What Is Clinical Trial Tokenization?

By Dan Schell, Chief Editor, Clinical Leader

Before talking to Tom Dougherty of Pfizer, did I know what tokenization meant in regard to clinical trials?

No, I did not.

Do I understand it now? Absolutely, and so will you if you attend his SCOPE Summit presentation titled, Fit-for-Purpose Use of Various Types of Tokens. Dougherty is director, RWE partnerships and innovation, RWE Center of Excellence, at Pfizer, and he assured me I’m not the only one who hasn’t heard of tokenization; he says it’s only been used in clinical trials for about three years.

Basically, tokenization means transforming PII (personally identifiable information) elements — first name, last name, gender, date of birth, zip code — into a unique identifier or “token.” That token has no meaningful value except it deidentifies all that PII in a uniformed way. A patient at a clinical site would have to consent to having their data turned into a token, but there’s a big upside for them. Once a sponsor has that token, they can send it to real-world data vendors such as Optum or Komodo to match that token to their data. “Then we can follow patients long-term in a very passive way,” explains Dougherty. “In a typical trial, you keep sites open for 5-10 years for long-term follow-up. Now you can tell patients they don’t have to come in for all those post-trial visits; we will follow them through real-world data.”

As you can imagine, not every trial is a fit for tokenization. For example, rare disease trials with less than 50 patients may not be as valuable as, say, a vaccine trial with thousands of patients. The chances of matching real-world data with those 50 patients are low. In fact, this will be the crux of Dougherty’s SCOPE presentation — figuring out what studies makes sense to use tokenization. 

I liked the whole patient-centricity angle of tokenization with it reducing future patient site visits, so I asked Dougherty why sponsors would not pursue this. Of course, cost is one factor; you have to pay companies to deidentify that data and create the tokens. But really, he says companies can recoup those costs on the back end since they’re not having to keep sites open for many years. Concerns over patient privacy are often a concern when consenting patients. But still, he says that, and the concerns of how this affects a trial’s workflow, can be overcome with more education. What kind? Well, you’ll have to attend his presentation and find out!

See you there!