DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.

Chair

Trisha D Simpson

Speaker

EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

The ADAPTABLE study, started in 2015, is the largest virtual study ever done in the clinical research industry. Speakers will review the lessons learned from establishing a technology process suited for 20,000 remote patients on this study.

Learning Objectives

Demonstrate a working knowledge of implementing remote consenting; Discuss updates on recent guidance documents and regulatory approvals for virtual data collection.

Chair

Anthony Costello

Speaker

ADAPTABLE: A 20,000 Patient Study Leveraging Health Systems, EHR, and Patients to Transform Clinical Research
Adrian Hernandez

REACHnet’s Recruitment for the ADAPTABLE Virtual Trial Using Technology at the Point-of-Care
Elizabeth Nauman

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-540-L01-P; CME 1.25; IACET 1.25; RN 1.25

This forum describes the electronic implementation of patient-reported outcomes (PRO)-based endpoint measures developed by the PRO Consortium for irritable bowel syndrome treatment trials. The panel will share lessons learned when pairing technology with clinical measurement.

Learning Objectives

Describe advantages of collecting clinical trial endpoint data electronically, particularly with patterns of data as observed in irritable bowel syndrome treatment trials; Discuss how regulatory agencies view the electronic capture of endpoints in clinical trials; Distinguish between operational and measurement aspects of the electronic implementation of PRO instruments used to assess endpoints in clinical trials.

Chair

Stephen Joel Coons, PhD

Speaker

Pharmaceutical Industry Perspective
David S. Reasner, PhD

ePRO Technology Provider Perspective
Cindy Howry, MS

ePRO Technology Provider Perspective
Adam Butler

FDA Perspective
Sarrit Kovacs

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Panelist
Virginia Hussong

Panelist
La Misha Fields

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

This CFAST session will focus on some of the innovative approaches being used to move towards E2E concept-based standards development and show the value these enhanced standards can bring for all stakeholders involved. Analysis elements (ADaM) and therapeutic area user guides (TAUGs) will also be discussed as well the therapeutic area (TA) Specification project which seeks to include TA metadata into the FDA standards catalogue.

Learning Objectives

Recognize the CFAST Initiative and the potential benefit of implementing these standards; Discuss some of the innovative approaches employed to move closer to E2E concept based data standards; Recall the FDA Therapeutic Area User Guide Specification project.

Chair

Rhonda Facile, MS

Speaker

CFAST Program Participation and the FDA Specification Project
Ron D. Fitzmartin, PhD, MBA

ADaM and Therapeutic Area User Guides: Current Thinking
Susan J. Kenny, PhD

Biomedical Concepts and End-to-End Metadata Development
Diane E. Wold, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are increasingly empowered with an awareness of their conditions and treatment options. The internet and search engines have provided patients with unprecedented access to information previously only held by health professionals. With this knowledge, patients often seek a level of interaction, explanations and general engagement in regular care that can be challenging. This session will discuss methods and strategies for the management of activities and communications involving patients in clinical trials.

Learning Objectives

Describe the challenges and opportunities when establishing greater patient centricity in clinical trials; Discuss how technologies will assist in the distributed management and monitoring of patient engagement including how such oversight will aid in improving compliance and data quality; Recognize the opportunities for direct-to-patient activities in clinical trials.

Chair

Doug Bain

Speaker

Applying Process Management to Support Site and Patient Engagement in Clinical Trials
Doug Bain

Enhancing Patient-Centered Research: Combining Technology with Other Direct-to-Patient Contact Strategies
Chris Watson, PhD

Patient-Centricity and Real-Time Data Monitoring
Bruno Gagnon, MPharm

Component Type: Forum
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will engage a panel of experts who will discuss current and emerging opportunities and trends in the representation and use of research data and describe a future vision for capitalizing on these to improve the future research process.

Learning Objectives

Describe current state, trends and opportunities such as data transparency, electronic health records, interoperability, wearable technologies, regulatory science, data standards and analytics; Describe a vision for future clinical research data systems and processes that can logically evolve from the current state to meet these requirements including opportunities to improve the research process.

Chair

Wayne R. Kubick, MBA

Speaker

Panelist
Dave Evans, MS

Panelist
Armando Oliva, MD

Panelist
Kenneth A. Getz, MBA

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will walk through the steps from vendor selection to global implementation of an eTMF software and associated services - both as a general approach and a case study for a top ten pharmaceutical company. It will elaborate on the various workstreams established to ensure success.

Learning Objectives

Describe the hurdles to successful global implementation of an eTMF; Discuss the importance of a robust TMF structure; Recognize that an eTMF is not about the software, its about the processes and workflows.

Chair

Karen Jane Roy, MPharm

Speaker

eTMF: Challenges and Possible Solutions
Laxman Kumar Jakkala, SR, PhD

Global Implementation of a Full Service Provision eTMF Software and Services: A Case Study
Martina M Duevel, DrSc

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research and include recent developments and novel techniques applied to big data integration and analysis that have the potential to improve the quality and costs associated with both early stage discovery and clinical development from conduct to completion of clinical trials.

Learning Objectives

Discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research; Identify how to use big data analytics to develop new insights from patient data long before previously possible.

Chair

John Piccone

Speaker

IBM Watson Health: Creative Innovation of Health Care and Life Sciences
John Piccone

Exploiting Big Data in Precision Medicine
Amrita Basu, PhD

The Big Data Gap: Harnessing Big Data to Accelerate Clinical Development
James Streeter

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore how companies are implementing successful risk-based monitoring (RBM), with particular emphasis on the realignment of processes and roles, and applying central monitoring and data quality oversight to support the RBM strategy.

Learning Objectives

Define key challenges in risk-based monitoring (RBM) implementation; Identify how processes and roles need to change in the organization to support the RBM; Discuss real-time analytics as a key enabler to achieve adaptive, centralized monitoring; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.

Chair

Teresa Ancukiewicz, MA

Speaker

Lessons Learned in Implementing Risk-Based Monitoring and eSource: The Data Manager’s Expanded Role
Vadim Tantsyura

Risk-Based Monitoring Best Practices for the Data Manager: Lessons Learned from Sponsors and Sites
Amita Malik, MS

Using Powerful and Pragmatic Central Statistical Analytics to Drive Quality into Clinical Trials
Erik Doffagne, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

The usage of wearables can be a challenge in the regulated and traditionally risk adverse pharmaceutical industry. This session reviews a case study of utilizing wearables from planning, to IRB, to final report in a large pharma clinical sub-study.

Learning Objectives

Describe the importance of reviewing standard processes when inserting wearables into a clinical trial; Discuss the support structure necessary for combining traditional clinical research with emerging technologies; Demonstrate an understanding of the change management necessary to run a successful wearables trial.

Chair

John H. Bunch

Speaker

Internet of Medical Things (IoMT) and Clinical Development: Challenges and Opportunities
Yury Rozenman

How to Get From Unknown Unknowns to Known Unknowns
Tilo Hache, MBA

Component Type: Session
Level: Basic
CE: CME 1.00; IACET 1.00; RN 1.00

This session covers the current role of global SAFE-BioPharma standard for identity and access management trust and EngageZone, Merck's initiative enhancing collaboration between it and hundreds of partner organizations. _x000D_


Learning Objectives

Evaluate risk associated with Internet-based collaboration; Discuss approaches to develop secure, trust-based information sharing; Define critical terminology such as multi-factor authentication, federation, and identity and access management.

Chair

Mollie Shields-Uehling

Speaker

Industry Perspective
Andrew Porter