The long road that takes a therapy from the laboratory to patients is marked by many different stages, all of them fundamental. However, one of these is very often overlooked and ignored, as if it were an unnecessary bureaucratic delay: the publication of the results of clinical trials on public registers within 12 months of the end of the trial, a standard required by the World Health Organization, regardless of whether or not the work is published in a scientific journal. According to what was reported by the WHO, “a considerable number of studies are not registered after one year”. In Europe, for example, 26% of studies were retrospectively registered (3,457 out of 13,254) in 2022. This leads to a lack of information which, in turn, can reflect on the sustainability of the research. This is especially true for oncology, which represents a significant share of global clinical research, highlights Cipomo on the occasion of its 28th national congress, which opened today in Syracuse and will end on May 11th.
“The progress obtained through scientific research has led, for many oncological diseases, to an improvement in the prognosis and a radical modification of the natural history of the disease – states Luisa Fioretto, president of Cipomo and director of the Oncology Department of the Toscana Centro healthcare company –. However , the habit of neglecting the step of publishing the results on a public register, the same one where the studies are registered when they are activated, can in some cases slow down progress in one of the sectors with the highest speed of innovation”.
Clinical trial registers are databases that can be consulted via the internet and developed by government bodies, research centers, scientific associations, which list the authorized clinical trials in progress or about to begin. “For the WHO, publishing the results only in a scientific journal is not enough – specifies Paolo Tralongo, president of the Cipomo congress and director of the oncology department of the Provincial Health Authority of Syracuse – but it is necessary to also report the data in public registers. Fulfilling this commitment helps improve healthcare, helping government agencies to properly allocate resources. Trials that are neither registered nor published remain completely invisible to both researchers and agencies regulators, who need to know all previous trials to determine the safety and effectiveness of a drug or device. Invisible trials also lead to significant waste in research, with important discoveries that are not shared.”
“Considering the progressive unsustainability of healthcare systems – highlights Fioretto – in order to determine whether the effectiveness of a drug justifies its cost, the decision makers in charge must be able to have access to the complete results of all clinical trials: this often does not happen with possible waste of public resources”. The publication of trial results in public registers is, therefore, more important than ever.
It is estimated, in fact, that every year around 85 billion dollars are wasted to finance expensive trials that do not contribute to the progress of medicine because the results are not disclosed and researchers find themselves needlessly duplicating trials on drugs that others have already documented the risks and/or lack of effectiveness. “Promising new approaches and potential risks can go unnoticed for many years and researchers do not have the opportunity to build on each other’s findings,” adds Tralongo. “All bodies funding research should adopt and follow WHO transparency standards for dissemination of the results of clinical trials with consequent advantages for the healthcare system and for our patients”, conclude Fioretto and Tralongo.
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