Major Discrepancies | What Clinical Trial Registries RECORD vs what is PUBLISHED

Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

Published: 23 September 2016

"Conclusions

"Our study identifies major discrepancies between what CTRs record and paediatric RCTs publish. Our findings should make clinicians who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols in line with published data. Clinical researchers and reviewers could search for CTR-RCT discrepancies to cross-check inconsistencies in core clinical trial reporting domains. Medical journals need to introduce rules that require investigators to submit the original Institutional Review Board-approved protocol (and its subsequent amended versions), and to explain any discrepancies. Assessing discrepancies would with little effort provide greater transparency, avoid wasting research resources, and encourage those who prepare medical recommendations and guidelines to think more critically. Future studies need to clarify whether the trial discrepancies we report warrant scepticism regarding study validity, or call for trialists to be more diligent about updating CTR data."

Another Excerpt:

"For example, trial (number 5 in Table 1) [29] addresses as primary outcome cognitive improvement and provides significant statistical difference between the intervention and control groups, but leaves unaddressed clinically important patient-centred outcomes, such as deaths and cerebral palsy. Even though deaths increased and cerebral palsy doubled in the intervention group, in their conclusions the investigators paradoxically report that ‘nonsignificant trends in the data suggested a small adverse effect’. In another trial (number 7 in Table 1) [31] an external DSMC decided to stop RCT completion early owing to hyperthermia in the infants enrolled in the intervention group. Neither the highlights section in the RCT nor the conclusions report this result. Although the published RCT reports when the trial stopped, our findings disclose an important clinically relevant feature, namely more harm than good for the primary outcome in the intervention group."

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1551-6