“Draft First Full Report” means the draft report based on the Main Master File describing the main objectives of the Phase III Clinical Trial and the outcomes and intended for publication, prepared by a writing group appointed by the Trial Steering Committee;
“Draft Supplementary reports” means any draft reports based on any Supplementary Master Files intended for publication subsequent to publication of the First Full Report, prepared by a writing group appointed by the Trial Steering Committee;
“First Full Report” means the final published report based on the Main Master File describing the main objectives of the Phase III Clinical Trial and the outcomes;
“Summary of Main Initial Findings” means a written report comprising a summary of the main findings of the Phase III Clinical Trial and the main conclusions supported by the initial analysis of the Trial Data pursuant to the Analysis Plan and intended for early release pending the preparation of the First Full Report;
“Supplementary Master File” means a set of analyses on which any Draft Supplementary Reports for publication from the Trial Steering Committee shall be based and prepared pursuant to the agreed Analysis Plan;
“Trial Data” means case record forms and related material (including copies of correspondence, hospital and clinic notes and discharge summaries, relevant information from telephone conversations and site visits) on individual participants received from the Centres and laboratory results obtained from the laboratories participating in the Phase III Clinical Trial. All such data will be anonymous;
(E) Confidentiality, publication of data and intellectual property rights
Access to and publication of data
28. The Draft First Full Report shall be agreed for publication as the First Full Report by the Trial Steering Committee (Indevus shall be entitled to attend but not vote at Trial Steering Committee meetings). It is anticipated that the First Full Report will be finalised ready for submission for publication within six months’ of the final trial participant’s follow-up visit. The Draft First Full Report and any Draft Supplementary Reports shall be circulated to the Trial Steering Committee together with a representative from Indevus (who will receive the reports under an obligation of confidentiality). The Trial Steering Committee will specify the deadline for receipt of any comments on the Draft(s) (to be at least 20 days from the date of circulation). The Trial Steering Committee may simultaneously release the Main Master File and any Supplementary Master File to the recipients of the Draft First Full Report (who will receive such documents under the same obligation of confidentiality).
29. In the event that the Trial Steering Committee decides that a Summary of Main Initial Findings will be necessary or desirable in the public interest, then it will prepare such a summary. All revisions of that document and the initial analyses on which it is based shall not be circulated outside the Trial Steering Committee (plus a representative of Indevus) and all recipients shall receive it under an obligation of confidentiality. Recipients of the summary document shall have an opportunity to submit their comments prior to finalisation of the document by the Trial Steering Committee.
37. It is expected that findings of the Programme will be published in the appropriate scientific literature, whatever the findings show. The Programme Management Board will be responsible for any publication of the Trial Data as set out in clause 38 below. The MRC will use reasonable endeavours to ensure that the Centres do not publish the Trial Data or any part of it without the prior written approval of the Programme Management Board.
38. The MRC will require the Centres to submit draft abstracts and full papers to the Programme Management Board for prior approval not less than 30 days prior to submission for publication. The Programme Management Board will circulate draft abstracts or papers to Indevus for comments within 1 week of receipt from the Centres. Indevus may, within 2 weeks of receipt of the draft abstracts or papers, submit comments to the Programme Management Board for consideration, or request a delay in publication of up to 30 days. An appropriately worded acknowledgment of Product supplied by Indevus in any publication will be agreed.