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I find it hard to pity Dr. Belcher's situation as the PI in an
industry-sponsored study. Satisfying both EU and US regulatory
requirements is cumbersome, but the potential benefits of cross-Atlantic
drug approval are tremendous. Furthermore, low-risk trials, such as the
questionnaire-and-interview research I am currently conducting, require
similar amounts of paperwork and time, but lack the per-patient income to
the PI and the benefit to the sponsor of a new drug approval.
Nurses and clinical research assistants are accustomed to mountains
of paperwork as a part of conducting and coordinating research. Perhaps
Dr. Belcher had not been immersed in this aspect of clinical research
before he agreed to carry out the trial. Welcome to the wonderful world of
clinical research, Dr. Belcher!
The risk that the drug would subsequently be abandoned, depriving Dr.
Belcher of authorship, comes with the territory.
Methinks Dr. Belcher needs to accept the realities of carrying out
research and stop whining.