Should sponsors and DSMBs share interim results across trials?

J Acquir Immune Defic Syndr. 2011 Dec 15;58(5):433-5. doi: 10.1097/QAI.0b013e318236eca3.

Abstract

Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials have been overlooked. When interim results from clinical trials can significantly affect the conduct of other trials and the welfare of the subjects in those trials, sponsors and DSMBs may have obligations to disclose results to the relevant parties. We propose that sponsors and DSMBs routinely work together in advance to develop a plan for disclosing relevant information in cases where it is necessary to protect the welfare of subjects in other trials. Channels of communication between sponsors, DSMBs, IRBs, and others involved in similar and concurrent trials will better protect both research participants and the integrity of the research enterprise.

Publication types

  • Editorial
  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural

MeSH terms

  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / therapeutic use
  • Clinical Trials Data Monitoring Committees / ethics*
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / methods*
  • Confidentiality / ethics*
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / prevention & control*
  • HIV Infections / transmission
  • Humans
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Interinstitutional Relations
  • Nevirapine / administration & dosage
  • Nevirapine / therapeutic use
  • Pregnancy
  • Zidovudine / administration & dosage
  • Zidovudine / therapeutic use

Substances

  • Anti-HIV Agents
  • Zidovudine
  • Nevirapine