Accesspoint 14: The Rise of Human Data Science in the Real World

Your digital copy of AccessPoint is just one step away! Please share a bit of information so we can ensure you receive future issues of AccessPoint and other content from Real-World Insights (if you wish). By filling out this form, you will have immediate access to the full AccessPoint PDF.

New & Events

human science improving outcomes

advances in data science

new application of human data

Download Publication

learn more

New & Events

human science improving outcomes

News, views and insights from leading international RWE experts

advances in data science

new application of human data

in this issue

We demonstrate how digital health technologies, machine learning with real-world data, and responsive, predictive modeling accelerate everything from clinical trial recruitment to the association of patient satisfaction to clinical outcomes. Our article on How Machines Learn reveals that teaching machines about healthcare isn’t that different from teaching humans. The more data we see, the more we can use, and the more accurate healthcare becomes. But it all comes down to human expertise, intellect and, yes, even creativity. Case studies reflect the real opportunity for patient-reported outcomes and real-world data to transform clinical trials. Improve satisfaction and adherence. Elevate the patient experience. And we move closer to understanding that real-world evidence makes developing and delivering precision medicine more precise. We uncover a company-wide opportunity to rethink how companies allocate resources for post market studies. How to adopt new methods and approach design differently. And how to leverage data to its fullest potential.

“Together with our clients, we are investing in – and committing to – advancing human health... to rising to the challenge, to be more precise.”

We have spent the past year bringing Quintiles and IMS Health together. We knew the potential was greater than two companies merging. We knew we were creating something new. We have emerged as IQVIA, The Human Data Science Company.™ Together with our clients, we are investing in – and committing to – advancing human health... to rising to the challenge, to be more precise. To embracing new technologies and methodologies. We are energized by how Human Data Science will accelerate our collective vision for the future. I hope you enjoy this issue of AccessPoint, and are inspired by the potential, and the reality, of Human Data Science to drive healthcare forward.

This is a special AccessPoint issue for us. It is our first as IQVIA.™ Much more than a new name, we are excited to be the world’s first Human Data Science company. And I am proud to introduce – and demonstrate – Human Data Science, using data science, healthcare expertise and human data together to better measure and improve health decisions and outcomes. In its component parts, Human Data Science did not start today. As you’ll see in this issue, it’s very much already in action. Now, it’s time to bring it together.

The Rise of Human Data Science in the Real World

news and events

HUMAN SCIENCE IMPROVING OUTCOMES

advances in data science

new applications of human data

President Real-World Insights jon.resnick@iqvia.com

Jon Resnick

read more From jon resnick

Volume 7 • Issue 14 • NOVEMBER 2017

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

The pace of innovation in new anti-cancer medicines is unprecedented. Advances in oncology diagnostics and therapies are transforming standards of care and significantly improving outcomes for patients. IQVIA plays an important role by supporting clinical research and observational studies, and providing access to high-quality healthcare data to enable real-world insights. Many of these therapy/therapeutic innovations were the focus of the 2017 European Society for Medical Oncology (ESMO) Congress in Madrid, where IQVIA teams joined more than 20,000 clinicians and industry researchers in sharing knowledge about cancer research and practice. Given the importance of the ESMO congress to the European medical oncology community, it was here that the Collaboration for Oncology Data in Europe (CODE) was launched. CODE is a groundbreaking new initiative aiming to significantly expand knowledge of anti-cancer medicines use in Europe via a dedicated Oncology Data Network (ODN). Led by IQVIA, the initiative has the support of leading biopharmaceutical companies AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Co, Merck KGaA (Darmstadt, Germany) and Pfizer. Ashley Woolmore, CODE Lead, Vice President, Real-World Insights and Head of European Data and Evidence Networks, sat down with AccessPoint to discuss the launch of CODE at ESMO, and to share his thoughts on how this innovative platform will support healthcare systems in providing financially sustainable patient care across the region.

