Authored by: Melissa E. Daley, Communications & Marketing Manager, CISCRP
The advent of the COVID-19 pandemic has scaled public interest in clinical research, and has increased the implementation of DCTs, decentralized clinical trials. SMEs from Curebase, a software and services provider specializing in DCTs, shared what DCTs are, how they work and differ from the traditional model of clinical conduct, and the importance of diverse participation in a 15-minute Flash Webinar. Arsheen Ali, Clinical Project Manager, began by outlining the conventional approach to clinical trials.
“Traditionally, clinical research activity occurs in person, at a designated physical location, which is generally referred to as a research site,” explains Arsheen. “A doctor, called a PI or Physician Investigator, along with other clinical research staff including nurses and clinical research coordinators, facilitate participant care and the collection of data around the clinical study so that the data can be analyzed.” Participating in a clinical study introduces many moving parts for patients and caregivers, including issues around travel to and from the study center, taking time off from work, coordinating childcare and other personal impacts.
To gain better understanding of how DCTs provide an added level of convenience for participants, Myra Lane, Lead Virtual Research Coordinator shared that
“Decentralized clinical trials help promote a more patient-centric approach, addressing participants needs that go unmet in traditional clinical trial models. DCTs typically incorporate the use of technology and digital tools that give the participant convenient options to provide information that’s needed for the trial, to interact with research staff, and to complete study activities.” The use of technology allows participants to complete part of, or in some cases, all the study activities remotely.
If there are parts of the study that cannot be completed remotely, an alternative location can be selected. This may include the participant’s home, workplace or their own doctor’s office. One example is when a mobile phlebotomist is sent to where a patient lives to conduct a blood draw.
“A decentralized clinical trial does not necessarily mean that a participant will never interact in person with a member of the research staff,” adds Adam Samson, Senior Director of Clinical Operations and Customer Success. Decentralized clinical trials can use a combination of approaches to coordinate patient care and study conduct. As in telemedicine, different communication forms are employed including phone calls, video calls and text messaging.
DCTs greatly scale the convenience factor for participants and caregivers. Traditional clinical trials often required long distance travel to the closest research site, hotel stays and time off from work. Removing geographic barriers and eliminating time constraints means that a greater diversity of patients are able to participate. For study data to represent a universal population, diverse participation is essential. DCTs are paving the way to opening clinical trials to populations that historically faced barriers to participation, including minorities and residents of rural communities.
“The term decentralized clinical trials does not refer to just one thing. It might be that everything is done from the participant’s home, or it could be that the participant chooses to go in for certain things. When it comes to the use of technology, it’s important for participants to understand what the details are around the devices and technology, in order to decide whether it’s something they’d be comfortable with,” says Adam.
Patients’ bodies react differently to medications based on characteristics including age, gender, race and ethnicity. By reducing burdens to participating in a clinical trial, DCTs increase access to clinical research to a diverse pool of participants. In turn, the length of time it takes to develop new treatments and therapies can be decreased.
“Participating remotely is just as important as participating in person,” says Arsheen. “Your participation makes a really big difference in moving science forward.”
Learn more about DCTs by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here.
To search for medical conditions in a specific location, visit our Search Clinical Trials page.
To stay informed about clinical trials, visit our Resources page.
