Benefits of Submitting INDs in eCTD Format

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On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference attendees included a number of smart and experienced eCTD professionals. During a round-table session, I asked the group if they were submitting INDs in eCTD format, and if so, why they felt there was value in doing so. I asked this question because at this date only 12% of INDs are submitted in eCTD format, and I’m curious as to why the number isn’t higher.

The answers surprised me a little. Almost everyone in the group exclusive of CROs (obviously captive to the wishes of their sponsors) had converted all active INDs to eCTD format. (It should be noted that all the respondents have marketed products at this point.) Their rational in doing so included:

  • Aversion to maintaining the overhead of two processes (one paper and one electronic) as they felt it would be confusing to their authors and publishers. Training on a single process is a big plus.

 

  • Development of a healthy aversion to paper, or “tree killing” as they put it.

 

  • Identification of eIND as an important training ground for their authors and publishers, giving them both experience and confidence for producing eCTD NDAs.

 

  • Potential for re-using documents such as M4 nonclinical study reports in an NDA (although most companies reported that they were re-submitting content in this case, not pointing to IND content – see my previous post Cross Application Links in eCTD for a discussion).

 

  • Increased attractiveness of an eCTD formatted product to a potential buyer (although they be acknowledged that this would not always be identified by the buyer.

 

  • Highly increased ability to communicate with the FDA when questions are raised. Information is on the user’s desktop instead of a remote archive.

Overall, support for eCTD IND was very strong in this group.

So why are so many INDs still in paper? The consensus was that for companies with only one product, investigator INDS, etc. the investment, even if modest, was probably not justified. However, the group felt that companies with marketed products submitting NDAs in eCTD format should strongly consider creating or switching their INDs as well.

Author: GS

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