Defining The Capabilities Required To Attain Digital Excellence In Clinical Trials
The State of Digital Adoption by Clinical Trial Sites
The COVID-19 pandemic posed significant challenges to clinical research. Clinical operations teams and clinical sites faced severe restrictions on travel and in-person interactions worldwide. As a result, in 2020 many trials were interrupted, delayed, or unable to launch and the enrollment of trial participants slowed sharply. To ensure the continuity of their research, many clinical trial teams adapted their operating model to decentralized, digital approaches such as providing home delivery of investigational study drugs, using online platforms for recruitment and enrollment, and enabling remote monitoring and virtual consultations via telemedicine and other applications.1 Despite the substantial disruptions, we see that:
- Clinical research continues to gain momentum. Our previous report analyzed the number of clinical trials initiated each quarter starting in Q4 2019 and found a steady increase in clinical research. Our latest analysis of the clinical trial database indicates that the momentum continues to increase.2 A significantly larger number of industry-funded clinical studies launched in the first half of 2021 compared with a year earlier (see Figure 1). The number of studies that launched in Q2 2021 was 42% higher than in Q2 2020; the number of publicly funded studies was 32% higher. We saw a similar trend for publicly funded studies.
- More drugs are gaining approval. In 2020, the FDA approved a large number of late-stage drug candidates for patient use, including fifty-three new molecular entities; in the past decade, only 2018 saw more FDA drug approvals.3 The momentum is continuing, with 29 new approvals in the first half of 2021.4 In 2020, more than half (58%) of the new approvals involved orphan drugs; 28% were submitted by large pharma firms; and more than 92% were first-cycle approvals. This is an encouraging sign that the FDA approval process is getting faster, albeit more expensive.5
Digital Technologies Can Improve Clinical Trials to Benefit All Participants
Starting from the initial diagnosis, patients who want to participate in testing new preapproval drugs face a complex journey. Patient profiles and behaviors, treatment response, logistics, and process-related uncertainties vary widely. Patient experiences can also depend on demographics and geographical location. From beginning to end, the patient journey is an uphill struggle because:
- Patients are unaware of clinical trials for which they are suited. Over half of patients in the US, and 85% in the UK, are unaware of ongoing clinical trials and haven’t seen any calls to participate in clinical research. Only 15% of patients have participated in clinical research programs—even though 75% say they would like to be involved in new drug testing.3 A small minority of patients actively seek out suitable studies after receiving their initial diagnosis. To get more participants, healthcare providers (HCPs), investigator sites, and sponsors need to find better ways to raise awareness. Digital recruitment channels to identify candidates—especially next-generation approaches based on electronic health record (EHR) databases, insurance claims, social media posts, and other types of real-world data and evidence (RWD/RWE)—promise to identify and reach a sufficient number of research participants, especially in the context of oncology and low-prevalence diseases.
- The enrollment process is complex and unsettling. After contacting a research site, patients undergo initial screening to ascertain their suitability; sign an informed consent agreement to enroll; and be randomly assigned to a treatment group. Many suitable candidates are not convinced that they understand and trust the process, and 35% of patients decide not to join a study or leave early because the informed consent agreement is hard to understand.4 Over 90% of oncology patients find it important to talk to the doctors and scientists leading the research and the nurses and other patients involved ahead of joining a trial.5 Multimedia approaches such as electronic informed consent (eConsent) clarify information and improve communication with research staff—who also have access to digital CRM systems—to support the enrollment process and patient follow-up.
- Medication and treatment monitoring can be logistically difficult. The hill gets even steeper once clinical testing begins. Medication and biomarker monitoring may require frequent travel to the research center. Adverse effects of the treatment can be unsettling, and reporting these may require additional consultations with doctors. Patients must also update clinical diaries manually rather than use easier digital solutions. Within a few weeks, 40% of patients no longer adhere to the prescribed treatment, and only 7% of the initially identified participants complete a trial.6 Virtual consultations, wearables, and electronic patient-reported outcomes (ePRO) for real-time symptom monitoring are examples of digital solutions that could help reduce the need to travel and simplify the logistics of the process.
- Successful medications are often discontinued and unavailable for continued treatment. At the end of the trial, patients are frequently left without any clinical support—even if they are still experiencing symptoms. When the drug being tested proves effective, patients lose access to its benefits and any possibility to continue treatment with the medication. This can have a negative impact on their willingness to participate in further studies and collaborate with the industry.
Improving Recruitment And Retention With Digital Will Have A Significant Impact On R&D
Pharmaceutical firms can realize significant benefits from holistically understanding and supporting the entire patient journey and using digital technologies to improve patient recruitment, retention, and adherence. This approach will raise pharma companies’ return on investment to new heights by:
- Reducing drug development cycle times and operational costs. The two largest sources of clinical trial costs are the operational costs of recruiting participants and supporting the many clinic visits required over the course of a trial.7 In 15% to 20% of cases, companies are unable to enroll a sufficient number of participants; half of all trials are delayed due to this problem, which results in losses estimated at $600,000 to $8 million per day. Consultation costs have also a significant impact on the industry—but these can be dramatically reduced by the adoption of digital approaches such as remote monitoring and virtual consultations. When hospital visits are critical, solutions involving digital integrations—such as commuting assistance via Uber—are also promising.
