Decentralized clinical trials (DCTs) allow researchers to increase the number of participants and collect better data. However, DCTs on their own can’t do this. Lacking the right tools that make documenting symptoms and experiences easy imposes limits on the best trials.
In order to streamline the process and maintain data accuracy, more sponsors and contract research organizations (CROs) are turning to electronic data capture (EDC) systems for their DCTs. Here is how these two elements work together to create better trial experiences.
The COVID-19 pandemic created a “sink or swim” moment for DCTs. Hundreds of hospitals limited their operations to essential procedures and many patients were quarantined at home and unable to travel for a trial. As a result, trial developers had to go to the patients. There was a rapid adoption of decentralized processes and electronic data capture systems to go with them.
“With hospitals diverting resources to care for Covid-19 patients, gene and cell therapies that require extended hospital visits to prepare or receive treatment will almost certainly be interrupted in some way,” Adam Feuerstein, senior writer and national biotech columnist at STAT News, wrote at the start of the pandemic.
In August 2021, the rise of the Delta variant created a similar surge in many hospitals, to the point where doctors in Florida and Louisiana were overwhelmed. This may not be the last pandemic or national crisis that halts clinical trials, and decentralized systems can prevent research from grinding to a halt.
“COVID has absolutely been a catalyst to dramatic changes,” says Jennifer Goldsack, CEO at Digital Medicine Society. “We are now moving towards a situation where we are building clinical trials for the first time around the patient, instead of the clinic and the industry and we have a suite of resources to do that, that we have never had before.”
Even when people aren’t living through a global health crisis, the use of DCTs can benefit patients. The ability for a patient to visit a nearby clinic instead of traveling to a specific trial site across the state or country makes trials more accessible. Electronic data capture plays a significant role in creating this accessibility.
Electronic data capture systems also allow researchers to collect better data. In the clinical trial world, real-world data refers to insights from outside of a hospital or controlled setting. Real-world data paints a more accurate picture of how patients react to the treatment in their daily lives.
“Real-world data is not new, of course, but it is only in more recent years that it has been gaining credibility in the clinical setting,” says Morris Panner, CEO of Ambra Health. “Real-world data and the evidence that results from it offers the possibility of deepening our knowledge about patients, diseases and potential treatments.”
As more researchers invest in EDC tools, they are finding ways to collect real-world data for different trials and treatments. New fields that wouldn’t normally seem friendly to real-world data are investing in this form of information collection through EDC systems.
“Most people assume that certain indications like oncology are not well suited to the decentralized [model],” says Dawn Anderson, managing director of life sciences at Deloitte. “But we are seeing more of an interest in collecting quality of life data, and daily living data, with connected devices, [electronic patient-reported outcomes] and [electronic clinical outcome assessments] supporting that.”
One of the main concerns about DCTs is data accuracy. Data isn’t valuable if it isn’t accurate. However, EDC tools can help patients, sponsors and CROs better collect data with simple interfaces and user-friendly digital tools.
Outside of data collection, the real-world data is likely to be more accurate with the help of EDC tools. Patients often give more accurate readings when they are outside of a clinical setting. For example, a nervous patient will have a higher blood pressure reading and pulse in a hospital than if they are testing themselves while relaxing at home. Luke Laffin, a preventive cardiologist at Cleveland Clinic, says patients who experience “white coat syndrome” should be tested out of the office to ensure their blood pressure isn’t actually dangerously high.
Additionally, DCTs can help researchers connect with less privileged groups of patients. These are candidates who can’t afford to travel for a trial or can’t miss work to attend standard clinic hours. A more diverse trial means researchers can also understand how treatments affect different demographics.
While EDC systems and decentralization can help with diversity, technology alone cannot solve every researcher’s inclusivity goals.
“It's not just as simple as saying, OK, we're going to have a way to make it easier for minority patients to participate in the study by allowing them to get their protocol evaluations done locally,” said Craig Tendler, vice president of clinical development and global medical affairs in oncology at Janssen. “I mean, that's part of it. But, to be frank, it's a small part, and you have to do a lot more.”
Decentralized clinical trials are not silver bullet solutions to research and EDCs will not solve all of the problems with DCTs. Governing bodies still need to create best practices for DCTs so researchers can follow a set of standardized practices.
“Regulatory agencies have a variety of approaches to DCTs, but currently there exists no agreed international standard for compliance in this area,” says Arnaud Benichou, vice president, head of sales, at Biocair International. “Understandably, many Clinical Research Organizations are risk averse and unwilling to move from tested systems that meet regulatory requirements without substantial evidence.”
That said, the use of EDC systems can help assure sponsors and CROs that there is a clear process in place — at least within that specific organization. EDC systems can also standardize data collection and implement quality checks. These efforts can help streamline the implementation of decentralized systems.
“The burden of data management and the required analysis is becoming a more urgent issue due to the volume of patient data that comes with data streaming from remote devices and patient apps,” write Brajinder Singh and Janel Firestein, partners at Clarkston Consulting. “Organizations need a configurable and/or single platform where the data can be collected, harmonized, and analyzed quickly and efficiently.”
The COVID-19 pandemic gave decentralized clinical trials the boost they needed to become widely accepted. EDC systems will help researchers improve their trials through the collection of real-world data combined with standardized clinical analysis. Together, DCTs and EDC systems can significantly move clinical research into the future.