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Indian study wins clinical trial of the year

11 Apr, 2011
Ekjut Trial in Jharkhand and Orissa
The Ekjut Trial in Jharkhand and Orissa.

Congratulations to the team behind the Ekjut Trial in Jharkhand and Orissa, which has been awarded Trial of the Year by the Society for Clinical Trials.

Led by researchers from the Institute of Child Health, UCL, and Indian voluntary organisation Ekjut, the trial evaluated how women’s groups affected neonatal mortality and maternal depression in very poor communities in eastern India.

In March 2010, they published their results in medical journal The Lancet, finding that, after three years of the intervention, women’s groups helped reduce neonatal mortality by 45 per cent and maternal depression by 57 per cent.

The Society said the trial was “an extraordinary cluster randomized controlled trial, conducted with high quality in a very difficult setting, and achieving dramatic results of great public health importance.” As one member of the judging committee said, it stood out because “the study gave the participants and their communities tools to continue the intervention after the study was over.”

Dr Prasanta Tripathy of Ekjut said this was always a key part of the trial. “This potential for continuation after the official end of the study was something that we thought about before the study began. We also agreed to extend the benefits of the intervention to the control areas if the intervention had an impact. We secured financial resources for the same, providing support to the groups through ‘facilitators’ from the same community and also disseminating findings for a possible roll-out by government.”

Professor Anthony Costello from the Institute of Child Health said the trial was “designed as a community effectiveness trial rather than an efficacy trial of a perfectly implemented intervention, which would be difficult to scale up in the real and resource-limited world in which these tribal populations live.”

“Such trials are essential in the developing world so that we can really estimate the impact and cost-effectiveness of what we do.”

The Ekjut Trial in Jharkhand and Orissa was funded by the Health Foundation, the UK Department for International Development, the Wellcome Trust and the UK Big Lottery Fund’s International funding programme.

The Trial of Year award is awarded each year to a randomized clinical trial published in the previous year that improves the lot of mankind, provides the basis for a substantial, beneficial change in health care, reflects expertise in subject matter, excellence in methodology, and concern for study participants, overcomes obstacles in implementation, and whose design, execution, and results is a model of clarity and intellectual soundness.

Image credit: Ekjut, Chakradharpur, Jharkhand, India, 2010.
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  1. normally distributed

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