing Pharmaceutical Sales Landscape: Recommendations for Achieving Compliance and Sales Excellence By: Wendy Heckelman, Ph.D. Dr. Wendy Heckelman, President and Founder of WLH Consulting, Inc.

More information

Effective Healthcare and The Cochrane Collaboration: Impact

Effective Healthcare and The Cochrane Collaboration: Impact Effective Healthcare and The Cochrane Collaboration: The Vision, The Output, The Impact Dr. Bruce Walker Senior Lecturer in Evidence based practice and Public health School of Chiropractic and Sports Science

More information

Current reporting in published research

Current reporting in published research Current reporting in published research Doug Altman Centre for Statistics in Medicine, Oxford, UK and EQUATOR Network Research article A published research article is a permanent record that will be used

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

Component 2: The Culture of Health Care

Component 2: The Culture of Health Care Component 2: The Culture of Health Care Unit 9: Sociotechnical Aspects: Clinicians and Technology Lecture 1 This material was developed by Oregon Health & Science University, funded by the Department of

More information

Richard T. Clark Chief Executive Officer and President. Executing on Our Strategy

Richard T. Clark Chief Executive Officer and President. Executing on Our Strategy Richard T. Clark Chief Executive Officer and President Executing on Our Strategy Merck s Plan to Win: Preparing for Our Future Success BECOME THE MOST TRUSTED INDUSTRY LEADER IN DELIVERING VALUE TO CUSTOMERS

More information

An Evidence-Based Approach to Reviewing the Science on the Safety of Chemicals in Foods

An Evidence-Based Approach to Reviewing the Science on the Safety of Chemicals in Foods An Evidence-Based Approach to Reviewing the Science on the Safety of Chemicals in Foods In considering the safety of chemicals added to foods, or present in foods due to environmental circumstances, we

More information

Clinical Trials and Screening: What You Need to Know

Clinical Trials and Screening: What You Need to Know Scan for mobile link. Clinical Trials and Screening: What You Need to Know What is a Clinical Trial? At A Glance A clinical trial is a research study that tests how well new medical techniques work in

More information

Antarctic Environmental Portal content development and editorial process

Antarctic Environmental Portal content development and editorial process Agenda Item: CEP 3 Presented by: Original: Australia, Belgium, New Zealand, Norway, SCAR English Submitted: 16/04/2015 Antarctic Environmental Portal content development and editorial process 1 Antarctic

More information

Application of Clinical Trial Certificate of Chinese Medicines in Hong Kong

Application of Clinical Trial Certificate of Chinese Medicines in Hong Kong Application of Clinical Trial Certificate of Chinese Medicines in Hong Kong D R. K F C H U N G D E P A R T M E N T O F P S Y C H I A T R Y U N I V E R S I T Y O F H O N G K O N G ( S E P T 2 0 1 4 ) Evidence-based

More information

Game Changers for Researchers: Altmetrics, Big Data, Open Access What Might They Change? Kiki Forsythe, M.L.S.

Game Changers for Researchers: Altmetrics, Big Data, Open Access What Might They Change? Kiki Forsythe, M.L.S. Game Changers for Researchers: Altmetrics, Big Data, Open Access What Might They Change? Kiki Forsythe, M.L.S. Definition of Game Changer A newly introduced element or factor that changes an existing situation

More information

ANONYMITY AND PSEUDONYMITY IN WHISTLEBLOWING TO THE U.S. OFFICE OF RESEARCH INTEGRITY

ANONYMITY AND PSEUDONYMITY IN WHISTLEBLOWING TO THE U.S. OFFICE OF RESEARCH INTEGRITY ANONYMITY AND PSEUDONYMITY IN WHISTLEBLOWING TO THE U.S. OFFICE OF RESEARCH INTEGRITY ALAN R. PRICE. PHD Reprinted from ACADEMIC MEDICINE, 1998 by H e Association of American Medical Colleges SPECIAL ARTICLE

More information

Formulary Management

Formulary Management Formulary Management Formulary management is an integrated patient care process which enables physicians, pharmacists and other health care professionals to work together to promote clinically sound, cost-effective

More information

Themes. Why is waste in research an ethical issue? Waste occurs in all stages of research. Research funding is finite

