The traditional randomized clinical trial places a significant burden on both patients and caregivers. Study participants face multiple costs including transportation to the study site, costs for lodging, meals, and dependent care. They have to take time away from work for clinic visits plus accompanying travel.1, 2 These burdens mean that getting adequate patient enrollment is one of the top issues facing medical investigators. In one survey, 44.3% of researchers reported patient enrollment as their greatest challenge.3 Studies show that 85% of clinical trials failed to recruit and retain enough patients to meet their enrollment targets, and 80% of trials failed to finish on time. Nineteen percent of clinical trials were terminated early because they failed to reach expected enrollment.2, 4
With the rise of COVID-19, enrolling patients in traditional clinical studies has become even more difficult. Decentralized clinical trials offer an alternative means of study participation. These types of investigations provide a more patient-centric approach to clinical research. They offer several advantages over traditional, site-based clinical trials. However, without the proper infrastructure in place, conducting these studies can also be difficult for a variety of reasons.
In this article, we discuss how decentralized clinical trials differ from site-based clinical trials. We look at the advantages they offer—as well as the difficulties they present. We also look at StudySource, an innovative technology solution from Veradigm® that can help investigators run decentralized clinical trials more smoothly and easily.
Decentralized clinical trials are clinical trials that attempt to ease participation for patients by reducing or eliminating the need to travel to specific study sites.2, 5-7 They accomplish this using technologies such as wearable digital health devices (“wearables”), patient apps, and smart phones to communicate with patients and collect data. Decentralized clinical trials use telemedicine, mobile healthcare providers, or patients’ personal physicians to interact with study participants.2, 5-9 The study procedures also differ from those designed for site-based studies. For example, the study medication and other research supplies may be shipped directly to the patient’s home or local health clinic versus being sent to the study site.
Compared to site-based studies, decentralized clinical trials reduce the time and financial burden on patients. This means decentralized trials may reduce drop-out rates, help studies run more smoothly, and accelerate patient recruitment. For example, decentralized clinical trials may make participation in research more accessible to patients in rural areas, where travel to and from the research site can be more challenging. Opening recruitment to a wider patient pool also increases the diversity of the patient population.2, 4, 8, 9
Decentralized clinical trials use technology to monitor patients and collect real-time data, which can increase the reliability and accuracy of study data. Since patient assessments are not restricted to scheduled visits to the research site, more frequent data collection is possible. All of these factors combine to reduce costs for study sponsors and help to support the process of reducing the time to market for medications.2, 4, 8
Decentralized clinical trials existed before the pandemic’s arrival, but COVID-19 has accelerated the adoption of decentralized clinical trial techniques.10-12 Many of the methods traditionally used in clinical trials were no longer practical when people worldwide were being told to remain at home; according to Michael Lauer, Deputy Director for Extramural Research for the US National Institutes of Health, around 80% of non-COVID-19 studies were stopped or interrupted during the pandemic.13
Decentralized trials are uniquely suited to the COVID-19 environment: Patients can be recruited remotely, physician visits can take place via telemedicine, and mobile technology can be used for remote data collection. Patient consents can be collected via telemedicine as well.11, 14 COVID-19 encouraged researchers to adopt decentralized clinical trial methodologies.11, 12, 14
The COVID-19 pandemic disrupted operation of existing clinical studies and accelerated changes in clinical trial methodologies. One survey found that 76% percent of respondents reported that COVID-19 increased their shift to decentralized clinical trial techniques.11 Another survey found that 57% of patient interactions and 79% of interactions between sponsors and researchers have begun to take place remotely.11, 12, 15
Decentralized clinical trials can solve many of the challenges inherent in site-specific investigations. However, without the proper infrastructure in place they can be difficult in their own right. Clinical trial regulations have not kept pace with the digital tools and technologies used for decentralized clinical trials, although efforts are underway. The Clinical Trials Transformation Initiative (CTTI), which published guidelines for decentralized clinical trials in 2018, has a project underway to update their guidelines to include the best practices that have emerged during the pandemic.9, 16 In addition, the Danish Medicines Agency recently published a document providing guidance on implementing decentralized methodologies in clinical trials.17
Even so, investigators are having to develop new procedures appropriate for the decentralized environment. For instance, they need to figure out how to deliver the investigational medication to patients in a way that is safe and compliant with study protocols. Similarly, the use of remote communications require additional considerations regarding data privacy, patient confidentiality, and finding ways to confirm patient identities.4, 7
Once procedures for the decentralized clinical trial exist, there is often a steep learning curve required to share those procedures with study team members, patients, and caregivers. Investigators need to ensure the new procedures are carried out safely and consistently. Novel technologies must be vetted, to ensure they provide safety, privacy, and high-quality data.4, 7
The use of wearables and other technologies also often means the researchers will need to deal with a much higher volume of data. A higher volume of data may require changes to how study information is managed. Telemedicine is another important aspect of many decentralized clinical trials. However, many states have inconsistent telemedicine laws. These differences may rule out some site-to-patient interactions, making management of patient-physician interactions a difficult aspect of decentralized clinical trials.4, 7
The rise of COVID-19 pressured investigators and research sponsors to alter the way they conduct clinical trials. Researchers implemented techniques such as telemedicine, remote patient monitoring, and electronic medical record tools to take the place of in-person patient meetings.
Now, experts predict that these changes are here to stay. Authors of a report in Nature Reviews Drug Discovery wrote that “there are indications that such innovation adoption could be lasting.”15 Among the investigators surveyed in this study, 46-78% expected the use of digital patient monitoring technologies to increase after COVID-19. Between 34% and 52% expected other decentralization methodologies to increase.15
Veradigm® is a member of the Decentralized Trials & Research Alliance (DTRA), an organization devoted to helping realize the full potential of decentralized clinical trials.18, 19 Veradigm StudySource is an innovative solution that can make conducting decentralized clinical trials easier. StudySource is designed for use with a decentralized model of clinical study. It does so by embedding research capabilities into existing point-of-care workflows, working directly with electronic healthcare records (EHR).
This innovative technology leverages EHR data throughout the phases of the clinical trial, from development of the study protocol to the point of data gathering. It helps research sponsors access deidentified EHR data to select patient candidates for the clinical trial. This efficiency speeds both site identification and patient recruitment.
StudySource’s integration with the EHR enables researchers to interact with real world data more efficiently and economically. As a result, researchers can gain insights more rapidly, reducing the amount of time needed from recruiting the first patient to published research.
Contact us for more information about how you can streamline research with Veradigm® StudySource.