Professional Developments in Clinical Data Management: The Changing Role of the Data Manager

Transcription

1 Professional Developments in Clinical Data Management: The Changing Role of the Data Manager Margarete Rudloff, DVMD Representative in the INCDMA 18 Nov 2009 The Evolution of Clinical Data Management 1

2 Overview INCDMA Whoweare Trends in technological developments Innovations and improving standards CDM interaction with monitoring Role of the Data Manager in the Future Conclusion 18 Nov 2009 The Evolution of Clinical Data Management 2

3 INCDMA The International Network of Clinical Data Management Associations Initiated by the UK based Association for Clinical Data Management (ACDM) and the French Data Management Biomedical (DMB) in Representatives of associations in other countries were idendified, and an informal network of contacts and quarterly teleconferences was initiated. 18 Nov 2009 The Evolution of Clinical Data Management 3

4 INCDMA - Members Associations included in the Network: ACDM, Association for Clinical Data Management, UK AHRDMA, Australasian Health and Research Data Managers Association, Australia ARCS, The Association of Regulatory and Clinical Scientists to the Australian Pharmaceutical Industry, Australia DADM, Danish Association of Data Managers, Denmark DMB, Data Management Biomedical, France DVMD, Deutscher Verband Medizinischer Dokumentare e.v., Germany PSDM, Pharmaceutische Statistiek en Data Management, The Netherlands SCDM, Society for Clinical Data Management, USA Finish Association of Data Managers, Finland Representatives: Nordic countries, Japan, Italy, Switzerland, Israel, Spain 18 Nov 2009 The Evolution of Clinical Data Management 4

5 INCDMA - Goals Develop an inventory of documentation available amongst its members, which will include both procedural and operational documentation Collaborate with DIA CDM and eclinical SIACs representatives to coordinate arrangements at conferences and involvement of INCDMA in program committees for CDM related workshops Collaborate with different organisations to generate webinars, tutorials or courses for all the countries participating in INCDMA Analyse the future role of the Data Manager. Define and identify additional and changing skill sets, requirements and training needs 18 Nov 2009 The Evolution of Clinical Data Management 5

6 Trends in technology and developments Past Double data entry, local lab, multi page diaries Current EDC systems, central lab, epro Future EHR (Electronic Health Records), more third party data (ECG, images etc.), data standards 18 Nov 2009 The Evolution of Clinical Data Management 6

7 Innovations and improving standards Evolution of CDISC, CDASH standards Data integrity Flexibility for adaptive designs Data protection IT system validation Data warehousing Regulatory Requirements 18 Nov 2009 The Evolution of Clinical Data Management 7

8 CDM interaction with monitoring CRAs and Data Managers work in the same system when using EDC More and more tasks can be performed remotely Integrated systems: EHR, IVRS, EDC, CTMS No SDV for data out of computerized systems More remote monitoring reduces costs 18 Nov 2009 The Evolution of Clinical Data Management 8

9 Feedback from a Panel session on Future of CDM Questions from the audience were: Is e-clinical guiding CDM in a bright future? Other industries dealing with large amount of data have standards, is CDM behind? Do you think CDM should be closer to sites in the future? Is there any interest to split functions (more fragmentation)? Is there a significant difference between CROs CDM and Sponsor CDM? 18 Nov 2009 The Evolution of Clinical Data Management 9

10 Role of Data Managers in the Future At the beginning there was paper Staff experience and background more administrative / clericial in nature Training needs were related to paper data entry, query writing, data validation activities Only some needs for key positions to have scientific background (e.g. coding, AE/con med evaluation) Data management evolution Data managers require more in depth technical knowledge Need expertise in data standards, IT system validation, regulatory requirements Outsourcing partnership requires relationship management skills 18 Nov 2009 The Evolution of Clinical Data Management 10

11 Results of a survey on CDM needs (ACDM) Updates on Technology Best Practices Laws & regulatory updates Learn skills related to complex, multicultural trial management Requirements on outsourcing & offshoring Increase therapeutic knowledge Update on trial designs: Bayesian and Adaptive Design Cost effective solutions 18 Nov 2009 The Evolution of Clinical Data Management 11

12 Options available for training and certification Companies need to enhance their training programmes for Data Managers External training courses available from outside organizations (ie. CDISC, DIA, ACDM, SCDM, others) ACDM college week, UK Data Manager Certification SCDM, US CDM Degree Programmes DMB, France 18 Nov 2009 The Evolution of Clinical Data Management 12

13 Conclusion CDM moves away from paper and query management tasks CDM plays an important role in R&D, using computerized systems reduces costs and timelines CDM is an innovative discipline and the role of the DM is evolving 18 Nov 2009 The Evolution of Clinical Data Management 13

14 Thank you! Contact: Margarete Rudloff Director, Clinical Data Management EU/AP Kendle 18 Nov 2009 The Evolution of Clinical Data Management 14