times. This is quite cumbersome and deters some patients from participating in research, and she asked why researchers could not use her monitor data. Another panelist, however, pointed out that manufacturers of such devices do not always “open up their APIs,” in other words, share data. And, I surmised that even if they did, that data would be in a format that is different from a similar device by a different manufacturer and would not readily aggregate. If only they would use CDISC metadata standards and ODM to ensure the audit trail information moves with the data and that the data could readily be aggregated!
The third topic I would like to touch upon in this too brief summary of a 2-day production (see #P4C2014 for a multitude of tweets about other comments and presentations at this meeting) is on the Faster Cures effort to address the consortium model. There was a panel discussion called “Playing Nice in the Sandbox.” Several consortia leaders, including those from IMI and C-Path, and Dr. Buckman- Garner from FDA (who works with public-private partnerships) were on this panel and participated in a subsequent private meeting to discuss how to “play nice.” Many mentioned the importance of [CDISC] standards to their work. Although CDISC fits the definition from FasterCures for a Consortium, CDISC is also a bit unique in that the standards are global and useful across all of these consortia (and there are no other harmonized global research data standards). One big issue seems to be preventing ‘consortia- fatigue’ and redundant efforts that deter those who want to contribute funding to these efforts – especially patients and patient advocacy groups. From the CDISC perspective, this would include discouraging efforts to create new or redundant standards. Our goal within CDISC is to welcome all- comers to develop global, consensus-based standards (or as NIH is now calling these community-based standards). The more comments we have on the standards for therapeutic areas as they are developed, the better the standards will be, and in turn the more they will be used/adopted and the better off patients will be when their precious research data are fully leveraged towards the better understanding of their diseases and the more rapid development of therapies.
In the closing panel, a representative of a melanoma foundation stated “Aggregated data is solving problems.” It is important that patients and their doctors realize the importance of data standards in making this possible. Suggestions on how to best communicate this to patient groups and clinicians are welcome!
By Rebecca Kush, CDISC President and CEO
Strength through Collaboration
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44