Pulse Report: Decentralized Clinical Trials

Contributed by:

Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

We tapped more than a dozen industry experts to share their insights on the market factors driving DCT adoption.

Decentralized clinical trials (DCTs), one of the hottest areas of discussion today, offer a more patient-centric approach to clinical trials. Some say the movement reflects a transformational philosophy in which fewer clinic visits are required and patient and caregiver burden is reduced. However, DCTs aren’t strictly new. Several of the technology components such as telemedicine, wearables, eConsent, eCOA, and eHealth records have been employed for years. What is transformational is the combination of multiple technologies to seamlessly knit together a better patient journey. With the DCT market ready to explode to an estimated value of $1.63 billion by 2027, according to Precision Reports, a CAGR of 14.8% during the 2021-2027 time period, we invited several industry experts to provide their insights on this burgeoning industry sector.

Pulse Point No. 1:
Market Growth Factors

Ronan Brown. IQVIA.
The need to efficiently identify, recruit, and engage the right participants for clinical trials drove the original focus on DCT models. Even with a hybrid approach, the goal was to simplify processes and reduce the burden on participants while equipping study teams with better, real-time data to deliver results faster. While the need to hasten recruitment, improve patient engagement, and drive new operational efficiencies continues to influence growing DCT adoption, the uncertainties around new COVID-19 variants and the global pandemic underscore the continued need for adaptable, hybrid DCTs to support patients, sponsors, and sites going forward.

Rob Bohacs. ClinOne.
The initial outset of COVID precipitated sponsors running ongoing studies that couldn’t simply stop, such as oncology trials, to immediately source remote solutions for trial continuity. This kick-started a hopefully long-term commitment from sponsors and CROs to bring beneficial technology to patients and sites. But the term DCT has become too vague — and the idea that sites won’t be needed anytime soon has gone too far. Sites are the lifeblood of clinical research; they maintain the relationships with patients and will continue to for the foreseeable future. I believe the best technology will support and enable sites to do their important work whether in-person or remotely without attempting to remove them from the process. Empowering patients does not mean deemphasizing sites. So, with all the focus on DCT vs. remote solutions, we need to clarify terms and continue to bring solutions directly to patients and families that improve their experience regardless of trial design.

Rosamund Round. Parexel.
A recent Jefferies report from April 2021 predicts that the global DCT market size will reach $4.4 billion by 2025. Given the incredibly rapid adoption of DCTs, the ongoing COVID-19 pandemic, benefit to patients in terms of trial access and experience, and the increased speed of enrollment facilitated by DCTs, I believe that this growth trend will continue and will perhaps fall somewhere between the two differing predictions mentioned above. We may see a slight drop-off in market growth post-pandemic, which leads me to temper my response. However, in an uncertain world it is difficult to predict when life will return to normal and in turn when the current urgency to deploy trials in the decentralized model becomes less pressing. There are a number of factors that will fuel growth, including the need to reduce trial cost and time, particularly given the ever-increasing complexity of trial designs; sites becoming more amenable to decentralized elements such as telemedicine, due to the level of familiarity and experience they have gained during the COVID-19 pandemic; and patients’ growing expectations for a more convenient way to access trials. With an increase in home-based options in their lives during the last 18 months and many patients now having experienced DCTs, it is unlikely that they will tolerate the practical challenges of traditional trial conduct long term.

Kevin Duffy. KPS Life.
Clearly, the pandemic had a dramatic influence on the accelerated acceptance of the DCT approach to clinical research. Before the COVID-19 crisis, there was a slow and somewhat steady migration to this model in select phases of development and on trial designs that were conducive to a less-traditional methodology. Further, a patient’s lifestyle and overall expectations as they relate to the requirements and rigor for participation in a clinical research project affect the uptake of the DCT model.
Ed Ikeguchi. AiCure.

Beyond the pandemic, the shift to DCTs is supported by several factors: patients want to participate in clinical trials in a convenient way; sponsors need to improve access to care and reach diverse populations that cannot travel to a clinic; and sponsors can improve data capture around a patient’s well-being vs. relying on sporadic clinical visits, and improve patient engagement by activating always-on avenues of support from a study clinician.

