“You wait all day for a bus and then 3 come along at once.” It’s a phrase I used to hear a lot in my younger days when I would often ride public transport. There’s been some of that going on this week, though not with busses. For me, this week it’s been the role of SEND in Historical Control Data (HCD) systems.

It must have been a year or two since this topic last cropped up, but this week, completely coincidentally, it’s been raised several times by different people in completely different contexts. When that topic is raised, immediately people start considering the role of standardized data, and the possibilities SEND brings.

Any potential HCD system has three components:

  1. A large wealth of data to draw on
  2. A way of harmonizing those data, particularly when the data come from different sources utilizing different structures and terms
  3. A tool to query, aggregate and visualize the data

As an organization that for many years was simply a software vendor, tool development and data harmonization would have sat well within our comfort zone. Yet without being able to draw on a significant volume of electronic data, there wasn’t much value in developing such tools.

The SEND standard is now opening that up as a possibility. This is because more data are becoming available since CROs are no longer just supplying the PDF study report, but also providing standardized electronic data.

Standardized data means consistent data, regardless of CRO or data collection system. That’s the idea that really opens up the possibilities for HCD systems. That final stumbling block to the value of a system, is now overcome.

As well as some organizations drawing on their own data, others are considering the possibility of pooling their control data. It’s an intriguing possibility. Some SEND tools, like Instem’s SEND Explorer, already have build-in visualizations for querying Historical Control Ranges. These would provide far more value when hooked up to such a vast database. This then came with questioning if there’s need for independent curation of the data, and maintenance of the database.

Anyways, having not thought about HCD for a while, I was asked about it in the context of our own data collection systems, then a query about SEND Explorer’s functionality, and then the possibility of data curation. “Just like busses, three come along at once.”

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.