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Reproducibility of treatment methodologies detailed in contemporary clinical trial reports

Pharmacy Department, Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia, Department of Pharmacy Practice, Victorian College of Pharmacy, Monash University, Parkville, Victoria, Australia

Joanne Vernon, B Pharm, B Pharm Sc (Hons)

Pharmacy Department, Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia

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.

Key Words: Oncology • literature • published • chemotherapy • protocols • reproducibility

Journal of Oncology Pharmacy Practice, Vol. 6, No. 2, 50-54 (2000)
DOI: 10.1177/107815520000600203


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