May 17, 2016 Minutes

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May 17, 2016 Call and Proposal for Working Groups


Next Call: Tuesday, May 31, 10 am ET

Attendees: Teresa Ancukiewicz, Mary Banach, Melissa Binz, Michael Colopy, Wendy Dobson, Eric Herbel, Johann Proeve, Geoff Low, Diane Lazzeri, Lisa Kammerman, Melissa Wissner, Mike Rubison, Dale Plummer, Johann Proeve, Rebeka M Revis, Michael Rubison, Sanjay Matange, Stanley Wei, Steve Wilson, Xiangyun Wang, David Wei

We welcomed everyone to our First PhUSE Data Visualizations and DIA RBM Group Meeting. Brief introductions were made focusing on how our group can help them.

Biweekly calls on Tuesday at 10 am ET worked for everyone on the call. Wendy Dobson will send out GoToMeeting reminders.

Please note that we are using GoToMeeting for our conference call software. GoToMeeting requires that each participant have a unique URL. Please accept Wendy’s invitations. We are open to new participants. Please send Wendy the email for a new participant. She will send out the invite.

Background

Mike Rubison provided a brief history of our group and our strategic plans for 2016. (Background: Crystal Allard from the FDA was the PhUSE Project Coordinator for the Emerging Trends Data Visualization in 2015. She asked Mike Rubison and Mary Banach to take over the helm of this group. Courtney McBean had been head of the DIA RBM Group. She asked Mary Banach to take over the helm of this group. Mary also asked Teresa Ancukiewicz to join Mike and Mary in co-leading the joint group.)

At the March 2016 PhUSE Computation Science Symposium (CSS) in Silver Spring, 25 people were interested in the topic and spent two days in meetings discussing what they would like to see in a Data Visualization group. The primary topic of discussion was how we could use data visualizations to help us with implementation of the FDA RBM Guidance document. We would then gradually expand our visualizations to other clinical trial uses. We want to focus on human studies headed for FDA approval, primarily Phase II and III. We do not want to duplicate work that others are doing.

Priorities Discussed at the CSS

At the CSS the following areas of interest and exploration were discussed for our work for 2016:

Standards within RBM Guidance • Identify and Propose Best Practices, Checklists & Tools • Identify Databases, References and Training Materials for RBM

Data Visualization as a RBM Tool for Efficiency, Quality and Efficiency • Focus on Clinical Trials supporting Regulatory Submissions • Identify and Pair Tools and Processes with Needs • Recommendations for SOPs and Validation

Interactive vs Static Visualizations • Compare Best Uses and Best Practices • Communicate Sources of Information, Libraries and Use Cases • Safety Graphics (CTSpedia) and other Resources

Technology Solutions and Comparisons • Products, Vendors and Open Source Tools and Applications • Implementation, Training and Best Practices • Range of Validation Requirements: from Query/Exploration to Reporting/Regulatory Submissions

Joint Activities with DIA

Following the CSS Meeting, Mike and Mary spoke to Peter Stokman, Johan Proeve, Teresa Ancukiewicz, and Steve Wilson from the DIA CTMS Community. We talked to them about helping the DIA RBM Group get re-started. They thought the idea of across Community collaboration was much needed and encouraged to talk to Barb Jones, Associate Director of DIA. Barb thought that bridging the two groups was a great idea and she would like to use us as model for DIA’s new site on identifying volunteers for Communities and projects. Mike and Mary then turned to Teresa to make sure that we are representing DIA’s priorities for our project.

Discussions

We briefly discussed why we are needed if TransCelerate is addressing RBM issues. Although TransCelerate is doing a great job on addressing RBM issues, many people and ideas are left out. TransCelerate only represents specific companies in the pharmaceutical industry. Academics, individuals from companies not in TransCelerate, and those individuals with other expertise are not included in TransCelerate.

Teresa Ancukiewics talked about the wide range of DIA Communities: representing data management, statistics, clinical operations, clinical trials management, but there is no cross community collaboration and communication. The interest is high in cross communication. Teresa pointed out that TransCelerate is great and provides us with a wealth of RBM information, but we need additional communication.

We discussed priorities in order to provide deliverables for the above topics of interest. We determined that there was not a need for a separate working group on communications but that each of the working groups would make communication a priority with their deliverables.

One priority that was often mentioned in the DIA RBM group was how we communicate what we are doing with the FDA inspectors. We have found that some companies thought that they were following FDA Guidance and yet there were problems with their inspections. Steve Wilson said that he will talk to the Office of Translation Science and see if Sean can help us.

Geoff pointed out that it is important for us to get names for sub-group and capture work products on the Teamwork site.

Johan Proeve said that it is important to let people know about the group and how they can help us. Rebeka Revis said that she is a member of the PhUSE Scripts Group and White Paper Group. If we have code or other materials that we would like to share, she will be happy to take care of this for us.

PROPOSAL

Mary was going to send out a survey following the May 17th call, but after talking to Mike and Teresa we came up with the following suggestions for sub-groups and principals in those groups. PLEASE click here to add or to remove your name. (You will need to register for the wiki in order to edit the page.)

We propose the following groups and suggested deliverables:

(1) RBM Guidance: Standards, References and Global Vision

Outline/Checklist for components for Instructional Guide for FDA Reviewers

(2) Data Visualization as a RBM Tool for Site Performance

Graphical presentations on evaluation of site performance

(3) Interactive vs. Static Visualization

Compendium from CTSpedia Safety Graphics and other sources

Compare and recommend static vs interactive graphs for information

(4) RBM Guidance: Monitoring, Compliance, Best Practices and Training

Develop a best practice checklist