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

Berlin, Germany

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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.

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STUDY POPULATION

Clinical and Commercial Applications of Digital Health

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by Nancy Dreyer, Jennifer Christian

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.

AD clinical trial challenges

Heralding the Era of human data science

Innovative approaches to improve AD clinical trials

MBA

YES

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PHD

PharmD, MS

Clearer lines of communication with payers

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MBA

MD, MBA

by John J. Doyle, HILARY F. ARMSTRONG

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12-15 February 2018

HIMSS

YES

Toronto, Canada

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PROTOCOL DESIGN

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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.

YES

World Orphan Drug Congress

YES

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advances in data science

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ISPOR

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

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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.

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HUMAN SCIENCE IMPROVING OUTCOMES

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Chicago IL, USA

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.

The Rise of Human Data Science in the Real World

“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 “

9-12 December 2017

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by Arun Parekkat, Stephen Jowett

YES

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

New & Events

YES

recruitment

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

Arlington VA, USA

ISPOR

13-15 November 2017

MBA, MSC

4-8 November 2017

by Andrei Stoica

MBChB, MRCP

MA, PHD

Connecting the digital dots

new applications of human data

Economic consequences of screen failures

MBA

YES

5-9 March 2018

Dr.PH, MPH

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

SCOPE

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.

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PHARM.D, MPH, PHD, FISPE

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PHD, MBA, MRES, MSC

esmo recap

MBA

How machines learn in healthcare

MPH

YES

MD, MBA, MS

MPhil

MCOM, MBA

YES

read this article

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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

meet us at these events

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

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PHD, MPH, FISPE, FDIA

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Optimizing patient care pathways

99.6%

BA, MA

MSC, MRPHARM.S, FISPE

Real-World Evidence Europe

BSc, MSc, PHD

Factors Influencing Treatment Satisfaction

advances in data science

human science improving outcomes

Jon Resnick

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Basel Switzerland

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ASH

RESOURCES

YES

Expertise In depth

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

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

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MD, FACC

Washington DC, USA

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

M.CHEM, MSC

Satisfaction with medication – capturing the patient perspective

MCHEM

MD, MBA

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MBA

Basel, Switzerland

IQVIA shapes public health discourse at Research Forum

Ground-breaking new collaboration led by IQVIA launched at ESMO

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YES

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.

19-23 May 2018

YES

learn more

PHD, MSc, PT

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24-25 April 2018

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.

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

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.

11-12 May 2018

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Volume 7 • Issue 14 • NOVEMBER 2017

News & events

RETHINKING YOUR EVIDENCE SPEND

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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.

news and events

News, views and insights from leading international RWE experts

YES

new application of human data

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Baltimore MA, USA

World Biosimilar

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

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Cynthia L. Verst

Payer engagement

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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.

Andrei Stoica

Ben Hughes

advances in data science

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COMPETITION

Matthaeus Rimpler

Emile Schokker

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

Optimizing patient care pathways

Stephen Jowett

Advances in Data science

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

17-18 November 2017

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BIO Europe

Andrea Spannheimer

Glasgow, UK

CMSS

Barcelona, Spain

Louise Parmenter

Next generation site identification- from theory to practice

Jon Resnick

YES

Natalia Balko Kotchie

failure rate

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view full infographic

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

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A light touch in long-term follow-up studies

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Spotlight on alzheimer’s disease (AD)

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

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Laurence H. Keller

A light touch in long-term follow-up studies

YES

Designs must carefully consider

21-24 April 2018

ISPE

Las Vegas NV, USA

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RWE Value Drivers – Strategy to Execution

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in this issue

RETHINKING YOUR EVIDENCE SPEND

Results of Model-Back Test

Payer engagement

YES

by Marla Kessler

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

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Susan Tansey

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Adam Collier

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Next Generation Site Identification – From Theory to Practice

Penny Randall

Alexandra Palmer

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.

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

Major resourcing requirements in terms of equipment and staff

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Alan Metz

23-25 January 2018

Brian Kelly

YES

Atlanta GA, USA

YES

human science improving outcomes

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Human Science Improving outcomes

ICPE RECAP

Edward E. Philpot

New & Events

17-19 April 2018

YES

new applications of human Data

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

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Jaime Thompson

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new application of human data

CMSS

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Nigel Rulewski

YES

John J. Doyle

Connecting the digital dots

Ana Maria Rodriguez

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Nicola Hall

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Kenneth Park

Rob Kotchie

31 Oct - 2 Nov 2017

Berlin, Germany

David Cameron

How machines learn in healthcare

Fez Hussain

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YES

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.

Marla Kessler

Barbara Arone

Jonathan A. Morris

Eric Gemmen

Erica Caveney

Sydney Clark

YES

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Luke Dunlap

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DIA

Nancy Dreyer

Ali Ashrafzadeh

Satisfaction with medication – capturing the patient perspective

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

YES

Orlando FL, USA

Hilary F. Armstong

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