Safety Meeting Minutes

January 2012

December 2011

November 2011

October 2011

September 2011

August 2011

July 2011

June 2011

May 2011

• Expectations of Subteams
• Reviewing within subteam *Reviewing graphs; finalize document *Recommended graphs *June meeting documents should be finished

• Need a time line to have Wiki up and running
• Best place to host Wiki for advertisement
• What will the wiki page look like?
• Finalize product *Introduce “Show & Tell”.
• Agenda for face-to-face meeting; two part meeting 1st half Show & Tell in the morning 2nd half business meeting confined to the working group
• Place to hold meeting?
• Dates of conference room availability

• CDER WO 1417 Bldg 22 ( Holds 35 people / in person meeting)
• CDER WO 2205 Bldg 22 ( Holds 100 people)

• No Updates

• Nothing to report

• Finalize what graphs & changes they want
• Clinical question outlined
• Thumbnail of graphs put on the Wiki
• Next meeting June 27 5 to 8 graphs finalized
• (Mat) Draft up vetting process for getting finalize draft

• Ken Koury- DIA structure is more in place
• The group under DIA umbrella?
• Discuss Offline

• Looking for someone to Chair
• Rich & Susan are committed to putting slides together

• Open discussion next meeting June 27, 2011
• Anything you think is going well & anything that needs improving

April 2011

• May 23, 2011 at 2:30 P.M.

• Had first meeting and at this time would like to get clarity on what the communication groups charge should be.
  • How to market the group o How to link with other groups and websites
  • Targeted Activities
    • Launching of the website Launch Date Launch date was initially targeted for June 1, 2011
• June 1, 2011 is not a reasonable launch date for the graphs and clinical questions. A sub-team will be formed in order to agree upon what information should be launched, and report back to the larger group.

• Brenda Crowe, Mac Gordon, Rich Forshee, and Mary Banach volunteered
• A conference call will be scheduled during the following week.
  • If there is enough time, this sub-team will also sketch out the tasks needed and a timeline.
    • Flow Chart
    • Class Graphs
    • Safety Graphs
• How should the safety aspects be emphasized?
• How should these graphs be linked to the clinical questions?
• The format for data are either .xpt or .csv
• Programming is not required at this time.

• Overall aim of the subgroup versus what can be achieved by the next month.
  • What the subgroup is willing to launch?

• Each group posts graphs and members review and mark either “yes” or “no”
  • The 8 principles from the General principles group should guide the member’s decision in choosing whether or not a graph is appropriate.
  • Clinical judgments o Whether the graph is meeting a need.

• Methods for solving the data structure issues:
  1. Attach as a separate file using the attach button at the top of the wiki
  2. Cut and paste the code into the form.
  3. If a graph can be created using a “point and click” method, describe the graph and the group will work on the code at a later date.

• CDER WO Adverse Events – Janelle Charles gave a summary of the group’s last meeting.

• Clinical questions and example graph PowerPoint presentation.
• SAS transport files (.xpt) and there word document description file
• There are a few more graphs to be produced.
• Programming is in the early stages. General Principles- Susan Duke gave a summary of the group’s last meeting.
• The groups activity has been centered on class graphs.

• All of the graphics have been reviewed and have comments.
• Programming is in the early stages.

March 2011

• April 25, 2011 at 2:30 P.M.

• Experienced in project management and communication
• Will work with the Communications Subgroup

• Subgroup meeting was held on Friday March 25, 2011
• Anticipate one more meeting to finalize the discussion of graphs
  • Once finalized, the group will begin discussing posting clinical questions and the corresponding graphs to the wiki.

• Subgroup meeting was held on Tuesday March 15, 2011
• Discussed feedback from the ISBS presentation that occurred on March 1, 2011
  • Uploaded simulated QT dataset onto wiki. o Will populate the site in short order.

• Subgroup meeting was held on Thursday March 24, 2011
• Discussed the list of 11 graphics principles
• Discussed the number of class graphs that needed to be created

• Subgroup meeting was held on Wednesday March 23, 2011
• Comments and Final Graphics are complete
• Will begin programming graphs so that a final deliverable may be uploaded to the wiki o Will be completed within the next meeting or two.
• The group is considering working on a document that would be a way to communicate clinical questions and have thumbnails that hyperlink to graphics.

