EDC/eCRFs and CDISC standards have offered numerous benefits to the Clinical Research industry in the past decade. The Clinical Data Interchange Standards Consortium (CDISC) finally made global, platform-independent data standards available to the industry, providing invaluable time gain throughout the acquisition, exchange, submission and archive of clinical research data and metadata. EDC/eCRF are now a widely accepted alternative for paper trials, and have numerous advantages such as immediate access to both trial data and trial status reports via the web, improved data quality by auto-queries that are fired by the EDC system as soon as data is entered, full control over the time point that trial changes are activated within an adaptive trial design, and so on.
That’s the current state of the industry; but the future is already here: PDUFA V, ‘accelerated study startup’, and ‘mid-study changes’ are just a few of today’s buzzwords.
PDUFA V enhancements include a phased-in requirement for standardized, fully electronic submissions during PDUFA V for all marketing and investigational applications
The FDA Study Data Standards Catalog currently documents support of CDISC standards; which means that the FDA components listed in the catalog has established processes and technology infrastructure to support the receipt, processing, review, and archive of study data using these standards. However, submission of study data using any other (proprietary) standard can still be discussed with the Agency.
|Version|| I.G.|| FDA Component|| Date Support Begins*|
||CBER, CDER, CDRH
||2009 - 10 -30 |
||CBER, CDER, CDRH
||CBER, CDER, CDRH
With PDUFA V, FDA is planning for standardized, fully electronic submissions in 2017. As a result, legacy data conversions towards the supported data standards will become indispensable.
While converting legacy data, it is important to maintain traceability of the results presented in the Clinical Study Report to the original data elements as they were collected in the case report form and represented in the SDTM and ADaM datasets. The SGS conversion engine can read and process a source-target mapping table which is key to guaranteeing 100% consistency between Extract Transform Load (ETL) code transforming legacy datasets and the traceability information provided in reviewer guides.
PDUFA V enhancements include an initiative to improve FDA’s clinical and statistical capacity to address submissions involving Patient-Reported Outcomes (PROs) and other endpoint assessment tools
As part of the FDA's patient-focused drug development initiative, Patient-Reported Outcomes (PROs) are getting increased attention. The aim is to allow for greater understanding of challenges that arise during development of outcomes assessment tools, potential strategies to overcome these challenges, and greater consistency in FDA’s approach to review, qualification, and usage of these tools in the drug development process.
Set-up and qualification of ePROs followed by distribution of the devices can be cumbersome and on the critical path when facing accelerated study start-up timelines. SGS can provide an integrated eCRF and ePRO web environment: set-up and roll-out of eCRF and ePROs are hardly any different. Patients have limited access to the eCRF/ePRO environment allowing them to complete their ePROs via the web using a home computer, tablet or smart phone. Although not possible with all patient populations, integrated eCRF and ePRO web environments - without a need for customized devices being shipped - are often the answer to a cost-effective solution when planning to collect Patient-Reported Outcomes.
Full SGS in-house EDC study-build which, depending on study complexity and re-usability of library eCRF forms, takes an average of five to eight weeks, through use of extensive eCRF libraries and a large UAT pool
SGS is both a Platinum member and a CDISC Advisory Board member. Additionally, SGS is a CDISC Registered Solution Provider for SDTM, ADaM and define.xml; and provides an authorized CDISC ADaM trainer. The SGS team has converted legacy data into SDTM for more than 230 trials on behalf of multiple clients.
The SGS EDC team has extensive experience in setting up eCRF applications for three major EDC systems: InFormTM (Oracle), Rave® (Medidata) and eClinicalOS (Merge). The eCRF designers understand how to translate client’s clinical data requirements into a well designed eCRF with associated completion guidelines and edit checks because they understand our clients’ language and needs from a clinical trial perspective.
SGS has spent time building up experience and efficiencies through developing extensive eCRF libraries and a large pool of testers for performing User Acceptance Testing. These processes allow SGS to meet competitive timelines for EDC set-up and system integrations.
Lastly, adaptive trial design is a specialty of the certified SGS EDC experts who can evaluate mid-study changes and implement them in the most efficient way, guaranteeing both continuous availability of the EDC trial and data consistency.
Fifth authorization of the Prescription Drug User Fee Act (PDUFA V) – explained:
Prior to enactment of PDUFA in 1992, FDA's review process was understaffed, unpredictable, and slow. FDA lacked sufficient staff to perform timely reviews, or develop procedures and standards to make the process more rigorous, consistent, and predictable. Access to new medicines for U.S. patients lagged behind other countries. As a result of concerns expressed by both industry and patients, Congress enacted PDUFA, which provided the added funds through user fees that enabled FDA to hire additional reviewers and support staff and upgrade its information technology systems. At the same time, FDA committed to complete reviews in a predictable time frame. These changes revolutionized the drug approval process in the United States and enabled FDA to speed the application review process for new drugs, without compromising the Agency’s high standards for demonstration of safety, efficacy, and quality of new drugs prior to approval.
PDUFA V ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2013-2017 that will allow the agency to fulfil its mission to protect and promote public health by helping to bring to market critical new medicines for patients.
Joris De Bondt
Head EDC and Data Standards - Clinical Research
SGS Life Science Services