Unanticipated Problem Resulting in Adverse Event in Clinical Trial
What should be the appropriate response to a subject receiving the wrong study drug resulting in severe nausea and vomiting?
a) The subject should have contacted the study site for authorization before going to the emergency room.
b) This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake.
c) This is an unanticipated problem, which resulted in an adverse event.
d) The IRB does not have authorization to require changes in the pharmacy procedures.
Answer:
c) This is an unanticipated problem, which resulted in an adverse event.
Before being administered to a patient, a study drug must be carefully examined because a mistake could result in extremely negative side effects. Even if the study coordinator is cautious and makes every effort to avoid mistakes that can hurt the patient, as was the case in the question, mistakes do occasionally get through the cracks. These mistakes that go unrecognized are incidents where an unanticipated issue led to a negative outcome.
In this scenario, the subject receiving the wrong study drug resulting in severe nausea and vomiting was an unanticipated problem. The study coordinator reviewed the subject's study records and discovered the error, highlighting the importance of thorough monitoring and oversight in clinical trials.
It is essential for the investigator to notify the Institutional Review Board (IRB) in such cases, and in this situation, the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. This incident serves as a learning opportunity to enhance procedures and prevent similar occurrences in the future.