The $20 Million advantage: What decentralised trials are really worth

By Graham Wylie · Chair and Chief Executive · Medical Research Network

For as long as I have been making the case for decentralised trials, I have had the same quiet problem.

The argument is a good one: bring the trial to the patient, recruit faster, keep people in the study, and spend less chasing them. But most of the evidence behind it has been ours – our data, our studies, our numbers. Persuasive if you already believe it; less so if you are a project director being asked to sign off a new way of running a trial.

So when an independent, peer-reviewed paper puts a hard figure on the value of a decentralised trial, it is worth looking at carefully. This post is based on the most recent of those studies into the ROI of decentralised clinical trial (DCT) solutions.

The paper comes from the Tufts Center for the Study of Drug Development (DiMasi and colleagues, published in Therapeutic Innovation & Regulatory Science). The DiMasi name will be familiar to anyone in drug development; his group produces the cost-of-developing-a-drug figures the whole industry quotes.

This time, they pointed their model at decentralised methods and asked the question I am asked in every commercial meeting: what is a DCT actually worth?

The headline number

Their answer, in one line:

Applying decentralised methods across Phase II and Phase III adds about $20 million in value per drug that enters Phase II—a roughly seven-fold return on what it costs to put those methods in place.

Broken down across phases, the financial return becomes even more striking:

• Phase II: Adds ~$8.8 million of value per drug (around a 5x return).
• Phase III: Adds ~$41 million of value per drug (around a 13x return).
• Across both phases: Roughly $20 million per drug entering Phase II (around a 7x return).

The Investment vs. Return

The decentralised methods cost approximately $473,000 per Phase II trial and $1.04 million per Phase III trial. Across the four Phase II and three Phase III trials a drug typically requires, that is the baseline spend against which the 5x to 13x return is measured.

The value calculated here is expected net present value, risk-adjusted across the entire development programme. While it is not a cheque you bank immediately, it represents a sophisticated, independent view of future commercial return.

Where the value actually comes from

As you might expect, the value does not primarily come from cutting operational costs. It comes, overwhelmingly, from time.

The single biggest lever in the Tufts model is cycle-time reduction – getting through each phase faster.

1. Faster recruitment
2. Better patient retention
3. Fewer stops and starts

These factors shorten the development timeline, bring the market launch forward, and lengthen the patent-protected window in which the drug actually generates revenue. While fewer protocol amendments and lower screen-failure rates help, they are secondary. The money is in the speed.

A decentralised trial is not primarily a cost-saving exercise. It is a cost-neutral or low-cost, time-saving exercise. In drug development, speed is everything – whether that means speed to market or speed to drug programme termination. Both are highly valuable.

Fewer hospital visits – and the catch

Dig under the cycle-time numbers and you find a single mechanism doing most of the work: fewer visits to the site.

Every visit you take away gives a patient a reason to say yes at consent, a reason to stay in the study, and saves days lost to chasing follow-ups.

However, notice that the paper measures value solely from the perspective of the drug developer. The benefit to the patient – less travel, less disruption, less of their life handed over to the trial – is real, but the authors deliberately leave it out of the $20 million figure. It sits on top, uncounted.

The catch in removing visits

There is a catch in how you remove visits that is somewhat hidden by the headline impact. The Tufts study is built almost entirely on the light, app-and-device end of decentralisation (low and ultra-low touch trials) – about nine in ten decentralised protocols used apps, wearables, or electronic data.

• Moving workload vs. removing workload: Shift a visit off-site with an app, and you have not removed the work; you have simply moved it onto the patient, who must now record the data themselves.
• Usability requirements: The technology must be genuinely consumer-ready – as effortless as the apps people use every day, supported by user-friendly patient infrastructure. A patient will not do at home what a coordinator is paid to do at a desk. If the tech is cumbersome, the burden simply reappears elsewhere.

The hybrid advantage: Technology + Home nursing

This is where a fully supported home healthcare model differs in kind, not just degree:

• True burden reduction: When a healthcare professional or nurse visits the patient, the trial visit genuinely leaves the hospital, and no new workload lands on the patient.
• Complex administration: In trials requiring repeated visits for the trial medication itself to be administered, an app cannot help – you cannot dose a patient through a smartphone.

When you combine consumer-ready technology for data capture with qualified home nursing for hands-on care and administration, you achieve results far greater than either approach alone. This is the primary reason why this independent $20 million figure – large as it is – actually understates the true value of the comprehensive models we run at MRN.

Key takeaways

1. The value is proven: Decentralised trials now have an independent price tag – roughly $20 million in value per drug entering Phase II (a 7x return).
2. Speed drives ROI: Value comes from cycle-time reduction, bringing forward product launch and extending the patent-protected earning window.
3. High-burden trials benefit most: The study highlights oncology and rare disease trials – where home nursing and technology have the greatest impact – as delivering the highest returns.
4. The decision is clear: If you are weighing up whether a decentralised design is worth the investment, the evidence is simple: it is worth far more than it costs.