Clinical trials – a guide for CAB members (page 17)

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  • All medicines can have negative effects in some people (called side effects or adverse reactions). Negative effects may include such things as headache, nausea, rash, or other physical problems. During a clinical trial, researchers must collect information from participants about any immediate and long-term negative effects.
  • To protect patients during the study, information collected about negative effects is checked regularly. Unexpected serious negative effects, which indicate that the medication is unsafe, may cause the trial to be stopped or changed by the Ethics Committee or the Data Safety and Monitoring Board (DSMB).
Published: August 31, 2008
Last edited: January 25, 2011