Under-reporting of safety data – cause for concern
Department of Pharmacology, All India Institute of Medical Sciences, Nagpur, Maharashtra, India
Department of Pharmacology, All India Institute of Medical Sciences, Nagpur, Maharashtra
|How to cite this article:|
Gajbhiye S. Under-reporting of safety data – cause for concern.J Postgrad Med 2022;68:129-130
|How to cite this URL:|
Gajbhiye S. Under-reporting of safety data – cause for concern. J Postgrad Med [serial online] 2022 [cited 2023 Jan 28 ];68:129-130
Available from: https://www.jpgmonline.com/text.asp?2022/68/3/129/353846
One of the important aspects of clinical trials is assessing safety, as the major reason for conducting a trial is to understand the benefit in light of the risk. There are various guidance documents related to how to report safety. It is the responsibility of all stakeholders to report, assess, and analyse these safety reports. However, it is noted that the study team conducting the clinical trials is under an assumption that the adverse events are to be adequately managed and need not be reported if they are not 'significant'.
The study conducted by Konwar et al. published in the current issue, highlights a serious concern regarding the trend of under-reporting of safety data. The papers analysed in the study are from a reputed journal and the duration is over a five-year period. It is very startling to know that less than half of the randomized controlled trials (RCTs) have reported safety statistics with the significance levels or confidence intervals. A checkpoint at multiple places is needed to tackle this issue.
The development of clinical trial protocol is the responsibility of the sponsor and the sponsor must ensure the appropriate capture using case record form and elucidating reporting of safety related updates. Incorporating the patient-reported outcome in assessment of safety is very vital. There are reports on inappropriate reporting of adverse events in literature. A study on recombinant human bone morphogenetic protein 2 used in spinal fusion, showed that as compared to the actual data (based on individual participant data or internal industry reports), 56% to 88% of effectiveness outcome and 23% of adverse events only were reported in published literature. Another study found that 64% of adverse events were not reported in journal publication. The sponsor has access to a clinical database and must meet the larger responsibility to report safety information to all stakeholders. Also, investigators must build a mechanism to reduce the influence of sponsors on the data reported.
Another important stakeholder is the investigator who apart from observing, evaluating, and managing the adverse event must ensure that all the adverse events are reported to ethics committees and sponsors. It has been reported in study conducted by Weston et al., that the safety assessment and reporting is not only incomplete but is also not conforming with protocols. Documentation of the subjective symptoms reported by participants must be ensured, because if they are neglected, it might affect treatment decisions later in clinical practice. Thus, investigators have a higher responsibility on their shoulders to project the true picture regarding the potential harm in clinical trials. Also, as highlighted by the authors it is important that the reviewers or editors of the papers acquire participant data and suggest incorporation of key findings related to safety.
One of the positive findings of the study by Konwar et al. is that the investigator-initiated studies (IIS) have higher reporting of safety data. These studies do have a more unbiased stand in reporting both components (benefits and risk) as suggested by this study. Landewé et al. reported receiving huge data in the form of safety updates and highlighted that these can be overwhelming for the ethics committees. The safety data thus needs to be analysed appropriately and summarised in a meaningful manner when given to various stakeholders.
The downside of not reporting these safety updates could be manifold. The under-reporting of the safety updates in published literature will affect the analysis in future systematic reviews and meta-analyses. Also, it will have an impact on everyday clinical practice as the prescribers will not expect these adverse reactions and have false opinions regarding the drug's safety. The patient will be at a greater loss as the informed decision that they make while choosing a particular therapy over others with the prescribers is not based on true facts about the drug. These can also over-estimate the maximum tolerated dose which the patients may not be able to tolerate in routine practice and this might have an overall impact on compliance of therapy. The pharmacoeconomic analysis done will have to include the cost of managing the adverse reactions which might hamper the predictions made for the drug. Thus, the problem must be addressed as the observation, collection, interpretation, analysis, reporting, and dissemination of this information is extremely important to protect the safety and well-being of the society at large.
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