Decentralized Clinical Trials (DCTs) are transforming the landscape of clinical research by harnessing digital technologies to facilitate remote patient participation. This patient-centric approach not only benefits participants but also ensures more inclusive and robust study results while reducing the workload for investigators. In the post-pandemic climate, a hybrid model is emerging that seamlessly integrates technology advances with traditional site workflows, creating a new era of clinical trials that harnesses the strengths of both. In a funding-constrained environment, DCT platform providers are looking to strike a balance between client satisfaction and cost reduction. They are focusing on delivering comprehensive solutions that include real-world evidence, integration with sensors and wearables, and tools dedicated to enhancing patient engagement and retention throughout the trial process.

• Decentralized Clinical Trial Platforms PEAK Matrix® Assessment 2023

  

  What is in this PEAK Matrix® Report

  In this report, we assess the capabilities of 22 platform providers specific to the decentralized clinical trial landscape. These platform providers are mapped on the Everest Group PEAK Matrix®, a composite index of a range of distinct metrics related to a provider’s capability and market impact.

  Content:

  In this report, we:

  • Examine the provider landscape for DCTs
  • Assess DCT platform providers on several capabilities and market success-related dimensions

  Scope:

  • Industry: Life sciences clinical development technology
  • Geography: global

  READ ON

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

Traditional IT and business process services (BPS) service providers are becoming more intentional in creating and activating career opportunities in underserved communities.

By identifying previously untapped talent pools that can provide leverage in various roles across the outsourcing industry, impact sourcing can create both inward (business) and outward (social) impact for service provider organizations.

Join Everest Group experts and Sustainability Fellows for an engaging discussion on creating meaningful and intentional impact sourcing programs that benefit both the business and the community. Together and with your peers, we will discuss what is needed to implement impact sourcing and how to be an agent of positive change in your community.

Participants will:

• Learn what peak impact sourcing looks like
• Explore foundational frameworks to design an impact sourcing program
• Uncover what success looks like
• Engage in a discussion around policy and best practices
• Discuss ways to steer the buyers’ mindset toward impact sourcing

Who should attend?

• Services provider stakeholders
• Internal diversity and inclusion leaders
• Sustainability leaders

Virtual Roundtable Guidelines

The only price of admission is participation. Attendees should be prepared to share their experiences and be willing to engage in discourse.

Everest Group will approve each attendance request to ensure an appropriate group size and mix of participants. The sessions are 90 minutes in duration and include introductions, a short presentation, and a facilitated discussion.

Clinical Development Platform

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The prospects for Generative AI in clinical development look encouraging. GAI can help speed drug development, improve protocol design, personalize treatment, and bring other benefits. However, the industry must be aware of the risks and responsibly operate GAI. Read on to learn more.

Contact us directly to discuss this topic further.

Given the lengthy, labor-intensive, and expensive process of bringing a new drug to market and conducting a clinical trial, clinical development stakeholders are constantly searching for technological solutions to automate workflows, streamline operations, reduce site and patient burden, and accelerate trial timelines.

Leveraging cutting-edge technology, Generative Artificial Intelligence (GAI) may unlock new horizons and revolutionize the entire clinical development value chain. Let’s explore this further.

GAI works by training underlying large language models (LLMs) on huge datasets containing billions of parameters. For example, ChatGPT is built on GPT-3, a model trained with over 175 billion parameters, far exceeding prior LLMs.

GAI outperforms conventional AI by not only analyzing and interpreting existing data but also generating text, images, audio, video, and other content. The latest innovation, GPT-4, takes this a step further by introducing multi-modality, allowing it to process non-text inputs like images and generate high-quality outputs.

The potential for generative AI in clinical development 

In the clinical development field, the opportunities with GAI are simply too big to ignore. It has the power to accelerate drug development, enhance patient engagement, improve protocol design, personalize treatment approaches, generate synthetic data, and much more.

Let’s take a closer look at the potential applications in clinical development to better understand the role that GAI can play in this domain:

• Patient recruitment and screening: By scanning a plethora of health and medical records, GAI can reduce the recruitment funnel and better identify suitable patients for clinical trials. The outcome of these interactions can be fed to a validated digital biomarker for the desired indication. This, in turn, can accelerate patient recruitment and improve diversity ratios
• Synthetic data generation: Synthetic datasets that closely resemble real-world patient data help researchers with limited data or no control group in randomized controlled trials (RCTs). GAI can help conduct simulations, test hypotheses, and accelerate the time to market. With the regulatory push in favor of synthetic control arms, GAI can be instrumental in generating synthetic data
• Protocol authoring: GAI can optimize the process of authoring protocols for clinical trials. It has the ability to scan through vast amounts of scientific literature, past trial histories, and databases and generate insights on the appropriate endpoints, dosage, patient population, treatment arms, and analysis procedures
• Patient engagement: AI-driven by LLMs can analyze patients’ medical history data and preferences and create personalized content. GAI-powered digital avatars can significantly improve patient engagement by providing personalized communication and educational information that ensures patients are included in the process and remain engaged and informed
• Real-time decision-making: During a trial, GAI can continuously monitor patient conditions (through data coming from wearables and sensors) and provide real-time support to investigators and researchers. This may entail preventive interventions, dosage modifications, improving medication adherence, and early detection of adverse events
• Study Data Tabulation Model (SDTM) transformations: SDTM involves mapping clinical data to a standard structure for regulatory submissions. GAI can analyze data from multiple sources and generate mappings that meet SDTM standards. This use of GAI would provide validation and quality controls, and automate repetitive tasks, expediting the whole process

