A proposed charter for clinical trial data monitoring committees: helping them to do their job well.

Marion Kay Campbell, Adrian Maxwell Grant, Sharon Katrina McCann, Anne Elizabeth Walker, Sheila Ann Wallace, The DAMOCLES Study Group

Research output: Contribution to journalArticle

156 Citations (Scopus)

Abstract

Formal monitoring of data from randomised controlled trials (RCTs) is becoming more common. Wide variation exists in the structure and organisation of data monitoring committees (DMCs), with little guidance on how they should operate. We used various strategies to consider the behavioural, procedural, and organisational aspects of data monitoring in RCTs: systematic reviews of DMCs and small group processes in decision making; surveys of reports of RCTs, recently completed and ongoing RCTs, and the policies of major organisations connected with RCTs; detailed case studies of four DMCs that faced difficult decisions; and interviews with experienced DMC members. The findings aided the development of a template for a charter for DMCs. We summarise the findings and outline the key considerations at every stage of the data monitoring process. Widespread use of a charter for the structure and organisation of DMCs would promote a systematic and transparent approach, and enable them to operate more effectively and efficiently.

Original languageEnglish
Pages (from-to)711-722
Number of pages11
JournalThe Lancet
Volume365
Issue number9460
Publication statusPublished - 2005

Keywords

  • RANDOMIZED CONTROLLED TRIALS
  • CONSORT STATEMENT
  • QUALITY

Cite this

Campbell, M. K., Grant, A. M., McCann, S. K., Walker, A. E., Wallace, S. A., & The DAMOCLES Study Group (2005). A proposed charter for clinical trial data monitoring committees: helping them to do their job well. The Lancet, 365(9460), 711-722.