Read Article

Download Publication

Ground-breaking new collaboration led by IQVIA launched at ESMO

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Real-world data (RWD) is playing an increasingly important role in proving the safety and efficacy of new and existing treatments. These data sets, applied to the right expertise and methodologies, are being used to support label claims, to identify trends among targeted patient populations, and to demonstrate real-world results often faster and at a lower cost than through clinical studies. IQVIA has been a leader in this space, developing a new world of innovative methodologies and study designs that enable faster and deeper insights into epidemiology, drug safety, risk and comparative safety and effectiveness. In August, we had a chance to showcase our expertise at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) in Montreal. ICPE is an annual event sponsored by the International Society for Pharmacoepidemiology (ISPE) which is dedicated to advancing global public health by providing industry professionals with a forum for sharing ideas and innovations about pharmacovigilance, therapeutic risk management and related research. “It is a fantastic forum to exchange scientific reviews, and to network with colleagues and customers,” said Alison Bourke, Scientific Director at the Center for Advanced Evidence Generation at IQVIA, and the current president-elect of ISPE. This year’s event had a huge turnout, with an estimated 1,500 experts attending, despite a last minute venue change,” she said. Each year conference topics are developed organically based on the interests of the ISPE member community. This year much of the content was focused on the future, and how pharmacoepidemiology is evolving to meet the needs of more specific patient populations, said Nancy Dreyer, Global Chief of Scientific Affairs, Real-World Insights, IQVIA.

Read Article

Download Publication

Showcasing expertise and insights on RWD’s impact on safety and efficacy studies

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

In May, IQVIA hosted its second annual research forum showcasing how academics and policy makers are using IQVIA real-world data to answer public health questions and inform policy debates. Real-world data (RWD) has become a critical ingredient in demonstrating effective real-world evidence in healthcare. Incorporating data from electronic health records (EHRs), patient registries, social media and other RWD sources helps manufacturers, payers and providers drive greater value and improved patient outcomes across the healthcare spectrum. “This data isn’t only valuable to drug developers, payers and providers,” said Alison Bourke, Scientific Director at the Center for Advanced Evidence Generation at IQVIA, and President-Elect of the International Society for Pharmacoepidemiology (ISPE). “Academic researchers and public policy experts are increasingly using real-world data to address public health issues and shape treatment guidelines,” she said. In May of this year, IQVIA held its second annual research forum to showcase some of the groundbreaking studies that academics, researchers and policy makers are conducting with IQVIA data. More than 20 experts gave presentations at the two-day event, sharing details about their findings, and discussing the powerful impact that real-world data and analytics are having on public health research.

Read Article

Download Publication

IQVIA shapes public health discourse at Research Forum

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

One foundational component of patient centricity is gathering feedback from patients on their experience and satisfaction with treatment. Although pharmaceutical manufacturers are generally eager to use patient reported outcomes (PRO) data, there is a concern that PROs will not be accepted by regulators or payers. The path toward such acceptance involves calibrating and verifying strong tools that can instill confidence in PRO measures. Although numerous disease-specific measures of patients’ Treatment Satisfaction with Medication (TS-M) have been cited in literature, less attention has been paid to developing a general measure of TS-M. This article highlights the importance of measuring treatment satisfaction in order to improve medication adherence and, ultimately, health outcomes.

Read Article

Download Publication

Payer engagement

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Factors Influencing Treatment Satisfaction

Read Article

Download Publication

Satisfaction with medication – capturing the patient perspective

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

RWE Value Drivers – Strategy to Execution

Read Article

Download Publication

With increasing demand for real-world evidence (RWE), sponsors are looking for more options to manage costs, serve multiple stakeholders, accelerate evidence development and increase the usability of study results. This article shows how one sponsor was able to rethink its robust Phase IV portfolio to find up to 40 percent cost savings for trials by using more innovative study designs. The results suggest that even industry leaders can benefit from additional expertise in the application of RWE.

RETHINKING YOUR EVIDENCE SPEND

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Read Article

Download Publication

England’s National Health Service (NHS) Cancer Vanguard leads the development of new care models that will be used as an inspiration to the rest of the country’s healthcare system. As part of its mission in setting the direction for cancer care in the U.K., the Cancer Vanguard, which is revered around the world for its cancer treatment, sought to identify opportunities for optimizing care pathways for colorectal cancer (CRC) and improving the patient experience. In collaboration with Merck, a long-term partner in Colorectal Cancer (CRC) research and treatment, and uMotif, a patient data-capture platform, IQVIA proposed a first-of-its-kind solution for analyzing and visualizing care pathways.

