Adopting WHO best practices in clinical trial reporting: the case of Aeras

Aeras is a nonprofit organization developing new, effective tuberculosis vaccines that are affordable and accessible to all who need them. It is headquartered in the United States, with a clinical development and operations office in South Africa.


In June 2017, Areas voluntarily committed to implementing WHO best practices in clinical trial transparency by signing up to the WHO Joint Statement on public disclosure of results from clinical trials.



In the same month it became a signatory, Aeras changed its internal Standard Operating Procedure for reporting clinical trial results to include reporting of all interventional clinical trials, Phases 1-4, within 12 months of primary study completion, even though Clinicaltrials.gov only requires the posting of results for Phase 2-4 trials.


At present, Clinicaltrials.gov lists Areas as the sponsor of 24 clinical trials. Of these, 19 trials have a primary completion point more than one year in the past, so according to WHO best practices, they should have posted summary results onto the registry.


Five of these 19 trials – all of them Phase 2 trials – have already posted their summary results on the registry. According to Areas, eight of the remaining trials missing summary results on Clinicaltrials.gov have already published their outcomes in the peer reviewed literature, and three more have manuscripts in planning.


Aeras confirmed that since signing the WHO Joint Statement, it has been working towards uploading results from past trials. The organization explained in a letter to TranspariMED that the backlog of Phase 1 trials has not yet been entirely cleared due to resource constraints.


TranspariMED welcomes Aeras’ commitment to ensuring that all clinical trial results are reported in line with WHO best practices, and will continue to document the organization’s progress as more summary results get posted on Clinicaltrials.gov.


Note: This blog was written based on registry data and correspondence with Aeras. It was not reviewed by Aeras prior to publication. Read this article to learn more about the WHO Joint Statement and why it matters.




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