Decentralized Clinical Trials (DCTs), in which clinical trial data is collected through sensors or remote monitoring devices, can deliver many benefits to pharmaceutical companies, including cost savings, better patient recruitment and retention, flexibility in operations, and improved data quality. Before the pandemic, although the technology and data to support DCTs existed, only a few pilots were conducted. Today, the pressing need for remote patient- and site-centric trials has increased investments in DCTs by pharma enterprises, and the momentum is expected to accelerate going forward, indicating that DCTs are here to stay. Additionally, technology advances, innovative business models, increased wearables support, US FDA’s push to adopt DCTs, and a holistic approach to clinical trials have strengthened the DCT landscape.
In this report, we assess the capabilities of 24 DCT platform providers. The providers are positioned on Everest Group’s PEAK Matrix®, a composite index of a range of distinct metrics related to the providers’ capabilities and market impact. The study will enable buyers to choose the best-fit provider based on their sourcing considerations, while providers will be able to benchmark their performance against each other.
The PEAK Matrix® provides an objective, data-driven assessment of service and technology providers based on their overall capability and market impact across different global services markets, classifying them into three categories: Leaders, Major Contenders, and Aspirants.
Chunky Satija, Vice-President at Everest Group, will join other industry experts in this webinar to discuss the evolving role of patient voice and diversity and specific strategies to apply to clinical study or pipeline.
Attendees will gain a foundational understanding of broad market trends, clarity on how technology is specifically enabling data-driven insights into study-specific populations, and hear about the real world impact on patients.
COVID-19 put the spotlight on Decentralized Clinical Trials (DCTs) that will last well beyond the pandemic-stricken years as the industry increasingly adopts digital solutions for conducting remote, virtualized, or decentralized trials. In this digital ecosystem, vendors need to focus on several strategic areas to provide a holistic DCT experience and stay ahead of the competition. Discover in this blog the five priorities that can help product vendors take the lead in the DCT ecosystem.
Decentralized clinical trials rose to popularity during the pandemic. As people around the world were advised to stay indoors, sponsors and Clinical Research Organizations (CROs) scrambled for an alternative solution. DCTs catapulted to the mainstream and disrupted the clinical trial landscape.
DCTs offer reduced dependency for on-site visits, increased patient convenience, and improved insights from real-time patient data. While the pandemic may slowly subside with increased vaccinations, decentralized trials are here to stay – continuously elevating the trial experience for patients, sponsors, and investigators.
With DCT adoption growing significantly, sponsors have varied sourcing criteria based on their priorities. We have observed that large biopharma companies prefer a unified platform while mid-and small-sized players are more interested in cost as their top sourcing criteria for DCT vendors.
Biopharma companies want vendors who feel the market pulse and offer tailor-made deal solutioning for increased DCT adoption, as illustrated below.
Sourcing criteria for selecting DCT vendors
Five focus areas for DCT vendors to enhance their value proposition
To increase DCT adoption and run trials holistically, sponsors and CROs require matured technology products as well as auxiliary services. Hence, DCT vendors should not only strengthen their product offerings but also up their game in delivering auxiliary services.
