Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare03.18.22
As of early 2022, sponsors have adopted decentralized clinical trials (DCTs) at a faster pace than sites. Recent data shows that 89% of sponsors use decentralized technology to support at least one of their clinical trials. Yet only 40% of academic medical centers and 50% of cancer centers employ this tech.
One reason for this divide could be a lack of understanding of what “decentralized technology” means. In my experience, most sites are already engaging in decentralized trial tactics like telehealth and remote data sharing: they just may not use the term “decentralized” for it.
That said, for decentralized trials to truly gain momentum and make clinical trials more accessible and patient-centric, we need sites and sponsors to agree that DCTs are a permanent shift in how we do business and not just a response to COVID.
Many patients count on research sites to provide access to novel treatment options, but distance and time commitments can prevent people from enrolling in trials. While it’s safe to argue that more acute diseases, like cancer, will always require some in-person care, COVID has shown us that there are a number of creative ways to provide quality care closer to home.
Further, recent data suggests that 92% of patients want clinical trials to embrace innovative technology, and the FDA encourages the use of decentralized methods to speed up trial timelines and increase patient retention.
So how do we combine decentralized technology and in-person site visits to create trials that work for patients? And how can we convince research sites and sponsors to align on this effort?
Why Many Sites Haven’t Embraced DCTs
One reason sites hesitate to try DCTs is the complexity of trial designs and the diseases they treat. This is especially true in cancer studies, where drug administration is complex and patients require heavier monitoring for safety and clinical care.
Complexity
In June 2021, approximately 4,576 decentralized trials were launched, but only 5% of those were oncology trials. However, when you step back and look at the drop-out rates in complex studies like cancer trials, you can’t help but see the potential value of more flexible treatment options, like those offered in a decentralized approach.
Fewer trips to congested medical centers for scans, blood draws, and nurse visits mean fewer expenses for participants and more time for them to live their lives. This will lead to better patient retention and better quality of data: ultimately resulting in faster approval times and more treatment options for all patients, not just those in clinical trials.
Data
The addition of point-of-care facilities and more technology also causes some sites to worry about having too much data. DCTs can collect data from sources like:
Additionally, redundant data entry opens opportunities for transcription errors, which can generate an increased number of data queries for the site and sponsor to manage. This slows down data lock and adds to the overall problem of protracted timelines for sponsors and sites.
Compliance
Finally, sites often worry about compliance when using decentralized trial technology. They need to know the technology follows local and federal regulations.
Whether a system is provided by the sponsor or the site, the site is ultimately responsible for ensuring its compliance with CFR Part 11, HIPAA, and GDPR. This can cause sites to hesitate before adopting technology.
However, sponsors and tech vendors can help triage this apprehension by providing sites with guidance on how best to implement systems at their sites.
How DCTs Can Help Sites
Although sites have understandable concerns about decentralized trials, DCTs can help sites create a more patient-centric experience by leveraging tools and practices validated for patient care during the pandemic. Decentralized trials can also speed up recruitment timelines and help sites serve diverse patients, without sacrificing data quality or compliance.
Patient-Centricity
Sites sometimes assume that patients coping with serious illness would prefer to do fully site-based trials. But seriously ill participants can still benefit from the convenience of decentralized, patient-centric trials.
Studies have repeatedly demonstrated the impact of financial toxicity and time commitments on a patient’s willingness to participate in oncology trials. These patients already endure so many doctors’ appointments as part of their standard care that the idea of adding even more site visits could deter them from participating in trials.
With a DCT approach, more cancer patients could sign consent forms from home or do quick check-ins via telehealth or their local Primary Care Provider. This eliminates some of the need for travel and lets patients save trips to the main site for more intensive tests or treatments.
However, the benefit of DCTs is not just limited to cancer patients. Other patients with serious illnesses could benefit from the same approach. In a recent survey of patients living with rare diseases (hemophilia, idiopathic pulmonary fibrosis (IPF), myasthenia gravis (MG), and sickle cell disease), 57% said they would rather participate in a decentralized, hybrid trial than a 100% virtual or 100% site-based one.
