Quality of reporting of phase II trials: a focus on highly ranked oncology journals

Abstract

Background: Phase II trials represent an essential step in the development of anticancer drugs. This study assesses the quality of their reporting in highly ranked oncology journals, investigates predictive factors of quality, and proposes reporting guidelines.

Patients and methods: We reviewed the table of contents of all volumes of eight peer-reviewed oncology journals published in English between January and December 2011 with a 2011 impact factor (IF)>4. Two reviewers assessed the quality of each report by using a 44-point overall quality score (OQS). Primary end point definition, justification of sample size, and definition of the evaluable population, were assessed separately to establish a 3-point key methodological score (KMS). Exploratory analyses identified predictive factors associated with scores.

Results: One hundred fifty-six articles were included. The median OQS was 28 (range: 9-35). OQS subsection analysis showed that reporting of statistical methods was low with a median OQS of 3. Median KMS was 2 (range 0-3). Primary end point definition, justification of sample size and definition of the evaluable population were reported in only 107 (68.6%), 121 (77.6%), and 52 (33.3%) cases, respectively. At multivariate analysis, registration on clinicaltrials.gov and IF>10 were associated with improved OQS. No associations for KMS were observed.

Conclusion: Phase II trial reporting is still poor even in journals with strict editorial policies. This may lead to biased interpretation of phase II trial results. Besides using a checklist during the preparation of their manuscript, authors should also provide reviewers and readers with the last version of the study's protocol.

Keywords: clinical trials; oncology; phase II trials; quality of reporting.