Themes. Why is waste in research an ethical issue? Waste occurs in all stages of research. Research funding is finite Why is waste in research an ethical issue? Elizabeth Wager PhD Publications Consultant, Sideview, UK Co-Editor-in-Chief : Research Integrity & Peer Review UK EQUATOR Centre Fellow Visiting Professor, University

More information

Professional Standards and Guidelines

Professional Standards and Guidelines College of Physicians and Surgeons of British Columbia Professional Standards and Guidelines Conflict of Interest Arising from Clinical Research Preamble This document is a guideline of the Board of the

More information

Areas where STATISTICS are used. Government Census, Law, National Defense

Areas where STATISTICS are used. Government Census, Law, National Defense What Is Statistics? American Heritage Dictionary: The mathematics of the collection, organization, and interpretation of numerical data, especially the analysis of population characteristics by inference

More information

Advance Diploma in Pharma Brand Management (ADPBM) TM

Advance Diploma in Pharma Brand Management (ADPBM) TM Division of Waksman Healthcare & Innoceutical, Mumbai, INDIA PROSPECTUS: 2012-13 Advance Diploma in Pharma Brand Management is an exclusive training program completely on the practical aspects of Pharma

More information

New Mexico State University

New Mexico State University The Office of Research Integrity & Ethics and the Office of Research Compliance Research Integrity and Compliance Human Subjects, Vertebrate Animals, or Biological Agents Luis A. Vazquez, Ph.D. Associate

More information

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this

More information

IMPLEMENTING BUSINESS CONTINUITY MANAGEMENT IN A DISTRIBUTED ORGANISATION: A CASE STUDY

IMPLEMENTING BUSINESS CONTINUITY MANAGEMENT IN A DISTRIBUTED ORGANISATION: A CASE STUDY IMPLEMENTING BUSINESS CONTINUITY MANAGEMENT IN A DISTRIBUTED ORGANISATION: A CASE STUDY AUTHORS: Patrick Roberts (left) and Mike Stephens (right). Patrick Roberts: Following early experience in the British

More information

Policy Focus Health Care Regulations Don t Help They Hurt!

Policy Focus Health Care Regulations Don t Help They Hurt! Policy Focus Health Care Regulations Don t Help They Hurt! Recipes for Rational Government from the Independent Women s Forum Hadley Heath, Senior Policy Analyst, Independent Women s Forum October 2011

More information

Improving quality, protecting patients

Improving quality, protecting patients Improving quality, protecting patients Standards of proficiency for Healthcare Science Practitioners 31 July 2014 Version 1.0 Review date: 31 July 2015 Foreword I am pleased to present the Academy for

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

The Consumer Price Index

The Consumer Price Index The price level is the average level of prices and is measured by using a price index. The consumer price index, or CPI, measures the average level of the prices of goods and services consumed by an urban

More information

RESPONSIBLE CONDUCT OF RESEARCH AND THE GLOBAL CONTEXT

RESPONSIBLE CONDUCT OF RESEARCH AND THE GLOBAL CONTEXT 1 RESPONSIBLE CONDUCT OF RESEARCH AND THE GLOBAL CONTEXT An Overview Scientific research is one of the great adventures of our time. Researchers are members of a global community that is producing new

More information

EMORY UNIVERSITY SCHOOL OF MEDICINE POLICY ON INDUSTRY AND OTHER EXTERNAL PROFESSIONAL RELATIONSHIPS. Table of Contents

EMORY UNIVERSITY SCHOOL OF MEDICINE POLICY ON INDUSTRY AND OTHER EXTERNAL PROFESSIONAL RELATIONSHIPS. Table of Contents EMORY UNIVERSITY SCHOOL OF MEDICINE POLICY ON INDUSTRY AND OTHER EXTERNAL PROFESSIONAL RELATIONSHIPS Table of Contents EMORY UNIVERSITY SCHOOL OF MEDICINE POLICY ON INDUSTRY AND OTHER EXTERNAL PROFESSIONAL

More information

The Board reviews risks to the Company s business plan at its scheduled meetings.