With 70% of patients living more than 2 hours from a research site, using decentralized methods like telemedicine or wearable devices can open up trials to patients who may have trouble traveling to sites on a regular basis.
Participant Recruitment and Inclusivity
80% of clinical trials experience delays because of recruitment, and many clinical trials fail to recruit enough elderly, Black, Hispanic, and Indigenous participants to accurately represent the population. By making it easier to recruit diverse patients quickly, decentralized trials can help sites meet recruitment deadlines while ensuring their trials are inclusive.
In one study, participants were given the choice of signing up for a decentralized or fully site-based trial. The site-based trial recruited just 1.25 patients per month, while the decentralized trial recruited 4.5 patients per month. The decentralized trial also recruited more patients from rural areas.
Though this trial was small, its results indicated that decentralized models work for speeding up recruitment and increasing diversity. The COVID-19 vaccine trials in 2020 and 2021 provided even more evidence that DCTs increase diversity.
Both Pfizer and Modera used decentralized methods for their Phase III vaccine trials. 9.3% of global participants in the Pfizer trial and 10.2% of participants in the Moderna trial were Black, and 28% of participants in the Pfizer trial and 20.5% of participants in the Moderna trial were Hispanic.
While these percentages still don’t fully reflect the U.S. or global population, they’re much better than the percentages for the average clinical trial, which consists of 5% Black participants and 1% Latinx participants.
By allowing participants to check in from home or neighborhood clinics instead of only at major research sites, Pfizer and Moderna reached local communities and made clinical trials a reality for people living in medically underserved areas.
How Sponsors Can Help Sites Become Comfortable with DCTs
The FDA supports decentralized methods, especially when those methods can speed up recruitment and increase diversity. The UK is also reworking its clinical trial regulations to make its trials more patient-centric, and the European Medicines Agency will soon enact new regulations to encourage flexible clinical trials.
This means that as long as sites have compliant technology and the support of their sponsors, they can embrace DCTs. But finding that technology can be tricky, and it’s one major area where sponsors can help their sites.
Choosing Site-Friendly Tech for DCTs
If sites plan to collect data using wearables, sensors, eCOA or ePRO software, they need software that integrates with their current software systems. They should be able to quickly import the data they’ve collected into their electronic participant records or electronic Investigator Site File (eISF).
System integrations and streamlined data flow are essential to ensuring that study staff can care for patients in and out of clinical trials. The elimination of manual data entry also increases site efficiency and overall quality of data.
That said, 48% of sites prefer working with sponsors who will use their existing infrastructure. So before sponsors hand out data-collection software for decentralized trials, they should look at what technology sites already have, such as a Clinical Trial Management System (CTMS) or eISF system. Then, they can choose decentralized software that integrates with sites’ pre-existing clinical trial systems.
Training and Preparing Sites for DCTs
When asked how confident they were in their ability to conduct DCTs, sites gave themselves a score of 5 out of 10. Sponsors can alleviate this discomfort by offering training and support on how to use decentralized technology.
Sponsors don’t have to do this alone, however. They can seek out technology vendors who offer in-depth training, customer service, and implementation support to sites. By choosing technology vendors who are willing to provide intensive support to sites, sponsors increase the chances that sites will adopt decentralized trial software and embrace DCTs.
DCTs Are a Black Box to Sites–But They Don’t Have to Be
Research sites want to ensure that all of their trials are compliant and provide excellent care to patients. Fortunately, decentralized trials can make this a reality by combining technology and home care with site visits for a more convenient, patient-centric experience.
With new data management technology and global regulatory support, DCTs are more compliant and practical than ever.
But if we as clinical trial professionals want sites to embrace DCTs, we need to ensure sites have access to technology that works for them, not against them. We also need to provide extensive training and educational opportunities to help sites, CROs, and sponsors understand the vital role sites play in DCTs.
