Adverse Events Subteam Minutes
4 June 2010
Minutes from the Adverse Events Subgroup Industry-FDA-Academia Safety Graphics Working Group
Meeting Date/Time: June 4, 10 – 11 am EST Attendees: Janelle Charles, Liping Huang, Mat Soukup, Jeff Summers, Stephine Keeton, Andreas Brueckner
Overview: Updates from previous meeting Discuss datasets, clinical questions, and graphs Action items
Minutes:
1. Introductions were made by all in attendance. We welcomed a new member: Andreas Brueckner, a biostatistician from Bayer Pharmaceuticals.
2. Updates from the previous meeting:
From the previous subgroup meeting, Mat, Liping and Qi would check on obtaining datasets that may be used by the group. Mat met with Brenda and Greg regarding the use of the first CDISC pilot data. He mentioned that access to the data by external bodies, i.e., non-CDISC members, can be problematic. However, Mat will try to talk to CDISC during the next week or at the DIA Annual Meeting regarding access to the data. Qi was unable to attend this meeting, but she sent her deliverables via email. She should be able to share the SOLVD datasets with the subgroup if the subgroup would like. She noted that the SOLVD datasets are quite old and are not in the CDISC format. Liping was able to obtain a dataset from Roche for an already marketed product containing 1146 de-identified patient records. The data is composed of two datasets – demographic data and AE data. The dataset is not in CDISC but in a standard data format. The group provided feedback to Liping about additional variables that may be included in the current dataset. Liping will determine whether all the additional variables are available to be included in the dataset. The group was reminded to email Liping with suggestions for additional variables to include in the dataset.
Additional updates were provided by Stephine regarding the Live Meeting. She reported that Adobe Acrobat Connect Professional is a tool to facilitate our graphics teleconferences. She submitted an ERIC ticket to find out more information regarding required software and availability. She will follow-up in the next meeting and provide information about software costs.
From the last general meeting, subgroups were requested to determine representatives to develop template slides and abstracts for upcoming conferences. Liping and Andreas volunteered for these tasks. Other members are welcome to contribute suggestions to Liping and Andreas. Mat suggested that it would be a good idea to add the abstract and slides as they evolve to the Wiki for comments and use by the general body.
The subgroup members were reminded to register to StatGraphics section of CTSpedia. Mat will add Andreas to the registration list. Mat encouraged members to check that they have access to the Wiki and to email Mary Banach or him with any difficulties accessing the Wiki.
3. Discussion of dataset, clinical questions and graphs:
Liping submitted a document of variables included in the Roche dataset for comments from the subgroup members. Suggestions of additional variables to be included are: site number and geographical location, medication start/stop dates, change in dose level, AEs leading to dose interruption. Members were encouraged to review Liping’s document and provide any additional variables needed.
A final draft of the clinical questions document was circulated to the subgroup. Andreas made a suggestion to include two additional questions. He will follow up with these questions within the next week. Liping suggested categorizing clinical questions, for example with headings ‘Frequency of AEs’, ‘Time to Event’, etc. She will make an attempt to create these categories prior to next subgroup meeting.
During the development of the clinical questions, the team was reminded to begin to compiling graphs to include in the final AE subgroup document. Liping submitted a selection of plots that may be helpful to answer some of the safety questions prior to the meeting. Some of these graphs were discussed. The group found that these graphs were very helpful and a good foundation to develop from. The general consensus was that the graphs should include a brief interpretation of the graphics as well as limitations in interpretation. Jeff and Mat suggested that including tables of summary statistics will be helpful to go along with the graphs. The discussion of graphs will be continued at the next subgroup meeting. Members were encouraged to continue submitting graphs corresponding to particular clinical questions including brief interpretations.
4. Action items:
Stephine will follow-up on the Adobe Acrobat Connect Pro. Mat will report on access to CDISC pilot data. Andreas will provide additional questions to Janelle. Liping will create categories for the clinical questions and send these to Janelle. Janelle will forward the updated clinical questions document to the subgroup.