Session 9 focused on TA implementation experiences to gain greater insight into the implementation of TA standards and whether these standards will help patients in the long term. This session began with a presentation by Enrique Avilès of C-Path who spoke on the “Application of TA Standards to Develop a new Clinical Outcome Assessment Instrument for Multiple Sclerosis”. (See also the article on Partnering for Cures in this newsletter.) The purpose of the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) initiative is to promote re-use of data and to develop a new clinical outcome assessment instrument and support its adoption. The MSOAC consortium is comprised of ten pharmaceutical companies, Patient Advocacy Groups, thirty academic organizations, as well as regulators and government funding organizations (see this link for more information). The project takes clinical trial data contributed by MSOAC member organizations and restructures it into CDISC SDTM data sets to build an integrated database to support research. Enrique’s message was that “in this era of big data we must put data to work over and over again, and we need to consider three key points: 1) “TA standards are not stand-alone, they are extensions and enhancement to SDTM and other foundational CDISC standards; 2) make things better; and 3) it is not about incremental savings, it is about being able to achieve something that a single organization cannot do without massive investment. Collaboration is key in this initiative”.
Enrique’s presentation was followed by Kevin Lee of Accenture who presented on “Implementation of CDISC TA Standards: Oncology” and provided a well-received overview on cancer epidemiology, the number of regulatory applications per year, what is collected and how data is mapped to the SDTM. Susan Zhao of Medivation presented on “Building Efficacy Analysis Datasets by Implementing ADaM; An Oncology Phase III Case Study.” Her presentation focused on implementing ADaM Basic Data Structure in Oncology studies. Topics included the role of ADaM and how ADaM Basic Data Structure (BDS) provides the tools needed to generate analysis. Speaker observations included the idea that ADaM bridges data and results. It also assists with the summarization and supporting reports for both the submission and post-marketing reporting obligations. The conclusion was that using ADaM BDS is clear, easy, accurate and efficient. And finally, Jacintha Eben, SGS Life Science Services, presented on “Implementation of Oncology-specific SDTM Domains.” The focus of this presentation was on the practical implementation of existing oncology-specific SDTM domains (TR, TU, RS). The presentation conclusion focused on the importance of eCRF-build, and explained how the data are related to and with each other.
Session 11 “Embracing Change for Patients” focused on the CFAST program, status at year two and lessons learned to date, how FDA is engaged in the program and some of the innovative approaches used in developing TA standards. Dr. Ron Fitzmartin (FDA) spoke about FDA activities around gathering requirements from medical reviewers and providing that information to CFAST teams in early stages of
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