- Increasing the rate of drug approvals. The approval of one extra drug candidate in the research pipeline can improve a pharma firm’s R&D productivity, boost its margin by up to $1 billion, and enable it to offer better pricing options to benefit patients.8 While about 70% of drug candidates fail because the clinical study can’t reproduce the levels of safety and efficacy seen in preclinical tests, the remaining 30% fail for reasons other than the clinical worth of the drug, including insufficient patient recruitment, high dropout rates, and data inconsistencies due to poor adherence to research protocols.9
The Key Capabilities That Produce Clinical Trial Excellence
To be approved for market, drug candidates must be tested in three phases. Phase I trials test for safety on healthy people; Phase II trials test for efficacy on small patient cohorts; and Phase III trials test larger patient cohorts. Each trial proceeds in five stages: 1) design (defining participant inclusion/exclusion criteria, endpoints, and biomarkers); 2) launch (selecting the site and identifying, recruiting, and enrolling potential participants); 3) execution (treating and monitoring patients); 4) closing (analyzing the data and submitting reports on safety and efficacy outcomes); and 5) follow-up (supporting patients post-trial and assessing the longer-term effect of therapeutics) (see Figure 2). Several types of digital capabilities can support patient touchpoints in all stages. Clinical trial organizations should focus on on-stage capabilities for processes that directly affect patients, including recruitment and retention, and behind-the-scenes capabilities for those that do not need a direct patient interface.
On-Stage Digital Capabilities For Patient Recruitment And Retention
On-stage capabilities are patient-facing and make touchpoints come alive by delivering patient experiences directly. Typically, the better firms deploy and use these, the better the experiences are. Success is defined by improving patient recruitment and retention throughout the trial journey. These capabilities include:
Recruitment and enrollment
Digital recruitment. These are business practices for recruiting participants via digital channels. They include advertising the clinical trial via social media, websites, email, text messaging, digital banners, web and mobile apps, third-party platforms, online communities, patient advocacy groups, prescreening tools, and digital concierges (researcher-led and automated chatbots).
Digital enrollment/eConsent and documents. These are business enrollment practices, such as eConsent, that provide patient consent information in electronic form. This can include multimedia components such as images, audio, video, diagrams, reports, chatbots, callout boxes, and digital signatures that aid the consent process. It may also include resources for exchanging information with researchers, clinicians, and other patients.
Digital clinical trial education. Digital education programs support patients and HCPs by providing detailed information on the pathology, adverse effects, trial rationale, and timeline via websites, apps, social media, emails, webinars, and digital lectures.
Retention and adherence
Virtual consultation. Virtual medical consultation methods for treatment and symptom checking include voice and video calls, text messaging and chat apps, and automated symptom checkers. These significantly reduce the need for both patients and doctors to travel, significantly improving the logistics of conducting the trial.
Remote monitoring. This is the practice of capturing clinically relevant patient data from mobile phones, wearables, implanted and in-home sensor technology, and at-home diagnostic kits. It enables continuous remote monitoring of biomarkers and other vital signs to better understand drug performance, respond faster to crises, improve research data quality, and reduce the need to travel to a clinical site.
Medication adherence. These are business practices dedicated to helping patients (continue to) take the medication as prescribed; they include treatment monitoring platforms, electronic alerts and chatbot reminders, electronic dispensers, ingestible sensors, mobile and web apps, and ePRO. Digital reporting of medical adherence also makes trial operations more efficient by automatically removing nonadherent patients from trial data reporting.
Patient communication. Communication channels with trial participants to assess trial progress and patient experiences in real time include digital tools for patient/HCP surveys, internet forums, patient groups, social media, and automated chatbots and communication systems.
End-to-end portals and platforms. These are single platforms or portals integrating all patient recruitment, retention, and adherence approaches and databases for an end-to-end digital trial such as virtual trial platforms and patient experience/engagement platforms.
Behind-The-Scenes Digital Capabilities
While not patient-facing, capabilities that leverage the power of data, such as data analytics platforms, RWD/RWE sources, and proprietary and third-party databases, are crucial to improving patient experiences. Clinical trial organizations should make it a priority to consolidate these digital capabilities, which are also important for capturing information and insights from ongoing trials in real time and optimizing content and decision-making to ensure successful, on-time study outcomes. These capabilities include:
Digital study design and launch. This is the digital approach to aspects of trial design like defining criteria for endpoints, biomarkers, and participant inclusion or exclusion. Digital design can leverage web or mobile apps for patient and HCP surveys to optimize protocols (including segmentation and behavioral analysis), smart tools for inclusion/exclusion, electronic case report forms, and tools for site selection and randomization. Digital can support key aspects of study design such as disease landscaping, new drug indications, protocol optimization, trial simulation, and synthetic control arms.
