Evolving Clinical Data Strategies and Tactics in Response to Digital Transformation

Area of Science:

• Clinical data management
• Pharmaceutical industry
• Clinical trial operations

Background:

• The increasing volume and variety of clinical data present significant challenges and opportunities for clinical data management organizations.
• Managing diverse data streams is crucial for efficient clinical trial operations.

Purpose of the Study:

• To quantify the impact of expanded data volume, sources, and diversity on clinical trials.
• To understand the challenges and mitigation strategies employed by the industry.

Main Methods:

• An online survey was conducted by Tufts CSDD between October and December 2019.
• Data from 149 individuals involved in clinical trials were analyzed.

Main Results:

• Companies utilize 3-4 different data sources in clinical trials, with some using up to six.
• Average times to database lock have increased by 5 days compared to 2017, potentially due to managing more data sources.
• Key mitigation strategies include formalizing data strategy, investing in analytics tools and technology, and developing data science disciplines.

Conclusions:

• Database lock cycle times are expected to increase without further investment in infrastructure and mitigation techniques.
• Nontraditional data sources are contributing to the growing data complexity.
• Further research is needed on organizations effectively managing these data challenges.