Clinical Trials of New Drugs Special Problems
The failure to include the posttrial period in the requirements of informed consent.
The failure to recognize that psychological and physical difficulties may result from the emotional consequences of loss of the trial agent.
The failure to consider potentially negative and harmful physical effects subsequent to agent withdrawal.
The failure to take account of long-term effects of an agent’s administration that are neither predictable nor foreseeable from short-term trials.
KeywordsPlacebo Effect Placebo Control Investigational Drug Posttrial Period Trial Agent
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