Manual catching up with the efficiency

In December 2017, I arrived in eCTD world to begin the electronic submission service by myself working at KCRN Research. It was the publishing instruction, and I had already thought of it as such from the perspective of an author of many scientific journal articles. But it was a technical instruction rather than a classical journal article one, and the instruction’s challenge, ‘us.regional.xml’ backbone — a type of eCTD submission standard — forced me to get familiar with the new language, xml. I was supposed to publish eCTD versions; the new requirements for eCTD publishing were scheduled increasingly to more regulatory documents as the FDA drove review efficiency. XML? Hmm.

Anyway, I had a working eCTD publishing on my arrival day, and I had one question to ask myself: “Should I learn the new language, xml?”

There were two main reasons for my concern. One was that the new language would be one of many technical languages that I would never be involved in, making me nervous about the wrong beginning of the unnecessary(?) topics. The other was that my efforts to learn new technical things would send myself into a person who would make things difficult rather than finding a more efficient way.

But as it turned out, the learning did contribute. The technical topic produced a “headache” in understanding the technical basics, but it didn’t last long. And more exciting, eCTD practice by myself eventually clinched over 100 technical submissions without major glitch problems.

Still, the memory of that arrival makes me a bit excited about the self-production where I am trying to expand more right now for another technical area. The “self-production” is contrary to taking use of bigger and larger men and system. And my own advocation is indeed for a minimal men and system in clinical research area: The minimal system does seem to be requiring bigger self-production, but I think it creates efficiency in some ways.

Trends in the clinical research world are moving towards more technical dependency than they’ve ever been. At least from a newsletter text mining with my eyes, I could easily lay out technical type texts for clinical research, thinking that clinical research money would increase and we have to pay back to get the technology in connection.

I think it’s too heavy for a single study goer. Technology-related tools must be made to cover all underlying situations in clinical trials, but many of the functions that have been devised in the tools may not be applicable in small and regional trials, where I would argue that manual skills are more effective and accountable.

Technology has made it substantially already and does it more in the clinical future. But, as I said, I think manual skills should be being a fit for some studies. But am I sure? Maybe not. I am just challenging.

The truth is that then, as now, the FDA is trying to increase the review efficiency with standard and highly formatted tools. Specifically, the FDA has implemented several measures to increase the efficiency of the drug review process, one of which is to implement new technologies, such as computer-aided datasets and common protocol templates, to help speed up the drug review process. I think of the FDA as the minimal system to follow in terms of technology— while trying to use manual skills to challenge the larger system.

Clinical research efficiency has become much more plausible than it seemed years ago. So, even if I agree with the process that could be streamlined with advanced technology, we might need to get manual skills anyway. I still believe in it.