Integrated Data Analysis SIG
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The IDA SIG came into being in June 2013 with an announcement of our charter and a call for volunteers to join. After a start-up phase and getting ourselves organized we became fully active at the beginning of 2014. At the moment we have over thirty members representing a wide variety of companies: Amgen, Astellas, Astra Zeneca, Bayer, GSK, Eli Lilly, Mylan, Novartis, Pfizer, Roche, Sanofi, UBC. We also have some academic members.
As stated in our charter, the SIG is focused on the following topic areas: Efficacy, Safety, Network Meta Analysis (NMA) and Data Transparency and we have one or more working groups within each area. We have a monthly TC for the whole SIG and more frequent TCs for the working groups. Our minutes and shared documents are made available to the SIG members using the LillyBox system maintained by Brenda Crowe (Lilly), who is also a leader of one of the Safety working groups. This system greatly aids communication among myself, the working group leaders and members and is to be recommended.
Given the relative young age of the IDA SIG, this article can only report on our plans (which are many) rather on the results we have achieved. As co-leader, with Chrissie Fletcher (Amgen), of the NMA working group, let me begin by reporting on the current plans for this group. After much discussion and consideration we have decided to write two papers. One on the “quality of reporting of NMA in the (non-statistical) literature” and the other on the “use and benefits of including individual patient data in an NMA”. A literature search and review is currently underway and we plan to begin work on the contents of our papers in the coming months. I know the inclusion of individual patient data in an NMA is a topic that is being, or has been, considered by other groups, e.g., as part of the Get Real project, but we plan to look at this subject from an industry perspective. As with all of the working groups in the IDA SIG, we welcome new members who have expertise in the topics we plan to research, especially those related to those of the two papers we plan to write. I am also pleased to point out that the NMA activities are being done jointly in collaboration with the EFSPI/PSI HTA SIG led by Chrissie Fletcher (Amgen).
The Safety topic is a large one and to reflect this we have three working groups. One is on the topic of “the advantages and use of individual patient data in meta analysis of safety data”, and is led by David Ohlssen (Novartis) and Sally Hollis (Astra Zeneca). Part of the motivation for this topic comes from the FDA panel meeting that was held last year to discuss the development of a possible FDA guidance for Meta Analysis. The second is on “safety labelling” and is led by Brenda Crowe (Lilly). The work of this group is quite advanced and a draft manuscript is close to completion. The third is led by Andrew Bate (Pfizer) and is working on the “integration of data in networks of observational databases (for active safety surveillance)”. This topic is one that needs much more involvement from mainstream pharmaceutical statisticians, as much of the principles of randomized controlled trials are directly applicable. All three groups have plans to write papers on their chosen topics. I expect that some the activities of these three working groups will have some overlap with the EFSPI Benefit Risk SIG and we hope in future to develop a strong relationship with that SIG.
Efficacy is also a large topic and this working group, led by Georgina Bermann (Novartis), is looking at how data integration over the different phases of drug development can improve decision making and what might be useful tools to aid this. The group also plans to develop generic case studies to evaluate these tools. We would welcome examples from a range of companies to help develop the case studies.
The work of the IDA Data Transparency group has now been realigned to support the more recently formed EFSPI/PSI Data Transparency SIG and so we have not set objectives for this working group.
As already noted, the topics covered by the IDA SIG will also be of interest to other EFSPI SIGS and we hope that more joint activities, like the one with the HTA SIG, will take place in the future.
For further information, or to join one of the IDA SIG working groups, please contact Byron Jones at firstname.lastname@example.org.
Byron Jones (Novartis)
Chair of the EFSPI IDA SIG.