Increased Focus Being Placed On Using “Real World Evidence” In Regulatory Decision Making
In This Issue
Jobs For Epidemiologists Have Increased Several Fold The traditional pathway to getting new drugs approved has been through the conduct of randomized control trials (RCTs). More recently, an intensifying focus on using nonclinical trial, real world data (RWD) and real world evidence (RWE) as part of a pathway to drug licensure is creating new possibilities and raising new challenges for all parties
involved--- regulators, scientists, and drug and insurance companies. At the same time, this new pragmatism about observational data is creating a huge boost for epidemiologists already inside biopharma and is creating new job opportunities for others. - Real World continues on page 2
Keynote Speaker At ACE Meeting Chronicles Thirteen Infectious Disease Threats Seen Under Five Presidents The Infectious Disease Challenge Called “Perpetual” “If history has taught us anything, it is that the new administration is likely to experience at least one infectious disease crisis of significance.” So spoke Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), and keynote speaker at the recent American College of Epidemiology meeting in New Orleans.
- Fauci cont'd on page 7 •
Volume Thirty Eight
-5WHO Sounds Alarm on NonCommunicable Diseases
-8Notes on People
less than 13 emerging infectious diseases or challenges since the Reagan administration in 1981-89 and during four subsequent Presidential administrations since his taking over the helm of the NIAID in 1984. He outlined the problems and the lessons learned during this talk at ACE. The challenges have only increased over the years.
Fauci chronicled the appearance of no
-3NAS Calls for Action to Address Bullying
-Real World cont'd from page 1 The Epidemiology Monitor ISSN (0744-0898) is published monthly by Roger Bernier, Ph.D., MPH at 33 Indigo Plantation Rd, Okatie, SC, 29909, USA.
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New Realities These new realities were the focus of a presentation made by Amgen’s Cathy Critchlow at the recent American College of Epidemiology meeting in New Orleans last month. The session was organized around the theme of epidemiology in the current political climate, and she provided her thoughts based on her work in the pharmaceutical Industry. According to Critchlow, RWD includes electronic health records, administrative/claims data, patient generated/reported data, prospective cohort studies, and other non-clinical trial health-related data such as that collected from wearable devices. Questions Addressed Among the types of questions being addressed or uses for RWE are a better understanding of a product’s benefit/risk profile and drug utilization in real world (clinical practice) settings, a better picture of the characteristics of patients most likely to benefit from a drug, better grasp of the patient response to therapy targets from genomics data linked to electronic health records, the extent of unmet medical need and size of populations that might benefit from specific drugs. Drivers Some of the drivers for this invigorated interest in using nonclinical trial data comes from the fact that there are simply more and better data being collected from a variety
of sources and computing power, methodology, and data science competency are “advancing significantly”, according to Critchlow. In addition, requirements embedded in the Prescription Drug User Fee Act VI and the 21st Century Cures legislation call for the Food and Drug Administration (FDA) to utilize real-world observational data and to evaluate the use of RWE in informing regulatory decisions. Case Examples Given the opportunities but at the same time the limitations of RWE, all parties involved are trying to decipher just how RWE can be effectively used. There are as yet no official standards by which to evaluate the quality of RWE, and this is a hot topic in the field, says Critchlow. Companies are beginning to accumulate a body of case examples to stimulate discussions of potential ways in which RWE could be used in reaching decisions about a variety of product labeling, drug safety, reimbursement, and other issues. The hope is that accumulating a body of case examples will together inform and help establish acceptable non-clinical trial data pathways to approval for drug utilization. Cautions Needless to say, it is critical to ensure that any RWE used in regulatory submissions is of sufficient quality to enable valid assessment of a drug’s benefits and risks, yet increasing costs of drug development, the greater need to address questions that cannot be addressed by clinical trials, and the greater availability of - Real World continues on page 6
National Academy Calls For Action To Address Bullying On Multiple Fronts Many Epidemiologic Research Needs Identified A National Academies committee which undertook a review of what is known and needs to be known to reduce bullying and its consequences has concluded “…Bullying is not a normal part of childhood, and is now appropriately considered to be a serious public health problem.” Selected Findings The prevalence data that are available indicate that school-based bullying likely affects 18-31% of children and youth, and cyber victimization ranges from 7-15% of youth. Some of the other findings in the report are listed below.