Anthony Costello. Medidata.
We are seeing customers completely rethink entire clinical development programs to most, if not all, studies to be decentralized in one way or another. When this starts to happen across the industry, the growth of the market opportunity will explode for products and related services scalable to address this new set of needs. DCTs have been around for some time now, but they gained monumental exposure during the COVID-19 pandemic when patients couldn’t visit sites and many sites were shut down.

Virtualizing solutions were necessary to enable continued patient participation in clinical trials, to monitor patients for safety, and to collect data on investigational drugs, vaccines, and devices. These patient-centric solutions are no longer “nice-to-have” additions. They are “must-have” solutions. DCTs are here to stay long after the pandemic. Incorporating visit and data capture flexibility into clinical trials has benefits for sponsors and sites, but most importantly for patients. When clinical trials become a convenient care option for more patients, we will see an acceleration of study and clinical program timelines.

David Coman. Science 37.
With traditional sites not available for in-person activities during the pandemic, decentralization adoption grew substantially. Encouraged by regulators to consider alternative approaches, sponsors and CROs were quick to incorporate digital technologies and other DCT methods into existing trials. According to an Industry Standard Research (ISR) survey of biopharma executives commissioned by us, more than 60% say their company conducted a clinical trial using at least some DCT elements within the last year. Our findings also indicate that more than 80% expect to conduct a clinical trial using at least some DCT elements in the coming year. Even before the pandemic, the traditional clinical research model needed an upgrade. Not only do traditional clinical trials take too long and cost too much, the traditional process still is overly burdensome for patients and providers and fails to take full advantage of widely available technologies that can improve operations while generating quality evidence. By leveraging decentralized technologies and methodologies, sponsors can speed enrollment, improve retention, and increase representation. In a recent ISR survey, almost 100% of biopharma execs predict DCT activity to increase in the coming years.

Marla Becker. Medable.
A focus on patient-centricity will continue to increase demand for remote treatment following the pandemic. The efficiencies are irresistible and precision medicine is increasingly becoming mainstream.

Vincent Keunen. Andaman7.
Multiple factors are driving the growth of DCTs, which have been made possible by technological advances such as smartphones and widespread internet access. Shifting from site visits to remote monitoring during the pandemic, at least in part, enabled the continuation of trials that would otherwise have been delayed. In truth, however, the industry had been moving towards this model for some time. The spiraling costs of clinical development and time pressures on healthcare professionals have made decentralization an attractive option. At the same time, the growing complexity of studies means researchers are increasingly being asked to collect more data points, more frequently, and at times that better reflect real-life situations — a shift that simply cannot be accommodated in the traditional, on-site approach.

Jeremy Edwards. Xperiome.
The move toward DCTs is being driven by two interconnected factors: improving the patient experience and resolving the challenges of study recruitment. More than 85% of trials fail to meet recruitment targets on time. This is — at least in part — due to the complexities of participating for patients: travel, out-of-pocket expenses, multiple visits to the site for treatments, and follow-ups. This is especially true for rare disease patients, where populations are geographically dispersed, so study sites are often hours or even multiple states away, and patients are typically limited in their ability to make multiple long journeys. This burden is further exacerbated because the patient does not typically travel alone, meaning caregivers must also take time off work or away from caring for others in the family. In a 2020 survey we conducted with our community members, we found that the prospect of traveling to sites was less attractive for rare disease patients. In fact, 60% of respondents said they liked the idea of having more of the study take place at home, and 50% liked the idea of using technology both to communicate with research staff and have their health monitored.

John Hall. Cluepoints.
The pandemic has accelerated the adoption of DCT approaches and demonstrated the benefits of virtualization to improving the patient and physician experience. We will see overall growth in the clinical trial market — the global clinical trials market is expected to grow at 5.7% per year to reach a value of $69.5 billion by 2028. There is increasing comfort with digital health technology among consumers, such as with fitness wearables, and physicians with telemedicine, which is smoothing the operationalization and logistical implementation of DCT approaches. This increased technical comfort among participants also has enhanced expectations of their clinical trial experience. Although more needs to be done, the regulatory landscape is evolving to simplify the adoption of DCT modalities.

