DCT and hybrid clinical trials: understanding the key reasons behind their enduring popularity

The global decentralised clinical trial (DCT) market is projected to expand at a CAGR of 15.26%^* between 2023 and 2031. In both fully decentralised clinical trials (DCTs) and hybrid alternatives, each year of growth means more opportunities for a wider pool of participants to contribute to crucial scientific research.

While on-site clinical trials will remain and provide cutting-edge findings, they are no longer the only route to valuable scientific breakthroughs. In part, this can be attributed to the continuous advances of technology. But it also reflects a stronger desire to create patient-centred clinical trials and the ongoing positive experiences of research participants.

Understanding the participant and CRO view of DCTs

A comprehensive CISCRP study^† found an almost identical willingness to participate in trials that involve study visits both at home and at a clinic, including occasional video conference calls, against trials operating 100% on-site and in-person.

That’s not surprising, given the patient benefits of DCTs. Demands on participants’ time and resources are lessened, because they no longer have to travel to clinical sites. Instead, the trial can be seamlessly integrated into the patient’s existing lifestyle and real-world setting. The ease of delivering data via connected devices has also removed any pressure on patients to record or monitor health results. Instead, a CRO wanting to check participants’ weights (scales), pulse readings (pulse oximeters), or inhalation and exhalation data (spirometers), can now do so rapidly through an extensive range of connected devices.

Several other benefits are also combining to ensure DCTs and hybrid trials are here to stay.

• Both patients and practitioners have ever-growing familiarity and comfort with health technologies. As smartphones and other connected devices have become ubiquitous in daily life, the element of uncertainty has been slowly eroded.
  
  
• Technological maturity means the market is increasingly populated by a wider range of solutions, giving CROs an ever-broadening capability to gather different datasets remotely. At the same time, emergency government responses to the COVID-19 pandemic resulted in the kickstart, development, and acceleration of regulatory acceptance.
  
  
• A growing understanding of the importance of patient-centred trials is putting a new and strengthened emphasis on the participant experience. Electronic consents and video call consultations are just some of the steps that can make the process easier for participants.
  
  
• DCTs and hybrid studies strengthen research findings by opening the potential participant pool to a much wider section of society. For hard-to-reach communities, lower social demographic areas, and those underserved by transport options, DCTs are often the only possible way in which they can participate in ongoing research efforts.
  
  
• Data from DCTs and hybrid trials also comes with the benefit of being ‘real world’ data. It is not gathered in a controlled clinical or healthcare setting. It is data collected during a participant’s day-to-day activities, giving a truly accurate reflection of health impacts in an undisturbed setting. Our availability of metabolic monitoring devices are a perfect example of this process, delivering CGM, BGM and BKM remotely.
  
  

Tackling the challenges of DCTs and hybrid trials

It’s important to acknowledge that no single trial methodology will suit all circumstances. DCT frustrations have been reported, including technology-related issues, data concerns, and supply chain and shipping management. That’s why the service offered by Woodley Trial Solutions has been specifically designed to tackle each of these head on, ensuring that CROs and sponsors have access to consistently high quality, fast data in all of their DCT or hybrid trials.

• Our advanced in-house technical product knowledge means our advisors are able to assist with expert device identification, guiding you through which products are best suited to both the demands of your trial and the regulatory frameworks of your chosen territories. Furthermore, our agreements with third-party data companies help to support the seamless and direct supply of patient data to CRO.
  
  
• Long-term and strategic investments in our logistics capabilities mean we have a proven and highly reliable method of getting equipment where it’s needed, when it’s needed – without breaking any budgeting parameters. As a recognised Importer of Record to over 100 countries worldwide, we’ve got the credentials and expertise to ensure your delivery arrives without delay.
  
  
• Our online and on-site technical support is already extensive, providing a huge knowledge base for CROs and other practitioners about the connected devices being used in their trials. 
  
  

Accessing a wider, more diverse research pool

With almost three-quarters of potential clinical trial participants living more than two hours from their nearest trial site^‡, embracing the value of DCTs and hybrid trials is an essential task for the entire research community. Operating these trials immediately invites the possibility of gathering data from a much more diverse population, while at the same time minimising any potential inconvenience to those taking part.

CROs and sponsors running DCTs have reported higher quality and faster data, easier patient recruitment, improved patient compliance, and an easier overall experience for each participant.

For help and assistance in identifying, sourcing and delivering the connected devices needed for your next trial, speak to our friendly, knowledgeable team today.