- Halt to microbicide trial sets back AIDS research. Moszynski, Peter // BMJ: British Medical Journal (International Edition);2/10/2007, Vol. 334 Issue 7588, p276
The author reports that two phase III clinical trials of a topical microbicide gel, cellulose sulfate, in testing for prevention of HIV in women have been stopped due to preliminary results that demonstrated an increased risk of HIV infection. Separate phase III trials of three other...
- Clinical Trials in CEE: Harnessing the Potential. Motteram, Peter A.S.; Richardson, Andy // Applied Clinical Trials;Sep2004, Vol. 13 Issue 9, p50
Provides an overview on the field of clinical trials in Central and Eastern Europe (CEE). Primary factor for considering CEE sites; Nonprotocol issues for CEE trials; Regulations governing clinical trials; Provisions under the EU Clinical trials Directive.
- Establishing ethical trials for treatment and prevention of AIDS in developing countries. Lo, Bernard; Bayer, Ronald // BMJ: British Medical Journal (International Edition);8/9/2003, Vol. 327 Issue 7410, p337
Developing countries have been hardest hit by HIV but often cannot afford the expensive drugs or high tech health care used in Western countries. How can researchers and sponsors of trials investigating treatment and prevention of HIV in developing countries make sure they take proper account of...
- Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. Evans; Pocock; Lievre, Michel; Menard, Joel; Bruckert, Eric; Cogneau, Joel; Delahaye, Francois; Giral, Philippe; Leitersdorf, Eran; Luc, Gerald; Masana, Luis; Moulin, Philippe; Passa, Philippe; Pouchain, Denis; Siest, Gerard // BMJ: British Medical Journal (International Edition);03/10/2001, Vol. 322 Issue 7286, p603
Discusses premature discontinuation of clinical trial for reasons not related to efficacy, safety or feasibility. Reasons why some trials are discontinued prematurely by their sponsor for strategic reasons; How public financial and scientific participation in some trials and increasing the...
- Statistics Notes: Concealing treatment allocation in randomised trials. Altman, Douglas G; Schulz, Kenneth F // BMJ: British Medical Journal (International Edition);8/25/2001, Vol. 323 Issue 7310, p446
Discusses the importance of concealing treatment allocation until a patient has entered a randomised clinical trial. Attempts to eliminate bias; How to ensure that allocation sequence will be concealed, including using external help; Difference between randomised and double blind trials.
- Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey. Hanley, Bec; Truesdale, Ann; King, Andy; Elbourne, Diana; Chalmers, Iain // BMJ: British Medical Journal (International Edition);03/03/2001, Vol. 322 Issue 7285, p519
Conclusions: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.
- CONSORT statement: extension to cluster randomised trials. Campbell, Marion K.; Elbourne, Diana R.; Altman, Douglas G. // BMJ: British Medical Journal (International Edition);3/20/2004, Vol. 328 Issue 7441, p702
Offers a look at the effective reporting of randomized controlled trials. Guidelines in the Consolidated Standards of Reporting Trials (CONSORT) statement; Discussion of methodological issues in cluster randomized trials; Quality of reporting of cluster trials; Extension of CONSORT statement to...
- Intention-to-treat analysis: Protecting the integrity of randomization. Mahaniah, Kiame J.; Rao, Goutham // Journal of Family Practice;Aug2004, Vol. 53 Issue 8, p644
Randomization is a crucial part of most clinical trials. The purpose of randomization in a trial comparing 2 groups is to ensure that the groups differ only with respect to the interventions being compared. Randomization determines not only which treatment subjects receive, but also how the...
- Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early. Mills, Edward J.; Singh, Sonal; Singh, Jerome A.; Orbinski, James J.; Warren, Mitchell; Upshur, Ross E. // BMJ: British Medical Journal (International Edition);12/10/2005, Vol. 331 Issue 7529, p1403
The article discusses how activism has stopped two clinical trials in developing countries that were investigating the effectiveness of tenofovir prophylaxis in preventing HIV infection. The ethical aspects of the trial design, the issue of inadequate care after the trial, and the lack of...