Clinical Researcher—June 2022 (Volume 36, Issue 3)
SITES & SPONSORS
MaryAnne Rizk, PhD
Creating new medications and medical devices is an enormous endeavor. Running a traditional, randomized controlled trials require millions of dollars and thousands of people to get it right. Now, as decentralized clinical trials (DCTs) become increasingly preferred, there are new spokes in the wheel (e.g., wearable devices, home-health nurses, systems integrators). Clinical trials, now more than ever, take a village.
We know that DCTs help improve trial speed, increase the number and diversity of participants, and collect better data. In fact, with the right tools, it’s possible to screen 10,000 patients per day, enable 30,000 per month to schedule appointments, and provide remote or in-person visits to more than 180 sites worldwide. With electronic informed consent (eConsent), electronic patient recruitment, and direct-to-patient shipments, a decentralized workflow enables greater patient access while providing a flexible and seamless experience across all users that improves trial operations and time to treatment.
However, operationalizing DCTs often requires an ecosystem of partners. When a certified group of companies coordinate efforts to design and execute DCTs, sponsors, investigators, and patients benefit. A connected ecosystem of DCT collaborators can streamline operations and data collection, and resolve interoperability challenges. With a coordinated approach, the industry will accelerate this new model to make better medicines faster, safer, and more effective for every biology around the world.
Like-Minded Partners Maximize DCT Benefits
Partnering implies a shared purpose, a desire to collaborate for the common good, and perhaps a better, faster way of getting things done. In the context of managing clinical trials, partnering has been fundamental for decades. Sponsors hire clinical research organizations (CROs) to manage clinical trial sites where investigators, in turn, depend on a variety of healthcare providers, including nurses, technicians, and office managers, to keep trials on track.
However, a new era of DCTs is dawning and is revolutionizing the conduct of trials by bringing the trial protocols directly to patients, who can engage with investigators locally, where they live and work—even in their homes. DCT technology is a tremendous boost to trial patient recruitment, retention, and population representation while capturing rich, real-world data (RWD) and reducing costs. Significantly, a new study from Tufts Center for the Study of Drug Development shows that, on average, DCTs can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, due to reduced trial timelines and other factors.
Even with these benefits, the industry is wading through how to implement the DCT model most effectively and at scale. To navigate these new waters, leading organizations are coming together to create an ecosystem of best-of-breed, trial-enablement providers. This network of like-minded organizations includes CROs, traditional and nontraditional investigator sites—new retail pharmacy sites among them—and leading data and technology service providers for biostatistics, electronic data capture (EDC) solutions, data repositories (such as electronic health records [EHRs]), workflow management, systems integration support, and more. These partners share a single mission to get more effective therapies to patients faster.
“There are a lot of moving parts in a DCT, but you cannot have more than 300 points in a value chain because that creates transactional inefficiencies and impossible-to-manage complexity,” explained Avi Kulkarni, vice president and life sciences research and development lead at Cognizant, a systems integrator. “On the other hand, one company cannot possibly innovate at every part of the value chain, so a limited ecosystem of best-in-class partners provides sponsors with the right balance of skill sets and manageability.”
A DCT partner network has the same hallmarks as today’s e-commerce systems for consumer goods—removing transaction friction between consumers, retailers, banks, and delivery systems to enable quick response and satisfied customers. Of course, running a clinical trial is a vastly different process than fulfilling a grocery purchase, but the common element is foundational technology that enables data to move seamlessly between systems.
Five Components to a Successful DCT Ecosystem
- Service partners—including CROs and systems integrators that provide outsourced expertise for trial deployment, project management, and support. For example, Advanced Clinical, Parexel, PPD (part of Thermo Fisher Scientific), Syneos Health, and other CROs can build and deploy clinical trials with certified expertise. Top consultants (e.g., Accenture) and system integrators (e.g., Cognizant) bring certified expertise in decentralized and hybrid trial deployment, study management, data analysis, insight generation, site relationships, and process optimization.