Content creation and scientific writing and reporting. These are the business practices related to creating and managing relevant and valuable information to attract, engage, and serve customers and other stakeholders. For clinical trials, the focus is on content for digital interactions among all participants, including research organizations, HCPs, patients, regulatory bodies, and institutional review boards (IRBs).
Customer relationship management. Customer relationship management (CRM) is a method for managing a company’s interactions with current and future trial stakeholders including investigator sites, contract research organizations, HCPs, and patients. It often involves using technology to organize, automate, and synchronize communications and provide technical support.
Strategy planning and integration. Strategy planning is the process of determining what digital capabilities are required for trial planning and execution. It often starts by orchestrating the patient journey from a trial perspective and then works backward to arrive at preferred digital capabilities.
Customer experience management. This is the practices that clinical trial teams use to optimize experiences throughout a trial. It involves understanding the specific needs of participants, creating and improving specific touchpoints and materials, and measuring overall participant satisfaction.
Compliance and regulatory. These are digital business practices for regulatory submission, labeling, and IRB approval, including the screening of new requirements and protocols. Examples include intelligent planning platforms and predictive querying tools.
RWD/RWE databases and platforms. These participant databases collect records and information on patient health from sources like EHRs, insurance claims, and lab and pharmacy databases. In addition to supporting patient and HCP outreach, they can be embedded into platforms to support study design, including synthetic control arms databases; smart tools for site selection and inclusion and exclusion criteria; recruitment channels; safety prediction patterns and trial simulations; and patient and HCP support for adherence and retention.
Clinical trial data analytics platforms. These data platforms include clinical trial management and electronic data capture systems. Analytics is typically used to derive insights about the patients themselves; suggest improvements for study design, recruitment, and patient engagement during the trial; and gain insight into performance against overall objectives.
Assess Digital Maturity and Tailor Digital Strategy to Transform Trials
Aligning the interests of the industry with its customers has always been a key concept of commercial operations—and it’s now becoming urgent for clinical operations. Today, drug development outcomes are limited by traditional touchpoints. Clinical trial organizations need to take an agile capability-building approach to assess the various needs of their trials, enable digital touchpoints, and respond flexibly. To achieve digital excellence in clinical trials:
Define the long-term ambition. To transform the experiences of patients in clinical trials, begin by establishing a long-term vision for what the experience needs to be and what value it needs to create for business and patient alike. Whether the goal is improving patient engagement, optimizing the research pipeline, reducing costs and timelines, accelerating digital transformation by enabling fully virtual and decentralized studies—or some combination thereof—investments, timelines, and focus will only be effective if underpinned by a clear ambition.
Assess the current maturity in digital excellence for clinical trials. An accurate understanding of today’s tech stack, the level of adoption by trial teams, and drivers related to the availability and adoption of digital technology are vital inputs into the capability roadmap. The roadmap objectives are determined by your ambition; the maturity assessment allows you to understand the capability gap you need to fill. In-depth analysis of the cost drivers determines how quickly the organization can create new capabilities.
Design a digital capability roadmap aligned with the research pipeline. While not all trials require the same capabilities, it’s essential to have a well-run catalogue of digital capabilities for clinical trials that is easy to set up, centrally available, and cost-effective and which gives teams clear usage guidelines. The team that builds the overall capability needs to align the roadmap with the overall research program as well as today’s portfolio and the future pipeline. More and more, we also see that they need to have the business acumen to be the change agent to shift the culture and imbue the organization with a digital mindset. Our interviews indicate that clinical trial organizations base their tech choices on specific disease-related factors and geographical location; this influences how they roll out new capabilities.
Align your internal skills, talent acquisition, and knowledge to (new) digital technologies. As part of your digital capability roadmap, focus on developing people and acquire talent experienced in the use of new technologies. Companies that don’t emphasize capacity-building will find that the digital capabilities they’ve purchased will remain unused shiny toys. Ongoing research suggests that firms need to create a strong learning and development foundation; make capabilities easy to deploy; and ensure that the overall organization gives employees the space, time, and resources to bring new, innovative digital initiatives to clinical trials.
MethodologyThe results presented in the report, including the list and definition of clinical trial digital capabilities, are based in part on a series of semistructured interviews with eight key internal and external stakeholders at the senior vice president level from midsize and large pharmaceutical companies. We asked interviewees how they define digital maturity; what the current state of digital transformation and patient experience is at their organizations; what digital tools and capabilities they use; and what digital strategy they think will be successful in improving the outcomes of clinical trials.
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Tim van Tongeren