Unreported clinical trial data “unethical”
WHO has called for the disclosure of all results from clinical trials for medical products.
The World Health Organization (WHO) has called for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence.
“Our intention is to promote the sharing of scientific knowledge in order to advance public health,” said WHO official Marie-Paule Kieny. “It underpins the principal goal of medical research: to serve the betterment of humanity.”
According to WHO, there is increasing empirical evidence to suggest that the results of many clinical trials are suppressed from the public. One study that analysed the reporting from large clinical trials (more than 500 participants) registered on ClinicalTrials.gov and completed by 2009 found that 23% had not reported any results. These unreported trials included nearly 300,000 participants.
Even where results are released, the process of publication can be very protracted. Among clinical trials of vaccines against five diseases registered in a variety of databases between 2006-2012, only 29% had been published in a peer-reviewed journal by the WHO-recommended deadline of 24 months following study completion.
WHO has recommended that from now on the main findings of every clinical study should be submitted to a peer-reviewed journal within 12 months after data collection ends and be published — in an open-access journal unless there is a specific reason why that’s impossible — within 24 months.
“It’s unethical to conduct clinical research without reporting the results,” says immunologist Dr. Vasee Moorthy, author of a paper discussing the rationale behind the WHO’s new statement. Europe and the United States have already made important regulatory strides to registering trials and making their outcomes public, Moorthy says.
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