• The group has volunteers from each of the subgroups except ECG & Vitals.
• An unofficial meeting was held the week of March 21st
  • 4 of 6 members attended
• Next meeting will be the first subgroup meeting and discuss
  • Roles and responsibilities
  • How best to support the working group
  • How to communicate internally and externally

1. Working Group members should view the finalized Labs and Liver Subgroup slides and provide comments.
2. Working Group members have been requested to volunteer for class graphs with the General Principles Subgroup.
3. Group members that will present at the conferences (DIA, ICSA, etc.) will meet for joint development.
   • Qi is in the process of setting up a meeting.
   • On the wiki there is a table where the conferences are listed. This should be used as a repository for all presentation slides.

1. Subteam Consensus and Development
2. General Group Consensus
3. Organization of Graphical Entries for a Specific Domain Area

• The meeting would be at the FDA
• A meeting for a full-day was agreed upon.
• FDA/Industry Meeting in September ends on Wednesday the 21st
  • Perhaps an add on day (the Thursday after the meeting)
  • Will use September 22nd as a working date o Possible conflicts should be circulated to Bruce Return to Top

February 2011

1. Working Group members should view the finalized Labs and Liver Subgroup slides and provide comments.
2. Working Group members have been requested to volunteer for class graphs with the General Principles Subgroup.

• March 28, 2011 at 2:30 P.M.

• The inclusion of vendors presents difficulty with regard to FDA Regulations. There is a rigorous legal process involved with establishing a CRADA (Cooperative Research and Development Agreement). To otherwise include a single vendor could result in criticism for not providing equal access.
  • An open invitation for all vendors to come and attend as consultants would be appropriate.
  • Group consensus: membership will not be extended to vendors.
  • During the roll-out phase vendors will be a part of the groups outreach.

• The Adverse Events Subgroup met on February 24, 2011
• The purpose of the meeting was to continue discussing graphs.
  • This discussion of graphs will continue during the March and April subgroup meetings.
  • Once the discussion is completed, a clinical questions and graphics document will be completed by the June meeting and posted to ctspedia for comment from the general group.
  • Draft graphs are available on the wiki under AE graphs.
  • A draft document is not available yet.

• The ECG and Vitals Subgroup met on February 10, 2011
• Norm Stockbridge is formally assigning a clinician to review the questions and the corresponding graphics.
• Data will either be simulated or anonymized.
  • No public ECG data supply available.
• Fabrice, George, and Rich are participating in a session at ISBIS in Berlin.
  • Discuss specific clinical questions and associated graphics the ECG group compiled.
  • Fabrice will speak more generally about the effort as a whole.
  • George will lead this session.
• Once the data set is in order it will be available on the wiki.

• The General Principles Subgroup met on February 17, 2011

• Attendees: Susan Duke (Chair), Mat Soukup, Mary Banach, Richard Forshee, Larry Gould, Qi Jiang, Fabrice Bancken, Brenda Crowe, Andreas Krause.

  Agenda: (1) Demo proof of concept of the public wiki (Mary), (2) get feedback from team on the first conference presentation (Fabrice), (3) discuss actions needed and date for launching the public wiki (Mat).

  Key Points:

  1. The team had helpful feedback for Mary's proof of concept, which is now ready to be demo'd to the full group. There has been a lot of work to get this far, especially by Mary, Mat, and a number of folks from Vanderbilt. Link to (eventual) public site: http://www.ctspedia.org/do/view/CTSpedia/StatGraphHome
  2. Fabrice received some useful feedback on his slides for the first conference. It was also recognized by many on the call that this first one will be helpful for subsequent conferences, as well as for what gets published on the wiki.
  3. The focus of Mat's topic was the classes of graphs. These will be needed prior to launch. It was agreed these should be completed by end of March. A launch date for the public wiki itself was not discussed, as we ran out of time. So far, five people have volunteered to create some of the other classes needed. Other volunteers are welcomed! Link to table of class graphs needed: http://www.ctspedia.org/do/view/CTSpedia/StatGraphHome#SeeBelow

• The Labs and Liver Subgroup met on February 23, 2011
• Finalized slides and have uploaded them to the wiki and are awaiting comments from the working group.
• A question was raised regarding authorship. As opposed to author, the term contributor will be used.
  • For example, if there is an application of a dot plot; one is not an author of a dot plot rather one is a contributor of an application of a dot plot.

