Within-Trial Decisions

5. References & Further Reading

References

  1. EMA guideline on data monitoring committees Doc. Ref. EMEA/CHMP/EWP/5872/03: here

  2. US Food and Drug Administration. Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees. Last accessed June 15, 2014: here
Further Reading

  • Fleming TR, Hennekens CH, Pfeffer MA, DeMets DL. Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials. J Biopharm Stat. 2014 Jun 13.

  • Katz ML, Archer LE, Peppercorn JM, Kereakoglow S, Collyar DE, Burstein HJ, Schilsky RL, Partridge AH. Patient advocates' role in clinical trials: perspectives from Cancer and Leukemia Group B investigators and advocates. Cancer. 2012 Oct 1;118(19):4801-5. (here)

  • Institute of Medicine. A National Cancer Clinical Trials System For The 21st Century. Reinvigorating the NCI Cooperative Group Program. Washington, DC: National Academies Press; 2010.

  • http://ec.europa.eu/research/health/pdf/event05/sue-pavitt_en.pdfs