Optimizing patient care pathways

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Read Article

Download Publication

Endpoints Measured from Randomization in a Clinical Trial Through to a Light-Touch Observational Follow-up Study

The predominate approach to assessing the long-term safety and effectiveness of marketed products has been to undertake extension studies that rely heavily on investigators to collect objective data on endpoints of interest, often over long periods of time. However, this is not necessarily required and can cost tens of millions of dollars. Instead, there are alternative, much more cost-effective designs that minimize clinicians’ involvement while satisfying multi-stakeholder needs. We have developed a lighter-touch approach that extends late-phase clinical trials by inviting patients into a non-interventional, follow-on study, sometimes referred to as a “rollover” study. In these studies, patients report notable health events, which later can be verified and validated, as appropriate. This direct-to-patient follow-up instills the “voice of the patient;” meets the needs of regulators, health technology assessment (HTA) bodies, physicians and patients; and is far more efficient than traditional approaches.

A light touch in long-term follow-up studies

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Read Article

Download Publication

Humans and Machines Work in Tandem from Data Processing to Advanced Analytics

Machine learning is transforming every facet of healthcare, as computer systems are being taught how to use Big Data to derive insights and support decision making. In this respect, teaching a computer, no less than teaching a child, is to “shape the future.” Educating a computer is a surprisingly labor-intensive process, requiring massive amounts of data, a nuanced understanding of every data element from every data source, years of trial and error, and extensive domain expertise. The key differentiator in machine learning is not the specific technology and science applied; it is in the volume and quality of the instructional material and the knowledge of the instructor.

How machines learn in healthcare

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Results of Model-Back Test

Read Article

Download Publication

The novel application of real-world data, statistical analysis, machine learning and predictive modeling has the potential to improve site identification for clinical trials – a process that still relies heavily on key opinion leaders (KOLs), historical experience and assumptions. There are ample statistics that emphasize how inefficient the traditional process is, and we are now gathering data points to demonstrate the degree of improvement that can be realized with the next generation approach. The following use cases quantify how these resources are accelerating site identification, improving patient enrollment rates and saving millions in operational costs per study.

Next generation site identification- from theory to practice

YES

I learned something new as a result of reading this article

YES

I would recommend this article to one of my colleagues

Thanks for reading! Please answer the following survey questions:

YES

This article contains useful information that will help me in my work.

Read Article

Download Publication

Clinical and Commercial Applications of Digital Health

Digital health – patients’ use of mobile devices, wearables and connected virtual assistants to deliver health – is becoming integrated into virtually every aspect of healthcare. Innovative applications relevant to the pharmaceutical industry include identifying patients for therapy, enhancing the value and outcomes of treatment, engaging patients and tracking disease severity in clinical care and trial settings. Adoption of, and investment in, these technologies has now scaled to the point that pharmaceutical companies are developing and pursuing comprehensive digital health strategies. A foundational factor in drawing insights from the data derived through digital health channels is data connectivity. Linking data alone is not enough. By using real-world data methodologies, we can ensure that digital-health data produce reliable and unbiased evidence, and we can trigger changes in care management that ultimately enhance patient outcomes.

Connecting the digital dots

by Marla Kessler, Murray Aitken, Alan Metz and Jon Resnick

“This is the time to start discussing Human Data Science. While the underlying concepts have been evolving, they have been kept distinct to the point of missing the real opportunity “

read this article

Heralding the Era of human data science

new applications of human Data

by NATALIA BALKO Kotchie, Luke Dunlap, David Cameron, CYNTHIA Verst

Next Generation Site Identification – From Theory to Practice

by John J. Doyle, HILARY F. ARMSTRONG

Connecting the digital dots

Broaden AD site base by increasing the number of sites ready for selection to perform AD trials

Develop new diagnostics/screening tools for amyloid or AD via a blood test

Help develop trial-ready cohort by validation and use of pre-screening centers

Use evidence-based metrics to determine the highest potential sites

Develop predictive algorithms to identify undiagnosed MCI patients (that go on to develop AD) through Dx and EMR data

Challenges in outreach efforts required for pAD and preclinical AD subjects and for more advanced subjects

STUDY POPULATION

For disease modiﬁcation trials is very high due to competing trials + geographical access to the 3 amyloid PET ligands

COMPETITION

Major resourcing requirements in terms of equipment and staff

RESOURCES

Burden for participants & sites Process for amyloid disclosure Level of stafﬁng needed to handle high screening throughout

