Christopher M. McSpiritt

Product Strategist

Business Architect

Go-to-Market Strategist

eClinical Enthusiast

Business Consultant

Christopher M. McSpiritt

Product Strategist

Business Architect

Go-to-Market Strategist

eClinical Enthusiast

Business Consultant

Blog Post

Documents Must Die: Embracing a Data-Centric Future in Clinical Trials

October 2, 2024 Uncategorized

Documents: Let’s Rethink Our Approach in Clinical Trials

Let’s talk documents. Love them or hate them, they’ve been a part of our world for, well, forever. Think back to the earliest days of human communication—cave art in places like El Castillo Cave in Spain, drawn over 40,000 years ago. Over time, we evolved through hieroglyphics, handwritten manuscripts, printing presses, and eventually, the bane of most office workers: Microsoft Word. And sure, Word made life easier for a while, but in the clinical trials world, we’re still tangled up in a web of documents. It’s time to rethink that.

Documentation: Why We’ve Always Done It

Documents have been essential for recording information and sharing it. We use them to lay out plans, pass on knowledge, provide instructions, formalize agreements, and track progress. From ancient scribes to today’s endless reams of trial-related paperwork, the reasons for documenting haven’t changed much. But here’s the thing: the world has moved on in so many ways—shouldn’t our documentation processes?

In clinical trials, the situation has reached ridiculous levels. The TMF (Trial Master File) Reference Model alone defines around 200 different document types, each one serving its purpose in executing a trial. We document to manage trials, protect patient safety, and show regulators we’re compliant. But what started as a necessary part of clinical trials has become overwhelming. If you’ve ever seen a clinical trial’s documentation stack, you know it’s a mountain—not just of paper but of inefficiency.

The Slow Evolution of Clinical Documentation

We’ve made some improvements over time, moving from rooms filled with hardcopy documents to shared drives, and then into optimized document management systems. But let’s be real: we’re still far from where we should be. Even with all the advances, we’re still relying on a model that’s been around for decades. We’ve taken baby steps when we need to be sprinting.

The problem is bigger than just using Word docs or PDFs. The entire process is manual, and that’s a huge issue. Teams are managing massive amounts of documents, often manually entering and re-entering the same information across different systems. Worse yet, we’re following rules created for paper documents in an era when data could—and should—be doing all the heavy lifting.

Why Documents Don’t Cut It Anymore

Let’s break it down:

1. Manual Everything: Documentation requires so much manual work, it’s insane. Dozens of people are often involved in managing these documents, with roles specifically designated to own and oversee documentation processes.

2. Data Lockdown: The information we painstakingly enter into these documents? It’s locked away. Once it’s in a doc, pulling it out or using it in other ways becomes a major hassle.

3. Repetition is the Name of the Game: We’ve all been there—copying and pasting between documents because one system doesn’t talk to another. It’s not just time-consuming; it’s prone to errors.

4. Stuck in the Past: The processes we follow are often designed for paper documents, even when we’ve gone digital. Someone drafts, someone reviews, someone signs, and someone files it away—rinse and repeat. The method is old-school and it’s not keeping pace with what today’s technology can do.

Reimagining the Future: Data Over Documents

Now imagine this: what if we could throw out the document-heavy process and instead, shift to a model where everything is driven by data? When we plan a clinical trial, instead of generating a mountain of protocol docs, we’d input the key information into a data-centric system. That data could then populate downstream systems and automate the creation of necessary documents on an as-needed basis.

But it doesn’t stop at reducing paperwork. This data-centric model could help with so much more: automating configurations, visualizing processes, and speeding up the workflow. For example, a well-designed trial could automatically influence the specs of databases, CRFs, and even statistical programming. The key here is that we wouldn’t be eliminating documents entirely, but rather, letting them be the byproduct of a smarter system—automated and derived from the data we already have on hand.

Who Benefits from a Data-Centric Approach?

Pretty much everyone involved in clinical trials stands to gain:

Patients: They’d have a better understanding of the study, especially if we move to more interactive consent processes instead of burying them in paperwork.

Trial Sites: Imagine sites having to create fewer documents because the system already knows so much about them. We’ve been pre-populating certain forms for years—it’s time to extend that logic further.

Study Teams: Instead of manually combing through document after document, study teams could rely on system-generated reports, drastically cutting down on time spent reviewing documents.

Regulators: Risk-based approaches could be driven by data reports and analytics, meaning regulators could focus on what truly matters rather than checking boxes on a document checklist.

Making the Shift to Data

So, how do we get there? It’s not an overnight fix, but there are steps we can take to start moving in the right direction:

1. Boost Data Literacy: The more people in the organization understand and are comfortable working with data, the easier this transition will be. It’s about changing the mindset from documents to data.

2. Challenge Documentation Norms: We need to critically evaluate why we’re documenting certain things. If a system already tracks it, why are we still documenting it?

3. Build the Right Infrastructure: A solid data infrastructure that connects with our transactional systems will be key to making this vision a reality. This infrastructure needs to store, manage, and integrate data across the entire trial lifecycle.

4. Create Data-Driven Interfaces: Developing user-friendly interfaces that align with workflows will make the shift easier. We still might need to render documents here and there, but the focus should be on managing the data.

Time to Move Forward

The benefits of moving to a data-centric approach are undeniable: faster workflows, better decision-making, enhanced collaboration, and cost savings. More importantly, it will help us comply with regulatory requirements more efficiently and bring life-saving treatments to market faster. We’ve been chained to documents for long enough—it’s time to rethink how we manage information in clinical trials. The future is here, and it’s driven by data, not documents. What are we waiting for?