Comments on `Maintaining confidentiality of interim data to enhance trial integrity and credibility' by TR Fleming et al

Abstract

Get full access to this article

View all access options for this article.

References

Abrams DI , Goldman AI , Launer C. et al. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. New England Journal of Medicine 1994; 330: 657-62.

Fleming TR , Sharples K. , McCall J. et al. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clinical Trials 2008; 5: 157-67.

Korn EL , Hunsberger S. , Freidlin B. et al. Preliminary data release for randomized clinical trials of noninferiority: a new proposal. Journal of Clinical Oncology 2005; 23: 5831-36.

http://www.fda.gov/oashi/aids/virals.html (accessed 4/22/ 2008).

Ellenberg SS , Fleming TR , DeMets DL Data Monitoring Committees in Clinical Trials: A Practical Perspective. John Wiley & Sons, Chichester, West Sussex, England, 2002.

Lieberman J. , Nauss-Karol C. , Salgo M. et al. Safety experience with dideoxycytidine (DDC) in an expanded access population. Int Conf AIDS 1992; 8: B87 (abstract no. PoB 3004).