ObjectivesTo establish the rates of publication and reporting of results for interventional clinical trials across Polish academic medical centres (AMCs) completed between 2009 and 2013. We aim also to compare the publication and reporting success between adult and paediatric trials.DesignCross-sectional study.SettingAMCs in Poland.ParticipantsAMCs with interventional trials registered on ClinicalTrials.gov.Main outcome measureResults reporting on ClinicalTrials.gov and publishing via journal publication.ResultsWe identified 305 interventional clinical trials registered on ClinicalTrials.gov, completed between 2009 and 2013 and affiliated with at least one AMC. Overall, 243 of the 305 trials (79.7%) had been published as articles or posted their summary results on ClinicalTrials.gov. Results were posted within a year of study completion and/or published within 2 years of study completion for 131 trials (43.0%). Dissemination by both posting and publishing results in a timely manner was achieved by four trials (1.3%).ConclusionsOur cross-sectional analysis revealed that Polish AMCs fail to meet the expectation for timely disseminating the findings of all interventional clinical trials. Delayed dissemination and non-dissemination of trial results negatively affects decisions in healthcare.

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Background For research with human participants to be ethical, risk must be in a favorable balance with potential benefits. Little is known about the risk/benefit ratio for pediatric cancer phase II trials testing targeted therapies. Objective Our aim was to conduct a systematic review of preliminary efficacy and safety profiles of phase II targeted therapy clinical trials in pediatric oncology. Methods Our protocol was prospectively registered in PROSPERO (CRD42020146491). We searched EMBASE and Pub-Med for phase II pediatric cancer trials testing targeted agents. We included solid and hematological malignancy studies published between 1 January, 2015 and 27 February, 2020. We measured risk using drug-related grade 3 or higher adverse events, and benefit by response rates. When possible, data were meta-analyzed. All statistical tests were two-sided. Results We identified 34 clinical trials (1202 patients) that met our eligibility criteria. The pooled overall response rate was 24.4% (95% confidence interval [CI] 14.5-34.2) and was lower in solid tumors, 6.4% (95% CI 3.2-9.6), compared with hematological malignancies, 55.1% (95% CI 35.9-74.3); p < 0.001. The overall fatal drug-related (grade 5) adverse event rate was 1.6% (95% CI 0.6-2.5), and the average drug-related grade 3/4 adverse event rate per person was 0.66 (95% CI 0.55-0.78). Conclusions We provide an estimate for the risks and benefits of participation in pediatric phase II cancer trials. These data may be used as an empirical basis for informed communication about benefits and burdens in pediatric oncology research.

Cerebral venous sinus thrombosis (CVST) is a rare type of stroke caused by a clot forming in one of the cerebral sinuses and subsequent blockage in blood drainage. The clinical presentation of this disease can be atypical and diagnosis might be challenging. The patient in this case study was a 33-year-old woman admitted to the perinatology clinic at 39+5 weeks of gestation to perform a planned caesarean section, who had previously been discharged home in good condition. The patient was readmitted to the hospital because of a headache, tingling sensation, and elevated D-dimers. A performed Computed Tomography scan revealed low contrast signal in the left cerebral sinuses and the left internal jugular vein. The diagnosis was CVST, with blood clots present in all mentioned vessels. Subsequent magnetic resonance imaging revealed hemorrhagic venous infarctions in the left cerebral and cerebellar hemispheres. The patient was successfully treated with painkillers and heparin. No additional coagulation defect was detected.