The Board reviews risks to the Company s business plan at its scheduled meetings. Pharmaxis Ltd 1. Board responsibility The Pharmaxis Board is responsible for ensuring the Company establishes and maintains a risk management framework for the oversight and management of risk. The Board

More information

Medical Liability Task Force

Medical Liability Task Force Medical Liability Task Force Report and Recommendations Oregon Health Policy Board November 9, 2010 1 The Board s Charge to the Task Force Investigate the current medical liability system Suggest opportunities

More information

International Society of Exposure Science (ISES) Strategic Plan: Creating a Safer and Healthier World by Advancing The Science of Exposure 2008 2011

International Society of Exposure Science (ISES) Strategic Plan: Creating a Safer and Healthier World by Advancing The Science of Exposure 2008 2011 International Society of Exposure Science (ISES) Strategic Plan: Creating a Safer and Healthier World by Advancing The Science of Exposure 2008 2011 Executive Summary Changes in the field of exposure have

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

What s Next for Data Sharing: Insight from the NIH Experience

What s Next for Data Sharing: Insight from the NIH Experience What s Next for Data Sharing: Insight from the NIH Experience Jerry Sheehan Assistant Director for Policy Development National Library of Medicine National Institutes of Health SHARE In-Person Meeting

More information

Master in Health Services Management

Master in Health Services Management Master in Health Services Management International Centre for Health Management (ICHM) Istituto Superiore di Sanità, Rome In collaboration with Ministry of Foreign Affairs (Italy) Directorate General for

More information

MOLOGEN AG German Equity Forum 2015

MOLOGEN AG German Equity Forum 2015 German Equity Forum 2015 Dr. Mariola Söhngen Chief Executive Officer Frankfurt am Main 24 November 2015 We are Pioneers in the Field of Immunotherapies Biotechnology company with focus on immunotherapies

More information

Why Are Drugs So Expensive? Learning About the Drug Development Process

Why Are Drugs So Expensive? Learning About the Drug Development Process Why Are Drugs So Expensive? Page 1 of 92 Why Are Drugs So Expensive? Learning About the Drug Development Process written by: Ann Newman Seventh Street Development Group This product is for your Personal

More information

Clinical Trials at PMH

Clinical Trials at PMH Clinical Trials at PMH What You Need To Know UHN Patient Education Improving Health Through Education A Guide for Patients, Their Families and Friends in the PMH Cancer Program This information is to be

More information

What does the AHSC mean for you?

What does the AHSC mean for you? > > > > > > > > > > > > > > > > > > > > What does the AHSC mean for you? Our vision for the UK s first Academic Health Science Centre a mini-guide for patients Quicker access to new medicines and new treatments

More information

Sponsorship Proposal 5K RUN/WALK. to benefit early lung cancer detection research at University of Colorado Cancer Center

Sponsorship Proposal 5K RUN/WALK. to benefit early lung cancer detection research at University of Colorado Cancer Center Sponsorship Proposal 5K RUN/WALK to benefit early lung cancer detection research at University of Colorado Cancer Center A NATIONAL CANCER INSTITUTE-DESIGNATED Lung cancer is the leading cause of cancer

More information

BACKGROUND TERMS 1. SCOPE OF WORK

BACKGROUND TERMS 1. SCOPE OF WORK PENN STANDARD CLINICAL TRIAL AGREEMENT ORS 05-08 CLINICAL TRIAL RESEARCH AGREEMENT This Agreement is entered into by and between: The Trustees of the University of Pennsylvania with an address at Office

More information

Business Continuity for Cyber Threat

Business Continuity for Cyber Threat Business Continuity for Cyber Threat April 1, 2014 Workshop Session #3 3:00 5:30 PM Susan Rogers, MBCP, MBCI Cyberwise CP S2 What happens when a computer program can activate physical machinery? Between

More information

Genentech Corporate Giving and Grants Tip Sheet Healthcare-Related Charitable Support

Genentech Corporate Giving and Grants Tip Sheet Healthcare-Related Charitable Support Genentech Corporate Giving and Grants Healthcare-Related Charitable Support Table of Contents What is Healthcare-Related Charitable Support... 2 Checklist..... 2 I. Log in... 3 II. Organization Registration

More information

MSc in Toxicology. Master Degree Programme

MSc in Toxicology. Master Degree Programme Master Degree Programme MSc in Toxicology Department of Pharmaceutical Sciences, University of Basel Swiss Centre for Applied Human Toxicology (SCAHT) Master of Science in Toxicology University of Basel