Bullying creates changes in the stress response systems and in the brain that are associated with increased risk for mental health problems, cognitive function, self-regulation, and other physical health problems. Data are unclear on the role of bullying as one of or a precipitating cause of school shootings Multicomponent schoolwide programs that involve classroom, parent, and individual elements bundled together appear to be most effective at reducing bullying Recommendations
The committee made 7 recommendations, several of which epidemiologists are in a
position to act on. According to the Committee, “This is a pivotal time for bullying prevention, and there is not a quick fix or one-size-fits-all solution. Nevertheless, science and policy have provided, and will continue to improve, tools needed to tackle this complex and serious public health problem.” These recommendations in abridged form are presented below:
Foster the use of a consistent definition of bullying Obtain more accurate prevalence estimates Evaluate the efficacy of antibullying laws Hold an annual meeting to facilitate collaborate and review of data Report findings annually to Congress to strengthen laws and policies Implement and evaluate evidence based bullying interventions Support bullying prevention training Implement prevention policies and programs on social media platforms
“…Bullying is not a normal part of childhood...“
“This is a pivotal time for bullying prevention ...“
Research Needs The NAS Committee investigated research needs and published a list of outstanding questions. Among the knowledge gaps most relevant for - Bullying continues on page 4
-Bullying cont'd from page 3
epidemiologists were the following:
“...there is not a quick fix or onesize-fits-all solution..."
“...doing so can make a tangible difference in the lives of many children.”
Conduct longitudinal research to track children through adulthood in order to more fully understand links among being bullied, substance abuse, and other behaviors including violence and aggression. Investigate evidence-based practices for integrating content on bullying preventive interventions into curricula for health care professionals. Conduct systematic evaluation of local policies to: (1) understand which components of anti-bullying policies must be included in an anti-bullying law to ensure a positive impact; (2) determine the full range of remedies available under state and local laws and policies; and (3) assess the capacity of federal antidiscrimination laws to address various forms of bullying. Conduct research on cyberbullying prevention programs. Study the disparities in prevalence between different groups (e.g., LGBT youth, overweight/obese youth, youth with specific developmental disabilities, socioeconomic status, immigration status, minority religious status, youth with intersectional identities, urbanicity).
Investigate evidence-based interventions that are targeted toward youth from vulnerable populations (e.g., LGBT youth, youth with chronic health problems, and youth with developmental disabilities) to reduce bullying-related disparities. Study how to improve the adoption and implementation of evidence-based programs, including testing models to better understand what works for whom and under what conditions. Conclusion
The report concludes on an upbeat note: “The study of bullying behavior is a relatively recent field, and it is in transition. Over the past few decades, research has significantly improved understanding of what bullying behavior is, how it can be measured, and the critical contextual factors that are involved. While there is not a quick fix or one-size-fits-all solution, the evidence clearly supports preventive and interventional policy and practice. Tackling this complex and serious public health problem will require a commitment to research, analysis, trial, and refinement, but doing so can make a tangible difference in the lives of many children.” To access the full NAS report, visit: https://tinyurl.com/yd8cqt3k ■
WHO Global Conference Sounds Alarm On NonCommunicable Diseases As One Of The Major Health Challenges Of Our Time Need To Accelerate Action Or Fail To Meet 2030 Target To Prevent Millions Of Premature Deaths The message was clear, based on the current rate of decline in premature mortality among persons aged between 30-70, the world will not meet its 2030 goal to reduce these deaths by one third. And the problem is huge, made up mostly of deaths due to cardiovascular diseases, cancer, diabetes and chronic respiratory diseases. Burden of Disease According to the WHO, in 2015, NCDs were responsible for 40 million deaths, representing 70% of all deaths worldwide. A large proportion of deaths were premature: over 15 million people (38% of NCD deaths and 27% of all global deaths) died between the ages of 30 and 70. 85% of premature deaths from NCDs occurred in developing countries, including 41% in lowermiddle-income countries where the probability of dying from an NCD between the ages of 30 and 70 is up to four times higher than in developed countries. Most of these 15 million premature deaths from NCDs could have been prevented or delayed. The Montevideo Roadmap emerging from a recent conference in Montevideo represents “a bold commitment by governments to intensify action to protect people from the harms of NCDs,” according to the President of Uruguay, a co-organizer of the meeting. He added “the human and economic costs are far too great to ignore.”