1. Public Announcements
   • Process for publicizing the group’s efforts outside of the conferences.
   • George Rochester has volunteered to lead the Communications Subgroup and is seeking 4 – 5 volunteers.
2. Communications Subgroup (purpose, role, scope, and outreach to subgroups)
   • Purpose: Market the activities and ideas of the working group.
   • Scope: Seek opportunities beyond conferences and engender greater community participation. Discuss an open forum day, and a “show and tell” day.
   • Time commitment: 2 hours per month.
   • Volunteers:
     1. Andreas Brueckner
     2. Janelle Charles
     3. Mary Banach
     4. Qi Jiang
     5. Susan Duke
   • Launch Date; what will be launched? (reference the Subgroup Report of Timelines and Deliverables)
     • Late May.
     • At least 2 weeks in advance of ICSA and DIA. So speakers can incorporate details from the website with in their presentations.

• Organize DIA, ICSA, and JSM speakers to develop a common set of slides for each subgroup.
• The Adverse Events Subgroup to discuss abstracts and slide templates for these presentations. This has been placed on the wiki as well.

• May provide ideas toward organizing the wiki.

1. The group needs volunteers for the class graphs.
2. Reiterated rationale for not having vendors and that the term “contributors” will be used instead of “authors”.

January 2011

• What would this group do?

• What will be launched?
• This item will be on the agenda for next months meeting.

• Attain milestones of what each must be completed.
• Deliverables

• Reviewed the Clinical Questions document in search of graphs, and vetting the graphs found.
• Creating a document of the graphs vetted.
  • Once completed this document will be posted for the entire working group.
  • The tentative time frame to complete this process is 2 – 3 months.
• There are 7 Questions total. Sections 1 and 2 have been completed. Sections 3, 4, and 5 are underway.

• Reviewed 4 categories of graphics and posted a document for each category on the wiki.

• Submitted selected plots to Norm Stockbridge’s group
  • Norm Stockbridge received the plots before the holidays and confirmed that he will appoint a contact person.
  • The group has a complete group of graphics, and is getting currently a clinical input.

• Working through concepts within the wiki
  • Producing a hyperlink that links to certain points on a .pdf or PowerPoint file e.g. a user may select a thumbnail and get more information. (Mary Banach has been working on this effort)
• Susan and Mary will discuss the progress and schedule more meetings for the General Principles subgroup shortly.
• Principles being discussed include;
  • Placement of the figure #, title, and topic within the graph.
  • Footnotes on the bottom of the graph.
  • Details regarding the color.
• Flush out the explanatory pieces that will serve as an intermediate step between Fabrice’s general design figures and the actual graphics entry.
• The thumbnails or Fabrice’s figures would hyperlink the user to a more detailed page that would discuss that particular graph.
• From the more detailed page the user could hyperlink to the graphics entries.
• Mary Banach is currently working on the forms for these entries as well.

• Come up with the graphic and provide the code to create a workable example.
• Software vendors may be able to take it to the next level within their package, e.g. SAS clinical.

• Working group members can have a “show and tell” within their respective organizations. • Journal
• AMSTAT News
• Trade publications
• Letter to the editor
• Tutorial a. With a tutorial there needs to be focus as to which users the group is targeting. b. The timeframe would be the next couple of months; once more mature materials have been posted.
• The ASA Bio-pharmaceutical section’s newsletter

• George Rochester will lead the Communications Subgroup and seek 4 to 5 volunteers to help.

