International Journal of Technology Assessment in Health Care

METHODS

Time to full publication of studies of anticancer drugs for breast cancer, and the potential for publication bias

Petra Harrisa1, Andrea Takedaa1, Emma Lovemana1 and Debbie Hartwella1

a1 Southampton Health Technology Assessments Centre

Abstract

Objectives: Nonpublication of results of clinical trials can contribute to inappropriate medical decisions. The primary aim of this systematic review was to investigate publication delays between conference abstracts and full journal publications from randomized controlled trial results of new anticancer agents for breast cancer. The review was restricted to anticancer agents previously, or due to be, appraised in the United Kingdom by the National Institute for Health and Clinical Excellence. A secondary objective was to identify whether there are any apparent biases in the publication and reporting of these trials.

Methods: We searched six electronic databases up to August 2007, including Medline and the Cochrane Library. Two reviewers independently selected studies, extracted and assessed the data.

Results: Six anticancer treatments were identified: docetaxel, paclitaxel, trastuzumab, gemcitabine, lapatinib, and bevacizumab. Of eighteen included trials, only four publications from three trials reported the same outcomes in both abstract and full publication. Time delays ranged from 5 to 19 months. Eleven trial abstracts were still without a full publication at the end of our searches, varying from 3 to 38 months since abstract publication. Observational analysis revealed no particular publishing biases.

Conclusions: Whereas delays in publication appear reasonable over a period of months, many were not published in full over a period of years and others would appear to be unlikely to ever be published. Further research should investigate the impact of publication delays on the availability of new drug treatments in clinical practice.

Footnotes

We are grateful for the input to our systematic review to the following experts: Ms. Suzie Paisley, School of Health and Related Research, University of Sheffield; Dr. Stephen Johnston, Royal Marsden Hospital, Sutton; and Dr. Sally Hopewell, The UK Cochrane Centre, Oxford. We also thank the staff at the Information Resource Centre, Wessex Institute. This project was completed as part of a short systematic review funded by the NIHR Health Technology Assessment Programme (Project No. 07/55/01). It has been published in full in Health Technology Assessment 2008, Vol. 12, No. 32, and can be found on the HTA Programme Web site (www.hta.ac.uk). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health. The authors report nothing to disclose.