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Insight Brief
A NEW APPROACH TO FASTER eCOA DEVELOPMENTFlipping the eCOA development lifecycle upside down to optimize real-time, direct-from-patient data collection. KRIS GUSTAFSON, Vice President, Global Head of eCOA, IQVIAANTHONY MIKULASCHEK, Senior Director, eCOA Operations, IQVIA
TABLE OF CONTENTS
Introduction 3
eCOA: Structured patient feedback 4
Lost in the waterfall 4
Capturing the right data, at the right time 5
Conclusion: The future of eCOA is here 6
About the authors 7
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eCOAs are a clinical research innovation that improve the quality of data being collected from patients and address the need for a more patient-centric trial environment. These assessments capture outcomes from the patient’s perspective through a variety of validated measures, amplifying the patient’s voice while providing sponsors with vital information about the trial experience and patients’ quality of life. This unfiltered approach to collecting patient feedback also provides regulators and payers with new insights into treatment benefits, increasing the likelihood of approval and optimal reimbursement.
The value of these tools is undisputed, but the way they are developed by many vendors, using a waterfall methodology of software delivery, is highly inefficient wasting valuable time and increasing the likelihood of downstream design changes, defects, and ultimately causing delays in being ready for first-patient-in.
Instead, IQVIA is taking a more agile approach to eCOA development. Using our novel IQVIA eCOA platform and a collaborative, iterative design philosophy, our designers can produce a fully functional eCOA in a day.
This evolution in eCOA development is cutting months from the trial planning process, accelerating first patient in, and helping sponsors reduce time, cost, and risk in the trial environment – ultimately becoming another tool to help bring new therapies to patients faster.
The value of eCOA tools is undisputed, but using a waterfall methodology of software delivery is highly inefficient... IQVIA is taking a more agile approach to eCOA development and can produce a fully functional eCOA in a day.
INTRODUCTION
4 | A new approach to faster eCOA development
ECOA: STRUCTURED PATIENT FEEDBACK
Capturing the patient voice in clinical research has become a top priority for the biopharma industry.
Part of the pressure to become more patient-centric is coming from industry stakeholders. Patients want to play a more active role in trial planning and data collection as a condition of participating in trials. Regulators and payers are also interested in hearing the patients’ perspective, and increasingly seek evidence of patient feedback when evaluating the safety and efficacy of a new drug.
Biopharma leaders are pushing this trend as well because they see the value of integrating patient feedback into their clinical trial and data collection.
eCOAs address all of these needs by providing structured assessments that capture the patient experience in ways that are measurable and meaningful. Sponsors can use the resulting data to shape their drug discovery and development strategies, improve clinical design, win regulatory support, and engage with healthcare centers and physicians who are focused on improving their patients’ quality of life.
LOST IN THE WATERFALL
The benefits of eCOAs are clear, but the way these assessments are typically designed within an EDC, Portal, ePRO, or traditional eCOA system adds months to the trial planning process. Our research shows sponsors spend an average of 16-20 weeks designing, building, tweaking, and validating eCOAs for every assessment used. We’ve also found deadlines are often missed due to miscommunications during handoffs in a traditional process.
This is a common challenge when project teams rely on a waterfall software development approach. In these projects, stakeholders develop a set of requirements for what they need, then hand it over to a development team – who is not typically involved in the planning process – and wait weeks, or even months, for the development team to bring back a finished product. Only then does the sponsor see that their vision was lost in translation and tangled with false assumptions of the requirements.
By that point, ten or more weeks will have passed, and the eCOA development has become critical path to first-patient-in, leaving sponsors to make a tough decision: use an imperfect tool even though it’s not exactly what they wanted, or delay the trial to correct it.
This kind of dilemma happens all the time with waterfall projects, due to handoffs, remote team communications, and disparate development process steps. But IQVIA is taking a different approach.
Patients want to play a more active role in trial planning and data collection as a condition of participating in trials.
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With IQVIA eCOA, we’ve flipped the waterfall software development lifecycle upside down. Our solution radically changes the traditional development approach and is built on a state-of-the-art platform which allows the study team to design, build and test assessments, in real-time. We can configure and deliver a working assessment on the first day of design and requirements review (sometimes even during the initial kick-off), providing complete transparency and control to the study teams.
CAPTURING THE RIGHT DATA, AT THE RIGHT TIME
When a customer has a need for a custom eCOA that is not already available in the IQVIA assessment library, our team works directly with them to build the assessment on the fly. By using a ‘spec-less’ agile design philosophy combined with an innovative software platform, sponsors simply explain what they want, and our design team helps them create it. This allows customers to rapidly generate quality assessments that optimize real-time, direct-from-patient data collection.
