DIA 2016 Annual Meeting

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

This session will define the strategic importance of the PCORnet Common Data Model in the use of electronic health records(EHR) and health plan data for research, its key role in the ADAPTABLE pragmatic trial, and how these experiences are generalizable to other stakeholders.

Learning Objectives

Assess the opportunities and challenges of using electronic health data for clinical research, including data management processes, coordinating center practices, and data quality; Describe the strategic role and development of a common data model for a national distributed research network; Evaluate the application of a common data model in the design of a pragmatic clinical trial.

Chair

Shelley Rusincovitch

Speaker

Leveraging a Common Data Model for a Pragmatic Clinical Trial in a Distributed Research Network: The PCORnet ADAPTABLE Study
Lesley H. Curtis, PhD

A Common Data Model and Diversity of Stakeholder Beliefs: How Do You Know What You Actually Know, Collectively?
Aaron Sorensen, MA

Applying the PCORnet Common Data Model to the EHR Ancillary Study of the HARMONY Trial: Strategy and Design Considerations
Carol E Koro, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Adverse drug reactions (ADRs) are an important part of a product label. In this session, we will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. We will also discuss the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.

Learning Objectives

Discuss how adverse drug reactions (ADRs) are presented in EU and US drug labels; Explain why the qualitative categories of ADR in an EU label and the pooling strategy to obtain ADR frequencies in a US label are inadequate; Describe improved approaches to summarize and present different types of adverse events; Describe key building blocks for a compliant end-to-end labeling system.

Chair

Brenda Crowe, PhD

Speaker

Rational Presentation of Adverse Reactions in Drug Labeling
Ellis Unger, MD

A New Paradigm in Patient Safety: The Importance of End-to-End Labeling and Tracking in Ensuring Pharmacovigilance Compliance
Oliver Steck, MBA

Augmenting Product Labels with Real-World Evidence: Lessons from OHDSI
Patrick Ryan

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

The 2010 Affordable Care Act amended the Public Health Service Act to create a new abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed biological product. A biosimilar should be shown to be highly similar to and to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. In this session, we will discuss important regulatory and statistical issues in the evaluation of biosimilars. A regulatory perspective will be provided on key concepts, and and industry representatives will describe approaches to critical aspects of biosimilar development such as the evaluation of immunogenicity and inference based on the totality of the clinical evidence.

Learning Objectives

Discuss key regulatory and statistical issues in the development and evaluation of biosimilars; Describe approaches to critical aspects of biosimilar development.

Chair

Gregory Levin, PhD

Speaker

A Novel Statistical Model of the Relationship Between Exposure to a Biopharmaceutical and Immunogenic Reactions
Marek Ancukiewicz, PhD

Statistical Methodology to Assess Biosimilarity Based on Totality of the Evidence
Zhiying "Jean" Pan, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-584-L05-P; CME 1.25; IACET 1.25; RN 1.25

Adaptive designs require more planning and teamwork than traditional clinical trials. In this session, the speakers will discuss their enhanced roles and those of the other team members.

Learning Objectives

Demonstrate how to lead and/or collaborate with all relevant parties on designing and executing adaptive clinical trials; Assess alternative adaptive trial designs for enhancing trial efficiency and patient safety; Describe how to design operational processes to minimize bias when unblinding data during interim analysis.

Chair

Eva R. Miller, PhD, MS

Speaker

The Biostatistician's Role in Adaptive Design Team: Power Calculations Using GSDesign
Kenneth Liu, PhD

The Drug Supplies Manager’s Role in Planning and Implementing Flexible Drug Supply Management in Adaptively Designed Trials
Micheline D Marshall, MBA

Pivotal Roles of the Statistician, Physician, and Project Manager in Simple and Complex Adaptive Trial Designs
Richard McNally

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-585-L01-P; CME 1.00; IACET 1.00; RN 1.00

Traditional clinical study designs and analysis methods may not be applicable to some pediatric studies due to unique issues with the pediatric population. This session presents emergent designs and methods appropriate to addressing these issues.

Learning Objectives

Recognize how clinical study design and statistical analysis methods can ease difficulties often found in pediatric clinical trials; Assess study designs and statistical methodology not typically used in standard clinical trials appropriate for pediatric clinical trials; Identify when and who to consult to improve the efficiency within a pediatric clinical trial.

Chair

Tammy J. Massie

Speaker

Enhancing Pediatric Clinical Trial Feasibility: Focus on the Use of Bayesian Statistics
Earl Seltzer, MBA

Panelist
Lisa A Kammerman, PhD, MS

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

Due to recent regulatory issues in manufacturing, statistical tools are used increasingly to understand manufacturing data. This provides opportunities to improve the evaluation of safety, quality, and efficacy criteria specified by regulators.

Learning Objectives

Discuss lessons learned in the use of statistics in pharmaceutical manufacturing; Identify the challenges and opportunities with application of nonclinical statistics; Describe the regulatory developments in the CMC area and the opportunities for statistical applications.

Chair

Surya P. Chitra

Speaker

A Case Study of Statistical Analysis of Integration Site Assay in the Application of Gene Therapy
Shu Zhang, PhD

Overview of CMC Area Statistics
Cassie Dong, PhD

Quality by Design Case Studies for Biologics/Biosimilars
Charles Li, MS