Safety Graphics Meeting Minutes

For questions about the minutes email us.

May 19. 2010
April 27, 2010
March 18, 2010
February 26, 2010
January 21, 2010

May 19. 2010

Click here for Word document of May 19th Minutes

Meeting Subject: Industry/FDA/Academia Safety Graphics Working Group

Teleconference

Meeting Date: Tuesday May 19, 2010

Meeting Time: 2:00 p.m. to 3:00 p.m. (EST)

Meeting Location: White Oak Building 21, Room 4560

Attendees	Mat Soukup (Chair), Bruce Weaver (Project Manager), Richard J. Anziano, Fabrice Bancken, Navdeep Boparai, Andreas Bruckner, Janelle Charles, Brenda Crowe, Suzanne Demko, Susan Duke, Richard Forshee, Eric Frimprong, Robert ”Mac” Gordon, Matthew Gribbin, Frank Harrell, Qi Jiang, Stephine Keeton, Leslie Kenna, Ken Koury
Absentees	Charles Cooper, Sylvia Engelen, Kate Gelprine, Frederico Goodsaid, Larry Gould, Ted Guo, Liping Huang, Antonio Paredes, Jadhav Pravin, George Rochester, John Senior, Jeff Summers, Mark Walderhaug, Markus Yap

Meeting Purpose: Accept the minutes from the previous meeting. Review the minutes from the Subgroups; Adverse Events, ECG/Vitals, General Principles, and Labs and Liver. Have an update on CTSpedia. Review Action Items from the previous meeting; review Data Sets, discuss and assign conferences to attend.

Points of Discussion

New Membership

Catherine Njue – Health Canada

Acceptance of the minutes from the previous meeting

Mat inquired if there was anything discuss from the previous months meeting. There was not and the minutes were accepted without further discussion.

Subgroup Meeting Minutes

Adverse Events – Stephine Keeton gave a summary of the group’s last meeting.

ECG and Vitals – Rich Anziano gave a summary of the group’s last meeting.

Antonio took an action item from the ECG and Vitals subgroup meeting to look into the feasibility of sharing pediatric ECG and Vitals data from the previous large group meeting. Antonio was not present to discuss this and it will be tabled until the next meeting.

General Principles – Susan Duke gave a summary of the group’s last meeting.

Discussed the group’s bio-sketch, and the prospect of using bio-sketches on CTSpedia.

Labs and Liver – Mac Gordon gave a summary of the group’s last meeting.

Action Items from the previous meeting

CTSpedia and the Subgroups

Mary Banach will be to point of contact for technical questions

The Wiki will be the location for sharing information, as opposed to email attachments.

-Each Subgroup should have there own page.

- Within this page start subsections based on a graphic that will address a specific clinical question.
- If there are issues programming graphics out, sketches can be scanned and submitted in jpeg format so it can be easily depicted on the site.
- This format will facilitate comments and further dialogue.
- Each group should develop a template for when a finalized graph is produced; what type of information should be depicted, how are the graphs going to classified (long term goal not immediate).

Data Sets small data sets acquired
- Pediatric Data Set – Leslie Kenna
  - - Has the pediatric form body, and has a link.
    - Find a way to distribute this smaller data set.
    - Mat will look into how to distribute this and other data sets and if the wiki can accommodate this effort; and what restrictions exist.
- Large Data Set – Brenda Crowe
  - - Robust data set contains a good spectrum of safety data.
    - De-identified
    - Contains Adverse events and Labs.
    - Perhaps vitals, but no ECGs
      - Brenda will report the status of this effort to Mat, Bruce, and the team leads; and identify members to provide assistance.
      - Brenda will attempt to initiate a web conference between Mat and Greg.
Conferences/planned presentations
- Mat has a presentation at the JSM Invited session for safety graphics. He will not comment specifically on what the group has devised. Mat will though mention; what the group is, what the membership is, and the specific goals to be achieved. This was put out to the membership and there were no objections.
- FDA/Industry Workshop in September. Mat will discuss the constructs of forming the group, preliminary results, and will not get into content (this will be addressed at the ICSA meeting). The focus will be what it took to get the group formed, and what members have done.
- Qi will attend the ICSA June 26 – 29, 2011 in New York, New York. This presentation will further advertise the group’s efforts and pick up where the Mat left off at the FDA/Industry Workshop. Qi described the ICSA/JSM partnership. Proposal: A session titled Innovative Drug Safety Graphical Presentation. Mat and Qi will organize this session and co-chair. There will be three speakers and one discussant or four speakers. Ideally the four speakers would be a lead or a delegate from the subgroups and speak for twenty minutes.
- Brenda raised the point of if we should do this for other meetings as well, and if we should develop a template and distribute them widely.