Catherine Gregor, MBA, CCRP, CCRC is the Chief Clinical Trial Officer at Florence. She has more than 15 years of experience analyzing and implementing change across back-office research operations for finance, clinical operations, regulatory, and health information systems. She has worked in a myriad of community and academic environments. Most recently, she served as the Director of Clinical Research Administration at the Vanderbilt-Ingram Cancer Center.
One reason for this divide could be a lack of understanding of what “decentralized technology” means. In my experience, most sites are already engaging in decentralized trial tactics like telehealth and remote data sharing: they just may not use the term “decentralized” for it.
That said, for decentralized trials to truly gain momentum and make clinical trials more accessible and patient-centric, we need sites and sponsors to agree that DCTs are a permanent shift in how we do business and not just a response to COVID.
Many patients count on research sites to provide access to novel treatment options, but distance and time commitments can prevent people from enrolling in trials. While it’s safe to argue that more acute diseases, like cancer, will always require some in-person care, COVID has shown us that there are a number of creative ways to provide quality care closer to home.
Further, recent data suggests that 92% of patients want clinical trials to embrace innovative technology, and the FDA encourages the use of decentralized methods to speed up trial timelines and increase patient retention.
So how do we combine decentralized technology and in-person site visits to create trials that work for patients? And how can we convince research sites and sponsors to align on this effort?
Why Many Sites Haven’t Embraced DCTs
One reason sites hesitate to try DCTs is the complexity of trial designs and the diseases they treat. This is especially true in cancer studies, where drug administration is complex and patients require heavier monitoring for safety and clinical care.
Complexity
In June 2021, approximately 4,576 decentralized trials were launched, but only 5% of those were oncology trials. However, when you step back and look at the drop-out rates in complex studies like cancer trials, you can’t help but see the potential value of more flexible treatment options, like those offered in a decentralized approach.
Fewer trips to congested medical centers for scans, blood draws, and nurse visits mean fewer expenses for participants and more time for them to live their lives. This will lead to better patient retention and better quality of data: ultimately resulting in faster approval times and more treatment options for all patients, not just those in clinical trials.
Data
The addition of point-of-care facilities and more technology also causes some sites to worry about having too much data. DCTs can collect data from sources like:
- Wearables or sensors
- Electronic Patient-Reported Outcome (ePRO) software
- Electronic Clinical Outcomes Assessment (eCOA) technology
- Electronic patient diaries
Additionally, redundant data entry opens opportunities for transcription errors, which can generate an increased number of data queries for the site and sponsor to manage. This slows down data lock and adds to the overall problem of protracted timelines for sponsors and sites.
Compliance
Finally, sites often worry about compliance when using decentralized trial technology. They need to know the technology follows local and federal regulations.
Whether a system is provided by the sponsor or the site, the site is ultimately responsible for ensuring its compliance with CFR Part 11, HIPAA, and GDPR. This can cause sites to hesitate before adopting technology.
However, sponsors and tech vendors can help triage this apprehension by providing sites with guidance on how best to implement systems at their sites.
How DCTs Can Help Sites
Although sites have understandable concerns about decentralized trials, DCTs can help sites create a more patient-centric experience by leveraging tools and practices validated for patient care during the pandemic. Decentralized trials can also speed up recruitment timelines and help sites serve diverse patients, without sacrificing data quality or compliance.
Patient-Centricity
Sites sometimes assume that patients coping with serious illness would prefer to do fully site-based trials. But seriously ill participants can still benefit from the convenience of decentralized, patient-centric trials.
Studies have repeatedly demonstrated the impact of financial toxicity and time commitments on a patient’s willingness to participate in oncology trials. These patients already endure so many doctors’ appointments as part of their standard care that the idea of adding even more site visits could deter them from participating in trials.
With a DCT approach, more cancer patients could sign consent forms from home or do quick check-ins via telehealth or their local Primary Care Provider. This eliminates some of the need for travel and lets patients save trips to the main site for more intensive tests or treatments.
