Virtual communications and data-gathering technology have expanded the possibilities for clinical research, so investigators are increasingly embracing options for conducting clinical trials outside of traditional research sites. Regulatory agencies such as the FDA see the potential for using decentralized clinical trials (DCTs) to increase the pace of discovery, so they have worked to provide guidance on conducting these DCTs.
If properly implemented, a decentralized clinical trial model offers a lot of potential scientific and administrative benefits. However, designing decentralized closed trials requires significant forethought.
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What Are Decentralized Clinical Trials (DCTs)?
In decentralized clinical trials, some portion of the clinical trial’s activities occur at locations other than the main clinical site, recorded with the use of digital tools. Alternate locations to a conventional healthcare facility can include participants’ homes or laboratory sites nearer to the place where participants live/work.
Technological advances in data gathering and the availability of videoconferencing apps have increased the ability of researchers to use decentralized locations for trials. In addition, new medical devices like digital health technologies (DHTs) can be used in place of traditional site-based tools to measure biological functions, record symptoms, and perform tests that measure functions like cognition, coordination, or vision.
The COVID-19 pandemic and the need for strict social distancing accelerated the adoption of DCTs. The pandemic itself prompted the initiation of a fully decentralized study to test the efficacy of hydroxychloroquine as prophylaxis against COVID-19 infection after potential exposure. This study enrolled 821 participants, most of whom were recruited through social media, using online surveys for follow-up.
The final study population contained a representative sample in terms of sex, and 39% of participants were from racial or ethnic minorities. While the study findings did not indicate that hydroxychloroquine was effective against COVID-19, the study design highlights how a DCT structure can be an effective mode of research, incorporating extensive remote data collection.
Of course, while the DCT model has distinct benefits, there are still challenges that researchers need to address when selecting a DCT structure.
Benefits of DCTs
Decentralized trials provide a number of benefits to researchers, easing recruitment challenges, improving data quality, and cutting the cost of administering the trial. More specific benefits of decentralized clinical trials include the ability to:
Access a Diverse Pool of Potential Participants
Remote participation options are attractive to many prospective participants. Older adults and individuals with disabilities may find travel to traditional trial sites to be a barrier to participation. Participants with work, household, or childcare responsibilities may similarly need schedule flexibility that traditional trials can’t allow. Moreover, clinical research facilities may be geographically inaccessible for some prospective participants. For example, individuals from racial and ethnic minority groups may disproportionately live in areas without research sites.
Offering remote options for participation can overcome many of those barriers to participation, thus increasing the pool of potential trial participants.
Collect Real-Time Data for a Study Team
Digital health technology like activity trackers, glucose monitors, blood pressure monitors, or spirometers allows participants to provide accurate readings on biological functions without coming in for clinical exams. This data can be collected continuously or at prescribed intervals. This allows for a greater quantity of data to be recorded over the course of the study.
Obtain Robust and Accurate Clinical Study Results
DCTs can provide robust data and a more diverse pool of participants than a traditional trial. As a result, they can deliver more complete findings from the trial.
The data collected during DCTs is often more consistent with the real-world use of the treatment. Participants can record information such as symptoms, pain levels, mood, diet, and physical activity as they engage in typical daily tasks, allowing researchers to understand how lifestyle and activity affect treatment results.
DHTs can automate certain data collection methods, relying on biometric sensors or tracking devices. These tools offer more timely and objective measurements, eliminating issues of reporters' bias or errors pertaining to participant memory. In addition, the highly individualized data can allow researchers to better explain differences in individual responses to treatment.
Improve Resource Management Efficiency
There are practical administrative benefits to DCTs. A 2021 article in the journal JACC: Basic to Translational Science notes that fewer central research sites mean lower administrative costs associated with maintaining the site.
In addition, DCTs reduce the time and effort spent dealing with institutional review boards, decreasing costs and site-specific inconsistencies. Fewer sites make it simpler to institute protocol adjustments as studies progress.
Challenges of DCTs
DCTs are not without challenges. Data protection, regulatory compliance, and managing participant safety are all factors that trial leaders must address (and can address by using platforms like Studypages).
Those seeking to engage in DCTs must remember to:
Protect Patient and Research Data
Participant privacy needs to be a top priority in any study design. Any data collection platform needs to comply with HIPAA rules, as well as any additional privacy regulations imposed by research sponsors, state governments, or international governments when DCTs include international participants. In addition, findings from the study need to be protected from hacking, with safeguards employed to ensure data isn’t changed or manipulated.
Control Patient Safety and Adverse Events
Ideally, trial designers can use a robust pre-enrollment process to screen out prospective participants who are at exceptional risk for adverse events. It’s incumbent upon researchers to develop contingency plans in the event of adverse reactions to a treatment. Investigators should alert participants to potential risks and provide detailed instructions for dealing with adverse events.
Comply With Regulatory Bodies’ Policies
Compliance with guidelines set by research institutions, federal and state authorities like the Food and Drug Administration, and any relevant international bodies is required for DCTs. Investigators must familiarize themselves with all relevant regulations regarding DCTs and ensure compliance for the duration of the study.
Access Clinical Trial Technology
Those engaging in DCTs require sufficient access to clinically viable devices. Investigators need plans to distribute devices to participants and to support/troubleshoot their operation. Investigators also need to ensure that participants have access to batteries or charging cables, as well as internet or cellular connectivity.
Easily Overcome Challenges in DCTs With Clinical Research
Using a specialized clinical trial management platform can streamline the management of DCTs. Studypages, for instance, offers an easy-to-use, secure app that simplifies recruitment and enrollment in trials. The app supports communication with participants so that researchers can easily share instructions and information during the trial. Real-time data collection and sharing across research sites offers immediate access to information about participants. The app is fully HIPAA- and GDPR-compliant, so participant data is never at risk.
To learn more about how Studypages can help manage DCTs, contact us today.