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April 25, 2001

Safety Reporting in Clinical Trials—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor


Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001

JAMA. 2001;285(16):2076-2078. doi:10.1001/jama.285.16.2076

In Reply: We agree with Drs Calis and Daniels, Drs Colebunders and colleagues, and Drs Kohl and Bonhoeffer on their complementary insights into safety reporting. Active surveillance for adverse reactions using rigorous, standardized questionnaires and other assessment instruments may yield more trustworthy information than passive surveillance using nonstandardized means. Colebunders et al refer, in particular, to research on HIV infection. This was the pilot field1 in our study and we fully agree that significant adverse effects often may be overlooked unless patients are systematically questioned about specific symptoms and signs and unless comprehensive long-term follow-up data are obtained. Long-term evidence about safety is important and we strongly favor long-term systematic approaches; not only for HIV-related therapies, but also for any other therapeutic and preventive measures. Immunizations are clearly an important field where latent and long-term adverse effects may be difficult to decipher. Initiatives such as The Brighton Collaboration are, therefore, most welcome. Similar efforts to systematize information about adverse effects should be developed in other fields.

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