Caroline Jackson, mdgroup’s Executive Vice President, Patient Services06.28.22
Hybrid and decentralized clinical trials (DCT) may be a hot topic in clinical research, but it’s worth remembering they are a means to an end rather than an end in themselves.
Success comes from prioritizing the needs of the trial and its participants in relation to the technology, not the other way round.
As such, MedTech and devices should enable a holistic, wrap around approach that combines innovative technology with in-person services, because the human touch is essential for a truly patient-centric experience, which dramatically boosts retention rates and creates better clinical outcomes.
There are two main reasons for this, the first being that the traditionally conservative pharmaceutical industry has been slow to adopt this tech-driven revolution. The other, perhaps more pertinent, factor is that not all studies are suited to the DCT model. Complete digitalization is, after all, limited to certain indications, patient populations, and phases of study.
Oncology patients, for example, will need scans and complex measurements which cannot usually be conducted remotely.
In addition, during an early phase study, drug administration tends to come with a higher risk profile than later on in the development pathway. It means patients may be better served on-site with access to specialist clinicians and emergency equipment and protocols. What’s more, not all visits will be subject to the same restrictions or requirements, even within a singular trial.
It makes sense, then, that rather than fully adopting the DCT model, many sponsors and CROs are instead opting for hybrid approaches that combine technology-driven off-site and staff-driven on-site activities in a way that meets the needs of the protocol in hand.
A staggering 37% of sites under-enroll, and 11% fail to recruit a single participant. It’s a problem that can result in delays of anywhere from one to six months, with each day adding between £600,000 and £8 million in direct and indirect costs to study budgets.1
In addition, latest estimates say that around 40% of those who sign up to a study drop out before it completes.2 This forces sponsors to either re-recruit, at a considerable per-patient cost, or face the risk of draining study power, and raising the likelihood of study failure. Every single recruit, then, is precious.
It makes patient centricity, with its ability to attract and engage people in the research process, a crucial consideration in the design of hybrid trials. Indeed, one of the oft-documented advantages of DCT and hybrid models is that by reducing the burden on patients, they can increase recruitment and retention rates.
Yet, this can be too simplistic a view. A blanket approach, using a technology that treats every person the same regardless of their preferences, will just not work.
Many people, whether it be due to their age, health condition, or digital literacy levels, for example, will be unable or unwilling to use telemedicine.
While some will be happy to welcome healthcare professionals into their homes for visits, others may need a little reassurance, and a few will reject this mode of care altogether. And while the more technically minded will appreciate the convenience of communicating with the site team through an app, others will need human interaction to keep them engaged.
If sponsors are to embrace the recruitment and retention benefits of hybrid, they must take all these considerations into account.
In short, a one-size-fits-all approach leaves patients feeling undervalued. Instead, companies should focus on individualized patient support.
A 2019 study of trends and implications in patient engagement initiatives, based on almost 12,500 responses to a global survey, found travelling to and from site to be the “most burdensome” element of participation.3
It also reported that people would welcome supportive services – more than a third (34%) called for concierge services, such as transportation to and from the study clinic, and 31% highlighted a wish for mobile applications to deliver things like electronic surveys and visit reminders.
However, the use of such solutions varies according to factors such as age, region, race, ethnicity, and social media use. Hispanic survey respondents, for example, are consistently more likely to use convenience-enhancing solutions than their non-Hispanic counterparts. The same trend was observed in younger versus older people, but younger participants were also the biggest users of non-technology-based solutions, such as home visits.3
These results clearly demonstrate that a one-tiered approach will not work for every participant. But industry-leading solutions will allow researchers to “mix and match” from a selection of tech- and staff-driven elements of trial design, to create a customized experience.
As the paper’s authors suggest, researchers could include a variety of convenience-enhancing solutions in their clinical trial designs. “Patient participants can choose the options that are most helpful to them, based on lifestyle factors such as work schedules, social media habits, childcare needs, and caregiver involvement,” they wrote.3
This allows clinic visits to be combined with home visits or telehealth in a way that matches both the needs of the protocol and the patient’s preference, for example. It’s a holistic approach that simplifies visits and data collection but also ensures site staff are supported and all the endpoints required by regulators are met.
Integrated software can support home visits with technologies like wearables or ambulatory blood pressure monitoring machines, and allow for data to be collected at the patient’s home or workplace, or at the site.
The key element is ensuring everything is as easy for the participant as possible, no matter where their appointment is held.
On top of enabling customizable home/site visit ratios, they also need to provide concierge-level transport when it is needed, and ensure admin tasks such as claiming expenses are quick and simple. They need to respond to security concerns by letting people know who to expect before they arrive, or requiring HCPs to check in and out of patient’s homes, etc.