- Data partners—enriching clinical trial data with real-world data is pivotal to accelerate effective therapies to patients faster to create a holistic profile of the patient and provide solutions for long-term follow-up after trial completion. Data providers are critical in helping connect real-world health records, claims, diagnostic, and other data sources with trial data. Connecting real-world data reduces the burden on patients and helps trial teams augment evidence before, during and after studies. This empowers sponsors to create compassionate engagement strategies to remain connected with patients post trials.
- Technology partners—when leveraging a variety of software, data, and wearable/connected devices, ensuring interoperability across systems is critical to providing a seamless data flow and experience for sponsors, sites, and patients.
- Direct-to-Patient partners—these organizations enable a patient concierge experience with home-health nursing and at-home testing and diagnostics. At-home sample collection and diagnostic partnerships improve patient enrollment, for example, and help the discovery of new biomarkers while reducing patient burden. Vault Health, which sold more than 10 million COVID-19 tests for at-home use, is one example.
- Site partners—these partners can include traditional sites and academic institutions as well as nontraditional retail pharmacy locations such as CVS Health to expand clinical trial access and engagement in their own or nearby communities for patients who cannot travel to distant clinics.
Services Partners: Providing Strategic Expertise
CROs play a central role in most clinical trials, and when they can draw on the talents of a partner ecosystem, a better outcome can result. Noolie Gregory, vice president of DCT operations at Syneos Health, noted that study setup can involve an elaborate negotiation with the study sponsors themselves. To simplify this, it helps to have a coordinated approach that addresses the sponsor’s specific needs.
“When we come together as a connected ecosystem of value-add partners, we can offer sponsors reliable, validated choices [concerning] the right technology [and] tools—and whether we need to focus around [electronic clinical outcome assessment] or integrated wearable devices or [on visualizing] data in a new way or mapping specific [key performance indicators]…that is where you have the benefit of those partnerships,” said Gregory. “We can start solving on a portfolio level rather than project by project.”
At the same time, CROs are working with various patient-facing, operational organizations to ensure that trials can proceed effectively and therefore can capture broader insights to fuel continuous improvements in DCTs. “For example, we can track how telemedicine is working across all suppliers and all trials to identify any common problems and address those for all,” Gregory added.
Some of Syneos’ clients want an enterprise-wide DCT approach, which calls for additional expertise. “We are working strategically with companies who want a holistic DCT strategy across the organization to find the right approach sensitive to their pipeline, their therapeutic focus, and their organization,” said Gregory. “It’s a transition period—everyone is at a different point on the change management curve. There are early adopters and laggards who are less certain, and that is human nature. A trusted partner ecosystem gives sponsors greater confidence wherever they are on the curve.”
Data Partners: Creating Seamless Data Integration
The fragmentation of health data is one of the greatest challenges facing healthcare today. Patients have a multitude of interactions with healthcare systems throughout their lives, and that information is retained in siloed databases across disparate institutions. With clinical trials being one of the most critical sources of evidence on drug effectiveness and safety, it is imperative to bridge the gap between clinical trial data and RWD to expand and extend trial value. DCTs naturally foster more RWD from various connected devices and wearable sources that, when combined with other clinical trial data, provide higher fidelity of efficacy and safety.
“Trials represent just a sliver of the data that describes patient health,” said Vera Mucaj, chief scientific officer of Datavant. “Linking [EHRs] and mortality data can support long-term safety and effectiveness measurement. Connecting insurance claims can add evidence of cost-effectiveness. And, connecting [RWD] to DCTs augments trial evidence at a fraction of the cost of collecting data through a traditional clinical study.”
When specialized data providers are part of a connected ecosystem organized to facilitate easy data access and sharing, it is possible to seamlessly incorporate patient health data sources like EHRs and RWD into the trial. In this way, sponsors can optimize protocol and study design by adding richer clinical details about patients’ health. Better information available in real time also helps ensure participant retention the duration of a trial because it empowers study teams with the information to expedite any necessary patient support.