Barriers Some of the key barriers to further progress are difficult to tackle and include countering the influence of the private sector on governments which prioritize trade over public health goals, and the lack of high-level political leadership that ensures that health in all policies is adopted as a strategy. This latter barrier is important since many of the main drivers of ill health lie outside the control of health ministries, systems, and professionals, according to conference organizers.
. "Most of these 15 million premature deaths from NCDs could have been prevented or delayed."
Risk Factors The main risk factors identified in the report are tobacco use, physical inactivity, harmful use of alcohol, unhealthy diets, and air pollution. The bulk of NCD preventable deaths could be prevented by addressing these risk factors. Recommendations
"...the human and economic costs are far too great to ignore.”
The Roadmap’s recommendations are organized around 9 categories, including:
Reinvigorate political action Enable health systems to respond more effectively to NCDs Increase significantly the financing of national NCD responses and international cooperation - WHO continues on page 6
-WHO cont'd from page 5
"...she sees growing capabilities to leverage real world data to inform decision making..."
Increase efforts to engage sectors beyond health Reinforce the role of non-State actors Seek measures to address the negative impact of products and environmental factors harmful for health Strengthen the contribution and accountability of the private sector and other non-State actors Continue relying on WHO leadership and key role in the global response to NCDs Act in unity
To read the Roadmap document and the full list of recommended actions, visit: https://tinyurl.com/y9384adw ■
-Real World cont'd from page 2 RWD, all argue for taking a more pragmatic approach. Issues According to Critchlow, some of the issues being faced to allow for more impactful use of RWE are: 1) Data accessibility, quality, and standards 2) Interoperability of electronic medical records and other systems 3) Analytic methods that ensure study validity 4) Preserving data privacy The Future In looking toward the future, Critchlow told the ACE audience that she sees growing capabilities to leverage real world data to inform decision making by regulatory and reimbursement agencies. However, with greater use will come greater scrutiny, and valid study designs and methods will remain critical. ■
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- Fauci cont'd from page 1 The Problems Ronald Reagan, 1981-89 HIV/AIDS George H W Bush, 1989-93 HIV/AIDS William Clinton, 1993-2001 HIV/AIDS West Nile Virus H5N1 Influenza Antimicrobial resistance
George W Bush, 2001-09 HIV/AIDS Anthrax H5N1 Influenza SARS Barack Obama, 2009-17 H1N1 Pandemic Influenza MERS Chikungunya Ebola Zika Antimicrobial resistance
Lessons Learned The lessons learned over these decades in fighting these newly emerging infectious disease threats, according to Fauci, are: 1. The need to have a strong global surveillance system or network 2. The importance of transparent and honest communication with the public. 3. The need for a strong public health and health care infrastructure or to have capacity building where these are deficient 4. Coordinated and collaborative basic and clinical research 5. Adaptable platform technologies for rapid development of vaccines, diagnostics, and therapeutics 6. A stable and pre-established funding mechanism—a public health emergency fund not unlike the Federal Emergency Management Agency funds available in the US after disasters. Readers interested in learning more about these disease threats can access “What Three Decades of Pandemic Threats Can Teach Us About The Future”. https://tinyurl.com/ycunmm8q ■
Notes on People Honored: Julie Palmer, Boston University professor of epidemiology, as recipient of the 2017 Distinguished Lecture on the Science of Cancer Health Disparities given by the Association for Cancer Research. She was honored for her work on the etiology of breast cancer in African American women.
