Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making.

The 21st Century Cures Act allows the US Food and Drug Administration to consider real world data (RWD) for new indications or post approval study requirements. However, there is limited guidance as to the relative quality of different RWD types. The ACE-RWD program will compare the quality of EHR clinical data, EHR billing data, and linked healthcare claims data to traditional clinical trial data collection methods. ACE-RWD is being conducted alongside 5-10 ancillary studies, with five sponsors, across multiple therapeutic areas. Each ancillary study will be conducted after or in parallel with its parent clinical study at a minimum of two clinical sites. Although not required, it is anticipated that EHR clinical and EHR billing data will be obtained via EHR-to-eCRF mechanisms that are based on the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard.

Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey.

BACKGROUND: Real-world data (RWD) and real-world evidence (RWE) are playing increasingly important roles in clinical research and health care decision-making. To leverage RWD and generate reliable RWE, data should be well defined and structured in a way that is semantically interoperable and consistent across stakeholders. The adoption of data standards is one of the cornerstones supporting high-quality evidence for the development of clinical medicine and therapeutics. Clinical Data Interchange Standards Consortium (CDISC) data standards are mature, globally recognized, and heavily used by the pharmaceutical industry for regulatory submissions. The CDISC RWD Connect Initiative aims to better understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance needed to more easily implement them. OBJECTIVE: The aim of this study is to understand the barriers to implementing CDISC standards for RWD and to identify the tools and guidance that may be needed to implement CDISC standards more easily for this purpose. METHODS: We conducted a qualitative Delphi survey involving an expert advisory board with multiple key stakeholders, with 3 rounds of input and review. RESULTS: Overall, 66 experts participated in round 1, 56 in round 2, and 49 in round 3 of the Delphi survey. Their inputs were collected and analyzed, culminating in group statements. It was widely agreed that the standardization of RWD is highly necessary, and the primary focus should be on its ability to improve data sharing and the quality of RWE. The priorities for RWD standardization included electronic health records, such as data shared using Health Level 7 Fast Health care Interoperability Resources (FHIR), and the data stemming from observational studies. With different standardization efforts already underway in these areas, a gap analysis should be performed to identify the areas where synergies and efficiencies are possible and then collaborate with stakeholders to create or extend existing mappings between CDISC and other standards, controlled terminologies, and models to represent data originating across different sources. CONCLUSIONS: There are many ongoing data standardization efforts around human health data-related activities, each with different definitions, levels of granularity, and purpose. Among these, CDISC has been successful in standardizing clinical trial-based data for regulation worldwide. However, the complexity of the CDISC standards and the fact that they were developed for different purposes, combined with the lack of awareness and incentives to use a new standard and insufficient training and implementation support, are significant barriers to setting up the use of CDISC standards for RWD. The collection and dissemination of use cases, development of tools and support systems for the RWD community, and collaboration with other standards development organizations are potential steps forward. Using CDISC will help link clinical trial data and RWD and promote innovation in health data science.

Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library.

Introduction: A guiding principle behind the development and deployment of the REDCap data management platform has always included attention to workflow design that allows easy implementation of best practices for clinical and translational researchers. CDISC standards such as CDASH have helped the clinical research community improve the efficiency, actionability, and quality of their clinical trials data, but have had limited uptake among the academic institutions. Objective: To create a scalable methodology to convert CDISC CDASH eCRF instrument metadata into REDCap data dictionaries for the purpose of simplifying adoption and use of CDASH instruments by research teams across the REDCap Consortium. Implementation: We have used our replicable methods to translate metadata from 34 CDASH Foundational eCRFs and 20 CDASH Crohn's Disease eCRFs into REDCap eCRF metadata and have made these instruments available in the REDCap Shared Data Instrument Library for widespread sharing and uptake across the REDCap Consortium. Users can import the standardized eCRFs directly into their REDCap projects for immediate use in clinical trial data collection. Conclusion: Disseminating CDISC standards through the REDCap community will increase the accessibility of these standards for academic medical centers. Having academic clinical researchers using CDISC standards may lead to more research datasets that interoperate with pharmaceutical sponsored trials, and more discoveries from secondary use of clinical research data.