About 15 years ago, when I visited a client's office to promote a certain EDC system, I would use the following catchphrases.
"By implementing this system, costs will be reduced by 20% compared to the conventional process."
"Compared to the conventional system, the work speed will be 1.2 times faster."
"As a result, the necessary subject data will be collected about two months earlier."
At the time, the client was said that "There is no way we can shorten the time by two months," but after one or two years had passed since the system was went to production, a number of clients began to make requests like:
"Since we started using EDC, subject entollment has become smoother, data cleaning time has been shortened, and we have even reached database lock two months earlier than the period written in the protocol. I'm sorry, but I don't want to pay the license fee for the remaining two months, so can you do something about it?"
This caused a difficult situation for the sales team.
To be honest, we thought that EDC would speed up data cleaning a little, but we didn't expect that it would make subject enrollment smoother, so we were all surprised by the unexpected effect. It's true that the implementation of EDC has reduced costs by 20% and improved work speed by 1.2 times, which was a groundbreaking event at the time, and it was a very good experience to be able to witness such an event.
On the other hand, I introduced the concept of EDC at the 3rd DIA Japan CDM Workshop in January 2000, started demonstrations of EDC in 2003, and started collecting actual clinical trial data with the EDC I built in 2006. By 2006, the current system format and work flow had been established, and although the system itself has been upgraded to add functions and new UIs have been introduced, it is clear that we have been using a system with similar functions and a similar workflow for nearly 20 years since EDC began to be used in Japan.
It's 2024 now, so from the perspective of DX, systems and business processes that are more than 20 years old should be subject to improvement, and since they are old, there is room for improvement everywhere.
And in terms of timing, by using AI systems that have appeared in recent years, especially since the COVID-19 pandemic,
"By introducing this system, the cost of monitoring will be reduced to one-eighth compared to the conventional process"
"The speed of creating SDTM will be 10 times faster than before"
"Case data that previously took 1.5 years to collect can now be collected in one year"
Systems that make this possible are appearing, and we are starting to see actual results. (See previous column)
These AI systems are particularly good at replacing or making extremely efficient the work that was previously performed by skilled technicians based on their many years of experience and intuition, or the work that was previously performed by high-cost personnel who spent a lot of time on processes that were not scientific. It can be said that this is the true essence of DX, which is "to provide a better experience than before by combining information technology with social, cultural, or economic activities."
Below is a video showing how replacing EDC with Akyrian's SDE can eliminate SDV, a data matching task commonly used in clinical trials.
Currently, most of the data collected in clinical trials, such as Electronic Medical Records, Lab test values measured in central laboratories, and ePRO data, are generated and recorded in electronic form from the generation stage, so it should be possible to collect them as is from data source directly. However, with EDC, the task of transcribing (re-entering) data from Electronic Medical Records to EDC is required, so in order to ensure the authenticity of the data, SDV, which is the process of comparing the data entered into the EDC with the data recorded in the Electronic Medical Record, is necessary. This has not changed even now, more than 20 years after the dawn of EDC. On the other hand, it is said that the cost of SDV accounts for 15% to 20% of the total cost of clinical trials, and if it becomes possible to abolish SDV by directly importing Electronic Medical Record data, there is no doubt that the cost of the entire clinical trial will be reduced and the speed will be increased.
The concept of direct data extraction (Source Data Capture, SDC) of clinical trial data from Electronic Medical Records was already being considered when EDC was introduced, and it was said that "EDC will soon be replaced by SDC." However, even now, more than 20 years later, no satisfactory SDC system has emerged. Akyrian SDE is a data extraction system from Electronic Medical Records developed to overcome this problem, and is a system that can extract 100% of the data stored in Electronic Medical Records. We hope that in the near future, SDE will replace EDC, and clinical trials will evolve to the next stage.