Over the past few years, impactful technology advancements have been made in the clinical trial industry, resulting in better opportunities to conduct decentralized clinical trials (DCT). COVID-19 further propelled the need for implementation of DCTs and the ability to collect data outside of the traditional site-focused model. 

There are now tools available within the industry to implement DCTs quickly and effectively. With proper application, impressive strides can be made to improve the site and patient experience, provide opportunity for data to be collected direct from the patient, and, in turn, reduce some of the challenges of collecting quality and real-time data.  

This blog will present information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data. 

Transition to DCTs and Technology Integration 

Prior to the start of the COVID-19 pandemic, measures were already in place to allow for direct clinical trial operations with patients, rather than through brick-and-mortar institutions. Reliance on third-party vendors for their processes and technology to address the need was common. As the effects of COVID-19 began to weigh heavily on healthcare, CROs needed to expand their abilities by moving away from sites and third-party vendors to set up and collect data. It was key to loosen reliability on these conventional methods and take ownership of data collection by building out studies based on technology available and getting the data collection applications in front of patients. 

Much like the transition from paper to electronic data capture, the progression of collecting data at sites to collection of data direct from patient is a result of the technology evolution. Applications can be automatically installed on personal or provided devices. These applications can operate much like what patients see in their daily use of social media. The prompts to collect the data can be intuitive, giving patients a clear understanding of what should be entered. All of this helps ensure the clinical trial data being collected and entered by the patient is quality.  

Once data is entered by the patients, it can be integrated with other patient data collected by the site and vendors, so a full account of the patient experience is available for review, reporting and analysis. For data to be integrated from different sources efficiently and effectively, the data collected across sources needs to be consistent and key data points aligned. With integration, data from one source can be the truth for all sources. This removes the need to duplicate entry of data and to reconcile it across systems. Integration also provides the opportunity for all data to be accessible in one system.  Integrating data is common practice for reporting and analysis but can also be an option for other purposes. Data integration performed within existing data collection systems, like the EDC system, removes the need to integrate data downstream so the focus can be on reporting and analysis. As an example, sites must have access to patient data. They may benefit from being able to view it in an EDC system rather than having to access data across multiple systems. Having patient data extracted from the EDC system provides all data for reporting and analysis. However, those benefits should be weighed against the effort needed to integrate all patient data into the EDC system, as well as the needs to manage that data from different sources. Integrating patient and site reported data into one system is likely straight forward and of reasonable scale, whereas including all third-party vendor data, like labs, may not be worthwhile given the quantity of data and the existing access to it via other means.   

Challenges with DCTs and Data Collection Software 

Arguably the largest challenge with DCTs is the collection of data from the patients themselves. By making the applications available and user friendly, there is greater ease in the use of technology and the entry of quality data. This provides patients with an enjoyable experience and removes some of the burden of data collection resulting in an increase of site satisfaction. Having data collection available at the source reduces the risk of misrepresentation and the ability to reach patients in more remote locations. There is no longer a need to rely on visits with a physician to collect data; therefore, a larger population of patients is reachable. 

Data Sharing Best Practices: 2022 and Beyond 

The bottom line: CROs are at the mercy of the sites and patients for collection of clinical trial data. CROs need to be mindful of available options and implement strategies that not only collect robust and quality data but provide sites and patients with ease in entering it.  

At Rho, we are embracing and expanding our DCT capabilities. We are continuing to observe new and alternative collection practices and learn what strategies are best for our clinical trial results. We see DCTs as a priority for us to operate successfully. Taking on new industry technology and applying it to better help clients and patients will allow us to become more well-rounded, driving results that will be easier and more effective for all parties. 

Conclusion 

DCTs are here to stay. As an industry, we are continuously developing the tools needed to implement quality and real time data collection. Looking forward, we need to continue to broadening technologies and skillsets that provide the best tactics for each study. 

Amanda Parsons, Senior Director, Clinical Data Management, is a senior leader with 25 years of experience in biostatistics and clinical data management. She has worked in all phases of clinical trials, as well as a variety of therapeutic areas. At Rho, Ms. Parsons provides oversight of Rho’s data management operations and is responsible for the people and processes that deliver on client and project needs.