But for this approach to work, it must be seamless. Rather than presenting people with a faceless interface or a haphazard mishmash of disparate platforms and solutions, researchers need to provide integrated, adaptive services that are backed up by the human touch.
While tech makes all of this possible, what makes it workable is using these online services as a conduit, rather than a replacement, for site/patient relationships. This is what can take clinical trial concierge services to the next level.
Sponsors and CROs need a holistic approach that considers the value of professionally trained in-person services supported by technical innovation. In this way trials can truly flex according to the needs of the study and the personalized needs of its participants – enabling the development of valuable, authentic relationships between key stakeholders, and accelerating the quality and speed of outcomes.
References:
1 Chaudhari, N., Ravi, R., Gogtay, N. J., & Thatte, U. M. (2020). Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspectives in clinical research, 11(2), 64.
2 PM Live. 5 reasons clinical trial drop-out rates are on the rise. (2021). Available at: https://www.pmlive.com/pmhub/clinical_research/couch_integrated_marketing/white_papers_and_resources/5_reasons_clinical_trial_drop-out_rates_are_on_the_rise#:~:text=Up%20to%2040%25%20of%20patients,remainder%20of%20the%20patient%20experience. Last accessed: 25th May 2022
3 Sine, S., de Bruin, A., & Getz, K. (2021). Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications. Therapeutic Innovation & Regulatory Science, 55(5), 1059-1065.
Caroline Jackson is mdgroup’s executive vice president, Patient Services. With more than 27 years of experience in the industry, Jackson brings a wealth of knowledge and understanding of the clinical development process to mdgroup’s Patient Service Department. In her role as executive vice president of Patient Services, Jackson helps clients embrace new technologies and decentralized solutions to facilitate better patient care, increase clinical trial diversity and reduce drop-out rates by empowering patients.
After graduating from the University of Southampton with a BSc in Pharmacology, Jackson then went on to work for companies including Bayer, PRA Heath Sciences and Synteract, where she was vice president of Vendor Management.
Jackson is passionate about truly putting patients first and increasing clinical trial accessibility by giving patients more choice in how they participate.
Success comes from prioritizing the needs of the trial and its participants in relation to the technology, not the other way round.
As such, MedTech and devices should enable a holistic, wrap around approach that combines innovative technology with in-person services, because the human touch is essential for a truly patient-centric experience, which dramatically boosts retention rates and creates better clinical outcomes.
Hybrid vs. Decentralized Clinical Trials
Reading trade publications, you could be forgiven for thinking that DCTs, in which site visits are replaced with technology-enabled home visits or patient-reported results, were ubiquitous. In reality, however, just a handful of “non bricks and mortar” trials have so far been conducted.There are two main reasons for this, the first being that the traditionally conservative pharmaceutical industry has been slow to adopt this tech-driven revolution. The other, perhaps more pertinent, factor is that not all studies are suited to the DCT model. Complete digitalization is, after all, limited to certain indications, patient populations, and phases of study.
Oncology patients, for example, will need scans and complex measurements which cannot usually be conducted remotely.
In addition, during an early phase study, drug administration tends to come with a higher risk profile than later on in the development pathway. It means patients may be better served on-site with access to specialist clinicians and emergency equipment and protocols. What’s more, not all visits will be subject to the same restrictions or requirements, even within a singular trial.
It makes sense, then, that rather than fully adopting the DCT model, many sponsors and CROs are instead opting for hybrid approaches that combine technology-driven off-site and staff-driven on-site activities in a way that meets the needs of the protocol in hand.
Patient-Centricity is Key
Even in today’s tech-enabled clinical trial environment, participant recruitment and retention remain among the biggest threats to study success.A staggering 37% of sites under-enroll, and 11% fail to recruit a single participant. It’s a problem that can result in delays of anywhere from one to six months, with each day adding between £600,000 and £8 million in direct and indirect costs to study budgets.1
In addition, latest estimates say that around 40% of those who sign up to a study drop out before it completes.2 This forces sponsors to either re-recruit, at a considerable per-patient cost, or face the risk of draining study power, and raising the likelihood of study failure. Every single recruit, then, is precious.
It makes patient centricity, with its ability to attract and engage people in the research process, a crucial consideration in the design of hybrid trials. Indeed, one of the oft-documented advantages of DCT and hybrid models is that by reducing the burden on patients, they can increase recruitment and retention rates.
Yet, this can be too simplistic a view. A blanket approach, using a technology that treats every person the same regardless of their preferences, will just not work.
Many people, whether it be due to their age, health condition, or digital literacy levels, for example, will be unable or unwilling to use telemedicine.
While some will be happy to welcome healthcare professionals into their homes for visits, others may need a little reassurance, and a few will reject this mode of care altogether. And while the more technically minded will appreciate the convenience of communicating with the site team through an app, others will need human interaction to keep them engaged.