At the center of our eCOA solution is the Sculptor tool. Built on a highly secure, scalable cloud-based SaaS platform, Sculptor enables simple set up of all eCOA study activities. The dynamic building tool offers easy-to-use features, including drag-and-drop functionality, pre-built widgets, and customizable logic, which make it possible for non-developers to rapidly assemble, adapt, and visualize their design in real time.
Traditional eCOA systems utilize inefficient processes, we’ve flipped the development cycleOur innovative approach to eCOA development
Traditional development model IQVIA’s visual development model
VS
Requirement Analysis
Design Documentation
Build / Program
Testing
UAT / Implementation
Design / Build / UAT
Testing
Implementation
Documentation
4-6 MONTHS traditional cycle timeline
Documentation artifacts
auto-generated from
design process
4-6 WEEKS agile cycle timeline
Simple ‘drag and drop’ functionality
Library of pre-built assessments
Auto generate specification documents
Reporting and integration options
Widget toolbox to build forms
Dynamic and scalable page canvas
Model assessment on multiple devices in real time
Dynamic building
tool with user
interface to
create and deploy
an eCOA solution
Sculptor tool
Enhancing the user experience
6 | A new approach to faster eCOA development
Because the sponsor is involved throughout the development process, the assessment is built to their exact specifications, eliminating the risk of miscommunications/misunderstandings resulting in late stage changes and delays.
Once the design is accepted, the platform automatically generates all the detailed requirements, specification documents, screen shots and test scripts required for validation, allowing for rapid review and submission.
Scribe is the patient facing application within the IQVIA eCOA solution. For patients, the application features a simple and consistent, user-friendly design that encourages interaction, which in turn, can improve compliance. It can be used online or offline and is supported by both iOS and Android devices.
CONCLUSION: THE FUTURE OF ECOA IS HERE
Designed with patient input, the IQVIA eCOA technology reflects deep knowledge and understanding of what matters to patients about their respective disease and treatment, while protecting privacy, to improve the overall patient experience while reducing the burden of study participation.
Our eCOA platform lets customers create a functioning assessment that works on a multitude of devices in a matter of hours.
This agile solution brings massive efficiency gains and drastically reduces cycle times, minimizing risks for sponsors while reducing the time to first-patient-in.
For trials facing recruiting challenges and those treating patients with a limited window of opportunity to participate, these benefits help make it possible to accelerate the trial from recruiting through market access, which can be a game changer for sponsors and the patients they treat.
Contact us today for more information or to schedule a demo: [email protected].
Abiity to use online or offline
Supported by iOS and Android devices
Passive study updates eliminating need to visit app store
Supports device provisioning by BYOD
Scheduling capability for alerts and reminders to improve compliance
Patient app
featuring a
simple and
consistent,
user-friendly
design
Scribe app
Improving the patient experience
Benefits of IQVIA eCOA
eCOA
Reduces cycle times and enables set up of eCOA up to
3x faster than traditional methods while improving quality
Increases efficiency by generating accurate, robust regulatory
and project documentation, eliminating manual efforts
Improves endpoint data quality and protocol compliance
through simplified patient engagement
Cloud-based, virtual eCOA configuration avaialble in real-time,
allowing greater transparency, control, and collaboration
As vice president and head of eCOA at IQVIA, Kris Gustafson leads a global team responsible for the strategic oversight and delivery of the IQVIA eCOA solution.
A biopharmaceutical industry veteran with more than 25 years of leadership experience in data management, information technology and clinical research, Kris has successfully led the integration, delivery, and management of technology solutions to meet customer needs. Kris joined IQVIA in 2012 and has held a number of leadership positions within the company, including the IT organization and was responsible for the delivery of multiple technology platforms. Prior to joining IQVIA, Kris founded a clinical technology company that developed IVR, IWR and ePRO products for clinical trials, which was later acquired by a leading contract research organization. Kris holds a Bachelor of Science degree in mechanical engineering from Washington State University.
As senior director at IQVIA, Anthony Mikulaschek leads a team that is responsible for the operational delivery of the IQVIA eCOA solution.
With more than 30 years of industry experience, Anthony has successfully led a variety of critical initiatives including validated system implementation, systems architecture/integration, business process reengineering, operations, and consulting. Anthony joined IQVIA in 2011 and has held several key technology leadership positions within the company. Anthony holds a Bachelor of Science degree in computer information systems from Purdue University.
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ABOUT THE AUTHORS
ANTHONY MIKULASCHEKSenior Director, eCOA Operations, IQVIA
KRIS GUSTAFSONVice President, Global Head of eCOA, IQVIA
CONTACT USiqvia.com/[email protected]
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