Document Detail


Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.
MedLine Citation:
PMID:  25419504     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.
Authors:
Judith M Kramer; David Vock; Howard E Greenberg; Cheri Janning; Lynda Szczech; Miklos Salgo; Suzanne Gagnon; Susan Ellenberg
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Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Therapeutic innovation & regulatory science     Volume:  48     ISSN:  2168-4790     ISO Abbreviation:  Ther Innov Regul Sci     Publication Date:  2014 Jul 
Date Detail:
Created Date:  2014-11-24     Completed Date:  -     Revised Date:  2014-11-25    
Medline Journal Info:
Nlm Unique ID:  101597411     Medline TA:  Ther Innov Regul Sci     Country:  -    
Other Details:
Languages:  ENG     Pagination:  413-419     Citation Subset:  -    
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