E-DRUG: Full Drug Trial Disclosure (3)
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Dear E-Druggers:
Dr. Offerhaus comments about the problems of journals having the
space or desire to publish all studies done in the development of a drug.
The problem of this data being made publicly available can be
addressed by breaking it down into smaller parts. The biggest part is
getting the sponsors and/or the investigators to write up and submit the
data to a publication. If the work is written in abstract form for a
professional society meeting, the abstract is published in the society's
journal. Some societies may even permit abstracts to be submitted for
publication only and not for presentation. Many of these abstract issues
carry an index of abstracts by subject so these abstracts are retrievable.
Often, these indices are available in digital form. Then, all that is
needed is one public data base in which these indices are collected and the
titles collated by subject. This should be well within the resources of
many public bodies at this time. If such a data base is set up, the
societies can be requested to forward their indices to the data base. If
the digital storage facility is large enough, the full abstracts could be
added as part of the data base for retrieval.
A system such as this, with its faults and deficiencies, would be
better than the present state of nothing. It would make the existence of a
study and some information about it public. It would complement a registry
of initiated studies. Writing only an abstract is a small enough burden for
any investigator to bear even if the study is "boring" and "of low
scientific value" since to know that the study is of low value, its results
must have been analyzed and a report, more or less formal, prepared.
The key problem is getting the work written up and submitted. This
proposal may make it easier to get all clinical trial results made public
since the writing part is easy. But whether the sponsor will want the
results made public is a much bigger issue that should be addressed by
ethics committees, institutional review boards, and professional
organizations.
regards
Marcus M. Reidenberg, MD, FACP
Professor of Pharmacology, Medicine, and Public Health
Head, Division of Clinical Pharmacology
Weill Medical College of Cornell University
Attending Physician, New York Presbyterian Hospital
Editor Emeritus, Clinical Pharmacology and Therapeutics
1300 York Ave., Box 70
New York, NY 10021
e-mail mmreid@med.cornell.edu
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