Bernard Vrijens. Aardex Group.
The DCT model is growing in popularity because it has the potential to address several long-standing challenges of research. For instance, by removing barriers to participation, it can make it easier and faster to recruit patients, therefore accelerating drug development timelines. It also removes geographical restrictions, making it easier to recruit from a population more representative of the product’s end user.

Regulators and payers are increasingly asking for this type of data. The rise of the patient-centricity movement is also playing a role, as DCTs are better able to facilitate collaborations between sites and communities than traditional approaches.

Nico Coetzee. CureClick.
Socioeconomical forces in the adoption of technology will be a driving factor.

Laura Acosta. Anju Software.
Right now, the market factors that will drive DCT the most quickly will be whatever drives reaching the population required for a successful clinical trial. This involves a couple of factors, including an aging population that tends to have a more difficult time getting to a clinic regularly to be involved in a clinical trial as well as areas of the world where there are fewer clinics or where a clinic may not be near much of the population. When COVID trials were rolling out, we also saw difficulty finding a suitable population for vaccine trials because factors for inclusion and exclusion were challenging. More and more vaccine trials were coming online, and they needed to enroll tens of thousands of subjects to expand beyond the boundaries of one clinic.

People may be willing to drive one hour, but are less likely to drive two hours and are unlikely to drive three hours, especially if it gets to the point where they are just going in for a 15-minute checkup on vital signs. People are now moving to work from home and are moving away from cities and spreading out. This will not make clinical trials easier, as people will no longer be interested in driving 45 minutes to go to a clinical trial. This COVID-caused population shift can also shift the focus on who is being researched in a clinical trial. Many clinical trials currently focus primarily on white men and a population that is much easier to target. Still, there is a lot of research going into diversity in clinical trials.

Cari Kniola. Aperio Clinical Outcomes.
The growth in DCT has been driven by several factors. Obviously, COVID-19 played a huge part in opening our eyes to the fact that DCTs are viable and worthwhile options and not just a buzzword. I also think the race to new therapies is tight, and any way companies can get a boost in patient recruitment and retention gives them an edge. DCTs give that boost.

Pulse Point No. 2:
Finding Common Ground

Rosamund Round. Parexel.
At present, companies are measuring what constitutes a DCT in different ways, and as a result regulatory guidance differs by country. A strong foundation with common nomenclature and best practices will aid moving the DCT industry forward. There are various industry initiatives underway to address the challenge such as DTRA, the ACRO DCT Working Party, and TransCelerate. These different groups all need to come together to truly implement industrywide best practices. Rapid adoption of innovation at the speed we have experienced with DCTs has never been seen before, so it makes sense that there are differences. But companies are clearly motivated to find common ground and to do so swiftly and pragmatically.

Niklas Morton. PPD.
There is a need for common nomenclature, however, the absence of such guidance will not delay progress in this area, as collaborative efforts are underway with industry-leading organizations such as the Association of Clinical Research Organizations (ACRO) and the Decentralized Trials Research Alliance (DTRA). There are planned efforts to harmonize DCT study conduct, including best practices. For example, there are ongoing workstreams across innovative industry groups such as DTRA.

David Coman. Science 37.
To continue the evolution toward a more fluid, patient-centered clinical research ecosystem leveraging multiple decentralized technologies and approaches, sponsors and CROs will require a consistent, technology-led operating system that’s agile enough to integrate into traditional trials with brick-and-mortar sites, and scalable enough to empower clinical trials entirely virtually — unbound by geographic limitations. Enabling a broader, more inclusive approach to study design and conduct, an operating system will become a requisite, integral part of the clinical trial process.

