Moving into the Future: A New Way to Collect and Manage ACTG and IMPAACT Data

Transcription

1 Moving into the Future: A New Way to Collect and Manage ACTG and IMPAACT Data Marlene Cooper, M.S. Director, ACTG/IMPAACT Data Management Center June 2015

2 Introduction The SDMC is beginning a long term project to implement a commercial web-based data collection and management system Typically called a Clinical Trials Data Management System, or CTDMS We will use Medidata Rave

3 Introduction We will continue to use parts of the current SDMC system, including Randomization LDMS A central database that will hold all historical data of the ACTG and IMPAACT

4 Rationale for a New System FSTRF and SDMC staff developed and have maintained a FSTRF CTDMS over a long period of time The system is validated, stable and generally meets the needs of the ACTG and IMPAACT networks However: Computing software technology is rapidly changing and further impacting medical research and care (e.g. EMR) The SDMC does not have the resources to keep the FSTRF CTDMS system current into the future

5 Rationale for a New System Some software companies have built CTDMS systems that are both capable and have large customer bases, providing them with the resources needed to keep up We wanted to implement such a CTDMS, while the current FSTRF system is still viable, in order to meet the needs of the networks well into the future

6 Selection of a Commercial CTDMS There are a number of systems with comparable capabilities The SDMC selected Rave because The system has a large installed base FSTRF has experience with it in other projects The vendor has developed considerable experience working with NIH-sponsored clinical trials networks (NCI, for example) and the NCI of Canada

7 Selection of a Commercial CTDMS Issues regarding Rave (and most CTDMSs): Available only as a cloud application. Sites with less-thanideal Internet may face challenges. Rave is study-oriented. It is difficult to look at information across studies, such as a site-wide accrual report. (We may have a partial solution) It is not ours. The SDMC will not be able to customize the software for special needs.

8 Selection of a Commercial CTDMS Some of the positive aspects, in addition to Medidata s resources to support and develop Rave: It s web-based. Any computer can be used as long as it is connected to the Internet and data is entered into the database in real-time. It s compact. Facilities such as query and data error resolution are integrated with the data entry screens and sites will have to do less coding than they do now. Reports are easy to access. Some reporting facilities are built in. Monitoring is built in. Site monitors can use it and interact with the sites through it.

9 Overall Approach Beginning next year, Rave will be used for clinical data collection and data management for all new studies Traditional CRFs will not be produced for these studies Most studies currently in progress will continue to use the FSTRF CTDMS system just as they do now Several current studies that will continue long-term will be migrated to Rave We will continue to use the same CRFs for them However, some changes might be necessary so they can be used with Rave (we will minimize the changes)

10 Overall Approach What this means: For the next several years, most sites will have to use both the FSTRF CTDMS and Rave to enter, QC and manage their data The extent to which that is true will depend on the mix of current and new studies in which a site is participating

11 Registration/Randomization The current registration/randomization system will continue to be the single study entry point for all studies Registrations will immediately be put into the FSTRF CTDMS or into Rave, depending on how the study is managed

12 LDMS Laboratories will continue to use the LDMS A Web version supporting ACTG/IMPAACT processing lab functions was released in May 2015 Labs on the Windows platform will be given the opportunity to convert to the Web version Data from LDMS will continue to be stored in the central database

13 Other Data Acquisition Other data submission systems (for electronic result files and sequencing data) will continue to be used as they are now Data from these systems will continue to be stored in the central database

14 Central Database Since 1990, the SDMC have maintained a central database for all ACTG and IMPAACT studies This database includes all registration/randomization, clinical, laboratory and ancillary data collected for these studies This will continue into the future. For studies managed in Rave, clinical data collected in Rave will be copied to the central database

15 Clinical Data Interchange Standards Consortium (CDISC) CDISC is an organization that has established standards for the acquisition, exchange, submission and archive of clinical research data and metadata CDISC compatibility was mandated by DAIDS in the last recompetition Per the FDA, any regulatory study that starts after 12/16/2016 will be required to be submitted using CDISC standards

16 CDISC/CTDMS Implementation The SDMC has been actively working on CDISC compatibility with a DAIDS CDISC consultant and supplemental funding has been provided by DAIDS for this effort The SDMC will begin to implement CDISC standards for data collection in new studies put into Rave Data collection screens will adhere to CDISC s CDASH standards Data entry screens will be organized differently as compared to the current system

17 CDASH What is CDASH? Clinical Data Acquisition Standards Harmonization Specifies sets of basic recommended data collection fields with prespecified field names and definitions Uses controlled terminology Initial studies: A5350 and its substudy A5352S

18 Education and Training SDMC staff are now undergoing extensive training in Rave and CDISC Education and training is planned for site staff and other Network members and collaborators Input will be sought from Network members

19 Network Education and Training DMC Newsline article released in May Sessions at network meetings DMC Demo Room Dedicated table with demonstration version and opportunity for Q&A Q&A and startup conference calls

20 Network Input Input from visitors to DMC Demo Room and DMC Medidata Rave table Consultation with focus group of site staff Collaboration with Data Management Committee to work on CDASH implementation

21 Site Training Web-based training provided by Medidata is an integral part of their system Training modules can be configured so that site staff are required to take and pass them before they are enabled to do work in Rave The DMC will incorporate Rave into our various site training curriculums

22 Impact on Sites For a period of 2-3 years (depending on the studies at a particular site), site staff will have to work in both the FSTRF and Medidata systems for Data entry Error resolution Query responses Delinquency resolutions Site staff may have to obtain cross-study reports from the DMC eportal (as they do now)

23 Impact on Sites The data collection paradigm will change for new studies implemented in Rave Paper CRFs will no longer be produced by FSTRF Worksheets or data collection notebooks, printed at sites, may replace them Data entry screens will be organized quite differently, with a greater emphasis on log-style forms and less coding

24 Impact on the Network Committees involved in site data management operations will face more demands on their time over the next year and a half Study teams will have to develop some sense of CDISC and become familiar with new data collection concepts

25 Impact on DAIDS Contractors Medidata provides support for site monitors PPD monitors are familiar with the system The DMC will work closely with the monitoring groups to configure and activate the monitoring features DAIDS-ES will continue to receive data from the DMC as it does now

26 Safety Data Another item the SDMC will be addressing during this transition is safety data collection Safety data collection in Rave will be re-designed using the CDISC model as a guide Harmonize data collection across ACTG and IMPAACT

27 FSTRF Software Implications In order to conserve programming resources, the SDMC will freeze most software in the FSTRF system in its current state. Exceptions: Bug fixes Registration/randomization system Software used to collect laboratory data from non-clinical sources

28 Implementation Progress FSTRF signed the Medidata contract on April 1, 2015 Several SDMC Medidata working groups created with specific focus areas Initial CDISC and Medidata training has been completed or is in progress

29 Timeline SDMC committed to implementing three studies in grant year 9 (through November 2015) Eight additional studies to be implemented in grant year 10 starting December 2015, including PHOENIX In grant year 10, reach steady state such that all new studies are implemented in Rave All long term studies that will continue past 2017 will be migration candidates

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