• A good way to save diagrams, especially flow-type charts. Also makes them easier to maintain, and add to later. A wiki plug-in exist for this.
• Another competing system is Asymptote. A wiki plug-in does not exist for this system. This is a high-level picture drawing. Examples are in the gallery of the Asymptote website. http://asymptote.sourceforge.net/gallery/

October 2010

• Next meeting is scheduled for on November 14
• Last meeting on was held on October 14.
  • The goal of this meeting was to discuss graphs pertaining to the first two sections of the Adverse Events Clinical Questions Document.

I. Inclusion of all p-values

• • Is it meaningful to include non-significant p-values or only include significant p-values which require further investigation; the consensus, if p-values are used then only include those that are significant.

II. Recommendations o Keep clinical questions in mind and find the graphs to address the questions.

III. Next meeting o The discussion of graphs pertaining to the clinical question document will be continued.

• The subteam met on October 12, 2010.
• Discussed topics other than clinical questions and graphs. Abstracts and presentations. Reviewed the Adverse Events material. AE subgroups material was suitable the ECG and vitals needs.
• How should presentations be standardized? This will be discussed later

• The subteam met on October 19, 2010.
• Andreas Krause joined the subteam.
• Discussed the categorical flow chart page created by Fabrice Bancken.
• Rich Forshee created a template for the intermediate page. It allows the use of thumbnails to go to the intermediate page.

• The subteam met on October 20, 2010.
• Then next meeting will be on November 5, 2010.
• The group has reviewed 24 graphics and review the remaining during the November meeting.
• Once finalized the graphics will be reviewed by the main group.
• Graphs under review are on the ctspedia website.

• R-graphic, SAS graphic with the code is sufficient now.
• In the creation a data set which is publicly available is preferred.
• This code does not need to be in SAS, nor be a macro with a range of options.

• General update; the Interdisciplinary QT Review Team has been given information about the Safety Graphics Working Group. The QT review team meets twice a week. Currently we are awaiting feedback and a date to meet with the Interdisciplinary QT Review Team.

• Qi Jiang, Ken Koury, Stephine Keeton, and Mark Walderhaug are presenting; and Andreas Brückner will be the chair. This will be in the Health policies and Statistics Session.

• “Decision making in Clinical Trials Graphics Make a Difference” Session chair will be Fabrice Bancken. Rich Anziano, Peter Bonet’(GSK), and a colleague of Brenda’s at Lilly will give the three talks. Rich Forshee has suggested Andrea Sutherland, a clinician from the FDA.

• ENAR, the Adverse Event sub-team has a standard abstract prepared.
  • Have each subgroup submit an abstract ready by November 15th.
    • If accepted each speaker must log into ENAR’s website, create a profile, and submit there presentation.
    • The time limit is 15 minutes for each speaker. There will be 7 speakers per contributed session. Eugenio Andraca-Carrera is the co-chair for ENAR 2011.
    • ENAR 2011 will be located in Miami, Florida. The dates are from March 20th to March 23rd.
    • A volunteer is needed

• Eventually a naming convention will have to be created for tags.
• Keywords used in tags can be used to find graphics faster than the search function.

• The old form contained 5 fields; author, email, date, original date, and modified date.
• With Forms fields may be added without altering other fields.
  • Modifications field will keep track of who has modified the original code and how.

September 2010

1. George Rochester will contact with Norm Stockbridge.
2. Mary Banach will discuss forms, and give an example of how to give credit for entries on ctspedia.
3. Fabrice Bancken will show a flow chart with categorical data.
4. Mat Soukup will discuss moving information to the public section of the wiki.
5. Ken Koury will extend an invitation to Andreas Krause
6. Janelle Charles took an action item to submit a contributed session for ENAR 2011.

• As the subgroups progress with there specific tasks
  • These items should be brought to the larger group for discussion, consensus and comment.
  • Each group should follow this pattern in order to prevent fragmentation, duplication of effort and miscommunication.
• There were questions regarding the submission of the abstracts and the use of the template.
  • The template should be used as a guide.
  • Abstracts should be tailored to the requirements of each conference.
    • They should be discussed with the larger group before they are submitted.
  • Adverse Event Subgroup charged to construct other slide templates.
    • Is the group responsible for construct slide templates for other conferences?
    • This should be a flexible process
    • The presentation will be a function of the speakers.
    • The presentation does not have to be the same each time.
    • The presentation may differ from conference to conference.

