Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation
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ORIGINAL RESEARCH
Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation Beth Harper, BSOT, MBA1 · Michael Wilkinson, MPH2 · Raj Indupuri, MBA3 · Sheila Rocchio, MBA3 · Ken Getz, MBA2 Received: 30 April 2020 / Accepted: 24 August 2020 © The Drug Information Association, Inc 2020
Abstract Background Contending with a continuously expanding volume and variety of clinical data poses challenges and opportunities for the industry and clinical data management organizations. Methods Tufts CSDD conducted an online survey aimed at further quantifying and understanding the magnitude and impact that expanded data volume, sources and diversity are having on clinical trials. The survey was distributed between October and December 2019. Responses from a total of 149 individuals were included in the final analysis. Results The survey found that companies use or pilot from one to six different data sources with the majority of respondents using or piloting 3–4 different sources of data in their clinical trials. The results showed that average times to database lock have increased an average 5 days compared to a 2017 study, possibly as a result of managing an even larger number of data sources. Finally, three key mitigation strategies surfaced as techniques respondents used to tackle expanding data volume, sources, and diversity: the creation of a formalized data strategy, investment in new analytics tools and more sophisticated data technology infrastructures, and the development of new data science disciplines. Conclusion Without further investments into infrastructure and developments of additional mitigation techniques in this area, database lock cycle times are likely to continue to increase as more and more data supporting a clinical trial are coming from nontraditional, CRF sources. Further research must be done into organizations who are handling these challenges appropriately. Keywords Clinical data · Clinical technology · Clinical data management · Data strategy · Data governance · Data science
Background and Introduction Volume, velocity, and variety, often referred to as the three V’s of big data, are well known concepts in the world of consumer data management [1]. From the millions of Facebook posts, Instagram images, or tweets that social media companies manage to the wide variety of apps and connected devices that generate millions of data points, we rarely give any thought to how these organizations ingest, process, file, and retrieve the incomprehensible amounts of data that are generated at faster rates each day. * Michael Wilkinson [email protected] 1
Clinical Performance Partners, Atlanta, GA, USA
2
Tufts CSDD, 75 Kneeland Street‑ Floor 11, Boston, MA, USA
3
eClinical Solutions, Mansfield, MA, USA
While the volume of clinical trial data may not compete with the scale of volume that Facebook manages, it has nonetheless grown 183% over the last decade [2]. Across nine different types of e-clinical trial data, the majority of companies surveyed in a 2
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