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An Examination of eClinical Technology Usage and CDISC Standards Adoption
Mary Jo Lamberti1, Rebecca Kush2, Wayne Kubick2
11 Tufts Center for the Study of Drug Development (CSDD), Boston, MA, USA.
Therapeutic Innovation & Regulatory Science
|September 18, 2018
Summary
Increased adoption of electronic clinical (eClinical) technology and standards by pharmaceutical companies and contract research organizations (CROs) can improve trial efficiency and approval rates.
Area of Science:
- Clinical research operations
- Drug development processes
- Regulatory compliance
Background:
- Collaboration between Tufts Center for the Study of Drug Development (Tufts CSDD) and Clinical Data Interchange Standards Consortium (CDISC).
- Study involved 10 companies: biopharmaceutical, CROs, and eClinical technology vendors.
- Focus on current and projected use of eClinical technology and standards.
Purpose of the Study:
- Examine eClinical technology and CDISC standards adoption.
- Assess perceptions and attitudes towards technology and standards.
- Identify barriers and benefits of adoption.
Main Methods:
- Comprehensive survey of biopharmaceutical companies and CROs.
- Analysis of clinical study data.
- Comparison of survey results with prior studies.
Main Results:
- Increasing use of specific eClinical technologies and standards observed.
- Barriers and benefits of eClinical trial tools and standards adoption identified.
- Differences between perceived and actual study data examined.
Conclusions:
- Wider adoption of standards can improve trial time, costs, and approval rates.
- Uptake of eClinical technologies may streamline operational processes and create efficiencies.
- Potential for enhanced drug development through technology and standards integration.
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