If sponsors are to embrace the recruitment and retention benefits of hybrid, they must take all these considerations into account.
In short, a one-size-fits-all approach leaves patients feeling undervalued. Instead, companies should focus on individualized patient support.
Customizable Solutions
Rather than designing the trial to suit the technology, sponsors and CROs need to customize the technology to suit the needs of both their trial and its participants.A 2019 study of trends and implications in patient engagement initiatives, based on almost 12,500 responses to a global survey, found travelling to and from site to be the “most burdensome” element of participation.3
It also reported that people would welcome supportive services – more than a third (34%) called for concierge services, such as transportation to and from the study clinic, and 31% highlighted a wish for mobile applications to deliver things like electronic surveys and visit reminders.
However, the use of such solutions varies according to factors such as age, region, race, ethnicity, and social media use. Hispanic survey respondents, for example, are consistently more likely to use convenience-enhancing solutions than their non-Hispanic counterparts. The same trend was observed in younger versus older people, but younger participants were also the biggest users of non-technology-based solutions, such as home visits.3
These results clearly demonstrate that a one-tiered approach will not work for every participant. But industry-leading solutions will allow researchers to “mix and match” from a selection of tech- and staff-driven elements of trial design, to create a customized experience.
As the paper’s authors suggest, researchers could include a variety of convenience-enhancing solutions in their clinical trial designs. “Patient participants can choose the options that are most helpful to them, based on lifestyle factors such as work schedules, social media habits, childcare needs, and caregiver involvement,” they wrote.3
This allows clinic visits to be combined with home visits or telehealth in a way that matches both the needs of the protocol and the patient’s preference, for example. It’s a holistic approach that simplifies visits and data collection but also ensures site staff are supported and all the endpoints required by regulators are met.
Integrated software can support home visits with technologies like wearables or ambulatory blood pressure monitoring machines, and allow for data to be collected at the patient’s home or workplace, or at the site.
The key element is ensuring everything is as easy for the participant as possible, no matter where their appointment is held.
On top of enabling customizable home/site visit ratios, they also need to provide concierge-level transport when it is needed, and ensure admin tasks such as claiming expenses are quick and simple. They need to respond to security concerns by letting people know who to expect before they arrive, or requiring HCPs to check in and out of patient’s homes, etc.
But for this approach to work, it must be seamless. Rather than presenting people with a faceless interface or a haphazard mishmash of disparate platforms and solutions, researchers need to provide integrated, adaptive services that are backed up by the human touch.
While tech makes all of this possible, what makes it workable is using these online services as a conduit, rather than a replacement, for site/patient relationships. This is what can take clinical trial concierge services to the next level.
Wrap Around Care
Partially decentralized clinical trials are here to stay, thanks to all the reasons outlined above. But tech alone isn’t enough to drive the benefits of hybrid trials.Sponsors and CROs need a holistic approach that considers the value of professionally trained in-person services supported by technical innovation. In this way trials can truly flex according to the needs of the study and the personalized needs of its participants – enabling the development of valuable, authentic relationships between key stakeholders, and accelerating the quality and speed of outcomes.
References:
1 Chaudhari, N., Ravi, R., Gogtay, N. J., & Thatte, U. M. (2020). Recruitment and retention of the participants in clinical trials: Challenges and solutions. Perspectives in clinical research, 11(2), 64.
2 PM Live. 5 reasons clinical trial drop-out rates are on the rise. (2021). Available at: https://www.pmlive.com/pmhub/clinical_research/couch_integrated_marketing/white_papers_and_resources/5_reasons_clinical_trial_drop-out_rates_are_on_the_rise#:~:text=Up%20to%2040%25%20of%20patients,remainder%20of%20the%20patient%20experience. Last accessed: 25th May 2022
3 Sine, S., de Bruin, A., & Getz, K. (2021). Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications. Therapeutic Innovation & Regulatory Science, 55(5), 1059-1065.
Caroline Jackson is mdgroup’s executive vice president, Patient Services. With more than 27 years of experience in the industry, Jackson brings a wealth of knowledge and understanding of the clinical development process to mdgroup’s Patient Service Department. In her role as executive vice president of Patient Services, Jackson helps clients embrace new technologies and decentralized solutions to facilitate better patient care, increase clinical trial diversity and reduce drop-out rates by empowering patients.
After graduating from the University of Southampton with a BSc in Pharmacology, Jackson then went on to work for companies including Bayer, PRA Heath Sciences and Synteract, where she was vice president of Vendor Management.
Jackson is passionate about truly putting patients first and increasing clinical trial accessibility by giving patients more choice in how they participate.