• Met on September 14
• Discussed conference slide template and abstract template.
• Drafts are posted on the wiki of the templates are posted on the wiki for the AE subgroup.
  • Group members were requested to review and comment upon these items.
• In the October meeting, the subgroup will return to its discussion of graphs.

• The subgroup met on September 7th.
• The QT was discussed.
• A general agreement was made to propose one concept per graph.
• The subgroup also discussed having a Clinician review the graphs for the clinical questions.
• The QT-review team within CDER could be shown our progress during one of there team meetings.
  • This would be a good brain-storming opportunity
  • George Rochester will touch base with Norm Stockbridge, the director of Cardiovascular and Renal Products as well as the group in Clinical Pharmacology

• The subgroup met on September 7th.
• Rich Forshee offered to create a template for an intermediate context page.
• Next meeting will be on October 19th.
• Mary Banach will discuss forms, and give an example of how to give authorship and acknowlegement for entries on ctspedia.
• Fabrice Bancken will show a flow chart with categorical data next month.
• Mat Soukup will discuss moving information to the public section of the wiki next month.

• The Labs and Liver meeting will occur on September 24th.
• The clinical questions document has been developed and divided into four categories.
  1. Baseline and trending
     • Half of these graphics have been reviewed by the Labs and Liver subgroup.
     • The other half will be covered at tomorrow’s subgroup meeting.
     • Once reviewed the remaining graphics will be added to the site.
  2. Associations to variables
  3. Liver
  4. General categories

• Authorship and best approaches
• Have several levels of credit.
• Mary Banach The template is being

• Has published papers that are related to pharmaceutical research graphics
• Is involved with modeling and simulation, and is publishing quite a bit on graphics for pharmacometrics.
• Is editing a book on graphics of clinical data.
• A general consensus was made to extend an invitation.

• In order to put information on ctspedia, one must be a member.
• Additionally, in order to have access to statistical graphics Mary Banach vets all requests. Statistical graphics is its own private group within ctspedia.

• The group reached a consensus to submit a contributed session and this action item was assigned to Janelle Charles.

• Rich Forshee has recruited Andrea Sutherland from CBER to speak as a discussant in the second session “Making Decision When Graphs are Available”.

August 2010

• The group met and agreed upon the following two action items
  • • Create a link on the wiki to upload all graphs in one location.
    • Several members of the subgroup will meet and update there conference slide template.
• Next meeting will be September 14, 2010

• Next meeting will be September 7, 2010.
• Comments have been requested for the graphs compiled. *The graphs are located on ctspedia site http://www.ctspedia.org/do/view/GraphicsWorkingGroup/ECGVitalSubteam

• Meeting was held on August 17, next meeting 3rd week of September
• Discussed the type of graphics to post to the wiki. * 4 categories: 1. Baseline and Trending, 2. Associated Lab Variables, 3. Liver Function Tests, 4. General

• Start a new public site for those searching for graphics and a method for implementing them.
• Setting permissions on the sections that can be viewed.
• Data Sets
  • Public Domain is easier to source in Data Sets Private space is not preferred, but it is being used for development work.
  • There needs be clarity between the graphics which need good principles and practices, and those under development. Production site and a “sand box”.
  • Other outside interest in what the group his doing.
  • Agree on 3 or 4 examples to show where the group is headed.
  • Include the caveat that this are not finished, and are a primer to contact Mary for more information.

• They are available for use on the site.
• The transport files are having issues.
• The link will not recognize the file type transport.
• There is not a construct in the wiki language for these files.
• Xml files can be read.
  • There are .csv files which are readily accessible.

• Example; if a graphic was found as a part of a presentation.
• The objective is to give credit and not claim plots that the group has found and extended. o
  • Methods of documentation
    • In the public wiki; in the commentary list an audit trail.
    • Over the next month when posting new material, try several ways of documentation. 1st Line where the graphic originally came from, 2nd Line who is currently working on it.
    • Try several methods over the next month and have a further discussion at in a month.

