Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation

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.