Time to full publication of studies of anti-cancer medicines for breast cancer and the potential for publication bias: a short systematic review.
OBJECTIVE
To identify the expected delay between publication of conference abstracts and full publication of results from trials of new anti-cancer agents for breast cancer and to identify whether there are any apparent biases in publication and reporting.


METHODS
Major electronic databases were searched to identify randomised controlled trials (RCTs) of the selected interventions for the treatment of breast cancer.


METHODS
A systematic review was conducted according to standard methods. Data were extracted from the included studies using a predesigned and piloted data extraction template.


RESULTS
Six anti-cancer treatments for breast cancer were included in the review: docetaxel, paclitaxel, trastuzumab, gemcitabine, lapatinib and bevacizumab. The literature searches generated 1556 references, from which 71 publications were retrieved and screened for inclusion. Screening identified 41 publications of 18 RCTs with at least one arm of treatment meeting the inclusion criteria for the review. Of the 18 included RCTs, only four publications (from three RCTs) reported the same outcomes in both an abstract and a full publication. Time between the abstract and full publication was 5 months in two cases, 7 months in one case and 19 months in one case (overall mean delay = 9 months). Eleven trials were identified that have not currently published in a full publication the data presented in an abstract or conference proceeding. The duration between publication of the abstracts and the end of August 2007 varied from 3 months to 38 months (mean delay 16.5 months). The longest delays in publication were for trials investigating gemcitabine (38 months) or bevacizumab (33 months). Observational analysis of the published and unpublished trials did not indicate any particular biases in terms of whether positive results were more likely to be fully published than non-significant ones.


CONCLUSIONS
It was surprising that only three of the 18 relevant RCTs had one or more full papers that reported the same outcome measures (and stage of analysis) as an earlier conference abstract. However, a limitation of this review is the small number of studies included. With a larger sample size than that in the present report, investigation into the effect of publication delay on decision-making might be feasible. Future research should include extension of this work to other anti-cancer drugs and investigation into the reasons for lengthy delays to full publication noted for some trials.
Takeda
A
A
Southampton Health Technology Assessments Centre, Southampton, UK.
Loveman
E
E
Harris
P
P
Hartwell
D
D
Welch
K
K
D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy*; D003245:Consensus Statements as Topic; D016206:Databases, Bibliographic; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D000077341:Lapatinib; D017239:Paclitaxel / Q000008:administration & dosage; D017594:Publication Bias; D011643:Publishing / Q000592:standards*; D011799:Quinazolines / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D043823:Taxoids / Q000008:administration & dosage; D013673:Technology Assessment, Biomedical / Q000592:standards*; D013995:Time; D000068878:Trastuzumab; D000093542:Gemcitabine
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D011799:Quinazolines; D043823:Taxoids; D000077341:Lapatinib; D003841:Deoxycytidine; D000077143:Docetaxel; D000068258:Bevacizumab; D000068878:Trastuzumab; D017239:Paclitaxel; D000093542:Gemcitabine