While GAI is generating buzz across industries, like any new technology, its benefits come with challenges. Pharmaceutical enterprises must be aware of the following risks and biases so they can be prepared to address them:

• Data quality and bias: GAI relies on the quality of training data for generating meaningful outcomes. The data used to train the models can have biases that can lead to disparities in patient recruitment and treatment recommendations. New AI models may not be well-suited to handle diverse languages, dialects, and cultures effectively
• Data security and privacy: A crucial consideration for using Generative AI in clinical development is patient data security. Ensuring compliance with the ambiguous regulations for digital technologies and AI in clinical development is complicated. AI models should comply with existing regulations like the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR) and be prepared for potential upcoming ones
• Ethical considerations: The use of GAI raises ethical questions, especially in using patient information to train the models. Patient data must be handled with strict confidentiality, and consent must be given at all times before using it to train any model
• Accountability: GAI cannot be held accountable for inaccurate treatment recommendations or a mistake in the protocol design. Completely relying on automated systems raises liability concerns and makes determining accountability challenging
• Sustainability: GAI models are trained on billions of parameters that require extensive computational resources often managed at large-scale data centers. As the use of GAI models and queries continues to grow, the carbon footprint also rises

Over-reliance on AI models without human intervention for decision-making can lead to unwanted consequences. Domain experts, clinicians, and researchers must be present to validate the outputs and use GAI responsibly while having minimal environmental impact.

Technology advances have always brought disruptions, and GAI is no exception. GAI can revolutionize data management processes and become an invaluable tool in clinical development. By better understanding its risks and biases, pharmaceutical enterprises can use GAI responsibility and reap its full benefits – making GAI’s future in clinical development look promising.

To discuss the future of Generative AI in clinical development, contact Anik Dutta, Nisarg Shah, and Madhur Kakade.

Learn more about the use cases and potential of GAI technology in our webinar, Welcoming the AI Summer: How Generative AI is Transforming Experiences.

Seeing impact sourcing in action at Vindhya e-Infomedia validated to Everest Group that this growing business practice is more than a feel-good story but a win-win for individuals, companies, and communities. Hearing about the positive benefits firsthand from people with disabilities employed at the Bengaluru center left a lasting impression on the analysts who share their perspectives in this blog.

The Everest Group team was excited to see impact sourcing in practice, some for the first time, at Vindhya e-Infomedia, but they also had questions about whether impact sourcing would live up to its promise.

The visit to the Bengaluru center exceeded their expectations and reinforced that impact sourcing is a business imperative in today’s ESG-focused times. Highlights of the trip were meeting Vindhya e-Infomedia Founder and Managing Director Pavithra Y. Sundareshan and hearing from its employees.

Impact sourcing specialist Vindhya e-Infomedia was founded in 2006 with a vision of uniting business with impact. It has centers in Bengaluru, Hyderabad, Nagpur, Mysore, and Krishnagiri (Tamil Nadu) and plans to expand across India and abroad.

Employing people with disabilities as its main workforce, the company provides data entry, claims processing, customer onboarding, payroll, and data management processes to such clients as Airtel, IBM, and SAP AG. With its team of more than 2,400 employees based in cities, Vindhya defies the stereotype that only small companies in India operate Business Process Outsourcing (BPO) centers in rural areas.

Impact sourcing specialists like Vindhya e-Infomedia intentionally hire people from marginalized communities and train them to deliver IT and BPO services. These providers offer economic opportunities to individuals who face difficulties in finding employment, such as people with disabilities, those from marginalized communities or without formal educational degrees, and single parents.

Hiring people from these target groups often requires organizations to enhance their physical and digital infrastructures and/or modify policies to create a conducive work environment. However, the idea is not to create separate work areas for impact hires but rather to bring inclusivity to everything at the workplace – a belief that runs at the very core of Vindhya’s operating system.

Inspiring employee stories

Impact sourcing has the power to change the trajectories of individuals’ lives, as the team learned from hearing about the backgrounds, job profiles, and aspirations of employees at the Bengaluru center. Their resilience, persistence, and tremendous willpower to achieve was uplifting to the analysts who focus their work on impact sourcing.

