Ever wonder how researchers keep human bias out of clinical trials? Or how the millions of units of experimental medicine that go to patients all over the globe are tracked? It starts even before the medicines are shipped out.
For any major pharmaceutical company that provides potential therapeutics to hundreds, or even thousands, of clinical trials being conducted all over the globe at any given time, the complications of the task are truly staggering.
Not only do the potential therapeutics have to be delivered on time, but they’re often refrigerated, and also have to be packaged in a way that ensures that people get the correct dose at the correct time of day, despite all the distractions of daily life. In the case of placebo-controlled, double-blind studies, the packages are often “blinded” — that is, the placebo and the potential therapeutic being tested are made indistinguishable — even before they reach the hospital or clinic where the studies are taking place.
One of the people overseeing this complex task at Pfizer is Michael Ku, Vice President of Global Clinical Supply (GCS), who supervises the delivery of more than 1 million packages a year to over 70 countries for clinical trials and compassionate use cases, also known as “expanded access.”
But it’s not just about the logistics for Ku.
“Clinical trials are what allows us to bring new medicines to patients,” says Ku, whose background includes years working at patients’ bedsides in a hospital as well as a pharmacy doctorate. “As a clinical pharmacist who has previously worked in a hospital setting, I have experienced firsthand the complexity of executing clinical trials from a clinical site perspective, and we are always looking for ways to make the clinical trial experience easier and more efficient for subjects and clinical sites.”
And that unique experience has informed innovations to what’s known as the “digital clinical supply chain” that are now being emulated by others in the industry.
Supporting Clinical Trials With More User-Friendly Medicines
One of those innovations is something called the Clinical Research Pharmacy (CRP) team, which finds ways to deliver the potential therapeutics in a more user-friendly way. For example, if the subjects in a study have rheumatoid arthritis, it may be as simple as providing bottles that are easier to open with arthritic hands. Or it could involve working with parents to find ways to deliver liquid medicines to toddlers always on the go.
We have to have empathy when we're going to make clinical supplies.
“We have to have empathy when we're going to make clinical supplies for those populations,” says Ku, who’s based at Pfizer’s facility in Groton, Connecticut. "As a clinical pharmacist previously working in a hospital setting, I have experienced firsthand the complexity of executing clinical trials from a clinical site perspective. Having what we do on the lab bench translate to a real-world clinic matters to the folks who actually have to take care of the patients.”
Using Technology to Keep Track of the Moving Pieces of the Puzzle
One of the other innovations that Ku and his team have been working on is to incorporate modern digital information technology — including bar coding and mobile apps — to keep better track of all those moving parts of the puzzle.
“We not only control the movement of the potential therapeutic, but we also control the information that hospitals use to tell the health care provider on how to give it,” Ku says, recalling the days of yore when dot-matrix printers were used to create scratch-off labels — like those used for lottery tickets — with a panel being scratched off each time a dose of a medicine was delivered to a subject in a study. “It’s critical in clinical trials to make sure we have the best data to determine whether a potential therapeutic is successful.”
This “digital supply chain” also simplifies the blind randomization process required in clinical trials while tracking things such as which subject gets which medicine at which dose. “The system guides the pharmacist to pick up the right vial and kit and make sure that it’s given to the right subject. It could be an active ingredient or it could be a placebo,” Ku says. “And we’ll label it so that nobody knows which is which, except by the serial numbers on the bottle. And the system knows which bottle has which ingredient.”
Ku’s team is even working on integrating the digital supply chain with voice-activated household assistants that have become popular nowadays, all to make the flow of information more seamless.
“The information is just as important as the potential therapeutic,” he adds. “I know what it’s like to take care of patients from the bedside, but I came to the pharmaceutical industry to hopefully have a bigger positive impact on a lot more patients.”