Interviewed: John Clemens, Executive Director of the International Centre For Diarrheal Disease Research, Bangladesh (ICDDR,B), on the occasion of his global research organization receiving the $2 million dollar Hilton Humanitarian Prize for 2017. Said Dr Clemens in speaking with the Huffington Post, "It’s wonderful to receive such a prestigious prize, judged by an independent panel of experts. The prize recognizes the significant contributions we have made to improving and saving the lives of millions of people through our scientific discoveries spanning the last 60 years."
Spotlighted: John Redd, epidemiologist in CDC’s Center for Global Health, in the Santa Fe New Mexican for his work in fighting Ebola in West Africa and his deep commitment to public health. According to a colleague, “He just loves his fellow humans. I can’t overstate how important that is when you’re dealing with something like a public health emergency. He feels the importance of this work at his core.”
Winner: Gitanjoli Rao, of America’s Young Scientist Challenge for her invention of a sensor that can more accurately detect lead levels in water. The 11 year old girl from Colorado will receive a $25,000 prize. She was motivated by the ongoing water crisis in Flint Michigan. She told media sources she wants to be either a geneticist or an epidemiologist when she grows up.
Profiled: William Foege, former CDC director, in a blog written by Bill Gates. He credits Foege with being his mentor on global health issues and helping to guide the Bill and Melinda Gates Foundation which has come to play a large role in international health. According to Gates, “I view Bill as the glue that held the global health community together, getting it to focus on the right priorities, like raising immunization coverage, and setting the stage for the progress we’ve seen in global health over the last 20 years.”
TENURE-SYSTEM FACULTY POSITIONS
Department Chair and Endowed Professor The Rollins School of Public Health (RSPH) of Emory University is recruiting a leader with a forward-looking vision to serve as Chair of the Department of Epidemiology (EPI; www.sph.emory.edu/departments/epi). Applicants should possess a doctoral degree (e.g., PhD, MD, or equivalent) in an appropriate discipline; a prominent record of academic achievement; a demonstrated capacity to secure external research funding; dedication to faculty career development and to training the next generation of epidemiology students; and strong advocacy for methodological and applied research. Candidates should have a strategic understanding of trends in the field; demonstrated ability to foster creativity and innovation; and proven leadership and management abilities. The committee will accept applications from candidates with a record that merits appointment as a tenured full professor. The Department Chair position is supported by an endowed chair. Women and minorities are encouraged to apply. More Info: http://www.epimonitor.net/2017-2383.htm Applicants should apply to http://bit.ly/2w5XK2h and email a letter of interest and curriculum vita to: Dr. Paige Tolbert, Search Committee Chair, c/o Nancy Sterk (email@example.com). Applications will be kept confidential and references will not be contacted without the permission of applicants. The starting date is negotiable and salary is commensurate with qualifications. Review of applications will begin immediately and continue until the position is filled.
Emory University is an Equal Opportunity / Affirmative Action / Disability / Veteran Employer.
IN NEUROEPIDEMIOLOGY Michigan State University College of Human Medicine is committed to educating exemplary physicians and scholars, discovering and disseminating new knowledge, and providing service at home and abroad. We enhance our communities by providing outstanding primary and specialty care, promoting the dignity and inclusion of all people, and responding to the needs of the medically underserved. The Department of Epidemiology and Biostatistics invites applications for tenured or tenure-system positions (Assistant, Associate, Full Professor) in the area of neuroepidemiology. Multiple tenure-system appointments are now available with competitive salaries and generous start-up packages that are supported by state general funds (i.e., “hard-funded”). Successful candidates will have demonstrated scholarship in population-level cognitive health during aging, and/or the epidemiology of age-related neurodegenerative disorders (e.g., Alzheimer’s disease, Parkinson’s disease, vascular dementia). Successful candidates will be expected to develop extramurally funded research programs on neurodegenerative conditions, teach epidemiology, biostatistics and/or related courses in their respective areas of expertise, as well as provide mentorship to trainees. MSU faculty have a national/international reputation in research related to age-related cognitive decline, Alzheimer’s disease and related dementias, Parkinson’s disease, and stroke in diverse populations. Joint appointments in clinical and basic research departments are possible. Requirements: Doctoral degree (e.g., PhD, MD or equivalent) with demonstrated expertise and sponsored scholarship in the epidemiology of neurodegenerative diseases. Applications will be accepted until these positions are filled. Candidates should apply online at http://careers.msu.edu for posting #4975. Include a letter of interest, curriculum vitae, and a 2-page statement of scholarly activities, research and teaching philosophy. Upon request, candidates should arrange for three letters of reference to be submitted to Jill Hamilton (firstname.lastname@example.org). For additional information visit: http://www.epi.msu.edu/jobpostings
MSU is committed to achieving excellence through cultural diversity. The University actively encourages applications and/or nominations of women, persons of color, veterans and persons with disabilities.