• Choosing the Right Graph flow chart (draft)
• Populating Flow Charts with clinical questions.
• How graphics and glossary entries will fit within the flow charts
• General Graphics Guidance (Slides are attached to this page in a file named *General Principles update on flowcharts layout 31Aug2010 v2.pptx*)

July 2010

• Welcomed Ken Koury as a new member
• Reported on Adobe Connect as an additional tool for teleconferences
• Liping Huang and Andreas Br\xC3ƒ¼ckner volunteered to develop conference abstract and slides. Will post their efforts on ctspedia before the next general meeting.
• Clinical questions document was discussed and uploaded to ctspedia.
• Question discussed; whether plots discussed will be at the patient level. Will profile plots be requested?
  • Examples have been posted on ctspedia
  • Sponsors generally not required to generate these plots.
    • They are generated with in the FDA

• Welcomed Leslie Kenna as a new member.
• Discussed graph types compiled thus far.
  • Whether the QT tool would be of use.
• Bioscience data; postural changes a drug may induce and getting clinical questions such as;
  • ECG data is in order.
  • Vital signs data – are there any unique displays that would not have been found with ECG’s?
  • The quality of QT correction, what are the longitudinal data as summarized as a mean profile over time
  • Categorical assessments o QT tool  Was developed at the FDA
    • The QT team is using this code to make graphics
    • Would like to have more information about what the code does
    • The code does not have sample data set.

• Encourage members to post their bio-sketches
• Fabrice Bancken will work on a glossary
• At the next meeting General Principles will discuss a draft item titled “Choosing the right graph”

• Following the recommendations of John Senior, the Labs and Liver group reviewed the presentations from the Hepatatoxicity Special Interest Group.
• Discussed the topic of drill down and interactive data sets.
• Discussed the need for data sets.
• Discussion of the RUCAM scale (scale to see whether liver damage can be attributed to a specific medication) the link to this has been added to ctspedia.

• Can always be emailed with questions, and has the ability to share desktops to solve problems.
• Nothing can be destroyed on the site. If anything needs to be recovered contact either Mary Banach or Mat Soukup.
• Plug-ins are available and can be added to the wiki
• If users do not have time to load information onto the site, send it to Mary Banach.

• The group has drafted a charter
• The interaction with DIA will cultivate support in the form of teleconferences, meetings, and workshops.
• Matt Soukup and Ken Koury met with Jerald Schindler.
  • Jerald Schindler sees this as its on working group under SIAC
  • There is no need to join the BDMPI or DIA
    • The core members of some of these activities would have to be DIA members.
    • No perceived disadvantage
      • A question was raised about getting a copy of the BDMPI’s charter for review.
      • Once finalized it will be sent to us for the purposes of harmonization.
      • Should ensure affiliation is not only beneficial but that does not change the scope of the working group.

• This has been posted and is being updated.
• Status of the ICSA – Qi Jiang
  • The group has been accepted to an invited session for this conference.
• The abstract for ICSA is on ctspedia and the format is available for the other groups to use.
• Details of accepted abstracts should be added to the status column.

• This will be discussed as at next months meeting.

• Have permission from CDISC to use the data sets in the first pilot of CDISC.
  • This data set will be available in the next few weeks.

• Use the point of contact/organizer for the meeting.

June 2010

• Standard data set from Roche with 1100 de-identified patients
• Clinical questions document under review, update next month
• Graphs discussed (ongoing process started in June),
• LeePing and Andreas will produce slide templates and abstracts.

• Discussed plots(real data set, individual profiles, individual profiles vs. summary plots) that were submitted
• QTC study and the data size
• Simulated data
• Next meeting there will be more clarity of what to share o Liping is gathering plots that describe QT studies.

• Minutes were posted directly to the wiki
• Last meeting Matt had a demo of how to use the wiki
• Discussion about “choosing the correct graph” for users
• Have been updating the General Principles page on the wiki with general principles
• Hyperlinks to preferred/favored graphics can be submitted by all group members there.

