Go Together

“If you want to go fast, go alone but if you want to go far then go together.” _Proverb

I don’t like moving slowly. I like to feel that things are moving quickly, and the end is in sight. I can become frustrated when things do not move quick enough. Yet, I continually see the value of the slower pace of going together.

While something that can be applied to many areas of life, it’s particularly true of standards development. I oversaw the development and eventual publication of SEND 3.1.1. Despite being an important yet relatively minor change, it literally took several years to go from idea to eventual publication. Many committees needed to approve, and many key stakeholders needed to be on board. The consultation was extensive, soliciting feedback across both nonclinical and clinical.  Much time was spent debating the possible use of ADaM (clinical analysis datasets) instead of SEND. Though it was slow, there is certain rigor which comes with going together.

SENDIG-DART v1.2 is just completing its 3-month public review. It feels like it’s taken an age to complete. Even getting to public review felt slow and arduous. We are currently scheduled for publication early in 2023 and even then, we’ll be years away from it being required by the Data Standard Catalogue.

Again, though it has felt slow, the truth is that the reviews and scrutiny result in a significantly improved standard. The multiple reviews and reviewers have ultimately been a huge benefit to the implementation guide. CDISC has a more rigorous process now that demands an example ‘proof of concept’ study along with conformance rules. Previously such things would be produced after publication. Now they are required before public review, far in advance of publication. The result is a better product, but at the expense of speed.

The eventual publication of SEND 3.2 will have taken significantly longer than the publication of SEND 3.1, but again with the benefit of having a far wider range of contribution and a more rigorous review process.

So, yes, the standards development process seems slower than ever and seems to require more effort now than it ever has before. But that’s the cost of going together.

‘til next time

Marc