Tearing up the clinical trials rulebook

Richard Young explains why operational excellence will remain a distant goal unless we create a new rulebook that has the user experience on page one

New technology can disrupt the trajectory of traditional industries, and ours is no exception. This is what happened three or four decades ago when electronic data capture (EDC) burst onto the scene, eventually becoming the primary tool for data collection and management. Over time, there were important benefits. For example, it used to take 8 to 16 weeks for data recorded during a patient’s visit to appear in the data management workstream. With EDC, the lag time shrank from weeks to days and even hours in many cases.

Key changes introduced new tradeoffs. For example, traditional EDC shifted the responsibility of data entry from sponsors to sites, fragmenting the data model without addressing the underlying data collection challenges. During the pandemic, we witnessed another decisive break with the past when the industry introduced new processes and technology to enable remote trial oversight and execution. Patients benefited from new ways to participate in studies, but site users struggled to manage data from multiple offsite sources.

Today, similar tradeoffs prioritise the needs of one set of users (e.g., patients, sites, clinical research, regulators, or pharmacovigilance) over equally important stakeholder groups. Despite the industry’s best intentions, operational efficiency and scientific rigor are not in lockstep. Today, we are forced to choose between scientific excellence and trial execution improvement. It should not be a choice. We need a fresh approach to these challenges — one that places user experience at the centre of our efforts — if we are to deliver on the potential of digital clinical trials.

Renewed focus on simplicity and speed

At a recent Veeva event for more than 500 European R&D and quality leaders, the discussion topics were surprisingly consistent. The industry is increasingly frustrated with the silo-driven approach suppressing operational efficiency. Obstacles include fragmented data, inefficient processes, and the heavy demands of manual tasks, not to mention the difficulty of breaking long-established ways of working.

It’s easy to see how disjointed technology and processes could hinder progress in areas that should be advancing faster. In data management, for example, the complexity of today’s clinical trials means it is far more challenging to be efficient. Trials that were linear at the start of my career are now four-dimensional. We’ve morphed into an era of platform, bucket, and umbrella trials that require amendments after almost every visit. Tanya du Plessis, chief data and solutions officer at CRO Bioforum, summarises the challenge: “We’ve gone from linear to almost circular [in data management]. It’s hard to determine where one step starts and the other ends, and that’s not even accounting for the volume or veracity of data.”

It’s fairly common now to see studies with 15 or more data sources or types. Yet, as an industry, we are not at the point where our systems and processes can easily manage non-conventional data at scale. The outcome is patchwork solutions that require complex data integrations. Instead of more automation, we rely heavily on manual solutions (such as emails and spreadsheets) to track data queries and cleanliness. This makes the data manager’s job harder and does nothing to boost productivity.

Even more troubling, a siloed approach to complex trials raises the risk of poor decision-making. Companies have introduced technology to collect data from sources that did not exist (nor were accepted) by regulators until a few years ago. Millions of new data points have had a huge impact, slowing data cleaning and reviews. It has become critical to gain central oversight of these tasks that are now undertaken in a decentralised manner.

How can we create a more connected approach? First, we need to focus more on the total experience in clinical trials across stakeholders. I believe today’s clinical trials are like a complex Rubik’s Cube, with each side representing an important user group. Each time you try to solve a problem for one set of users, you need to specifically review the experience of other users to determine the overall impact. Just as you can’t solve a Rubik’s Cube with one move, the challenges we face in clinical trials are too big to address with one phase of digital transformation. Instead, we need to take incremental steps and focus our innovation efforts on eliminating daily time-consuming tasks.

For instance, data managers need better tools to aggregate, clean, and provide data with less manual effort. We can automate activities like data cleaning, medical coding, safety signals, and predictive analyses, which are all too often still on paper or in spreadsheets. Technology can also eliminate manual processes to simplify the data manager’s job, like end-of-study data or serious advance-event reconciliation.

Having a holistic view of clean and concurrent data is important. Not only does our database need to scale to match today’s complex clinical trials, but we also need the capability to harmonise data from multiple sources without custom coding. The data model we require needs to be simultaneously flexible to adjust to future trial requirements and robust enough to handle today’s complexity.

Catalyst for more productive trials

There are more tools available than ever before and greater opportunities to run studies more efficiently. However, by introducing an avalanche of new systems, we have significantly increased the burden on users with seemingly few efficiency gains.

If we are to make a real difference in productivity, the priority should be to work with sites to understand their frustrations and burdens. On the patient side, simplifying the number of tools patients use could improve participation and choice. Then, we can move on to offering them a consumer-grade experience that meets specific needs, such as easy methods of reminder management or dispensing and travel support.

The shared objective of the life sciences industry is to ensure that the right patients can participate in the right clinical studies. This means ensuring they are enrolled as quickly and seamlessly as possible. We are responsible for accelerating this process so that medicines and therapies can be delivered to the broader patient population as fast as possible. The time is right to embrace new ways of working. With a combination of optimism, pragmatism, and impatience, we could write a new rulebook that leads to enduring change.

Richard Young is with Veeva Systems

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