The industry is doing an average job as our data suggest; best practices would require a network-based clinical research ecosystem in which DCT components are integrated into trial protocols from the onset. In a recent ISR study, almost 60% biopharma executives say that their organization does not have the internal capabilities to operationalize any components of a decentralized clinical trial. In lacking internal capabilities but anticipating their increased adoption, biopharma developers face a familiar problem, whether to build internal infrastructure to coordinate and integrate DCT into clinical trial operations, or to outsource these activities. In either case, these data demonstrate a need for a network-based clinical research ecosystem in which DCT components are integrated into trial protocols from the onset, easing the burden on patients and providers while providing the requisite level of quality, efficiency, and expertise.

Tim Davis. Veeva.
The industry needs to define decentralized trials because often, organizations only think of patient-facing technology when the term includes much more than that. Patient applications are an essential part of decentralized trials, but if each patient’s data stays in the app, sites will need to use multiple logins across different systems to access that information. These applications often don’t connect to sponsor systems either, making it hard to share data and leading to issues with transparency, delays, and costly integrations. Best practices for DCTs should extend well beyond patient-facing solutions. The industry needs to consider an end-to-end digital trial to make it easier for all stakeholders and enable seamless information sharing throughout a study.

Bernard Vrijens. Aardex Group.
Common nomenclature and best practices across the industry would reduce variability and guarantee comparability between studies, while also facilitating external validation. In clinical trials, we seek to limit the variability between participants as much as possible. We do this through a range of measures, such as inclusion/exclusion criteria, standardizing assessment procedures, selecting the “best” patients by site, and preferring hard outcomes over self-assessment. With the uptake of the direct-to-patient approach of DCT, however, we will inevitably experience an increase in variability between and within patients. There are two ways to approach this: recruiting the unrealistically large sample sizes that will be needed to show a meaningful effect despite the variability, or focusing on managing the key sources of variability. We would suggest the latter. Medication adherence is one of the most important sources of variability within a clinical trial, but, thanks to modern digital adherence monitoring, is relatively easy to manage. Adherence to allocated trial intervention is fundamental for sound interpretation of ITT analysis, and should, therefore, become best practice in DCTs.

Pulse Point No. 3:
DCT Adoption Factors an Advantages

Laura Acosta. Anju Software.
One of the biggest drivers of adopton will be the ablility to recruit a more diverse patient pool and get more patients that geographically could not physically get to a site. The pandemic has brought this need to the forefront. These capabilities always existed, but COVID started pushing hybrid and virtual trials, with patents now allowed to have televisits, and not having to come into the office as frequently as well as having drugs shipped directly to their homes, so they are not going to want to turn back to participating in standard trial settings. DCTs will be driven by patient demand, and COVID made it clear that this is a way of doing healthcare. While it may not cost less initially, doing clinical trials this way will potentially save the industry long term from running another trial on a more diverse patient population or running a trial in another county, or adding or changing criteria as the trial goes on.

Trials that have difficulty recruiting patients will loosen the requirements of participating in standard trials, resulting in further savings. With COVID, people are working from home and moving out of cities, and the accessibility to the internet will make it easier to do decentralized clinical trials.

Ed Ikeguchi. AiCure.
The stretches between clinical visits hold critical information about a patient’s response to treatment and a medication’s performance. Accessing this traditionally uncaptured data can lead to improved data quality, enhanced patient outcomes, and quicker, more cost-effective trials. A hybrid model that keeps sites at the center of a study and employs AI-assisted technologies to complement their work virtually gives patients a convenient way to access care, while reducing site burden related to basic data collection. By ensuring patients always have the support they need, DCTs can enrich the relationship between patients and sites, resulting in more engaged patients and more efficient sites.

Ronan Brown. IQVIA.
For patients, DCTs expand access to clinical trials by making participation easier no matter where they live. Access is critical, especially among patients for whom clinical research is an important care option. For sites, DCTs allow investigators to oversee more patients or even more studies from a single site.

With telemedicine visits and connected devices fueling efficiencies, DCTs make better use of investigators’ time and make in-person visits with patients more meaningful. For sponsors, DCTs help them enroll and engage the right patients more efficiently, helping deliver lifesaving and life-enhancing interventions to the market faster than ever before.

