In my last posting, we were talking about the CDISC working conference where I mentioned that one of the highlights of the week was the FDA public webcast. In the past, sometimes these have included surprising announcements which have generated a flurry of activity as we all try to digest and respond to the latest announcement. This time around was a little different, but none the less curious.

Over the years, this public meeting has grown and changed in format. Back when I first became a CDISC volunteer, this meeting seemed like a cozy fireside chat between some FDA reps and some CDISC volunteers. Full of candor, it had the air of old friends catching up over a coffee. Maybe I have nostalgic goggles on. Maybe.

Today it has grown into a far more formal and inclusive event. Presenters now include representatives from the likes of PMDA in Japan and BioCelerate. The discussion between CDISC and FDA is also now more formalized with written questions being submitted in advance to eData, and an FDA representative giving pre-prepared answers with no provision for further questions or follow up discussion.

To the casual observer, the meeting itself would have perhaps seemed a little uneventful with the agency choosing to answer a few questions with fairly uncontroversial answers. However, scratch beneath the surface and there’s more to this story. To me, far more interesting is what was not said.  I’m referring to the fact that the original questions submitted included detailed background and assumptions regarding the scope of SEND before we got the actual 7 individual questions. The agency then chose to answer only 2 of these and chose not to respond to the other 5. Obviously, it is highly speculative to try to guess why the agency chose to respond to some questions and not others, but my personal opinion is that in not answering those questions, the message is being given that the ‘Scope of SEND’ section in the Technical Conformance Guide is clear and should be followed, regardless of the challenges it may bring. I say this because the questions that were not answered generally relate to the difficulty a few organizations face in following the Scope of SEND statement. In the presentation, the agency acknowledged that they didn’t answer the specific questions, but again wanted to reiterate the point that if the study is required to support safety decisions, and that if the study can be modeled in SEND, then it should be submitted in SEND. No matter the challenges that brings.

Some organizations and specialist SEND service providers are in a good place and already comply with the Scope of SEND statement. Yet, I am aware that there are some organizations really struggle with it due to lack of investment, resources or expertise. Also, some may not have adequately planned SEND into their timeline.

As I mentioned earlier, the event is more inclusive now, and interestingly it was the BioCelerate presentation regarding cross-study analysis that seemed the most controversial and provoked the most discussion. Soon the discussion turned to the question “is SEND for analysis, harmonization or exchange?” but I think that’s probably a great blog discussion for another day.

‘Till next time


Published by Marc Ellison

Self-confessed SEND nerd who loves geek-ing out about everything to do with SEND. Active CDISC volunteer and member of the CDISC SEND extended leadership team. Director of SEND solutions at Instem responsible for all our industry leading SEND products and services.