Earlier this year Digital Journal reported that the U.S. Institute of Medicine was calling for results from human clinical trials to be made available to independent researchers within 18 months of the trial being completed. The primary reason for this was to allow new drugs and their side-effects easier for medics to evaluate.
The concern is that some key data is withheld from independent evaluation, which makes informed decision making more difficult. This is not only a practice of many drug companies. Regulators as well have sometimes been reluctant to provide full information, especially about trials that have not worked or where there is a dispute about the data outcomes.
Now WHO has made a similar request. Here WHO has recommended timelines for researchers to register the findings and techniques of clinical trials. Who has stated that all results must be submitted to a scientific journal within 12 months of completion. This is not only something that should apply to current trials; it should also be applied retrospectively to already completed drug studies.
WHO argues that if studies are not released in a timely manner:
It affects understanding of the scientific state of the art.
It leads to inefficiencies in resource allocation for both research and development and financing of health interventions.
It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.
It potentially distorts regulatory and public health decision making.
The WHO announcement has been welcomed by supporters for more openness in science. This includes the science writer Dr. Ben Goldacre. Quoted by The Verge, Dr. Goldacre said that the WHO’s decision was “powerful and welcome.” He also added that it “represents important progress on a long-standing and global structural problem.”
Goldacre also supports the WHO request that previous studies are made public. This is because most people are using medications that were tested and released decades ago.
He also adds that: “doctors and patients of the future may well look back on [the withholding of study data] with amazement, much as we look back on medieval bloodletting.”