Rob Bohacs. ClinOne.
Whether remote, DCT, or whatever term we want to apply to it, any technology or solution that empowers patients directly is a win in my book. Far too many of the solutions in our industry are geared toward sites — which, by the way, don’t necessarily want to use all these different systems. I’m simply amazed how few directly support patients and, critically, their caregivers, family members, and loved ones. And I’m frankly taken aback at the utter lack of understanding of the realities of a clinical trial’s impact on patient lives. Modern technology can help connect patients to clinical trials and navigate a very complex process, and enables them to participate by, for example, arranging Uber Health transportation in their daily life so they can continue to go to the grocery store, or to visit friends or relatives, while they are unable to drive after a trial procedure. Speaking from personal experience with my own family, anything that understands the challenges facing patients and makes their day a little easier, helping them to participate in a trial without getting in their way, provides the biggest advantage in my view.

Rosamund Round. Parexel.
The two biggest advantages of DCTs are: improving patient access to and experience in clinical research, particularly for patients from underrepresented and rural communities and increasing speed of enrollment, enabling sponsors to bring new medications to market faster, which is a huge benefit to patients.

David Coman. Science 37.
When a sophisticated operating system with technology platform is deployed in combination with specialized networks, such as patient communities, telemedicine investigators, mobile nurses, remote coordinators, and connected devices, it can enable universal access to patients and providers, which leads to faster enrollment, greater retention, and a more representative patient population. Our own studies have shown we can achieve 15-times faster enrollment, 28-times greater retention, and three-times more diversity. All the while, reducing burden on patients and increasing compliance and helping to accelerate the development of treatments that impact patient lives.

Nico Coetzee. CureClick.
The biggest advantages to DCTs are scale and bringing trial and potential cures to the masses.

Vincent Keunen. Andaman7.
DCTs provide a multitude of benefits. By reducing site visits, they can lower the burden on study teams and study participants. They also streamline the process, which lowers costs and accelerates drug development. In addition, by enabling “out of hours” data collection, DCTs capture meaningful real-world data that can inform the creation of real-world evidence that can supplement the findings of clinical trials. Crucially, DCTs allow the for the inclusion of the patient perspective that regulators are increasingly asking for.

Jeremy Edwards. Xperiome.
For us it’s all about the patient. The rare disease community is keen to participate in trials, but the barriers are arguably higher for them than anyone. Trials are limited and may be states away, travel is arduous and often requires the attendance of a caregiver or family member alongside the patient. Therefore, every site visit is an additional barrier to participation that frequently just cannot be overcome. The potential for DCTs, whether entirely virtual, or simply to reduce the number of in-person visits, is a real game-changer for rare disease research. It reduces the barrier to participation for patients and their families and helps pharma meet recruitment targets by increasing the reach of trials. Ultimately, what we want is more choice for patients.

Tim Davis. Veeva.
DCTs improve access to research by allowing patients to participate even if they live far from a recruiting site. They also deliver greater reach into underserved and minority patient populations because of their convenience and flexibility. The face-to-face interaction between patients and sites is not going away. Still, the patient-facing applications used in DCTs bring studies into patients’ homes and reduce the burden of participation. This promises better enrollments and retention and greater patient diversity, which can drive long-term improvements in the quality and outcome of clinical research. Taking traditionally manual and paper-based processes and digitizing them enables faster data capture. The key is ensuring those apps can share information with sponsor and site systems to integrate into the broader clinical data set. This allows study teams to access data sooner and make more informed trial management decisions.

Pulse Point No. 4:
Barriers to Overcome

Marla Becker. Medable.
Top barriers span from asymmetric expectations across stakeholders and fundamental differences in DCT across therapeutic areas to insufficient regulatory purview, operational gaps by vendor type, and lack of training for physicians, patients, and coordinators.