Conferences of Interest and point person

- 1. JSM – Brenda Crowe
  2. ENAR 2011 – Janelle Charles
  3. Society for Clinical Trials – Mac Gordon
  4. FDA/Industry – Brenda Crowe
  5. DIA Annual – Mat Soukup
  6. 2011 International Chinese Statistical Association – Qi Jiang
  7. Statistical Methodology in Research and Development – Fabrice Bancken
  8. World Drug Safety Congress (Europe) - Qi Jiang
  9. PSI (Statisticians in the Pharmaceutical Industry) – Susan Duke

Deliverables:

Dates of the conference
Location of the conference
Can a proposal be submitted?
Deadlines for proposals
The structure for the proposal

Open Discussion

Additional discussion of DIA workshops, the possibility of working with other technical groups, DIA, and the Online Journal Club – Ken Koury

Action Items

Antonio took an action item from the ECG and Vitals subgroup meeting to look into the feasibility of sharing pediatric ECG and Vitals data from the previous large group meeting. Antonio was not present to discuss this and it will be tabled until the next meeting.
All members should register on CTSpedia, and then contact Mary Banach (mary.banach@vanderbilt.edu) to receive access to the Statistical Graphics Web.
Mary Banach will give a brief introduction on how to use the wiki.
Each group should develop a template for when a finalized graph is produced; what type of information should be depicted, how the graphs will be classified (long term goal not immediate).
Mat will look into how to distribute data sets, and if the wiki can accommodate this effort; and what restrictions exist.
Subgroups identify a representative to speak for 20 minutes at ICSA.
Subgroups develop a standard slide set for conferences.
Conferences of Interest and point person

JSM – Brenda Crowe
ENAR 2011 – Janelle Charles
Society for Clinical Trials – Mac Gordon
FDA/Industry – Brenda Crowe
DIA Annual – Mat Soukup
2011 International Chinese Statistical Association – Qi Jiang
Statistical Methodology in Research and Development – Fabrice Bancken
World Drug Safety Congress (Europe) - Qi Jiang
PSI (Statisticians in the Pharmaceutical Industry) – Susan Duke

Deliverables:

- Dates of the conference
- Location of the conference
- Can a proposal be submitted?
- Deadlines for proposals
- The structure for the proposal

Return to Top

April 27, 2010

Click here for Word document of April 27th Minutes

Meeting Subject: Industry/FDA/Academia Safety Graphics Working Group

Teleconference

Meeting Date: Tuesday April 27, 2010

Meeting Time: 2:00 p.m. to 3:00 p.m. (EST)

Meeting Location: White Oak Building 21, Room 1539

Attendees	Ken Koury (Chair), Qi Jiang, Richard J. Anziano, Navdeep Boparai, Janelle Charles, Suzanne Demko, Susan Duke, Richard Forshee, Eric Frimprong, Robert ”Mac” Gordon, Stephine Keeton, Leslie Kenna, Antonio Paredes, George Rochester, Markus Yap, Fabrice Bancken, Charles Cooper, Brenda Crowe, Larry Gould, Matthew Gribbin, Frank Harrell
Absentees	Andreas Br\xC3ƒƒ\xC3‚¼ckner, Sylvia Engelen, Kate Gelprine, Frederico Goodsaid, Liping Huang, Pravin Jadhav, Qi Jiang, George Rochester, John Senior, Mat Soukup, Jeff Summers, Mark Walderhaug

Meeting Purpose: Accept the minutes from the previous meeting. Review the minutes from the Subgroups; Adverse Events, ECG/Vitals, General Principles, and Labs and Liver. Have an update on Website/Statforum. Review Action Items from the previous meeting; Duke Clinical Research Data Sets, and large public and placebo data.

