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Replies to post #405122 on Anavex Life Sciences Corp (AVXL)
Determining Timelines
Once you have determined your key stakeholders, you will want to determine timelines to ensure steady progress continues to be made on the document. If you’ve chosen to utilize a scope document, you’ll want to include these timelines in it, so the entire team is aware of the project process, the timing requirements, and each gating item (key gating items are summarized in Figure 1).
Figure 1: Preparing, Writing, and Review of the Clinical Study Report—Key Gating Items
Preparation of Data Writing and Document Review
o Data cleaning and query resolution o Write non-results sections
o Plan tables, listings, and figures (TLFs) o Perform literature review
o TLF creation and revisions o Write results sections
o TLF editing o Cross team/stakeholder review
o Data-lock process o Incorporation of revisions
o Final TLF preparation o Finalize report for submission
Time management is paramount for clinical trial submissions to regulatory authorities. Attendees at medical writing conferences over the course of a five-year period (2008 to 2013, n=78) were surveyed to determine to how long each step of the CSR process can typically require.{8}
To complete a “moderately complex” CSR for a Phase III study with 200 to 400 participants, the surveyed medical writers responded with a mean answer of 16.9 days from the receipt of the final tables, listings, and figures (TLFs) to delivery of the first draft of the CSR. They estimated a mean of 25.7 days from the first draft to the final draft routed for review. The time from database lock to completion was reported to be on average 83 days.
The NDA process is not for the faint of heart. For the University of Iowa, it was a
consuming four-year journey. Although NDA submissions are fully electronic, the 68GaDOTATOC
submission was over 1300 pages and included over 200 hyperlinked documents.
This is a remarkably short application by NDA standards, with its brevity attributable to the
substantial use of literature for non-clinical sections (animal study and toxicity data), and orphan
drug specific rules that allowed for fewer subjects in the pivotal trials that supported the
application. For perspective, this is 10-100X shorter than a typical therapeutic drug application
for a non-orphan indication. For an academic institution, the planning, drafting, assembly, and
electronic submission of the NDA to meet formatting requirements requires contracting with
consulting firms. The cost of the drafting and submission process will likely run into the
hundreds of thousands of dollars.
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