Anthony Costello. Medidata.
It’s important to remember that very few companies have enough experience with decentralized clinical trials to be in any position to define “best practice.” There are several critical industry consortiums that have formed to bring industry leaders together in an effort to share learnings and to build a standard foundation for DCTs — ranging from regulatory recommendations to best practices and common nomenclature. More importantly, we need to ensure that solutions are designed for patients by patients. Too often, technology solutions and study designs/best practices are developed without the partnership of patients and clinical trial sites — the ultimate consumers of the solutions. This results in suboptimal experiences and can lead to increased frustrations and underutilization of innovative technologies.

Ronan Brown. IQVIA.
It’s time to clarify and create new regulations that better support DCTs across geographies. Data privacy is one critical area: specifically remote data capture, how those data are captured, transmitted, used, and shared. We need integrated technology platforms that support better patient engagement, improve safety through continuous, clean data collection, AI and ML, and dovetail with traditional trials to support hybrid approaches. We must partner with sites to improve DCT acceptance. When we include PIs and site staff in trial design, we can create DCT models that help sites successfully deliver remote oversight and telehealth.

Niklas Morton. PPD.
There are a number of barriers that, as an industry, we need to overcome. There is a common misconception around the level of investment required to implement digital and decentralized trials. Protocol development is too often progressing to near-finalization with a traditional mindset, with considerations for decentralization/digitization then being applied much later in the process. This results in a challenging situation in which changes are seen as potentially unwinding previous discussions or potentially delaying study progress. Study sponsors should be looking to prospectively put the patient at the center of their protocol design considerations from the outset. Regulatory bodies should aim to provide deeper clarity with guidance that clearly articulates their position around DCTs and related digital tools. In some cases, the absence of documented regulatory support has been interpreted as a lack of support for these approaches, when that might not necessarily be the case.

Sponsors should recognize that adopting a DCT strategy also means adopting a digital data acquisition strategy. They therefore should consider how systems will integrate and data will flow. This also includes the human factor/user experience, such as placing themselves in the shoes of an investigator/coordinator or a patient to better understand the number of platforms/logins that will be required. Not all endpoints can be collected in a decentralized or digital manner, but the vast majority can. It’s important to think about how and when endpoint collection can be streamlined, weighing patient preference.

Kevin Duffy. KPS Life.
It comes down to the FDA’s overall acceptance of the new methodology and, as always, the ability of the technological advances to keep pace with the needs of any given protocol.

Tim Davis. Veeva.
Even though there is no clear definition for DCTs, most companies face the same challenges in clinical operations. First, there is the need for interoperability between sponsor systems, site operations, and patient-facing applications. Without a seamless flow of information, decentralized trials won’t deliver the expected efficiency and speed benefits. Additionally, despite some interim guidance during 2020, there hasn’t been any harmonized regulatory agreement on requirements for running decentralized trials globally. Generally accepted guidelines would significantly increase the industry’s adoption of DCTs.

John Hall. CluePoints.
Clinical trials are unfamiliar experiences for patients, and this can be heightened by the use of decentralized elements such as data-capture devices and home nursing. Patients vary in their comfort with and access to technology. Improvements are needed in the approaches and resources available to train and support participants, and in how user interfaces are tailored to specific patient populations. Regulatory guidance still differs quite significantly from country to country. A good example is in the adoption of eConsent and data privacy regulations. As a result, implementing decentralized approaches in multi-country studies comes with additional complexities in trial design and planning. There is a need for more unified approaches to simplify study conduct for global studies. There is limited understanding of the dimensions of risk in decentralized trials and how to effectively mitigate or manage such risks.

Central monitoring tools and approaches to visualize and analyze data in the dimensions of variability that are typical in full or hybrid-DCT studies are required.

Data collected via DCTs platforms are also not routinely integrated with other operational clinical trial platforms resulting in suboptimal interactions with sites, participants, and other stakeholders. Clinical-trial sponsors need to overcome internal challenges around skepticism, operating models for DCTs and expertise across in-house functions to drive routine adoption.

