Even before Covid-19 disrupted the traditional model for clinical trials, researchers were harnessing the power of technology to make trials more accessible and improve data collection.
The movement has coalesced under the banner of decentralized clinical trials, or DCTs, which use technology and other non-traditional approaches to monitor patients and collect data without limitations in geography. Another anticipated benefit included the ability to recruit a wider patient population.
The pandemic accelerated the adoption of DCT, but also forced researchers to go back to the drawing board as they grappled with the limitations of the DCT model. What is becoming increasingly clear is the need for a hybrid approach that considers patient perspectives and the impact on clinical trial sites.
Marie Rosenfeld (Source: Astellas Pharma)
“Whenever possible, we should give patients the choice to participate in a clinical trial in a way that makes the most sense for them,” said Marie Rosenfeld, senior vice president and head of clinical sciences at Astellas Pharma.
“Patients and researchers had little choice but to rely on technology and otherwise unconventional practices to perform trials in the early days of Covid-19 as the virus limited personal access to health care providers,” Rosenfeld said. “We all took pretty dramatic approaches to keep the trials we had going.”
The sponsors learned a lot about the pros and cons of the approach, both for patients and trial sites.
Hitting the limits
“Access to and interest in technology has proven to be among the main constraints for DCT. Some patients struggle with constant Wi-Fi access, while others continue to prefer in-person visits,” Rosenfeld said. She cites an example of a study of women’s health during the pandemic, in which patients felt that going to the doctor’s office was safer than allowing health workers into their homes.
Meanwhile, the trial sites ended up raising a flood of technology-related questions, turning them into de facto IT support centers and creating issues around reimbursement.
In short, DCTs were not as frictionless as they were made out to be. “It is highly unlikely that the traditional DCT concept will be implemented as originally intended,” noted Rosenfeld.
Evolving to a hybrid approach
DCT has a place, especially for long-term follow-up and large outcome studies. But a hybrid approach – one that includes digital elements – may be more appropriate.
“At Astellas, we are evolving our approach to clinical trials to fully leverage the value that technology can bring in delivering the patient-led clinical trials of the future,” said Rosenfeld. “We can increase the quality and quantity of data collected and improve the patient experience, while enabling faster decision-making and accelerating the drug development process.”
The technology will facilitate more real-time data collection, giving companies and treating physicians more useful information earlier in the process.
In an oncology trial, for example, researchers could combine a device/wearable with other non-biometric data collected from a patient via an app. Used in combination, the technologies can allow patients, even in early oncology trials, to spend less time in the doctor’s office and more time with their families at home, while having the infrastructure to monitor and ensure their safety. Meanwhile, the data can alert the treating physician to potential medical problems, provide researchers with more reliable information about the potential side effects of the product being studied, and allow patients to feel safe in a more hospital-friendly environment.
In other trials, remote data collection can allow patients to leave the hospital earlier than they would otherwise.
Providing the best of both worlds for patients
If researchers want to succeed with a hybrid model, they must be able to translate the technology into strong clinical performance. For Astellas, this may involve using a combination of external technology solutions with some existing or in-house development.
“We have an opportunity to build on our expertise in traditional pharmaceutical development by taking pioneering healthcare technology and applying it to clinical trials in a way that is meaningful to patients,” Rosenfeld said.
Rosenfeld expects it will take three to five years for fully realized hybrid clinical trial models to become the norm. Key to acceptance will be the ability to demonstrate how hybrid trials yield useful data and lead to regulatory approvals.
“We believe the hybrid approach provides the ‘best of both worlds’ to both patients and clinical trial sites,” she said. “We look forward to being a part of shaping how this all plays out.”
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