With the exponential rise in DCT adoption, new players are rapidly entering the DCT landscape. In this marketplace, how can vendors offer value and stay on top of the competition? Our analysis reveals the following five areas that can help DCT vendors elevate their offerings above others:
Inorganic growth – Considering the speed of digital disruption in the clinical trial landscape, inorganic growth is the fastest way to grow and expand capabilities. Technology-based DCT product vendors are focusing on improving their consultative positioning by combining high-tech and high-science under one platform. Two recent examples are THREAD acquiring Modus Outcomes, an organization that supports eCOA selections, designs patient-centric trials, and fosters scientific delivery of DCTs. Similarly, Clinical Ink acquired Digital Artefacts to enrich the data coming from patient-reported outcomes with situational awareness and active and passive digital assessments
Partnerships – DCT product vendors increasingly seek to partner with specialists to enhance the delivery of auxiliary services. These unions aim to increase trial efficacy and eliminate risks and delays while improving the experience for patients and site practitioners. Some recent deals include Science 37 collaborating with Foundation Medicine to accelerate the patient selection process for oncology trials. THREAD has entered alliances with Almac Clinical Technologies to reduce trial delays and risks and also with endpoint Clinical to simplify trial operations for site personnel
Human capital development – Investments in human capital are either focused on designing a simple unified platform for seamless patient experience during trials or on expansion and marketing operations. This has led product vendors to add new positions like Chief Growth Officer, Chief Design Officer, Chief Strategy and Expansion Officer, etc. Medable, Science 37, THREAD, Castor, and ObvioHealth have made significant investments in hiring or opening multiple roles directly or indirectly related to DCT solutions to expand their services and establish strategic partnerships
Funding – Multiple DCT vendors have raised significant funding to enhance their DCT program. Science 37 has recently become a public-listed company, thereby making enough funds available for DCT expansion and growth. On the same lines, Medable has secured a US$ 304 million Series D funding, taking the total company valuation to just over US$ 2 billion. It plans to use the funds to improve access to clinical trials worldwide and accelerate new drug development. ObvioHealth had raised US$ 31 million in its latest round of funding, while Castor raised US$ 45 million in its series B funding. While ObvioHealth plans to direct funding to enhance its proprietary IT capabilities and make new hires, especially keeping in mind the APAC region, Castor is focusing on accelerating trials and maximizing the impact of research data on patient lives. These activities clearly echo the positive investor sentiments towards DCT solutions
Geographic expansions – Enterprises are looking for studies that are global or beyond the North American (NA) region, pushing DCT vendors outside their established geographies into the Europe, Middle East, and Africa (EMEA) and Asia Pacific (APAC) markets. Both THREAD and Medable have established offices in Dublin, Ireland to expand their presence and grow the market for decentralized trials in the EMEA region. ObvioHealth has partnered with Anatara Lifesciences to launch DCTs in Australia, and Science 37 has partnered with CMIC Holdings to enable and advance its DCT offerings for Japan and the APAC region
The age of decentralized trials has begun, and sponsors are shifting away from the site-anchored approach to hybrid or completely decentralized trials. They are looking to convert their piecemeal deployments into a comprehensive strategy aimed at enhancing the trial experience for patients, sponsors, and CROs.
To cater to this rising demand, DCT product vendors need to leverage advancements in digital technology and enhance their value proposition. With a deep focus on inorganic growth, partnerships, human capital, funding, and geographic expansions, providers can offer a seamless DCT experience in 2022 and well into the future.
The biggest benefit of Decentralized Clinical Trials (DCT) is the opportunity to enhance the patient experience, but the process is rife with challenges that create disengagement. The problem is not that patients are unengaged, but rather the vendor products are not always very engaging. The solution lies in undertaking a patient-first approach. Discover the tenets of a patient-first design approach in this second blog in our continuing coverage of this timely topic.
The pandemic has propelled decentralized clinical trials (DCT) into the mainstream, and multiple enterprises have transitioned into the virtual model for conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model. What do enterprises mean when they talk about patient experience? Read our blog, How Decentralized Clinical Trials Put the Patient Experience at the Forefront, to find out.
To deliver a superior patient experience and derive maximum benefit from this model of conducting trials, enterprises and vendors must be aware of the patient-facing challenges that might pose major hindrances. A closer look at the top challenges will help businesses develop effective measures to improve patient engagement and retention.
Major patient-facing challenges
The entire remote model has reduced in-person interactions. Insufficient communication from sites and sponsors often leads to disengagement among patients. The human touch, an important psychological aspect in healthcare, goes missing in this model. Added to this is the burden of learning about new products and technologies.
