Reproducibility of treatment methodologies detailed in contemporary clinical trial reports

Abstract

Objective. To assess the reproducibility of treatment methodology detailed in contemporary published clinical trial reports. Design. Published articles focusing on clinical trials involving the administration of chemotherapy for the treatment of cancer were selected. The data required for the administration of chemotherapy was determined by an experienced oncology pharmacist. Outcome measures. The degree of potential impact of the omission of relevant detail was assessed. The overall reproducibility of the methodology was then classified as reproducible, reproducible with further literature evaluation, or not reproducible without communication with the authors. Results. Ninety-two articles were reviewed. Ninety percent of articles omitted data required to enable reproduction of the methodology. Of these, 5.4% omitted essential data which could only be obtained by communication with the authors. Over 57% of articles required further detailed literature evaluation before the methodology could be reproduced. A number of articles contained errors or ambiguity. Discussion. The focus of the article and journal contributed to the completeness of the methodology. Guidelines for the preparation of manuscripts for publication in biomedical journals need to be reviewed. Practitioners and editors must be cognizant of the limitations of published methodologies. Conclusion. A significant number of articles contained omissions, ambiguity and even errors, which would prevent the methodology being reproduced. The majority of methodologies could be reproduced with the interpretation of an experienced oncology pharmacist, or by utilising resources for detailed literature evaluation.

Performance of different data sources in identifying adverse drug events in hospitalized patients

“…In order to be comparable, we also report the standard evaluation and analysis of ADEs and drugs. Detailed information [12,15,16] on ADEs in oncology has been rarely published. Our study focuses primarily on the performance of different data sources in capturing ADEs, similarly to the study of Classen [4].…”

“…A portion of these ADEs are preventable [13,14], though published protocols differ in dosage, duration of treatment, and applied cycles. Ambiguous information in the literature concerning the correct administration of the drugs can impair reproducibility [15] and reduce the effectiveness of therapy, which results in increased hospital days and reduced life span [16]. Additional hospital days add major costs to the health care system [17].…”