DIA 2019 Global Annual Meeting

Component Type: Workshop
Level: Basic

This workshop will discuss the factors that create a positive patient experience for the female clinical trial participant with regard to protocol design and clinical trial participation.

Learning Objectives

Elucidate the factors that create a positive patient experience for the female clinical trial participant – a historically underserved stakeholder group with regard to protocol design and clinical trial participation.

Chair

Bonnie A. Brescia

Component Type: Workshop
Level: Intermediate

Using a case study, participants will discuss a real-life example of a manufacturing roadblock and discuss problem-solving strategies, the importance of taking prudent risk, and building the right team for success.

Learning Objectives

Analyze risks and recognize trade-offs in preclinical development planning; Identify problem-solving strategies and formulate a plan to proceed accordingly in development planning; Apply case study-specific steps and learnings to any potential scenario; Apply best practices in participants’ own work.

Chair

Sandy Macrae, PhD

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use blockchain to show the design and implementation of faster, less onerous user identification processes through permissioned access to a federated database pointing to a variety of traditionally siloed sources (inc. EMR, wearables, IoT etc).

Learning Objectives

Describe how a blockchain-powered health wallet could support greater efficiencies across the clinical trial process.

Chair

Adama Ibrahim, MBA

Speaker

Facilitator
Maria Palombini, MBA

Facilitator
Jim Nasr, MBA

Facilitator
Disa Lee Choun, MBA, RPh

Blockchain
Mathew Rose, MD, MS, MSc

Component Type: Workshop
Level: Intermediate

Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.

Learning Objectives

Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.

Chair

Terry Katz, MS

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-625-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop gives participants a hands-on experience with designing and building chat bots as service automation agents for their functional area. Participants will identify opportunities for Conversational AI and leave with a working prototype.

Learning Objectives

Identify specific opportunities to leverage automation to engage with internal and external customers; Discuss fundamentals of how bots are designed and how to think through the logic and use cases; Describe how to get hands-on experience designing and making a working prototype; Discuss how to put automation and chat bots into a real world practical context.

Chair

Bryan Hill

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-697-L04-P; CME 1.25; IACET 1.25; RN 1.25

Participants will engage in an “overcoming obstacles” activity designed to encourage collaboration among rare disease patients, trial sponsors, and advocates. You will identify obstacles to trial participation and work to develop creative solutions.

Learning Objectives

Describe valuable and detailed input from patients on clinical trial design; Design patient interactions that encourage collaboration among patients, sponsors, and advocacy group; Explain how to optimize clinical trials to ensure they meet the needs of rare disease patients.

Chair

Kelly Franchetti, RN

Speaker

Patient Perspective
Kim Stephens, PhD, MA

Industry Perspective
Kelly Franchetti, RN

Academic Perspective
Ellyn Getz

Component Type: Workshop
Level: Intermediate

This workshop will provide a dynamic environment for participants to share experiences related to medication adherence in drug development, and to learn new approaches for collecting, analyzing, and reporting adherence data.

Learning Objectives

Describe the extent of challenges with medication adherence across all phases of drug development; Identify where risk of medication non-adherence with a drug may arise: initiation, implementation and discontinuation; Evaluate strategies to collect, analyze, and report medication adherence across phase 2-3 clinical trial settings.

Chair

Sarah Clifford, PhD, MSc

Speaker

Facilitator
Lina Eliasson, PhD

Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra