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Institution

Tufts Center for the Study of Drug Development

About: Tufts Center for the Study of Drug Development is a based out in . It is known for research contribution in the topics: Drug development & Clinical trial. The organization has 78 authors who have published 258 publications receiving 16047 citations.


Papers
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Journal ArticleDOI
TL;DR: Study results indicate that firms are using an average of 6 different applications to support each clinical study and that companies are collecting a range of data types including that from case report forms, lab procedures, pharmacokinetics, biomarker, outcomes assessment, mobile health, and social media.
Abstract: The volume and diversity of data collected to support each clinical study has increased dramatically in response to the rising scope and complexity of global drug development programs. The Tufts Center for the Study of Drug Development conducted an online survey of 257 unique global companies-77% drug development sponsors and 23% contract service providers-to assess clinical data management practices and experiences. Study results indicate that companies are using an average of 6 different applications to support each clinical study and that companies are collecting a range of data types including that from case report forms, lab procedures, pharmacokinetics, biomarker, outcomes assessment, mobile health, and social media. Companies report that the primary electronic data capture (EDC) is capturing traditional data types but not many of the newer ones. Respondents report spending an average of 68.3 days to build and release a study database, 8.1 days between the patient visit and when that patient's data are entered into the EDC system, and 36.3 days on average to lock the database following the last patient last visit. Average cycle time durations are longer and more variable than those observed ten years ago. Subgroup differences (eg, by company size and company type) and factors contributing to data management cycle time and experience are discussed.

12 citations

Journal ArticleDOI
TL;DR: The potential economic impact of genomic medicine and the challenges that lie ahead are discussed.
Abstract: Recent years have seen increased use of genomic technologies in a variety of research and clinical settings. Genomic medicine is not a cost-containment measure per se, but is viewed as having the potential to bend the healthcare cost curve. Currently, it is unknown how systematic adoption of genomic medicine in clinical practice will impact healthcare costs. This article discusses the potential economic impact of genomic medicine and the challenges that lie ahead.

11 citations


Authors
Network Information
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Performance
Metrics
No. of papers from the Institution in previous years
YearPapers
20219
20208
201914
201815
201710
201611