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Responses
Author(s) -
Canner Paul L.
Publication year - 1979
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1979255part2657
Subject(s) - wish , task (project management) , term (time) , closing (real estate) , medicine , adverse effect , mechanism (biology) , psychology , epistemology , law , political science , sociology , philosophy , pharmacology , physics , management , quantum mechanics , anthropology , economics
Dr. Klimt and Dr. Stamler both made brief mention of the fact that in closing out a study we may wish to consider setting up a mechanism for long‐term follow‐up of the patients to determine cause of death or more rarely for certain nonfatal end points beyond the end of the study proper. I would like to expand briefly on these comments and pose two questions. First, under what circumstances is such long‐term follow‐up warranted? And second, what means are available for accomplishing this task? With regard to the first question, we can all think of a number of reasons why it might be desirable to carry out such a long‐term follow‐up program, particularly if a study terminates with a conclusion that one or more of the treatment regimens are both effective and safe. One would like to be able to determine whether the beneficial effects of the treatments continue to hold up over the next 5 or 10 years and whether there are any latent carcinogenic or other adverse effects of the treatment. It does not seem quite so clear whether such long‐term follow‐up is warranted for treatments found by the trial to be ineffective and/or unsafe. A case might be made for follow‐up for latent carcinogenic effects even in instances such as this. I would be interested in any comments that the participants or anyone in the audience may have concerning this issue.