Conducted a Clinical Trial in India? It maybe Yes and No!

Conducted a Clinical Trial in India? It maybe Yes and No!

The mystery of India’s missing clinical trial results
Shreya Dasgupta. BMJ 2020;371:m4835

Around eleven years ago  India had made a very welcome move – it was mandatory to register every clinical trial, in a national registry. The CTRI or the Clinical Trials Registry of India, created in 2007,  would then have a database of every trial registered, its progress at various stages and its results. The researchers could also link the registration record to a paper when it was later published in a journal.

In order for trial results to be shared in the public domain, every researcher who registers a study in the CTRI is expected to publish the results in the registry within 12 months of finishing the study. And not just this but also submit a scientific article about the study to a peer reviewed journal.

The article however tells us that less than 3% of records have links to published papers and over 74% of records remain unpublished. The author – a freelance journalist has discussed these issues with several doctors and the opinions to make a change include, making inclusion of results mandatory, and also lots more of mentoring and awareness that good research conduct means closing all loops.

Researchers who do literature searches usually search first in the published literature databases like PubMed, EMBASE and more. And so the need to publish in a peer reviewed journal is definitely important. The time between submission by an author and acceptance by the journal is not always predictable, so one cannot give a mandate of time here.

Two things are important –

  1. Researchers who search, must know about searching clinical trial registries and the need for this, in addition to journal indexes
  2. Researchers who have registered in the CTRI should publish their results in the registry as early as they can, in order that their research findings are available

We at QMed would add, that till the mandate happens, people must learn that literature search is not just about googling, not just about searching the published literature, but also about searching databases like the CTRI and other trial registries. When more people search and ask for results, there will be an added reason and motivation for updating results

We thank Denny John – Adjunct Assistant Professor at Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala,for getting this article to our notice

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