This study examined randomized trials of statins to investigate the reporting of muscle-related adverse events (MRAEs). The study highlights the importance of critical appraisal of trial design and data collection methods from clinical study reports. Internal company trial documents were requested from the European Medicines Agency and Health Canada for all clinical trials of atorvastatin, rosuvastatin, fluvastatin, and simvastatin. 25 of the 85 trails obtained and screened for documents met the inclusion criteria for assessment.
This study tested a sleep promotion intervention (randomized controlled trial) in children with recently diagnosed central nervous system tumors admitted to the hospital for high dose chemotherapy in preparation for autologous stem cell rescue. We hypothesized that disturbed sleep of hospitalized pediatric oncology patients would be reduced by altering the hospital sleep environment. Therefore, a randomized, attention-controlled sleep intervention was implemented in children and adolescents with central nervous system tumors admitted for 6 days for high dose chemotherapy prior to stem cell transplant. Children and adolescents diagnosed with medulloblastoma or histologically similar tumor, 4 to 19 years and their parent were recruited over 3 years.Questionnaires used to gather the data were: Fatigue Scale-Child, Fatigue Scale-Adolescent, Fatigue Scale-Parent. Data was also obtained using actigraphy.
An adapted version of the Brighton Collaboration priority list was used to evaluate serious adverse events (SAE) of special interest observed in mRNA Covid-19 vaccine trials. In December of 2020, reviewers searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate SAE results tables for these trials. For each trial, blinded SAE tables were prepared. Using these blinded SAE tables, two clinician reviewers judged whether each SAE type was an adverse event of special interest (AESI). Risk ratios and risk differences between vaccine and placebo groups were calculated for the incidence of AESIs and SAEs.
This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The primary outcome measures include presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). The dataset is comprised of an audited table of extracted and derived variables the details for which are described in an accompanying readme file. The uncorrected (original) and corrected extraction sheets as well as audit records are available upon request from Peter Doshi, corresponding author (firstname.lastname@example.org).