The team was truly inspired! Here are the stories of four individuals who demonstrated the ways impact sourcing is benefitting individuals, families, and communities:

Vidya Patil

• Vidya Patil has been associated with Vindhya for eight years and currently handles banking payment collections and customer communications. Speaking in her native Marathi, she shared: “विंध्या सोबतचा ८ वर्षांचा हा प्रवास माझ्यासाठी अविश्वसनीय होता. अपंग व्यक्ती असुनही, विंध्या येथे नोकरी मिळाल्याने मला आर्थिक स्वातंत्र्य आणि स्वावलंबन मिळाले. या नोकरीमुळे, कुटुंबाबर अवलंबून असणार्या मला, कुटुंबाचा पोशिंदा बनवले. तसेच मला माझ्या भाचीच्या उच्च शिक्षणासाठी समर्थन करण्यासही सक्षम केले. विंध्याहे केवळ कामाचे ठिकाण नसुन; ते माझ्यासाठी दुसरे कुटुंब आहे. माझ्या भावाच्या आरोग्य आणीबाणीच्या काळात‌ त्यांनी दिलेल्या आर्थिक आणि भावनिक आधारासाठी, मी विंध्याची कायम ऋणी राहील”

“The job at Vindhya gave me financial freedom and self-reliance. It has transitioned me from being a dependent to a caretaker and a breadwinner for my family. With this job, I could support my family as well as support my niece’s higher education. Vindhya provided immense financial and emotional support to me during my brother’s medical emergency. Vindhya is not just a workplace but a family itself, and I will always be utterly grateful to Vindhya.”

Digbijoy Adak

• Digbijoy Adak spoke in Bengali about his experiences overcoming barriers to gain self-sufficiency: “আমি দশম ক্লাস অবধি পড়াশোনা করেছি | আমি কম্পিউটার ব্যবহার করতে জানি | যেহেতু আমার পড়াশোনা বেশি নয়, আমি কোনো ভালো সম্মানযোগ্য কাজ পাইনি | জীবন যাপনের জন্য আমি একটা ছোট অর্কেস্ট্রা দলের সঙ্গে কাজ করতাম | এই সময় আমি ভিন্ধিয়া কম্পানি সম্পর্কে জানতে পারি | আমার এক বন্ধু সেখানে কাজ করছিলো আর আমাকে এই ব্যাপারে জানিয়েছিল | আমি এখন খুবই খুশি | আমি ভিন্ধিয়া-তে কাজ করতে পেরে একজন স্বাবলম্বী এবং স্বনির্ভর মানুষ হিসেবে পরিচিতি পেয়েছি |”

“I had completed my 10^th grade education and knew how to use computers. However, since I was not highly educated, I was not able to find a good respectable job. I used to work with a small orchestra group for my livelihood. During that time, I came to know about Vindhya. A friend of mine was working here and informed me about it. I am very happy now. I have found a job in Vindhya and have become a self-sufficient and independent person.”

What he did not say directly but implied, is that his disability has been an unjust cause of discrimination in the past. At Vindhya, one’s disability status is not a barrier to a good job.

N Yashoda

• Having a hearing impairment does not prevent N Yashoda from excelling at converting documents from paper to digital. With her lip-reading skills and the aid of an experienced sign language translator/guide, Yashoda has fully integrated into Vindhya’s operations.

Madhabi Sardar

• Madhabi Sardar has a master’s degree, but a visual impairment prevented her from gaining a decent, well-paid job – until Vindhya. She now heads the braille team and aims to become a singing maestro in the future, showing it’s never too late to dream big.

The real significance of this business practice can be seen in the countless lives touched by the dignity of a good job, as these inspiring and heart-warming stories show.

Impact sourcing obstacles

Like any journey, even this one has obstacles. Impact sourcing often requires an extensive process to access the right talent. Additionally, investments in skilling and upskilling resources pose a challenge in managing high training costs.

The lack of benchmarks to measure key performance indicators (KPIs) or evaluate success makes it difficult to prepare appropriate success stories and business cases for impact sourcing. However, impact sourcing specialists are implementing robust practices to mitigate these challenges, and meaningful collaboration among all involved stakeholders is needed.

The visit was an eye-opening, humbling experience for the team who saw that the benefits of impact sourcing go beyond providing a paycheck but also give individuals a sense of community and belonging.

Pavitra’s parting words that impact sourcing is about ‘shared prosperity’ resounded with the analysts. Building partnerships to create an impact that benefits all involved stakeholders is needed to move the practice forward.

Everest Group commitment

The visit reinforced Everest Group’s commitment to advancing impact sourcing globally. As a signatory of the Clinton Global Initiative’s “Commitment to Action,” the firm has pledged to bring in half a million impact sourcing full-time equivalents (FTEs) into the ecosystem by the end of 2025 and has committed its research and expertise to help enterprises frame their impact sourcing strategies.

For more insights on measuring and using data for better business outcomes, register for the virtual roundtable, Measuring the Impact of Impact Sourcing. To discuss impact sourcing, reach out to rita.soni@everestgrp.com, aman.birari@everestgrp.com, or anik.dutta@everestgrp.com.

Decentralized Clinical Trial

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Decentralized Clinical Trials

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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

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.

What areas should product vendors focus on to stay ahead in the DCT ecosystem? Reach out to nisarg.shah@everestgrp.com and anik.dutta@everestgrp.com to discuss.

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

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.

What are your views on how businesses can improve the patient experience? Reach out to nisarg.shah@everestgrp.com and anik.dutta@everestgrp.com to discuss further.

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.

What are your views on the patient experience in DCTs? Reach out to nisarg.shah@everestgrp.com and anik.dutta@everestgrp.com to discuss more.