• John Senior and Ted Guo attended the Labs and Liver meeting.
• Discussed his groups activities
• John recommended the group review FDA site that houses the Hepatotoxicity Special Interest Group
• Labs and Liver group is reviewing 6 years of presentations and graphics at this site.
• Finalized the clinical questions document
• Beginning to upload graphics into the CTSpedia website
• At the group’s next meeting, they will begin discussing data sets.
• Question: Format for the slides for the ICSA meeting.
• There should be a common format
• It was agreed that the slides are flexible enough that there can be difference within subgroup. Agree upon; template, fonts, and color.

• Feasibility of sharing pediatric ECG and Vitals data
• There have been issues acquiring this data from Duke Clinical;
• The data is not open to everyone. Non-FDA will have to access the information individually and pay a fee.
• This data will be distributed from the wiki openly and we should use simulated data.

• Most subgroups are using the wiki.
• All members should begin submitting input in CTSpedia as opposed to distributing emails and attachments.
• As the website is populated the group will get a better idea of how to structure the site.

• General Principles Team is building a common template.

• Data sets can be uploaded onto the wiki
• The wiki can handle large data sets.

• Conference points of contact will populate the table with the details as they become available.

• It is not certain if the group can have a complete session.
• The groups input may be submitted as a part of one of the statistic sessions

• Discussion of the former PhRMA Biostatistics Data Management Technical Group
  • A former sponsor of this effort does not formally exist any more.
  • The group though has not gone away and is looking for a home under the DIA umbrella.
  • Would provide the advantage of being part of a larger statistical organization.
    • This group is a collection of statisticians with an interest in pharmaceutical applications that have regulatory implications. This is a good fit with DIA.
    • Joining a larger statistical organization prevents misconception of collusion. This is particularly an industry concern
    • More information is needed regarding
      • Limitations
      • Ownership
      • Long term constraints
• How to approach DIA
  • Conference Organizing Organization
  • Professional Organization
    • Example the Virtual Journal Club
      • DIA membership requirement?
      • Before the conversation is taken forward the group needs to be aware of the pros and cons
    • Do we want to keep affiliation with the new Biostatistics Data Management Technical Group?
      • BDMTG will have an association with the DIA
      • Ken Koury will get more of an update and brief the group next month.

• Tabular summary of the conferences will be posted on the Wiki by Mat Soukup where meetings may be identified and speakers can volunteer.
  • Conference points of contact will populate the table with the details as they become available.
• Do we want to keep affiliation with the new Biostatistics Data Management Technical Group. o BDMTG will have an association with the DIA o Ken Koury get more of an update and brief the group next month.

May 2010

• 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.

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

• Register on CTSpedia further instructions will be sent 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 o
• 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 o 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 o 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.

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

1. 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.
2. All members should register on CTSpedia, and then contact Mary Banach (mary.banach@vanderbilt.edu) to receive access to the Statistical Graphics Web.
3. Mary Banach will give a brief introduction on how to use the wiki.
4. 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).
5. Mat will look into how to distribute data sets, and if the wiki can accommodate this effort; and what restrictions exist.
6. Subgroups identify a representative to speak for 20 minutes at ICSA.
7. Subgroups develop a standard slide set for conferences.
8. 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

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

April 2010

March 2010

• 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.

February 2010

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

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

• 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.

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

• 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.

• Subteam Meeting minutes will be forwarded to Bruce Weaver.

January 2010

• 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
      1. How will these data sets be maintained, how will users contribute to this in the future?
         • Frank Harrell will address this in the future.
      2. 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.
      1. Since these graphics may end up on a label, this group is important.
      2. 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.

• 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.

• Bruce Weaver should distribute Graphics from Susan Duke to group members o

• 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.

• 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.

• 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.

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I	Attachment	Action	Size	Date	Who	Comment
pptx	General_Principles_update_on_flowcharts_layout_31Aug2010_v2.pptx	manage	445 K	14 Sep 2010 - 17:54	UnknownUser	These powerpoint slides are a part of the meeting minutes from August 31, 2010