Alison Holland, Head of Decentralized Trials, Medable, Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health01.19.21
If 2019 was the year of personalized medicine, 2020 was the year of decentralized trials but there’s still significant progress to achieve. Industrywide, the decentralized approach to clinical trials is philosophically embraced for all its advantages but operationalizing it – particularly mid-flight on studies – requires a commitment to overcoming fear of change. The model’s inherent flexibility will be instrumental to calming any concerns and will drive widespread adoption through 2021.
Decentralized Clinical Trials (DCTs) are unique by design. In contrast to the rigidity of traditional randomized control trials, DCTs offer a modular framework, affording choice to sponsors, sites, and patients. As research stakeholders become accustomed to having options, DCTs will be expected, if not stipulated, in all future protocols.
This year brings a tipping point, where patients recognize how much less burdensome it is to participate in DCTs, how technology enables rather than hinders, and how many ways sites and sponsors can save with this approach. The freedom to create trial designs that work best for each site, each patient, each protocol will be too great of a siren song. Here, industry experts share their predictions on other changes that will shape the clinical environment in 2021.
Decentralized clinical trials will enhance patient care and drive study participation.
Alison Holland, Head of Decentralized Trials, Medable
As decentralized clinical trials become standard, the next big hurdle will be learning how to adapt to data received in real-time daily. We will need answers to “how do we verify the quality of data collected remotely and how do we respond digitally to the speed of change?” It will be a shift. We will need to identify new capabilities that will offset traditional activities, such as CRAs and study safety teams to seeing the data daily, as it is collected and reviewing it from home or anywhere digitally rather than waiting to review study data once a week, or month, in person at sites.
As important, healthcare professionals will need to learn to engage with patients more frequently, remotely at times, to ensure their health is being actively monitored and adjusted, and to ensure the integrity of the data being collected. Trial participants will receive the gold standard of care, which will lead more patients to view trial participation as an effective healthcare option. Rather than viewing clinical trials and pharmaceutical development with skepticism, patients will see trials to receive top-rate care and be part of the development of breakthrough medicines.
For this to come together, however, DCTs must be built on a unified platform where all trial data is reported and visible in one system for all stakeholders. Sites must be alerted when patients input their data and respond in real time for the ultimate in patient-centricity. By the end of the year, decentralized trials managed on a unified platform will thrive and garner greater trial participation, speeding up clinical trial timelines and accelerating the speed of effective drug development.
Decentralized trials will transform the role of the CRA.
Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health
Clinical monitors (CRAs) today continue to perform a wide range of activities while on site, with a heavy reliance on source document verification, albeit in a reduced fashion with the implementation of risk-based monitoring. With the addition of decentralized capabilities and a wide range of new data flows, less data will be found in direct source and will require enhanced ways to review.
No longer will CRAs be performing source document verification, but rather they will be evolving to clinical data review and more complex analytics about the data they are supporting. Time on site will be managed closely with a primary focus on establishing stronger relationships with site staff, supporting the site in managing study risks, and driving quality across all activities. Finally, increased use of technology to enable both site and patient involvement in the clinical study will require CRAs to serve as a first line troubleshooter, and importantly as a therapeutic area expert in incorporating these tools in the study delivery.
Traditional CRA therapeutic expertise will be enhanced with deeper understanding of the patient population and analytical skills that include comparison of multiple data inputs and outputs that will not always originate at the site but from the patient themselves, via home health care, and from wearables. Collaborating across the site staff, DCT vendors, and clinical trial delivery partners takes on new meaning.
Remote technology will create opportunities to operationalize and improve trial execution.
Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health
Historically, the inclusion of vendors providing services and technology to support the execution of clinical studies has increased project oversight complexity and new dimension to timeline management and risk mitigation. Delivery teams not only had to manage the usual challenges of start-up delays, patient recruitment and retention issues, and database setups, but also inclusion of vendor capabilities and timelines that could impact the overall execution of a clinical study. Through the inclusion of decentralized capabilities in a deliberate fashion, partnerships between delivery teams and DCT vendors (home health, technology platforms, biomarker/biosensor developers) create opportunity for alignments earlier in the planning of the study and for mitigation strategies that proactively address challenges and create opportunities for integrated operating models.