Points of Discussion

New Membership

Yaning Wang Adverse Events Subgroup, and the Labs and Liver

Subgroup

The following members will attend subgroup meetings only.

Rob Fiorentino ECG and Vitals Subgroup

Pravin Jadhav ECG and Vitals Subgroup

Jeff Summers Adverse Events Subgroup

and General Principles Subgroup

Hao Zhu ECG and Vitals Subgroup

The following have requested to be informed of the Working Groups

progress but are currently unable to commit time to the groups ecorts.

Kate Gelperin

Ted Guo

John Senior

Acceptance of the minutes from the previous meeting

Ken inquired if there was anything discuss from the previous months meeting. There was not and the minutes were accepted without further discussion.

Subgroup Meeting Minutes

Adverse Events – Stephine Keeton

ECG and Vitals – Rich Anziano

General Principles – Susan Duke

Labs and Liver – Mac Gordon

Action Items from the previous meeting

Update on Website/Statforum – Ken Koury
Duke Clinical Research Data Sets – Antonio Paredes
QT data – Leslie Kenna

Announcements and Open Discussion

What sample data will be available to use?
2011 International Chinese Statistical Association (ICSA) Applied Statistical Symposioum

June 26-29, 2011

New York , New York

Discuss the idea of organizing a safety graphics session.

Open Discussion

Return to Top

March 18, 2010

Click here for Word document of March 18th Minutes

Meeting Subject: Industry/FDA/Academia Safety Graphics Working Group

Teleconference

Meeting Date: Thursday March 18, 2010

Meeting Time: 3:30 p.m. to 4:30 p.m. (EST)

Meeting Location: White Oak Building 21, Room 1537

Attendees	Mat Soukup(Chair), Qi Jiang, Richard J. Anziano, Navdeep Boparai, Janelle Charles, Suzanne Demko, Susan Duke, Richard Forshee, Eric Frimprong, Robert ”Mac” Gordon, Liping Huang, Stephine Keeton, Leslie Kenna, Antonio Paredes, George Rochester, Markus Yap
Absentees	Ken Koury, Fabrice Bancken, Andreas Br\xC3ƒƒ\xC3‚¼ckner, Charles Cooper, Brenda Crowe, Sylvia Engelen, Federico Goodsaid, Larry Gould, Matthew Gribbin, Frank Harrell, Mark Walderhaug

Meeting Purpose: Accept the minutes from the previous meeting. Review the minutes from the Subgroup Meeting. Solicit volunteers for leadership and membership of the groups that will focus on clinical questions, and general principles. Discuss submitted gallery links, change of meeting duration from 1 hour and 30 minutes to 1 hour, and the recruitment of clinical/medical membership.

Points of Discussion

Acceptance of the minutes from the previous meeting

Mat inquired if there was anything discuss from the previous months meeting. There was not and the minutes were accepted without further discussion.

Subgroup Meeting Minutes

Mat solicited the working group for volunteers to join one of the four subgroups and for volunteers to lead them. Mat noted that Brenda has a data set identified and this could be used to build skeleton forms. George noted that Duke Clinical Research has several data sets. Acquiring these data sets was made an action item. Antonio volunteered to be responsible for this action item. It was also noted that there is a source of public and placebo data. Leslie volunteered to be responsible for the collection of this data.

A question was raised regarding a common work area. It was noted that Frank Harrell’s site is not scheduled to be online for another 6 weeks.

Markus inquired if medical imaging is of interest.

George pointed out that medical imaging is not excluded, graphics will be entertained.

Susan noted that she has some medical images.

George stated that we are pushing towards integrated analysis.