Technology Partners: Ensuring Interoperability Across Systems
DCTs often require multiple systems across the value chain, but the greatest value comes when these systems are connected in a vetted ecosystem of best-in-class providers who already have an in-depth understanding of the many nuances in the life sciences industry. For patients, system interoperability simplifies the remote clinical trial experience. For investigator sites, it simplifies their workflow and provides a consolidated, single source of truth with real-time access and single data entry (avoiding redundant work for staff). Finally, sponsors benefit with improved compliance and increased data quality with a streamlined workflow plus complete visibility into all activities across studies.
For example, Oracle’s Clinical One system brings together various data sources—including sites, eConsent forms, wearable sensors, patient apps, EHRs, and labs. This enables all study partners to make better decisions through access to hundreds of data types from extensive external sources across interactive response technology, EDC, clinical trial management systems, custom systems, and more.
“Being part of a partner ecosystem streamlines decentralized trials and puts the patient at the center of the trial while providing robust data analysis for sites that can unlock better insights and ultimately better outcomes for sponsors,” said Henry McNamara, senior vice president and general manager of the Health Sciences business unit at Oracle.
Direct-to-Patient Partners: Providing the Human Face of DCTs
The organizations that engage in direct patient interaction are on the front line of trials and crucial to the success of a DCT. They are the human face of what can seem a cold, sterile process, so it’s important to align with partners with shared goals for patient care.
“We do much of the hard work of the clinical trial,” said Alexander Pastuszak, MD, PhD, president for clinical care and chief clinical officer at Vault Health. “We interact with the patient via telehealth or at home. We support DCTs with specialized services that fill the gaps of commonly used digital technologies, doing this at scale through clinical study staff and the technology that supports them. For instance, we can provide investigators and virtual sites for studies and send clinical practitioners to do in-home patient assessments and collect diagnostic samples, and then ensure those samples get to the right labs, quickly and efficiently. As a part of an ecosystem, we capture these interactions and the data that go with them in a single system that informs the rest of the trial.”
Pastuszak continued, “A DCT partner network is hugely valuable to sponsors. It streamlines the number of different vendors down to the very best few, simplifying trial management complexity, but still providing sponsors with choice. In addition, it allows sponsors to fill in the gaps by engaging a network of best-in-class capabilities to optimize the trial process. At this point, a single entity that tries to provide all DCT services will only have a mediocre result and that benefits no one.”
Site Partners: Improving Patient Access and Experience
DCTs expand site access by connecting patients with remote sites, offering easier ways to collect patient data, and bringing the onsite experience home using telemedicine. However, it’s critical to empower sites with customized training modules, best practices, and individual certifications to expand decentralized trial knowledge. This is one advantage of leveraging site partners already trained and certified on DCTs. It removes some of the friction that comes with change management.
The Value to All
A collaborative ecosystem, rather than any one company alone, allows sponsors to scale their strategies to put patients at the center of care with remote trial access, superior user experiences, and a range of services, connected devices, and data sources. An ecosystem of best-in-class partners provides differentiated value through strategic alignment across therapeutic areas; preconfigured solutions for faster go-to-market delivery; technical enablement for user adoption; and trial design innovation.
Of course, partner networks are not a panacea—they can be set up well or poorly, and coordination can be smooth or rough. However, when there is a reliable technology platform that interfaces smoothly with both the tech and human elements of trial management, there is great potential to leverage all the advantages of DCTs. In other words, done right, a network improves the trial experience for all.
Patient experience and safety are improved by ensuring appropriate trial continuity and proactive care. Sites benefit by being able to differentiate to provide long-term, compassionate patient engagement. DCT technology that can track and follow patients for five to 10 years or more improves sustainability of care. Further, for sponsors, RWD can be incorporated to improve protocol and study design, thereby improving enrollment and outcomes. A DCT partner network also adds layers of patient and trial insight for ongoing improvement as the industry continues marching down the road of DCT transformation.
MaryAnne Rizk, PhD, (email@example.com) is Chief Strategy Officer for Medable, developing and leading the company’s global partner and innovation ecosystem for decentralized trials. She also serves as an adjunct professor at the Stevens Institute of Technology.