A new study published in the journal PLoS Medicine has found strong evidence that a significant portion of information on adverse events, gathered from clinical trials, remains unpublished.
A new study published in the journal PLoS Medicine has found strong evidence that a significant portion of information on adverse events (AEs), gathered from clinical trials, remains unpublished and is incompletely reported. This information should prompt treating physicians and researchers to dig deeper to better understand the side effects of specific treatments.
For the current analysis, the authors combed through 15 medical databases, conducted internet searches, gathered data from conferences, and contacted experts in the field to assimilate information on side effects and adverse effects of treatments—28 methodological interventions met the set inclusion criteria, 9 of which compared the proportion of trials that reported AEs based on published results. The objective was to quantify underreporting of AEs and measure its subsequent impact on systematic reviews of AEs.
Less than half (46%) of the published documents reported AEs, compared with 95% of corresponding unpublished documents. The trend was similar for unmatched studies, where 43% of published studies reported AEs compared with 83% of unpublished studies. The authors concluded that between 43% and 100% (median, 64%) of AEs would be missed if only the published versions of studies were included in their analysis. Additionally, the authors found the following:
Based on their findings the authors believe that the number and range of AEs are much higher in unpublished data compared with the published version of the same studies. Including unpublished data “can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events,” they wrote.
The value of a treatment is a combination of its efficacy and its unwanted effects. A drug that improves disease symptoms while simultaneously causing adverse events that lead to additional treatment or hospitalization may not be the most valuable option. Unless all the documented evidence that results from a study is openly published by participating researchers and drug developers, patients and physicians will remain ill-informed when making care decisions. Publication bias and unreported harms data could lead to erroneous judgement by physicians on the benefit to harm ratio of a treatment. This, the authors state, calls for an urgent policy intervention to allow full public access to AE data.
Reference
Golder S, Loke YK, Wright K, Norman G. Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med. 2016;13(9):e1002127. doi: 10.1371/journal.pmed.1002127.
Contributor: More Informed Management of Preeclampsia Is Necessary
November 29th 2023At present, it is difficult for clinicians to identify patients at greatest risk for developing preeclampsia with severe features and tailor treatment plans for them; this difficulty increases costs significantly.
Read More
Provisional CDC data show that US babies gained roughly a year in life expectancy in 2022; study findings indicate that the COVID-19 pandemic significantly raised the risk of preterm birth for expectant California mothers; New York Attorney General Letitia James said about 4 million New Yorkers were affected by a data breach of the medical transcription company Perry Johnson & Associates.
Read More
Understanding the Unmet Need for Therapies to Treat Rare Bile Duct Cancer
May 24th 2022On this episode of Managed Care Cast, we bring you an excerpt of an interview with a co-chair of the 2022 Cholangiocarcinoma Foundation (CCF) annual conference, held earlier this year, about the significant unmet therapy needs facing most patients with this rare cancer.
Listen
Gene Therapy Success in UK Likely Depends on Overcoming Education, Psychological Support Challenges
November 27th 2023Education, psychological support, and implementation guidance are the top unmet needs identified by investigators from the United Kingdom concerning gene therapy use for hemophilia.
Read More