February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations
One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy (SCE), the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE).
Why is publishing these clinical summaries difficult? And more importantly, what can we do to make this process easier?
Why is Publishing Clinical Summaries Difficult?
Before we can understand how to make publishing clinical summaries easier, we have to first understand why they are difficult.
Here are my reasons. You may have others!
- They’re big
Although there’s a page limit on the SCS and SCE, there’s no limit on the ISS and ISE. I worked on one ISS that was 1300+ pages. Documents that big provide special challenges even before you get to the publishing stages.
- They’re high-profile
With the exception of the label no other documents are under as much scrutiny as these summaries. Why? Because the claims made in the label have to be supported by these documents. Consequently almost everyone will want to look at these, possibly even people from commercial.
- They’re usually among the last documents to arrive at publishing
Because they can’t be finalized until the last study is completed and analyzed, these documents usually get published at or near the very end. Thus they’re always on the critical path.
- They reference LOTS of different data sources
In terms of publishing, this is the biggest challenge.
These summary documents typically have their own source tables and figures. In addition, they’ll reference source tables and figures from individual study reports. And if that wasn’t bad enough, these tables and figures can and often do have exactly the same numbers.
Furthermore, they’ll reference in-text tables and figures from study reports, and those tables and figures may have the same numbers as the in-text tables and figures within the summaries. How do you know which one the writer meant to reference?
You need to make sure that you and the writer are on the same page when these tables and figures are being referenced (more on that later).
There isn’t much we can do about those first two bullet points but there are things you can do about the others. Let me explain.
Work Closely with Your Publishing Tool Vendor
I can give you general advice based on my experience with my publishing tools, but here’s the first thing you should do to make publishing your clinical summaries easier:
Contact your publishing tool’s vendor
You may never have published an NDA or MAA before but almost certainly someone else using your tool has…and your tool’s vendor probably helped them!
Before you start publishing your NDA/MAA, contact your vendor and ask them for advice on best practices. They have a vested interest in seeing you succeed because they’ll be able to tell potential customers about your submission. They also want you to do well because they don’t want you bad-mouthing their product.
I simply can’t stress this one enough. If I had contacted my publishing tool’s vendor earlier, I might have learned a tip that would have cut my NDA publishing time by 20%! That’s big.
Work Closely with Your Medical Writer
If you and your medical writer work together you can reduce the publishing time and avoid the unexpected. Here are a couple of ways I work closely with IMPACT’s medical writers to save myself time.
- Figure out how you want things referenced and communicate it to the medical writers
This is the most important thing to do.
You want to eliminate any possible confusion about which table or figure they mean. Come up with a standard based on how you plan to link to data sources. If you’re using some form of a keyword linker, you need the writer to reference tables and figures exactly the same way each time.
For example: CSR X, Table 1.1.1; CSR Y, Table 1.1.1; ISE Table 1.1.1
- Work with your medical writer throughout the writing process
No one wants to get surprised by anything at the very end, right?
Ask your medical writer for early drafts of the summaries and if you have time (yeah, I know…) try running them through your eCTD publishing tool or at least rendering them to PDF. Also, talk to your writer and ask what, if anything, you can do to help get the documents done early. Every hour you buy them is another hour you’ll have available if something does go wrong.
Other Suggestions
Here are some other suggestions to help make publishing clinical summaries easier:
- Do as much work as you can before the final documents come to you
Depending on what your vendor told you, you might be able to partially link the summaries before they’re final (yes, really!). We use a keyword linker tool to do this with CSRs and it’s a huge timesaver.
- Develop a plan for QC findings
If your organization doesn’t have an SOP for these kinds of things, you’ll want a plan to deal with changes requested by the QC reviewers. As an example, let’s say a summary referred to Table 18.3.2 and they meant Table 8.3.2. Depending on your tool, fixing the text might require that you completely republish and relink the document, while simply changing the link would probably take about 30 seconds. I know which fix I would pick, but the people making the decisions may choose differently.
If you’d like to learn more about this topic, come listen to my talk at the DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum on February 10th from 1:30 to 3:00pm in Bethesda, MD where I’ll be co‑presenting with two medical writers on the topic of the handoffs between medical writing and publishing.
Category: Regulatory Operations
Keywords: NDA publishing, Module 2.7.3, Module 2.7.4, Summary of Clinical Safety, Summary of Clinical Efficacy, Integrated Summary of Safety, Integrated Summary of Efficacy, ISS, ISE, SCS, SCE
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