Designs must carefully consider

PROTOCOL DESIGN

$29,100/Prodromal Patient $33,600/Pre-Clinical Patient

80% screen failure rates in Prodomal AD 90% screen failure rates in Pre-Clinical AD

Economic consequences of screen failures

High screen failure rates + competing trials at many of the same global sites

recruitment

of 244 agents tested for efﬁcacy in slowing AD progression (2002-2013)

99.6%

failure rate

Innovative approaches to improve AD clinical trials

view full infographic

AD clinical trial challenges

Spotlight on alzheimer’s disease (AD)

by Nancy Dreyer, Jennifer Christian

A light touch in long-term follow-up studies

Advances in Data science

by Andrei Stoica

How machines learn in healthcare

by Marla Kessler

Clearer lines of communication with payers

read this article

Payer engagement

by Ana Maria Rodriguez, ERIC GEMMeN, ALEXANDRA PALMER, Louise Parmenter

Satisfaction with medication – capturing the patient perspective

by Nancy Dreyer, Emile Schokker, Matthaeus Rimpler, Barbara Isquith Arone

RETHINKING YOUR EVIDENCE SPEND

by Arun Parekkat, Stephen Jowett

Optimizing patient care pathways

Human Science Improving outcomes

esmo recap

IQVIA Institute Research Forum

meet us at these events

The IQVIA Real-World Insights (RWI) team brings together unrivaled experience and therapy area expertise from life sciences, consulting, government and academia. With proven expertise in all key therapy areas, as well as a range of global markets, we have a track record of helping clients capture opportunity and embrace innovation in an increasingly complex pharmaceutical landscape.

Expertise In depth

News & events

ICPE RECAP

Download Publication

19-23 May 2018

Baltimore MA, USA

ISPOR

11-12 May 2018

Chicago IL, USA

CMSS

24-25 April 2018

Berlin, Germany

Real-World Evidence Europe

17-19 April 2018

Basel Switzerland

DIA

5-9 March 2018

Las Vegas NV, USA

HIMSS

21-24 April 2018

Toronto, Canada

ISPE

12-15 February 2018

Orlando FL, USA

SCOPE

23-25 January 2018

Washington DC, USA

DIA

9-12 December 2017

Atlanta GA, USA

ASH

17-18 November 2017

Arlington VA, USA

CMSS

13-15 November 2017

Barcelona, Spain

World Orphan Drug Congress

6-8 November 2017

Berlin, Germany

BIO Europe

4-8 November 2017

Glasgow, UK

ISPOR

31 Oct - 2 Nov 2017

Basel, Switzerland

World Biosimilar

PharmD, MS

Cynthia L. Verst

Jaime Thompson

Susan Tansey

PHD

Andrei Stoica

Andrea Spannheimer

MBA, MSC

Emile Schokker

Nigel Rulewski

PHD, MSc, PT

Ana Maria Rodriguez

MD, MBA

Matthaeus Rimpler

MBA

Jon Resnick

Penny Randall

MD, MBA

Edward E. Philpot

BSc, MSc, PHD

Louise Parmenter

Kenneth Park

MBA

Arun Parekkat

BA, MA

Alexandra Palmer

Jonathan A. Morris

Alan Metz

M.CHEM, MSC

Rob Kotchie

MBA

Natalia Balko Kotchie

MBA

Marla Kessler

MD, MBA, MS

Brian Kelly

MD, FACC

Laurence H. Keller

Stephen Jowett

MBChB, MRCP

Fez Hussain

PHD, MBA, MRES, MSC

Ben Hughes

MA, PHD

Nicola Hall

Eric Gemmen

Luke Dunlap

Joan L. Drucker

PHD, MPH, FISPE, FDIA

Nancy Dreyer

Dr.PH, MPH

John J. Doyle

MCHEM

Adam Collier

MBA

Sydney Clark

PHARM.D, MPH, PHD, FISPE

Jennifer Christian

Erica Caveney

MPH

David Cameron

MSC, MRPHARM.S, FISPE

Alison Bourke

Ali Ashrafzadeh

Barbara Arone

MPhil

Hilary F. Armstong

MCOM, MBA

Murray Aitken

The IQVIA and E360 names and logos, as well as any other IQVIA service or product names or logos are the registered trademarks or trademarks of IQVIA. All third party trademarks are the properties of their respective owners and are used for purposes of identification only. Copyright © 2017 IQVIA. All rights reserved. PB.0008-1-11.2017