Patients have very limited digital literacy and may find it extremely difficult to operate a new sensor, a smartphone, or an application. Vendors are struggling to develop robust training and support programs while enterprise buyers are more concerned about patient education capabilities and post-implementation support in their sourcing criteria.
All these factors create a general sense of discomfort and disengagement among patients, thereby defeating the principal benefit that vendors and enterprises expect from a DCT solution.
How can vendors overcome patient-facing challenges?
Designing a patient-centric solution is the best way to address these challenges. Having a deeper understanding of patients’ journeys and their pain points, while involving them in solution design will lead to greater compliance and engagement. The following exhibit highlights the various tenets of a patient-first solution.
Exhibit 1: Tenets of a patient-first design approach
Six aspects of a patient-first design approach
Empathetic: DCT solutions should portray a deep understanding of the needs, well-being, and interests of patients, fostering trust and emotional connection. Vendors need to map the entire trial journey and look at it more holistically rather than logistically. Incorporating patient feedback into designing solutions will reduce a lot of stress and burden on patients
Secured: Concerns with data security, compliance, and privacy have increased with the rise in DCT adoption. Patients fear the consequences of device and network hacking, data leaks, and unauthorized access to data. DCT vendors must incorporate stringent security and compliance measures, secure the networks, and prevent all types of unauthorized access. With precise security measures in place, patients will feel safer with their data and will be more willing to share data for clinical research
Adaptable: DCT solutions must be able to incorporate the changing patient context, needs, and preferences to build fluid experiences. The same solutions should be adaptable and scalable as per the study requirement, ensuring a consistent patient experience and providing long-term sustainability
Engaging: Delivering engaging content is the best way to keep patients motivated in this digital world. Interactive educational materials, timely communication of trial progress (lay summaries), and patient reports go a long way in increasing patient engagement and retention. Patients can be motivated by increasing their trial literacy, setting up patient advocacy boards, and rewarding them for their contributions to the trial
Personalized: A one-size-fits-all solution will not work as patient experience varies at each stage and with each individual. Individualized care and personalized solutions help in building trust, loyalty, and retention rates among patients. Giving patients the liberty to choose their treatment plans (wherever possible), creating patient-specific digital ads, and supporting patients via artificial intelligence (AI) assistants are some of the ways to incorporate personalization into clinical trials
Reciprocity: Patients, vendors, and enterprises should be encouraged to communicate and share relevant experiences. Beyond trial periods, vendors and enterprises can engage patients with information on lifestyle, new developments on drugs or medical devices, upcoming trials, diet plans, etc. This type of communication will increase the willingness among patients to share personal data with AI systems as well as the scope with vendors, leading to more customized solutions that promote relevant and progressive experiences
Patients do not want to be treated as mere statistics. They want the touch of empathy and personalization, pushing DCT vendors to think more ‘humanly’ and add ‘emotional’ content while designing DCT solutions.
When all the above elements are incorporated in building DCT solutions, it will not only increase participation and adherence but also improve the brand value and bottom line for DCT vendors.
Over and above the empathy-backed approach toward creating a patient-centric solution, DCT vendors and enterprise buyers can look further at certain initiatives aimed at improving patient experience.
A sheer lack of awareness among patients regarding ongoing or planned trials exists. Enterprise buyers and vendors should spread information about upcoming clinical trials and steps to participate in them while promoting the ease of using digital technologies (via social media, newsroom, public releases, etc.). Home-care nurses or physicians still must make monthly calls or visits to motivate patients and add some scope for face-to-face interactions between patients and healthcare professionals.
Though the pivot or the integral enabler for DCT solutions is technology and connected systems, the focus should be on improving the patient experience and building the future towards a patient-intuitive smart DCT solution suite.
How Decentralized Clinical Trials Put the Patient Experience at the Forefront
With the COVID-19 pandemic accelerating the adoption of Decentralized Clinical Trials (DCT), the opportunity to deliver a patient-centric experience is viewed as a top benefit of this alternative mode of clinical trials that uses digital and remote technologies. What factors are enterprise buyers looking for DCT vendors to provide in their platforms to increase satisfaction and ultimately drive patient enrollments? Learn about the five factors that go into a “patient centered” experience in this blog.