Mat asked the group for volunteers to each of the four subgroups.

Adverse Events	Labs & Liver	ECG/vitals	General Principles
Stephine Keeton	Mac Gordon	Rich Anziano	Susan Duke
Janelle Charles	Susan Duke	Antonio Paredes	Brenda Crowe
Liping Huang	Qi Jiang	Mat Soukup	Rich Forshee
Qi Jiang	Leslie Kenna	Markus Yap	Qi Jiang
Mat Soukup	Mat Soukup		Mat Soukup
			Markus Yap

Recruitment of clinical/medical membership

Mat raised the issue of recruiting medical membership. The objective is to recruit at least two clinical/medical members for each of the subgroups, one from the FDA and one from PhRMA.

Gallery Links

http://addictedtor.free.fr/graphiques/thumbs.php contributed by Richard Forshee

This site has content from a wide array as well as all of the accompanying code. Rich noted that this site appears to be down.

http://www.math.yorku.ca/SCS/Gallery/ contributed by Andreas Bruckner

Andreas was not on the line and no further information was provided.

http://biostat.mc.vanderbilt.edu/StatGraphCourse contributed by Frank Harrell

Mat noted that this site is used by Frank for his classes.

Working Group Meeting Length

The monthly working group teleconferences will be reduced to an hour. For scheduling purposes conference room reservations will still be made for an hour and a half to allow further discussion if necessary.

Action Items

Acquisition of Duke Clinical Research Data Sets – Antonio Paredes
Acquisiton of large public and placebo data – Leslie Kenna
Distribution of Subgroups and further solicitation of membership – Bruce Weaver
Subgroups:
- Begin to collect examples.
- Formulate a mini-plan and distribute it at the next meeting. This mini-plan should include broad timelines.
- Address the questions/areas from the “Path Forward”(first subgroup meeting minutes.

Return to Top

February 26, 2010

Click here for Word document of February26th Minutes

Meeting Subject: Industry/FDA/Academia Safety Graphics Working Group

Teleconference

Meeting Date: Friday February 26, 2010

Meeting Time: 11:00 p.m. to 12:30 p.m.

Meeting Location: White Oak Building 21, Room 3560

Attendees	George Rochester, Mat Soukup, Ken Koury, Richard J. Anziano, Fabrice Bancken, Navdeep Boparai, Andreas Br\xC3ƒ¼ckner, Janelle Charles, Charles Cooper, Brenda Crowe, Suzanne Demko, Susan Duke, Sylvia Engelen, Richard Forshee, Federico Goodsaid, Eric Frimprong, Robert Gordon, Larry Gould, Matthew Gribbin, Frank Harrell, Liping Huang, Stephine Keeton, Leslie Kenna, Antonio Paredes, Mark Walderhaug, Markus Yap
Absentees	Qi Jiang

Attendees

George Rochester, Mat Soukup, Ken Koury, Richard J. Anziano, Fabrice Bancken, Navdeep Boparai, Andreas Br\xC3ƒ¼ckner, Janelle Charles, Charles Cooper, Brenda Crowe, Suzanne Demko, Susan Duke, Sylvia Engelen, Richard Forshee, Federico Goodsaid, Eric Frimprong, Robert Gordon, Larry Gould, Matthew Gribbin, Frank Harrell, Liping Huang, Stephine Keeton, Leslie Kenna, Antonio Paredes, Mark Walderhaug, Markus Yap

Absentees

Qi Jiang

Meeting Purpose: Introduce three new group members. Update group members on the most recent version of the charter including group name change. Have a brief review and in-depth discussion of the sample graphics from Susan Duke. Discuss the Repository Detail Outline supplied Mat Soukup and Frank Harrell. The group will be updated on the FDA/Industry Workshop meeting by Stephine Keeton. The draft bibliography will be submitted to group members, and additional entries will be requested.