More information

Clinician Investigator Program

Clinician Investigator Program Clinician Investigator Program Queen s Clinician Investigator Program: Developing the next Overview The Queen s University Clinician Investigator Program (CIP) is an intensive, research-based postgraduate

More information

Application summary. Lead applicant. Type of Intermediate Fellowship requested. Application title. Proposed duration of funding (months)

Application summary. Lead applicant. Type of Intermediate Fellowship requested. Application title. Proposed duration of funding (months) Application summary Type of Intermediate Fellowship requested Application title Proposed duration of funding (months) Proposed start date Name of administering organisation Lead applicant's address at

More information

PCORI Methodology Standards: Academic Curriculum. 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved.

PCORI Methodology Standards: Academic Curriculum. 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved. PCORI Methodology Standards: Academic Curriculum 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved. Module 5: Step 3 Search the Literature Category 11: Systematic Reviews Prepared

More information

Fraud Prevention and Deterrence

Fraud Prevention and Deterrence Fraud Prevention and Deterrence Fraud Risk Assessment 2016 Association of Certified Fraud Examiners, Inc. What Is Fraud Risk? The vulnerability that an organization faces from individuals capable of combining

More information

Ethical Issues in Animal Research

Ethical Issues in Animal Research Ethical Issues in Animal Research Overview Perspectives on Animal Research Animal Rights vs. Animal Welfare Benefits of Animal Research Laws and Regulations The IACUC Protocols and the 3 R s AAALAC Accreditation

More information

The Clinical Trials Process an educated patient s guide

The Clinical Trials Process an educated patient s guide The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-

More information

INNOVATING FOR TODAY S HEALTH ECOSYSTEM

INNOVATING FOR TODAY S HEALTH ECOSYSTEM THE HONEYBEE CHRONICLES: PART FIVE INNOVATING FOR TODAY S HEALTH ECOSYSTEM An interview with Gregory Downing, Executive Director for Innovation, Immediate Office of the Secretary, United States Department

More information

Fifth Scientific Conference for Students of Higher Education in the KSA

Fifth Scientific Conference for Students of Higher Education in the KSA Fifth Scientific Conference for Students of Higher Education in the KSA April 28 - May 1, 2014 Riyadh Dr. Khondokar M. Nahiduzzaman Department of City & Regional Planning (CRP), KFUPM October 31, 2013;

More information

CTEP Workshop. An Overview of the NCI s Cancer Therapy and Evaluation Program (CTEP) CTEP s Mission. Workshop Objectives. NCI Organizational Structure

CTEP Workshop. An Overview of the NCI s Cancer Therapy and Evaluation Program (CTEP) CTEP s Mission. Workshop Objectives. NCI Organizational Structure CTEP Workshop Elizabeth Ness, RN, MS Director, Staff Development Center for Cancer Research National Cancer Institute Workshop Objectives At the end of this workshop, participants will be able to: Discuss

More information

What is care that works best?

What is care that works best? How do we know which types of health care work best? 1 URAC Health Tip Sheets for Consumers This document is part of a series of information resources to help you get good quality health care. For additional

More information

Vaccines Research & Development. Exhibitor

Vaccines Research & Development. Exhibitor International Conference on Vaccines Research & Development Nov 2015 02-04 Baltimore USA Bronze Sponsor Exhibitor Bronze Sponsor : United Scientific Group Welcome Message United Scientific Group takes

More information

Data Management Considerations for the Data Life Cycle

Data Management Considerations for the Data Life Cycle Data Management Considerations for the Data Life Cycle NRC STS Panel 2011 November 17, 2011, Washington DC Peter Fox (RPI) foxp@rpi.edu, pfox@cs.rpi.edu Tetherless World Constellation http://tw.rpi.edu

More information

Implementing Evidence-Based Practices in Behavioral Health. Mark P. McGovern, Ph.D. Geisel School of Medicine at Dartmouth

Implementing Evidence-Based Practices in Behavioral Health. Mark P. McGovern, Ph.D. Geisel School of Medicine at Dartmouth Implementing Evidence-Based Practices in Behavioral Health Mark P. McGovern, Ph.D. Geisel School of Medicine at Dartmouth Implementing Evidence-Based Practices in Behavioral Health Sponsored by the Hazelden

More information