Tag: DCT

Everest Group Declares “The Age of Decentralized Clinical Trials Has Begun”

Everest Group also joins DTRA, offering members accessibility to pioneering research on clinical technology

 

DALLAS, March 29, 2023 —Everest Group today released its latest research report on Decentralized Clinical Trials, which documents a 38% increase from 2021 to 2022 in the number of trials conducted with a decentralized and/or virtual component. Everest Group predicts that the adoption of DCTs by pharmaceutical companies will rapidly accelerate as early adopters praise the approach for putting patient experience at the forefront.

DCTs enable patients to participate in a clinical trial from the comfort of their homes through the use of technology (such as sensors or remote monitoring devices) and home-visit services. In an Everest Group survey of buyers of DCTs, interviewees reported that 20-25% of their trial portfolios were decentralized or hybrid in nature today, but that 80-90% of their trial portfolios will be decentralized/hybrid by 2027. When asked to name the biggest benefit of DCTs, two out of three of those buyers interviewed (67%) cited “improved patient enrollment and retention rates.” Other benefits named include reduced cost (20%), reduced trial timelines (13%), more diverse patient populations (13%), getting real time data (7%), and enabling complex scoring and analysis (7%).

These findings and more are detailed in the Decentralized Clinical Trials Adoption Playbook. This playbook looks at more than 50 DCT case studies across different therapy areas and informs enterprises about the trends, benefits and challenges in DCT adoption to help them design a strategy for seamless DCT adoption. (A complimentary abstract of this report is available for download.)

Everest Group also released today its 2023 Life Sciences Decentralized Clinical Trial Platforms State of the Market Report, which analyzes the current state of the DCT market. The report explores adoption and market trends; the DCT platform providers’ landscape; the enterprise view of DCT platform providers; Environment, Social, and Governance (ESG) initiatives; and emerging technology opportunities in the industry. (A complimentary abstract of this report is available for download.)

Pandemic Spotlight on DCTs Revealed Major Benefits to the Approach

Traditional clinical trials are an expensive affair, costing upwards of US$2.6 billion and up to 12 years in research effort before approval by a regulatory body. Additional burdens of the traditional approach are patient recruitment challenges, patient adherence and engagement challenges, and regulatory challenges.

During the COVID-19 lockdowns, clinical trial activity came to a halt because patients could no longer travel to hospital networks to participate in a clinical trial. Fortunately, DCTs breathed new life into these paused clinical trials and delivered a host of benefits beyond those offered by the traditional clinical research approach. As a result, enterprises have accelerated their plans toward DCT adoption, looking to convert their piecemeal deployments into a comprehensive strategy aimed at enhancing the trial experience for patients, sponsors and Contract Research Organizations. Additionally, recent technological advances, the proliferation of wearables, and the regulatory pressure on the industry to adopt DCTs following the pandemic have made the DCT landscape ripe for disruption.

Everest Group Partners with DTRA

Everest Group also announced today that it has joined the Decentralized Trials Research Alliance (DTRA) to support the organization’s mission of advancing policies, research practices and new technologies to make clinical trial participation widely accessible.

“Today, pharmaceutical companies are optimistic about and investing in DCT trials, and Everest Group sees great potential in the market; however, because the technology and adoption is nascent, additional stakeholder education, product innovation and partnerships are needed,” said Nitish Mittal, partner at Everest Group. “DTRA is one of the few bodies which is driving standardization in the process and stakeholder education in this space. We’re pleased to support the DTRA mission and to contribute by giving DTRA members access to Everest Group’s curated clinical development technology research.”

A frontrunner in the research of clinical technology, Everest Group has a deep research portfolio focused on the demand and supply side of DCTs. By partnering with DTRA, Everest Group aims to disseminate information about the DCT market (such as DCT product suppliers and their capabilities, enterprise DCT adoption trends and sourcing considerations, DCT state of the market, etc.) to various stakeholders responsible for adoption and continued success of DCTs.

About Everest Group

Everest Group is a leading research firm helping business leaders make confident decisions. We guide clients through today’s market challenges and strengthen their strategies by applying contextualized problem-solving to their unique situations. This drives maximized operational and financial performance and transformative experiences. Our deep expertise and tenacious research focused on technology, business processes, and engineering through the lenses of talent, sustainability, and sourcing delivers precise and action-oriented guidance. Find further details and in-depth content at www.everestgrp.com.

Decentralized Clinical Trial Platform PEAK Matrix® Assessment 2023

Top Decentralized Clinical Trial Platforms

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.

DOWNLOAD THE FULL REPORT Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023

What is in this PEAK Matrix® Report:

In this report, we examine the provider landscape for DCTs and assess DCT platform providers on several capabilities and market success-related dimensions.

Scope:

  • Industry: life sciences

  • Geography: global

LEARN MORE ABOUT Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023

Our Thinking

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What is the PEAK Matrix®?

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.

LEARN MORE ABOUT Top Service Providers

Can You Hear Me Now — How Patient Voice Can Reshape Trial Design for Diversity and Inclusion | Webinar

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.

Register for the webinar

When

Tuesday, May 24, 2022, at 11:00 am CDT, 12:00 pm EDT, 4:00 pm GMT, 9:30 pm IST

Where

Live, virtual event

Presenters

Chunky Satija
Vice-President, Everest Group

Noah Goodson
PhD, Decentralized Study Design Lead, THREAD Research

Fabio Gratton
Cofounder and CEO of inVibe Labs, a Division of THREAD

Dima Hendricks
Sickle Cell Health Coach, University of Pittsburgh

Register for the webinar

Understanding Strategic Investments by Decentralized Clinical Trials (DCT) Product Vendors | Blog

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.

Everest Group’s Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found improving patient recruitment and retention are the top reasons behind sponsors adopting DCT solutions.

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

Slide1

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:

Slide2

  • 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.

What areas should product vendors focus on to stay ahead in the DCT ecosystem? Reach out to [email protected] and [email protected] to discuss.

Explore more information about DCT adoption trends and providers. Learn more

What Matters Most When Choosing a DCT Provider? | Webinar

Everest Group Practice Director Chunky Satija will join Medable Chief Executive Officer Michelle Longmire and Chief Growth Officer Sans Thakur to discuss the growing Decentralized Clinical Trials (DCTs) market and give insights about how to best prepare your organization for the future.

Key discussion points will include:

  • How the DCT market landscape is evolving and what trends to look for in the future
  • What small, medium, and large-sized companies should look for in selecting a digital or DCT provider
  • What distinguishes the Medable product and service offering from other providers
  • Ways to future-proof your decentralized and hybrid trials for success

When

Monday, October 4, 2021, at 11:00 am CST, 12:00 pm EST, 4:00 pm GMT, 9:30 pm IST

Where

Live, virtual event

Presenters

Chunky Satija
Practice Director, Everest Group

Michelle Longmire
Chief Executive Officer, Medable

Sans Thakur
Chief Growth Officer, Medable

The Future of Decentralized Clinical Trials Starts with a Patient-first Design Approach | Blog

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

Picture1 6

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.

What are your views on how businesses can improve the patient experience? Reach out to [email protected] and [email protected] to discuss further.

How Decentralized Clinical Trials Put the Patient Experience at the Forefront | Blog

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

Picture1 5

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.

What are your views on the patient experience in DCTs? Reach out to [email protected] and [email protected] to discuss more.

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