Clinical Trials of New Drugs Special Problems

  • Martin Roginsky


Terminating an investigational drug in a clinical trial carries with it certain risks for subjects that are too often disregarded in the research protocol despite clinical indications that this critical posttrial period be anticipated prior to initiating the study. The potential for adverse consequences, as well as ethical considerations underlying all human experimentation, make it essential to consider special areas of concern relevant to the postadministration phase of the clinical trial. There are specific ethical and moral rights of subjects which may be jeopardized at trial conclusion, and there are direct harmful effects that may occur only in the posttrial period. These two concepts may be further divided into the following separate topics that warrant individual discussion:
  1. 1

    The failure to include the posttrial period in the requirements of informed consent.

  2. 2

    The failure to recognize that psychological and physical difficulties may result from the emotional consequences of loss of the trial agent.

  3. 3

    The failure to consider potentially negative and harmful physical effects subsequent to agent withdrawal.

  4. 4

    The failure to take account of long-term effects of an agent’s administration that are neither predictable nor foreseeable from short-term trials.



Placebo Effect Placebo Control Investigational Drug Posttrial Period Trial Agent 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Martin Roginsky
    • 1
    • 2
  1. 1.Division of Endocrinology and MetabolismNassau County Medical CenterEast MeadowUSA
  2. 2.Department of MedicineState University of New York at Stony BrookStony BrookUSA

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