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The clinical trial space had one of its most significant disruptions in decades in the early days of the pandemic. Now, some clinical trials are normalizing, but decentralized clinical trials are also growing.
To learn more about what is likely on the horizon for clinical trials in 2022, we reached out to Jan Pieter Kappelle, VP of strategy of 4G Clinical. Kappelle is optimistic about continued growth of decentralized clinical trials and the spread of digitization throughout the supply chain.
1. DCT trial designs will continue to grow
The adoption of decentralized clinical trials (DCT) surged in the early days of the pandemic. “When we started up in this pandemic almost two years ago, studies really ground to a halt,” Kappelle said. As drug companies scrambled to adapt, many embraced a direct-to-patient (DtP) model for patients.
Jan Pieter Kappelle, VP of strategy of 4G Clinical [Image courtesy of 4G Clinical]
But growth in DCT trial designs remains strong, Kappelle said. “There’s an interest from industry and people who acknowledge that the DCT structure makes a lot of sense for the future,” he said.
The DCT approach has several advantages. First, it makes it easier to optimize clinical trial diversity and accelerate enrollment. “In a DCT trial setting, you have a much greater access to patients, which on the sponsor side is very much appreciated because this can accelerate your enrollment of patients in the study.”
DCT trials also are empowering for clinical trial volunteers. “The voice of the patient becomes much more important,” Kappelle said. Conversely, patients in the past tended to have a more passive role. But as the internet continues to grow, patients have become better informed about active clinical trials. “Patients are getting much more vocal,” Kappelle said.
2. The digitization of clinical supply chains continues
A few years ago, the hype was high regarding the promise of the Internet of Things (IoT), which promised to optimize nearly every conceivable industry. Fast-forward to today, IoT adoption in the pharmaceutical sector remains at an early phase.
“It’s early days,” Kappelle said. “The whole IoT component is not well matured in clinical trials.”
Still, a growing number of clinical trials use wearables to collect data from patients. “But if you look into managing the clinical supply chain, a lot of the activities are done in a fragmented way,” Kappelle said.
Supply chain digitization promises to help tame the chaos. “The manufacturing activities, including the packaging and labeling, the drug product, manufacturing, drug substance manufacturing — all of those things are generally managed in different systems,” Kappelle said.
Occasionally, a company will use an integrated enterprise resource planning (ERP) or material requirements planning (MRP) system to keep track of such disparate elements. But often, sponsor companies working with multiple contract manufacturers face the challenge of dealing with various ERP or MRP systems. “If you want to take a look holistically at what’s happening in your supply chain, you have to go to many systems and consolidate everything yourself in something like an Excel environment,” Kappelle said. “And then hopefully, you can make something meaningful out of it.”
But a growing number of large biopharma companies are moving to the concept of a technology platform that gives them an end-to-end view of their supply chain. “The big pharma biopharma is leading. They are working with the large consultancy firms to come up with solutions,” Kappelle said.
3. Smart packaging concepts will get more attraction
In traditional clinical trials, patients self-administering an investigational drug often log the date and time of each dose in a diary. The process, however, is not always accurate, leading regulators to question the validity of studies that rely on such data.
Emerging smart packaging technologies promise to automate such prosaic dosing matters. “It all started with smart blisters,” Kappelle said. Smart blisters holding capsules or tablets include an electronic circuit that sends an electronic signal to a nearby device — often a smartphone — to log each dose. “There’s a capturing of the timing of the event that a pill was pushed out of the packaging, which is still not a direct indication that the medication was taken at that point in time, but it’s at least a step closer to what probably happened in reality,” Kappelle said.
Similarly, smart pill bottles and smart syringes are available to track each dose’s timing.
Despite the promise of such technologies, smart packaging in pharma is “not widely adopted yet,” Kappelle said. “They are still used in more or less an experimental setting by some of the larger biopharma companies,” he added. “But if you think about drug accountability, drug compliance is really important. And these kinds of technologies can assist in proving some kind of adherence and compliance.”
4. Adoption of real-time drug tracking grows
Passive temperature loggers have a long history in the pharmaceutical industry for tracking temperature excursions in the pharmaceutical supply chain. “It’s still in the current state,” Kappelle said. “You just initiate temperature loggers at the point of origin of the shipment, and when the shipment arrives, you start reading the data out and figuring out whether you had a temperature excursion or not.”
But data loggers can’t offer precise, granular information for cell and gene products. “You need to know continuously if the product is in the right conditions,” Kappelle said. The situation is similar for high-end biologics, which tend to be very expensive. “It becomes critical to see if a product is at risk of getting a deviation of any kind of aspect in terms of light, humidity, temperature shock and vibration.”
Filed Under: clinical trials, Drug Discovery
