futurpositif

Since early 2019, I have paid close attention to TransCelerate’s “process harmonization” portfolio of initiatives:

• Clinical Content & Reuse
• Digital Data Flow
• eSource (now via the HL7-FIHR Vulcan Accelerator)

For most of that time, I have been a very active participant in one or more of these, and for the past while, I’ve been actively partnering and supporting team members and organizations who continue to do this important work.

The theme that connects these initiatives is summed up with the tagline “breaking the document paradigm.” What does that mean?

An analogy about money

When you use accounting or tax preparation software, you appreciate that there are a few ways of getting your financial information into those platforms. You can take paper copies of your receipts, expenses and statements (if you still receive them that way) and type the information into the software. Or you could copy-paste the information from a .pdf version.

What many of us do, though, is to integrate our banking, credit card and other accounts directly into those platforms to save that manual re-entry. When it’s time to create financial statements or file tax returns, the information is already there to be used for reporting or whatever purpose we intend.

In many ways, we have gone beyond documents as a way of capturing and transmitting our financial information to make it more useable and mobile.

What about clinical research and drug development?

When we create documents that describe clinical research, either the description of the procedures for how a clinical trial will be done (a Study Protocol or a laboratory manual, for example), or a report of the observations and conclusions from that trial (a Clinical Study Report), the product is still largely document-based, even if those “document” formats are electronic, like .docx or .pdf. The first step for anyone who wants to use that information, is to extract the information from the documents and move it into a more accessible format or system.

What TransCelerate’s Process Harmonization initiatives share is the vision of changing that: What if information could be recorded in a “digital” format, as close as possible to where it’s created, then reused by all the downstream systems that need that information?

Such a vision could also include enabling the capture of study observations directly from a medical record at a clinic, and ensuring the required study procedures and schedule can be “read” into a medical clinic’s health records system (i.e., the eSource initiative).

From truckloads of binders to a shared platform for data submissions

The vision also extends to shifting the way study data are eventually compiled and sent to regulatory bodies to support the approval of a new treatment.

When I started in the industry, a New Drug Application consisted of literally truckloads of documents. Things have evolved, and we are no longer even sending truckloads of digital media (like CDs or optical discs). More than 95% of submissions are transmitted electronically. But the information contained on those submissions often summarizes study observations within hundreds or thousands of .pdf files. The vision of “breaking the document paradigm” also refers to digital documents, so the information can be in its most useful format.

While thousands of .pdf files is certainly an improvement over thousands of paper documents, there’s still more work to be done.

Documents as outputs, not inputs

Of course, there is still value in being able to visualize data that’s well laid out in a traditional document format. Without that structure and visual organization, it’s difficult for us to make connections and inferences, or to draw conclusions consistently. But rather than using document formats as our primary container for data and observations, documents can be utilized as a format to collect and organize outputs. The data exist primarily in their accessible and reusable digital formats, and can made available to any downstream use, including representation in a traditional document-based reporting format.

Moving the needle

Given that a single Study Protocol can represent several hundred pages, and regulatory submissions for New Drug Applications can run to millions of pages, this is no small effort. There has been significant progress across the industry in the past few years. Drug development has the benefit of learning from other industries and the vendors that have supported efforts there.

I am proud to play a small part in addressing this challenge. While “separating information from documents” sounds obscure and perhaps a little nerdy, we know that it will make a big difference for the patients who are waiting for us to develop new insights and new treatments.