Pharmaceutical companies are focused on implementing CDISC data standards1 to ensure compliance with FDA mandates that go into effect December 2016, and state clinical trial data should be compiled and submitted in forms that are accurate, reliable and reproducible.
Most executives agree that data standards will deliver commercial and operational benefits, allowing more efficient sharing of clinical information among pharmaceutical, bioscience and medical device companies; clinical services organizations; and technology developers—all of which will speed time to market of new products.
Despite these benefits, standards adoption has been fragmented and slow. Spurred by the FDA deadline and actions by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA), companies face a ticking clock to address barriers and expedite adoption of data standardization.
It was this reality that led Accenture to undertake a survey of executives at life sciences organizations on behalf of CDISC (Clinical Data Interchange Standards Consortium) to assess various dimensions of data standards implementation. The survey explored:
Industry impact of CDISC standards, including benefits and barriers.
The challenges of metadata management generally, including governance and infrastructure.
The utility of a data standards maturity model, and how it could spur faster, higher rates of adoption of data standards.
The survey of 77 executives in the United States and Europe was conducted in late 2014 and early 2015. Respondents represented pharmaceutical, biotech and medical device manufacturers, as well as academic medical centers and clinical research organizations. The survey findings clearly reveal that companies are at different stages in their data standardization journey.
Findings and recommendations
Many, if not most, companies struggle with some combination of issues related to data capability, metadata management and governance dimensions. The questions for many organizations are: How can I make progress toward data standardization given the scarcity of resources and experience, and—once data standardization efforts are in flight—how can I ensure that the potential benefits are captured?
To help companies resolve these issues, Accenture developed a Clinical Data Standards Capability Maturity Model. Using the model as a guide, companies can take a methodical approach to moving through five distinct levels of maturity in each dimension. This is a journey that can be expedited by targeted assistance from third-party providers. Ultimately, companies that reach level 4 or 5 will reap the most business benefits from data standardization, as well as ensure regulatory compliance.
1The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and free