Vincent Keunen. Andaman7.
Standardization of terminology and best practices is always a good idea. But rather than reinvent the wheel, we should look at how we can improve existing initiatives. Key to this is improving interoperability of data sources, a long-standing challenge in the clinical trial arena. When a patient attends two hospitals, for example, his or her health data will be collected in two very different ways. The same information may be captured in two different languages, according to two different data standards. One site may codify the data with standard systems, while the other may use a proprietary coding system. Each may use different identification authentication mechanisms, and a different data schema or data organization method. All this leads to duplication, introduces the potential for error, and obstructs access to the rich real-world data researchers need to inform real-world evidence.

Laura Acosta. Anju Software.
The FDA and government bodies need to put an end date to lifting DCT restrictions after the COVID pandemic is resolved essentially. Some of those restrictions have been extended, and some have not been reviewed. We must get to a point where we are comfortable allowing all trials to follow those same guidelines. Things like remote monitoring, which is one of the temporary restrictions lifted during COVID, need to be solidified so the whole industry can get on board. This is where hesitancy comes from. Another big barrier for DCTs is something that has long existed with standard trials: having people do the trial as expected, taking drugs when they are supposed to and maintaining their trial diary, and better and more frequent interaction with sites, which can be enhanced with things like telemedicine or wearables in which real-time notification is necessary to make sure the subject is following protocol as best as they can. So, hesitancy with a fully DCT comes from the touch points with a subject far fewer and far between.

Bernard Vrijens. Aardex Group.
There are three main barriers to alignment on DCTs across stakeholders. The first is regulatory acceptance. Sponsors and CROs need clear guidelines on best practice approaches to the implementation before they can be confident in the adoption of DCTs. The second is the sheer variety of virtual/remote clinical trial technologies that are currently available. The industry needs a system of validation and market standardization to ensure the solutions are robust and evidence-based. Finally, there is a need to guarantee the right ratio of remote to personal contact. DCTs do not, and should not, mean leaving participants to their own devices. People still need “the human touch,” and interaction, trust, and relationships will remain the key to successful clinical trials, whether they are on-site, completely decentralized, or hybrid.

Cari Kniola. Aperio Clinical Outcomes.
There are several things that are keeping us from all being on the same page with DCTs. One is a clear regulatory framework on what is acceptable and what isn’t. Another is concerns about data privacy. With remote technologies come increased data risks, and how many of us are comfortable saying with certainty that a technology we’re evaluating checks all the boxes? Budget impact is also a factor — for those that haven’t seen the increase in patient recruitment/retention demonstrated first-hand, it’s hard to justify adding the cost. (PV)

~~~~~~~~~~~~~~~~~~~~~~~~~

DCT Market Size

According to Precision Reports, the global decentralized clinical trials (DCTs) market size is projected to reach $1.63 billion by 2027, up from $610 million in 2020, a CAGR of 14.8% from 2021 to 2027. We asked our experts how accurate this estimate is.

~~~~~~~~~~~~~~~~~~~~~~~~~

DCT Experts

Laura Acosta
VP of Product Management
Anju Software

Marla Becker
Product Marketing Manager
Medable

Rob Bohacs
Founder and Chief Solutions Officer
ClinOne

Ronan Brown
Global Head of IQVIA Decentralized Trials Solutions, Integrated Technology & Compliance
IQVIA

Nico Coetzee
Chief Marketing Officer
CureClick

David Coman
CEO
Science 37

Anthony Costello
CEO, Patient Cloud, Senior VP, Medidata
Medidata, a Dassault Systèmes company

Tim Davis
VP, Strategy, MyVeeva for Patients
Veeva Systems

Kevin Duffy
Chief Commercial Officer
KPS Life

Jeremy Edwards
CEO
Xperiome

John Hall
Senior VP Business Development, EMEA & APAC
CluePoints

Ed Ikeguchi
CEO
AiCure

Vincent Keunen
CEO and Founder
Andaman7

Cari Kniola
Director, Corporate Strategy
Aperio Clinical Outcomes

Niklas Morton
Senior VP
PPD

Rosamund Round
VP, Patient Innovation Center and Decentralized Clinical Trials
Parexel

Bernard Vrijens
Scientific Lead and CEO
Aardex Group

Posted in:

Post a Comment

You must be logged in to post a Comment.

FEEDBACK