Clincal Trial Data Trends: Decentralised Trials Digital Endpoints

With the sudden onset of the COVID-19 pandemic, the Life Sciences industry has changed. Industry sponsors have focused on keeping on-going clinical trials moving forward, as well as allowing new studies to start – all in a way that does not compromise the safety of patients or employees. While strategies and trends within the clinical trial industry are always shifting and evolving, 2020 accelerated innovation and industry movement in ways we could not image a year ago.

We believe that we are now deep in the move towards decentralised trials, while also managing the need for an increasing patient-centric trial experience, advances in digital health and an increase in data sources. Together, this translates to increased data complexity – from how the data is collected to how it is managed and how it is reported – and an increased need for oversight of these processes to ensure compliance.

What do the experiences of 2020 mean for trials and biometrics in 2021 and beyond? What are some key trends in clinical trial data to be aware of going forward? We asked our data experts for their opinion and here are our clinical trial data trends to watch in 2021:

  • Decentralised Trials
  • Digital Endpoints
  • Data Analytics and Visualisation
  • Data Strategies
  • Patient-centric Trials
  • Evolution of Data Management

In this article we will be looking closer at these trends that we believe will be changing the industry in 2021.

Decentralised Trials

In recent years, much has been said and written about decentralised trials. However, the industry as a whole is generally conservative and slow to change. This can be partly due to the significant cost of clinical trials: sponsors can be reluctant to risk their investment on new or unproven technologies and regulatory strategies.

Due to the rapid adoption required during the pandemic, both to manage ongoing trials and start COVID-19-focused trials, decentralised trials have become more and more real. With various strategies and approaches being implemented, it is likely that almost every new clinical trial will have some sort of decentralised component.

A decentralised trial can incorporate technology as relatively straight-forward as app-based eConsent, to more complex hybrid clinic/home visit trials requiring integrated telehealth components and data collection tools.

In 2021, we should see improved data collection methods, such as simple ePRO devices or apps, and tools to account for the increasing number data sources, along with more technology-based solutions integrated with EDC systems for remote source-data access and verification to increase the effectiveness and efficiency of remote-based monitoring visits.

Digital Endpoints

We expect to see clinical trial endpoints evolving to become more patient-centric and more meaningful, including endpoints derived from digital devices, or digital endpoints. A traditional clinical endpoint, for example, a six-minute walk test, can have little meaning for patients’ day-to-day life. In contrast, a wearable can track daily activity and algorithms can be developed to derive relevant endpoints from the data collected such as flights of stairs climbed, or time spent not sitting. These endpoints are more relatable to the patient, having a direct correlation to an improved quality of life.

In 2021, watch for companies to develop specific strategies for device management, data collection and algorithm development to support more widespread use of these digital endpoints.

Data Analytics and Visualisation

With so many data sources, having an integrated data viewing solution is a must. No longer can CRAs, medical monitors or even investigators see all of the available data in a single EDC system.  Companies will need to implement a data visualisation strategy if they have not already to facilitate overall data viewing, on-demand patient profiles and medical monitoring, as well as provide a central database of record for the clinical trial.

A well-implemented system could also be used for data safety monitoring committees. With real-time access to all data points, presented in concise graphical displays, data safety monitoring committees can make patient safety decisions more quickly fully harnessing the power of all collected data. This translates to reduced trial time and better safety oversight for patients.

Data Strategies

Today’s clinical trials can have more data sources than ever, including RTMS, central laboratories, biomarker data, ePRO, eConsent, EDC systems and digital devices, such as wearables.

In 2021, we will see even more companies develop broader and more robust data strategies to manage this increase. These strategies will include how to best collect the data, how to efficiently manage and integrate the data, and how and where to store the data. Many companies may even develop a specific digital-data strategy to specifically manage data collected from wearables.

A digital-data strategy should include multiple facets from device provisioning to data collection, reconciliation, and cleaning. A comprehensive strategy will also include a data-focused risk assessment and management to fulfill ICH requirements and reduce the burden associated with the necessary oversight.

Patient-centric Trials

More than ever patients want to be involved in the clinical trial process and want access to their data once the trial is over. In the ICH E8 (R1) Global Meeting summary notes, it is noted that patient advocacy groups remarked on how clinical trial design does not always meet the needs of the patients. In addition, allowing patients the ability to choose how to participate in trials, either all in-clinic, all-virtual, or a hybrid, can increase enrollment and overall compliance.

In 2021, we can expect to see the continued move toward patient centricity with more hybrid trials, increased patient involvement via advocacy groups even at the planning stages, and widespread implementation of easy-to-use technology to improve data collection and quality. Overall, the theme will be to continue the reduced burden on the patient.

Evolution of Data Management

With the increase in data sources, digital data collection tools and risk-based monitoring, the role of Data Managers will continue to evolve in 2021. They will remain the stewards of the clinical trial data but how they fulfil that role will change. Now is the time for data managers to brush up on their statistics to support risk-based metrics, refine their project management skills to lead effective collaboration between the owners of various data sources and develop technical skills to support development of automated, validated processes for data integration or reconciliation.

Summary

We believe that in 2020, the Life Sciences industry has gone through an irrevocable change and in 2021 there will be much more focus on further enhancement of technology with buy in from sponsors, providers and patients. There is #nogoingback. The industry is poised to evolve and involve patients in ways never seen before, leading to better trials, better treatments, better outcomes and better lives.

In 2021 and beyond, we expect to see data professionals embracing new technologies, new endpoints and new tools to achieve the most important goal – bringing life-changing therapies to patients safer, faster, smarter, in an innovative and cost-efficient manner.

How can CROS NT support your clinical trials?

At CROS NT, we support the transformation of the Life Sciences industry to ensure that reliable and safe clinical trials can be conducted regardless of what challenges we face. Our biometrics experts have extensive knowledge in the management and reporting of data generated in clinical trials across Phases I-IV. We provide various data collection, reporting and visualisation systems and can customize an approach that works the best for you.