When COVID-19 brought traditional clinical trials to an abrupt halt, Decentralized Clinical Trials (DCT) proved to be a savior for sponsors looking to safely restart their paused research activities. While DCTs have been around for a decade and are slowly gaining traction, the pandemic accelerated the use of these alternative methods to collect clinical trial data through sensors or remote monitoring devices carried by a patient.
The top reason for moving toward this model has been its patient-centered focus that makes it easier for more people from a broader geographic area to participate in trials without the need to visit a site.
The growing mainstream acceptance for DCTs has increased the appetite among clinical research organizations (CROs) and sponsors to adopt the latest technologies and virtual models for clinical trials. This has resulted in an uptick in innovation and DCT product adoption recently. We see DCT vendors increasingly focus on co-innovation, continuous product improvement, and market education to help clients get started on their DCT journey.
Top benefits of DCT adoption
Our Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found the most promising benefit for enterprises to consider decentralizing their trials is the opportunity to enhance the patient experience – a benefit that two out of three DCT product buyers also agree with based on Everest Group interviews. Other advantages of DCTs include reducing trial costs and timelines, attracting a more diverse patient population, and capturing real-time data for trials.
With DCTs, patients can now take part in a study from the comfort of their homes, spend more time with their family members, and focus on work and other responsibilities. This mode of clinical trial also opens the door to the patients who suffer from mobility issues and allows sponsors to reach a global audience, increasing inclusivity and diversion.
This new patient-centric approach is driving increased enrollment and retention rates. With these valuable benefits, it is not surprising that having a people-orientated platform has become central to enterprise buyers in making their sourcing decisions – even more so than innovation or reviews from other buyers.
What do buyers want from DCT vendors?
What do enterprises buyers mean when they talk about patient experience? Multiple facets contribute to the notion of patient experience as presented in the exhibit below.
Exhibit 1: What enterprises buyers mean when they say patient experience
Five factors to enhance patient experience with DCTs
Patient experience can be broken down into the following aspects:
User-friendly interface – The User Interface (UI) of DCT applications and devices must be simple, yet effective. They must provide clear instructions and display only relevant and concise content. It should be well organized, making all options easily accessible and ensuring that the application can be used with minimal explanation
Easy to set up platform/app – Patients should have an easy time setting up a wearable, sensor, or application. It should be intuitive even to an average user with limited exposure to digital devices. The device should be as close as possible to a ready-to-use mode
Smooth operation – The applications or devices should not pester patients with unnecessary notifications, malfunctions, or failures that would cause unwanted frustrations, resulting in reduced patient engagement. A smooth operation with minimal or zero disruption is the best-case scenario
Robust education and training – Patients come with different levels of digital literacy, and they need to be supported during the trials. They must be aware of how to enroll themselves for the trial, schedule appointments, feed in data, and get important information about their health and the trial. Sponsors can create the knowledge pool, conduct training sessions, and build artificial intelligence (AI) bots to provide education and training to patients
Multilingual app and support – To reach a global audience, multilingual offering and support must be available. The devices or applications used should provide instructions and information in the commonly used languages across the world. If a trial is geographically focused, the regional language should be configured in the device
Enterprises want DCT solutions to integrate smoothly into the daily lives and operations of patients. Patients should not feel isolated when doing the trial since the significant amount of digital literacy required might deter them from participating.
Vendors also need to be aware of the top patient-related challenges that might hinder them from elevating the patient experience through their products and services. Multiple challenges might lead to an inferior experience, resulting in disengagement and dropouts. DCT vendors and enterprise buyers must identify these challenges and take discrete steps to improve the patient experience and engagement.
Keep following this space as we dive into the top patient-related challenges and present initiatives aimed at improving the patient experience.