RESUMO
BACKGROUND: The Tufts Center for the Study of Drug Development (Tufts CSDD) collaborated with the Clinical Data Interchange Standards Consortium (CDISC) on a joint working group study with 10 participating companies including biopharmaceutical, CROs, and eClinical technology vendors. The objective of the study was to examine current and projected use of eClinical technology and standards across respondent organizations and in clinical studies and to gather perceptions and attitudes about technology and standards adoption. METHODS: The Tufts CSDD study examined the use of eClinical technology and CDISC standards through a comprehensive survey combined with analyses of clinical study data among biopharmaceutical companies and contract research organizations. RESULTS: The results suggest increasing use of specific eClinical technology solutions and standards. The barriers to adoption of eClinical trial tools are addressed as well as the benefits of standards adoption. Differences between respondent perceptions and actual study data are examined, and the survey results are compared with those from prior studies. CONCLUSIONS: The results of the study indicate that increasing use of standards could translate into improvements in time, costs, and overall approval rates. The study also observed an uptake in the use of eClinical technologies that could potentially create efficiencies and streamline operational processes.
