DIA 2016 Annual Meeting

Component Type: Workshop
Level: Intermediate

It is easy to get lost in the terminology around understanding the why of a problem – audit finding, response, CAPA, root cause analysis, fishbone diagram. This practical session will get you working with others on an example issue, using some basic ideas on root cause analysis and trying them out. You will learn the basics of getting to why without worrying about the terminology. Getting to the why when something goes wrong on your trial means you have the best chance of determining ways to stop the same thing impacting your trial (or another one) again. It’s a key part of a learning organization.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Apply root cause analysis techniques to determine probable root causes of an issue (such as from an audit finding); Explain the purpose of root cause analysis.

Chair

Keith John Barber

Speaker

Facilitator
Helen Howitt

Component Type: Workshop
Level: Intermediate

One aspect of patient-reported outcome (PRO) instrument development that continues to perplex the field is the interpretation of change scores. How much change must be observed on a PRO instrument to be able to say that a patient has experienced a treatment benefit? This session will provide a brief background on commonly-used and novel methods for assigning meaning to PRO score changes, and then attendees will participate in one of three activities where these methods are demonstrated. The goal of the methods demonstrated in each of these three activities is to identify a threshold at which changes on the PRO instrument are deemed meaningful. The first activity will be a mock exit interview where a participant is probed about their experience during a clinical trial and the meaning behind their observed PRO scores. The second activity will be a mock bookmarking exercise where a participant rates hypothetical vignettes as better, worse, or the same as their own condition using items from a PRO instrument. The third activity will be a group exercise on synthesizing results from multiple methods into one responder definition (i.e., the triangulation process). The session attendees will reconvene at the end of these exercises to discuss the value and challenges of each method.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize the value of and challenges with different methods for informing the interpretation of change on PRO instruments by engaging in mock exercises demonstrating these methods in practice.

Chair

Cheryl D. Coon, PhD

Speaker

Facilitator
Scott Komo, DrPH

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.

Chair

Robert Paarlberg, MS

Speaker

Facilitator
Helle M Gawrylewski, MA

Component Type: Workshop
Level: Basic

The life science industry is dominated by teams. High-functioning teams create a dynamic where innovation and productivity flourish; however, even the most motivated teams can have challenging team members or be derailed by uninformative feedback, critique, and criticism. Obtaining team buy-in and actionable feedback can be challenging, especially while endeavoring not to appear defensive or strident. Initially, this session will outline specific team member personalities that can disrupt a project or process. Small groups will focus on strategies for keeping cool, obtaining information, and maintaining team rapport. Attendees will be encouraged to share their examples and solutions within their small group. This will be an interactive session for attendees at all levels.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the challenges of critique and criticism; Detail strategies for handling challenging team members; Strategize how to create a better rapport.

Chair

Robin Whitsell

Component Type: Workshop
Level: Intermediate

This session will offer participants an exciting opportunity to participate in an agency-style strategic brainstorm session designed to help clinical teams improve the value of their study brands by developing a stronger and more purposeful connection to the brand, key study objectives, and various stakeholders.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Demonstrate strategic tools that can lead to more meaningful communications for internal and external stakeholders.

Chair

Neil Weisman

Speaker

Facilitator
Robert Klein

Facilitator
Marie Eckerd

Component Type: Workshop
Level: Basic

Typically content is created and managed and delivered as large static documents. Content is created multiple times by multiple authors and content is siloed between content creators and product lines. Multiple inconsistent versions of content exist.

Submission-related standards such as eCTD and SPL require structured content; however, these standards only provide the capability to submit content, they do not support the need to more effectively create and manage content. Structured content is today’s best practice for the creation, management, and delivery of content for clinical, labeling, and promotional materials. We will introduce you to the concepts of structured content in a fun, interactive way, then take you through real-world examples so you can understand the inner workings of structure. You will leave with 10 Steps to Structure guidelines.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the concepts and benefits of structured content.

Chair

Ann Rockley, MLIS

Component Type: Workshop
Level: Basic

Participants will “learn by doing” how poorly conceived and executed tables and graphs can actually prevent understanding of the science. In contrast, when data presentations are well-designed, they can communicate the key messages of even very large and complex data sets. After a short presentation on the fundamentals of good data presentation, participants will be divided into smaller working groups where they will be challenged with complex and difficult to understand examples of figures and datasets and asked to consider what are the key messages and the best method for communicating them. These real-life data examples are guaranteed to open eyes and enlighten. After each exercise, the groups will come back together to discuss, share, and analyze the messages and their presentations, and conclude with a summary of lessons learned.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Demonstrate how to change uninformative tables and graphs into data presentations that communicate clearly.