Points of Discussion

New Members

Markus Yap – Commissioner’s Fellow (Biologist) in OCS
Richard Forshee - CBER
Mark Walderhaug – Alternate from CBER

Charter

Qi Jiang updated the major project deliverables section of the Charter. George Rochester completed the roles and responsibilities section of the Charter.

Review of Sample Graphics

Need to devise a method of governing content that does not contradict the ideals of a wiki format:
- Provide Levels for content
- Enlist a rating system e.g. Amazon Ratings

Repository Detail Outline

Will be several weeks before we have a clean design.
Rather than having a private section, we should have an open approach. As the site becomes more official, we can have a private wiki.
- A mid-level approach would be a wiki with groups.
The question of how best to develop this pallet was posed.
- A small group can develop the pallet and be ready for dissent later.
- Have input from a large group and have dissent built in.
Put up R gallery and add code.

Bibliography

A sample bibliography was submitted.
Additional entries were requested from the group members.

FDA/Industry Workshop

There will not be a graphics section
There will be a Safety Signal Detection section.
3 confirmed speakers.
Remains to decide whether the session will be plenary or concurrent.

Action Items

Subteam Meeting minutes will be forwarded to Bruce Weaver.

Return to Top

January 21, 2010

Click here for Word document of January 21st Minutes

Meeting Subject: PhRMA/FDA/Academia Safety Graphics Working Group

Teleconference

Meeting Date: Wednesday January 21, 2010

Meeting Time: 2:00 p.m. to 4:30 p.m.

Meeting Location: WO Bldg 21, Room 3560

Attendees	George Rochester (Chair), Matt Soukup(Co-Chair), Richard J. Anziano, Fabrice Bancken, Frank Harrell, Ken Koury, Larry Gould, Liping Huang, Qi Jiang, Robert Gordon, Susan Duke, Janelle Charles, Charles Cooper, Stephine Keeton, Leslie Kenna, Antonio Paredes, Bruce Weaver(Project Coordinator)
Absentees:	Andreas Bruckner, Navdeep Boparai, Brenda Crowe, Matthew Gribbin, Sylvia Engelen, Suzanne Demko, Federico Goodsaid

Meeting Purpose: Introduction of working group members, charter finalization, major milestones for 2010, web-hosting, and documentation.

Points of Discussion

Charter finalization

It was noted that the numbering in Section 1 is out of order and 1.2 is listed twice.
In section 1.4 should state “exploration and reporting”.
- Perhaps these tools could identify safety problems;
  - Include exploration and reporting.
  - Better understanding in reporting.
Concerning the Project Scope in addition to ISS, exploratory graphs, and study reports.
- Include that the static graphics should be printable.
High Level Project Plan
- Much of what will be developed will be useful to epidemiological studies.
- The Charter may be adapted continuously.
- As these tools are developed they aide in the production of new drugs. Should the Scope(1.4) reflect this.
Milestones
- Remove ‘Project Authority’ from the charter, leave only ‘Milestones’ as the heading for Section 2.
- Some major safety questions must be incorporated in 2.1.a.
- Define 2.1.a.iii “regulatory review and business processes”
  - 2.1.a.iii should be its own sub-section, 2.1.e
  - What were the “business process”?
    - This was the basis to describe how to use the pallet effectively. Recommendations for implementation of future work streams. More detail is required.
- A discussion of 2.1.b “Develop a palette of statistical graphics for specialized reporting of clinical trials data” by Matt Soukup.
  - It is critical to development that data sets be submitted.
    - Users should be able to share how they have used graphics to display information.
    - Users should be able to submit data sets for information the do not know how to display.
    - New clinical data in CDISC format.
    - If any members of the working group have dummy data sets that could be used, they should submit them.
  - Members should discuss and share graphics they have.
    - This will require further discussion and assignments.
  - Points of discussion

How will these data sets be maintained, how will users contribute to this in the future?
- Frank Harrell will address this in the future.
What will be the standards for text and graphics? e.g.
- Resolution and properties for graphics.
- Rules for text
- Something beyond rules to encourage better graphics.
- When the wiki is used how will best practices be ensured?
- There should be some regulation of content e.g. a review process.
- An outline to describe best practices.
- In addition to proper credit, a disclaimer should be included that this data has not been verified for a desired level of quality.
  - Contributors should not feel responsible if their name was attached to some code and it fails to run.
  - Legal will be involved.
- Documentation
  - A statement of purpose should be included so users know how to interpret graphs.
  - In the interest of time Section 2.4 Major Project Deliverables will be assigned to a volunteer.
    - Qi Jiang Volunteered.