Beginning with a patient journey map that includes the identification of each of the DCT touchpoints, teams will have a visual mechanism by which they can identify overlaps, bottlenecks, and dependencies to align the DCT service providers and enhance the experience for sites, patients, biopharma, and service providers. Trial oversight will include innovative management approaches to resolving the risks and reduce the burden of duplicative steps. Furthermore, experience with technology platforms and the workflow support that they provide can create business process optimization opportunities across the clinical trial delivery spectrum.
Decentralized Clinical Trials (DCTs) are unique by design. In contrast to the rigidity of traditional randomized control trials, DCTs offer a modular framework, affording choice to sponsors, sites, and patients. As research stakeholders become accustomed to having options, DCTs will be expected, if not stipulated, in all future protocols.
This year brings a tipping point, where patients recognize how much less burdensome it is to participate in DCTs, how technology enables rather than hinders, and how many ways sites and sponsors can save with this approach. The freedom to create trial designs that work best for each site, each patient, each protocol will be too great of a siren song. Here, industry experts share their predictions on other changes that will shape the clinical environment in 2021.
Decentralized clinical trials will enhance patient care and drive study participation.
As decentralized clinical trials become standard, the next big hurdle will be learning how to adapt to data received in real-time daily. We will need answers to “how do we verify the quality of data collected remotely and how do we respond digitally to the speed of change?” It will be a shift. We will need to identify new capabilities that will offset traditional activities, such as CRAs and study safety teams to seeing the data daily, as it is collected and reviewing it from home or anywhere digitally rather than waiting to review study data once a week, or month, in person at sites.
As important, healthcare professionals will need to learn to engage with patients more frequently, remotely at times, to ensure their health is being actively monitored and adjusted, and to ensure the integrity of the data being collected. Trial participants will receive the gold standard of care, which will lead more patients to view trial participation as an effective healthcare option. Rather than viewing clinical trials and pharmaceutical development with skepticism, patients will see trials to receive top-rate care and be part of the development of breakthrough medicines.
For this to come together, however, DCTs must be built on a unified platform where all trial data is reported and visible in one system for all stakeholders. Sites must be alerted when patients input their data and respond in real time for the ultimate in patient-centricity. By the end of the year, decentralized trials managed on a unified platform will thrive and garner greater trial participation, speeding up clinical trial timelines and accelerating the speed of effective drug development.
Decentralized trials will transform the role of the CRA.
Clinical monitors (CRAs) today continue to perform a wide range of activities while on site, with a heavy reliance on source document verification, albeit in a reduced fashion with the implementation of risk-based monitoring. With the addition of decentralized capabilities and a wide range of new data flows, less data will be found in direct source and will require enhanced ways to review.
No longer will CRAs be performing source document verification, but rather they will be evolving to clinical data review and more complex analytics about the data they are supporting. Time on site will be managed closely with a primary focus on establishing stronger relationships with site staff, supporting the site in managing study risks, and driving quality across all activities. Finally, increased use of technology to enable both site and patient involvement in the clinical study will require CRAs to serve as a first line troubleshooter, and importantly as a therapeutic area expert in incorporating these tools in the study delivery.
Traditional CRA therapeutic expertise will be enhanced with deeper understanding of the patient population and analytical skills that include comparison of multiple data inputs and outputs that will not always originate at the site but from the patient themselves, via home health care, and from wearables. Collaborating across the site staff, DCT vendors, and clinical trial delivery partners takes on new meaning.
Remote technology will create opportunities to operationalize and improve trial execution.
Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health
Historically, the inclusion of vendors providing services and technology to support the execution of clinical studies has increased project oversight complexity and new dimension to timeline management and risk mitigation. Delivery teams not only had to manage the usual challenges of start-up delays, patient recruitment and retention issues, and database setups, but also inclusion of vendor capabilities and timelines that could impact the overall execution of a clinical study. Through the inclusion of decentralized capabilities in a deliberate fashion, partnerships between delivery teams and DCT vendors (home health, technology platforms, biomarker/biosensor developers) create opportunity for alignments earlier in the planning of the study and for mitigation strategies that proactively address challenges and create opportunities for integrated operating models.
Beginning with a patient journey map that includes the identification of each of the DCT touchpoints, teams will have a visual mechanism by which they can identify overlaps, bottlenecks, and dependencies to align the DCT service providers and enhance the experience for sites, patients, biopharma, and service providers. Trial oversight will include innovative management approaches to resolving the risks and reduce the burden of duplicative steps. Furthermore, experience with technology platforms and the workflow support that they provide can create business process optimization opportunities across the clinical trial delivery spectrum.
