Читать книгу Randomised Clinical Trials - David Machin - Страница 133

The results from the different centres will be analysed together and published as soon as possible. Individual clinicians must not publish data concerning their patients which are directly relevant to the questions posed by the trial until the main report is published. This report will be published under the name of the Asian Lichen Planus Collaborative Study Group listing all members of the group and any others contributing investigators.

In the event, the editor of the journal publishing the eventual report of Poon, Goh, Kim, et al. (2006) refused publication under a group name although a full list of contributors was permitted. Thus, collaborative groups may need to verify the policy of the target journals before stipulating a formal policy in this respect.

Example 3.27 also underlines an important requirement that individual groups should ‘not publish data concerning their patients which are directly relevant to the questions posed by the trial until the main report is published’. An important reason for this is that such publication can only (at best) refer to a subgroup of the total number of patients recruited to the trial. This number is consequently less than that stipulated by the design and so any analysis will be underpowered for the hypotheses under test. So, for example, such an analysis may report ‘no statistical difference’ in situations where the whole trial data may conclude the opposite. Premature publication by an individual group may also jeopardise the acceptance for publication of the report of the final trial results.