However, the benefit of DCTs is not just limited to cancer patients. Other patients with serious illnesses could benefit from the same approach. In a recent survey of patients living with rare diseases (hemophilia, idiopathic pulmonary fibrosis (IPF), myasthenia gravis (MG), and sickle cell disease), 57% said they would rather participate in a decentralized, hybrid trial than a 100% virtual or 100% site-based one.
With 70% of patients living more than 2 hours from a research site, using decentralized methods like telemedicine or wearable devices can open up trials to patients who may have trouble traveling to sites on a regular basis.
Participant Recruitment and Inclusivity
80% of clinical trials experience delays because of recruitment, and many clinical trials fail to recruit enough elderly, Black, Hispanic, and Indigenous participants to accurately represent the population. By making it easier to recruit diverse patients quickly, decentralized trials can help sites meet recruitment deadlines while ensuring their trials are inclusive.
In one study, participants were given the choice of signing up for a decentralized or fully site-based trial. The site-based trial recruited just 1.25 patients per month, while the decentralized trial recruited 4.5 patients per month. The decentralized trial also recruited more patients from rural areas.
Though this trial was small, its results indicated that decentralized models work for speeding up recruitment and increasing diversity. The COVID-19 vaccine trials in 2020 and 2021 provided even more evidence that DCTs increase diversity.
Both Pfizer and Modera used decentralized methods for their Phase III vaccine trials. 9.3% of global participants in the Pfizer trial and 10.2% of participants in the Moderna trial were Black, and 28% of participants in the Pfizer trial and 20.5% of participants in the Moderna trial were Hispanic.
While these percentages still don’t fully reflect the U.S. or global population, they’re much better than the percentages for the average clinical trial, which consists of 5% Black participants and 1% Latinx participants.
By allowing participants to check in from home or neighborhood clinics instead of only at major research sites, Pfizer and Moderna reached local communities and made clinical trials a reality for people living in medically underserved areas.
How Sponsors Can Help Sites Become Comfortable with DCTs
The FDA supports decentralized methods, especially when those methods can speed up recruitment and increase diversity. The UK is also reworking its clinical trial regulations to make its trials more patient-centric, and the European Medicines Agency will soon enact new regulations to encourage flexible clinical trials.
This means that as long as sites have compliant technology and the support of their sponsors, they can embrace DCTs. But finding that technology can be tricky, and it’s one major area where sponsors can help their sites.
Choosing Site-Friendly Tech for DCTs
If sites plan to collect data using wearables, sensors, eCOA or ePRO software, they need software that integrates with their current software systems. They should be able to quickly import the data they’ve collected into their electronic participant records or electronic Investigator Site File (eISF).
System integrations and streamlined data flow are essential to ensuring that study staff can care for patients in and out of clinical trials. The elimination of manual data entry also increases site efficiency and overall quality of data.
That said, 48% of sites prefer working with sponsors who will use their existing infrastructure. So before sponsors hand out data-collection software for decentralized trials, they should look at what technology sites already have, such as a Clinical Trial Management System (CTMS) or eISF system. Then, they can choose decentralized software that integrates with sites’ pre-existing clinical trial systems.
Training and Preparing Sites for DCTs
When asked how confident they were in their ability to conduct DCTs, sites gave themselves a score of 5 out of 10. Sponsors can alleviate this discomfort by offering training and support on how to use decentralized technology.
Sponsors don’t have to do this alone, however. They can seek out technology vendors who offer in-depth training, customer service, and implementation support to sites. By choosing technology vendors who are willing to provide intensive support to sites, sponsors increase the chances that sites will adopt decentralized trial software and embrace DCTs.
DCTs Are a Black Box to Sites–But They Don’t Have to Be
Research sites want to ensure that all of their trials are compliant and provide excellent care to patients. Fortunately, decentralized trials can make this a reality by combining technology and home care with site visits for a more convenient, patient-centric experience.
With new data management technology and global regulatory support, DCTs are more compliant and practical than ever.
But if we as clinical trial professionals want sites to embrace DCTs, we need to ensure sites have access to technology that works for them, not against them. We also need to provide extensive training and educational opportunities to help sites, CROs, and sponsors understand the vital role sites play in DCTs.
