While it is well known that the complete results from each study are almost never published in full in journals, it turns out that this also applies to many of the side effects discovered during clinical trials.
Up to 64% of side effects are left unreported
According to a meta-analysis by the universities of York, Norwich and Manchester and led by Su Golder from York’s department of health sciences, there is “strong evidence” that side effects are incompletely reported in peer-reviewed journal articles describing research findings on the clinical benefits of drugs and other medical treatments.
This essentially means that the unreported side effects are often left unnoticed. The study by a group of researchers found that about 64% of side effects would be missed by readers looking only at the published reports about the medical treatments studied, which is a very substantial number.
The authors conclude that full reporting of adverse events in journal articles is essential to allow patients and doctors to assess the balance between the benefits and harms of medical treatments, noting “the urgent need to progress towards full disclosure and unrestricted access to information from clinical trials”.
They also note that “the inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events.”
The main takeaway of the study is that published journals do not contain much information on the adverse effect. Meanwhile, the data regarding the side effects are more available in the unpublished documents of the same study. The most likely reason being publication bias with an inclination to report what is deemed as more ‘sensational’ material.
Cancer trials also rife with side effect under-reporting
The discrepancy starts from the source. The trial physicians tend to discard the more common effects reported by the patients. This leads to loss of precious data and is bound to have a cascading effect in terms of creating a communication gap.
Francesco Perrone, director of the Clinical Trials Unit at the National Cancer Institute of Naples, Italy and his colleagues analysed the side effects reported by over 1,000 breast and lung cancer patients and trial physicians for their study in 2015.
Their comparison of side effects reported by patients and their physicians in three separate cancer drug trials found that the physicians’ perception of the adverse effects is much less compared to that of the patients. In fact, doctors under-reported by up to 75% how many patients had six of the most common chemotherapy side effects.
“Patients should be empowered to directly report subjective side effects and be active in defining the tolerability of anticancer drugs,” said Perrone.
He added that the results should also push doctors toward spending more time listening to the patient’s experience of symptoms.
Such findings reemphasise the need for a doctor to look beyond just the published works to gather more relevant data and draw conclusions before recommending any new treatment to a patient. There is also a dire need for full disclosure and unrestricted access to clinical trial results.
Countermeasures to overcome this occurrence and to provide more reliable data on the outcome of clinical trials are being established in several ways. The U.S. FDA encourages physicians to report any side effects through their reporting system. Still, it greatly relies on a physician or a patient noticing something unusual and makes the effort to report it. MIMS
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