regulatory agencies. These include CDASH, Protocol Representation Model, Lab, SDTM, ADaM and ODM.
Medical Devices The medical devices presentation was a case study from Janice Englund in collaboration with Olesya Masucci from Theorem Clinical Research. They received the data and CRFs from a medical device study for conversion into SDTM and received little guidance from the sponsor. Englund and Masucci found that the CDISC SDTMIG for Medical Devices made some variables easy to map, but others were more challenging, and there were many opportunities for improvement in the Implementation Guide. That said, most of the device-related information could be represented using the standard.
The study that was being converted involved comparing the efficacy of standard of care alone to standard of care plus the device therapy. Three CRFs were presented, and while the second and third CRFs were fairly straightforward examples of the Device-in-Use SDTM domain, the first CRF was a conglomeration of variables from device and non-device domains. In addition, the data were being mapped directly to SDTM without first being mapped to CDASH, thereby bypassing some of the CDASH design elements that make annotating CRFs easier.
The mapping experience resulted in a list of issues and comments that will be very helpful in improving the SDTM Medical Device standards. As suggested above, mapping without sponsor participation was very challenging. Using CRFs that were not CDASH-conformant required making many guesses about mapping, and putting many variables into supplemental qualifier and Findings About domains, which reduced the usability of the data. The study design complicated the matter further as subjects in the standard of care-only treatment arm did not use the device and were not exposed to the treatment agent, and thus did not appear in any of the device domains nor the EX exposure domain.
In the observation of the author (Howard), however, the most important point was that it is simply not possible to map device study data using only the Device Implementation Guide. It absolutely must be used with the SDTM Implementation Guide for Human Clinical Trials, as the basic rules about SDTM implementation are not duplicated in the Medical Device IG. With an understanding of the basic rules, many of the mapping problems were resolved.
Additional Observations While medical device research has historically been a very small part of the therapeutics market, and has received proportionately less attention from industry and the regulators, this has begun to change in recent years. Among events that may be influencing this are:
Strength through Collaboration
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