Chair

Barry Drees, PhD

Component Type: Workshop
Level: Intermediate

This session will include a facilitated discussion about common application experiences applied through case-based learning and will encourage audience members to share similar or different experiences in their risk-based monitoring implementations.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain how to apply the implementation lessons of risk-based monitoring to your own situation.

Chair

Brett Wilson

Speaker

Facilitator
Lisa Horne-Lucero, BSN

Facilitator
Kate Owen

Component Type: Workshop
Level: Intermediate

This session will provide an overview of the use of MedDRA and Standardised MedDRA Queries in the review of New Drug Applications. It will include practical exercises designed to promote discussion of best practices and solutions to challenges in premarketing pharmacovigilance. Participants will gain a valuable insight into how FDA analyzes MedDRA data, with an emphasis on data quality.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Chair

David Richardson, MD

Speaker

Facilitator
Christopher Damian Breder

Component Type: Workshop
Level: Basic

Drug developers, regulators, and payers are increasingly relying on large, linked, and networked databases to discover and test new therapies; inform regulatory and funding decisions; monitor therapies in practice and fine tune therapeutic approaches. The use of such “big data” resources is scientifically exciting but raises a number of ethical issues relating to participant consent and confidentiality; ownership, and benefit sharing; and effects on clinical trials, regulatory and funding processes, and the physician-patient relationship. This session will include an exercise to explore the ethical issues raised by biomedical research that uses “big data” resources.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize that there are many different kinds of “big data” with many different applications in public health and biomedicine; Discuss the key ethical issues arising from research involving “big data,” including consent, confidentiality, ownership, benefit sharing, and effects on clinical trials, regulatory and funding processes and the physician-patient relationship; Express whether, when and how “big data” research should be conducted so it is ethically sound.

Chair

Wendy Louise Lipworth

Component Type: Workshop
Level: Intermediate

In this fast-paced, highly interactive session, we will:

• Provide participants with a basic overview and vocabulary for human-centered design methodology through a brief didactic presentation;

• Through brief case studies, communicate examples of how human-centered design methods have been utilized by clinical development R&D organizations via a pharmaceutical industry consortia and by individual pharmaceutical companies to progress challenges and initiatives;

• Stage an interactive dialogue amongst participants on challenges and considerations specific to clinical development when integrating design thinking methods into areas of opportunity for improved efficiency and quality outcomes.

Participants will be challenged to rapidly learn the basic concepts of human-centered design, integrate their subject matter expertise to identify potential challenges and past analogous experiences, and develop creative solutions to using human-centered design as a catalyst for improving how industry solves common challenges in clinical development. Having achieved the above objectives, participants will leave with take-away materials to facilitate immediate integration of design thinking methods into their respective projects and initiatives.

This session is coordinated with “Design Thinking to Redesign the Clinical Trial Business Model and Improve Efficiency and Quality of Clinical Trials” (Wednesday, 10:30-11:00 am, Track 11).

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Identify areas where human-centric design approaches have or could be leveraged within clinical research to progress challenges and initiatives; Explain strategies for avoiding or overcoming common challenges to introducing design thinking methods into research organizations; Build a network of like-minded professionals who are interested and/or active in using design thinking in their projects and initiatives within clinical research and development.

Chair

Dennis Salotti, MBA, MS

Speaker

Facilitator
Steven B. Whittaker

Facilitator
JoAnn Muir

Component Type: Workshop
Level: Intermediate

Increasing complexity in clinical trial protocols makes implementation and reporting difficult. The lack of consistency across protocols compounds the issue. TransCelerate BioPharma Inc. has released a Common Protocol Template that provides a common structure and model language. The common protocol template is a foundational element in the longer-term movement towards an electronic protocol. Participants will rotate through interactive, discussion-based stations to learn about the Common Protocol Template and inform its future development. Topics will include:


• Implementation: benefits and overcoming common challenges
• Technology Enabled Edition: how content reuse and metadata capture is possible today
• Experience from the Trenches: lessons learned and FAQs about the template.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the value of harmonizing protocols across industry; Discuss the TransCelerate Common Protocol Template; Identify implementation challenges and strategies for overcoming them.

Chair

Robert L. Ferendo

Speaker

Facilitator
Virginia Nido, MS

Facilitator
Stacy J. Tegan

Facilitator
Bryan Yee

Component Type: Workshop
Level: Intermediate

If you are sometimes having trouble identifying and managing your stakeholders in other regions, especially in East Asia, then please join us! In this session, which corresponds to “Global Stakeholder Management: Across the Ocean Between East and West” (Wednesday, June 29, 10:30 AM), we will have the opportunity answer your questions as well as share experiences, best practices, and advice.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss practical advantages and limitations of stakeholder management implementation.

Chair

Atsushi Tsukamoto