Section 3 Project Structure
- Frank Harrell was asked if he could recommend any others in academia with interest in the groups effort. Rich Highburger at Temple University was recommended.
- Vendors could be brought in but not as members so the group does not loose scope.
- Section 3.1.2(d) Patient groups and health care providers.
  - Since these graphics may end up on a label, this group is important.
  - There are no group members from section 3.1.2(d); we may include them when there is content to present for the outreach/training.

Web-hosting

Frank Harrell
- - Web-hosting platform can do what is required.
  - Good statistical practice is not documented. This may be a good objective.
  - Develop a compendium of test data sets with specific data sets that reflect reality.
  - Collect simulation designs;
    - 4 period cross over designs
    - Dose studies
    - 2x2 designs
  - If this could be a community platform for sharing ideas, that would be an added benefit.
  - CTSpedia just moved to Vanderbilt, and can bring various areas of expertise.

Documentation

Bruce Weaver should distribute Graphics from Susan Duke to group members

Future Meetings

Monthly teleconference that will take place on the third Wednesday of each month.
Face to Face meeting to coincide with either JSM or DIA.
Industry Workshop in September.

Major Milestones

Complete Section 2.1(a) by the first quarter.
Complete Section 2.1(b) by October 2010.
Create a repository by the end of the first quarter, Matt Soukup, Frank Harrell.
Education quarterly aim for different conferences and set as an ongoing objective.

Assignments

Roles and Responsibilities will be added to the charter by George Rochester.
Education, this is an ongoing objective that will take place at various conferences.
FDA Industry Workshop Planning Meeting Next Monday.
- - This will be a good meeting to communicate and have a discussion.
  - Susan Duke and Stephine Keeton will attend, follow up and see if a Graphics Session was accepted for the Workshop in September. Susan Duke will be the point of contact for this meeting.
Mat Soukup will send Bruce Weaver a Repository Detail Outline for circulation to group members.
Susan Duke will provide a format for documentation.
Bruce Weaver will distribute Graphics from Susan Duke to group members.
Add Highburgers to the bibliography to be circulate, this publication as it is a good place to start when reviewing graphs.
Bruce Weaver will circulate Bibliography and solicit entries from group members.

Return to Top

Topic attachments
I	Attachment	Action	Size	Date	Who	Comment
doc	Industry-FDA-Academia_Graphics_Working_Group_Meeting_Minutes_April_27__2010.doc	manage	40 K	02 Jun 2010 - 13:32	UnknownUser	Meeting Minutes from the working group teleconference on April 27, 2010
doc	Industry-FDA-Academia_Graphics_Working_Group_Meeting_Minutes_February_26__2010.doc	manage	35 K	02 Jun 2010 - 13:35	UnknownUser	Meeting Minutes from the working group teleconference on February 26, 2010
doc	Industry-FDA-Academia_Graphics_Working_Group_Meeting_Minutes_March_18__2010.doc	manage	49 K	02 Jun 2010 - 13:32	UnknownUser	Meeting Minutes from the working group teleconference on March 18, 2010
doc	Industry-FDA-Academia_Graphics_Working_Group_Meeting_Minutes_May_19__2010.doc	manage	57 K	02 Jun 2010 - 13:29	UnknownUser	Meeting Minutes from the working group teleconference on May 19, 2010
doc	PhRMA-FDA-Academia_Graphics_Working_Group_Meeting_Minutes_January_21__2010Draftl.doc	manage	58 K	02 Jun 2010 - 13:36	UnknownUser	Meeting Minutes from the working group teleconference on January 21, 2010