MSU is an Affirmative Action, Equal Opportunity Employer.
Columbia University’s Psychiatric Epidemiology Training Program announces openings for a postdoctoral fellow beginning September, 2018. The program provides social scientists, epidemiologists, psychologists, and psychiatrists with research skills in psychiatric epidemiology. Training involves coursework in substantive issues and research methods, and participation in an affiliated research unit. Postdoctoral stipends range from $47,844–$58,560 depending on years of experience. Application deadline: December 01, 2017. Contact: PET Program Administrator, Columbia University, School of Public Health, 722 W. 168th St., Room 720-A, New York, NY 10032 EMAIL: mailto:email@example.com Columbia University is an equal opportunity employer (EOE).
Assistant Director Office of Surveillance & Public Health Preparedness PN# 18351: ASSISTANT DIRECTOR (Exec Level) The Assistant Director provides public health expertise and leadership for the Department. They serve as a consultant for ongoing public health practice as it relates to prevention, communicable and chronic diseases, emerging public health issues and has extensive knowledge of population health, preventive medicine, Laboratory oversight, Public Health Preparedness, Jail Health program and Epidemiology. Preference will be given to applicants that possess a Master's in Public Health or Epidemiology or PhD in a field closely related to the duties of the position. Seven (7) years of progressively responsible experience are required. With at least three (3) of those years in a managerial capacity. A Master's degree may be substituted for two (2) years of experience. Full job description: http://tinyurl.com/y94ucuqw Online application: http://www.houstontx.gov The city of Houston is an EEO Equal Employment Opportunity employer. Preference shall be given to eligible veterans per Executive Order 1-6.
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Assistant / Associate Professor Community Health & Epidemiology Dalhousie Universityâ€™s Department of Community Health & Epidemiology, Faculty of Medicine invites applications for a tenure stream position as an Assistant/Associate Professor in patientcentered outcomes research. Applicants must have a PhD (or equivalent) and a strong track record of conducting research in the areas of epidemiology or health services to be considered for this position. This position will be based at Dalhousie Medicine New Brunswick (DMNB) in Saint John, NB.
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The application deadline is midnight on January 2, 2018, or until the position is filled. All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority. Click here to read a full description of this position and how to apply: https://tinyurl.com/y9urdqpd
ONLINE Epidemiology & Biostatistics Course (AVME801), February 26 to June 20, 2018 - Senior Lecturer, Dr. Lou Gallagher Students taking this course will be expected to have a degree in Health Science with a background in statistics and public health. Course modules include: Evaluating current scientific evidence, Modern Occupational Epidemiology and Study Designs, Inferential and Descriptive Statistics, Sampling and Measurement, Confounding and Interaction in Occupational Epidemiology, Regression Models and Writing a Grant Proposal. Students will conduct a literature review on the evidence for occupational disease and design and present an original research proposal. Grades are a mixture of live presentations and online quizzes. Cost is approximately $6700 USD. / Enroll now until January 15. / Teaching site : https://tinyurl.com/y8sfcn3m Contact email@example.com for instructions on how to enroll.
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Published on Oct 27, 2017
This month The Epidemiology Monitor includes calls for the use of "real world evidence" and for action to end bullying. Information from Ant...