quarta-feira, janeiro 11, 2006
Estudo SMART descontinuado
O estudo SMART estava a decorrer nos seguintes hospitais:
- Hospital Curry Cabral
- Hospital de Cascais
- Hospital de Egas Moniz
- Hospital de Santa Maria
- Hospital Joaquim Urbano
- Hospital São João
Editor, HIV Treatment Bulletin
The Steering committee for the SMART study have decided to stop further recruitment for the SMART study due to futility, and that people on the treatment interruption arm will receive recommendations to restart treatment.
Although the trials Data and Safety Monitoring Board (DSMB) agreed in November that the study was safe to continue, a more recent review of the data showed a statistically significant difference in AIDS events between the continuous treatment arm and the treatment interruption arm.
The DSMB made a recommendation to stop the study, and the steering committee, after reviewing the unblinded dataset at a meeting in Australia, have agreed to follow this recommendation this morning.
I don't have any further details about these events - whether they are mild (candida etc), or arise from protocol violations (failure to restart when CD4 count falls <250>- further recruitment is stopped from today
- data will continue to be collected
- patients in the discontinuation arm who are currently off-treatment will be recommended to restart treatment.
This final point is the most immediate practical issue, as many patients may be stable and well off-treatment, maintaining a high CD4 count that is well above the trials determined protocol for restarting treatment, and may want to make a personal decision not to restart treatment.
One of the first messages that is also likely to be widely circulated, and which has a huge commercial impact for the pharmaceutical industry is that 'treatment is for life'. Although none of the data has been released yet, I find this aspect most depressing, and think that this would be the wrong interpretation from the decision that has been made to stop the study.
It is clearly disappointing that this study, planned as the largest and one of the longest running studies, that also has a high level of support in the community, is being stopped before recruitment was even completed, after only 2 of the planned 9 years follow-up.
However everything is in the details of the study results. It may be that the study answer has been reached much earlier than expected, and the benefits of continued treatment clearly outweigh any use of treatment interruption. Or it may be that the original study assumptions did not match actual reported events and that the study design itself can't answer the original question.