Digital R&D Transforming the future of clinical development

Biopharma R&D has changed the face of disease management over the years. Yet many in the field admit that clinical development has fallen behind in adopting digital technologies, which have the potential to change how research organizations can engage with patients, innovate in patient care, and execute processes to drive efficiencies. While digital transformation is a complex, resource-intensive, and lengthy undertaking, the rewards are well worth the effort.

Executive summary

IN the last decade, biopharma companies successfully brought to market many breakthrough treatments that have transformed deadly diseases into manageable chronic conditions, raised the standards of medical care, and helped improve the quality of patients’ lives.

However, many in biopharma R&D admit that the current high-risk, high-cost R&D model is unsustainable. A number of clinical trial activities still use the same processes as in the 1990s, and the clinical development enterprise has largely failed to keep pace with the ever-growing amounts of real-world evidence, genomics information, and emerging data sources (such as biosensors). Harnessing this data could help demonstrate that new treatments result in differentiated improvements in patient and health economic outcomes. Yet companies are challenged to generate this evidence as efficiently as possible to allow for a meaningful return on R&D investment.

Digital technologies can transform how companies approach clinical development by incorporating valuable insights from multiple sources of data, radically improving the patient experience, enhancing clinical trial productivity, and increasing the amount and quality of data collected in trials. Collectively, digital technologies can help achieve the following strategic objectives in clinical development:

  • Engage effectively with patients and stakeholders through targeted, omni-channel interactions to meet their needs and foster loyal relationships
  • Innovate in patient care by catalyzing the development of products and services to deliver value for patients, health care providers, and payers
  • Execute efficiently by digitizing and rationalizing processes to drive efficiencies, cycle time reductions, and cost savings

But where is the industry in adopting these transformative technologies? We interviewed 43 leaders across the clinical development ecosystem to understand the current level of adoption of digital technologies and how it can be accelerated. We found that the industry has been slow to digitize its clinical development processes, and that digital adoption varies widely. Even the most advanced organizations are simply piloting several technologies in different areas of clinical development, focusing on piecemeal solutions or new tools to support the existing process.

Our research and client experience suggest that digital transformation is a complex, resource-intensive, and lengthy undertaking. But the rewards can be significant: Early adopters can benefit from better access to and engagement with patients, deeper insights, and faster cycle times for products in development. Many in our study expressed a desire to be fast followers, but given the complexity of operationalizing a digital strategy, the reality is that undue delay could put organizations at a competitive disadvantage.

At the same time, our research also indicates that biopharma companies and contract research organizations (CROs) will need to overcome several challenges to realize the potential of digital in clinical development: immature data infrastructure and analytics, regulatory considerations, and internal organizational and cultural barriers. Biopharma companies should consider building updated data infrastructure and governance, engaging early with regulators to discuss new technologies, and developing a measured approach to evaluating and implementing technologies within their organizations. CROs can enable this change by advancing interoperable digital platforms and vetting promising technology applications. Cross-industry consortia could help advance the industry as a whole by offering a forum to share early successes and supporting the development of standards.

The time to act is now. Biopharma companies that do not pursue a comprehensive digital clinical strategy risk falling behind.

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The promise of digital

The industry is under pressure to develop innovative medicines; demonstrate differentiated value to patients, providers, and payers; and reduce cost and time to market to maximize return on investment. Deloitte’s analysis of return on pharmaceutical R&D investments for a cohort of 12 large biopharma companies shows a sustained decline from 10.1 percent in 2010 to 3.2 percent in 2017.1

As the industry looks for ways to improve the performance of today’s R&D model, many companies are turning to digital technologies. Most think of digital as a collection of technologies, platforms, and advanced analytics, such as connected devices, mobile applications, artificial intelligence, machine learning, and robotic processes. As companies look to apply these technologies either individually or in combination to perform operational activities, such as recruiting patients, improving adherence, and capturing and analyzing data, it could, however, be useful to conceptualize digital not simply as a platform or technology, but as a way of doing things differently. In our view, digital provides opportunities to:

  • Engage effectively with patients and investigators through targeted, omni-channel interactions to meet their needs and foster loyal relationships
  • Innovate by catalyzing the development of products and services to drive value for patients, health care providers, and payers using data and innovative platforms such as digital endpoints, real-world evidence, and telemedicine
  • Execute efficiently by digitizing and rationalizing processes to drive efficiencies, cycle time reductions, and cost savings

Looking at digital through this lens can help shift the focus from individual technologies and solutions to how these technologies collectively can help accomplish bigger clinical development objectives and identify strategic opportunities that a narrow technology-centric view might miss.

Research approach

Deloitte interviewed 43 industry stakeholders involved in the drug development process to:

  • Explore where the industry sees value and opportunities for digital in the clinical development process
  • Understand reasons behind the relatively slow pace of adoption of digital technologies in clinical development
  • Uncover strategies to overcome barriers and accelerate the adoption of digital in clinical trials

For the purposes of our research, we defined “digital” to our interviewees as a collection of the following technologies:

  • Social media and online platforms
  • Mobile applications, wearables, biosensors, and connected devices
  • Automation (robotic process automation and robotic and cognitive automation)
  • Cognitive technologies (machine learning, artificial intelligence, natural language processing, natural language generation)
  • Analytics and visualization
  • Blockchain
  • Virtual/augmented reality

Value levers for digital technologies in clinical development

Digital technologies have helped change the way retail, finance, and banking industries communicate with and deliver their products and services to customers.

Through the course of our interviews, we heard that digital technologies have the potential to transform clinical development as well—especially in the way companies engage, execute, and innovate. Applied to trials, these technologies can address many of the pain points faced by patients, investigators, and trial staff.

Engage: Patient-centric clinical development

As consumer expectations evolve, trial participants will likely demand a more patient-friendly clinical trial experience. Yet the industry has often been slow to meet even the most basic of expectations. As the vice president (operations) of a CRO said,

“If you think about the logistics—driving or taking transport to the site, parking, checking in, sitting in a waiting room, only to answer a few questions . . . All of that could be obviated by mobile technology. Patients will push back against research studies that ask them to come in for nonsensical visits.”

Digital technologies can support many of the goals of patient-centricity by making trial participation less burdensome and more engaging and by redefining how patient care is delivered during clinical trials.

  1. Collaborate with patients in the research processCompanies could gain more insight from trial participants by treating them as collaborators instead of subjects in the research process. Although not a standard approach for the industry just yet, forward-looking clinical teams have responded to this demand by incorporating patient inputs into the trial process. This can be achieved through patient representation on advisory boards, study pilots, surveys, focus groups, and crowdsourcing technologies. These clinical teams also incorporate patient feedback on their trial experience and use this information to shape the final product.
  2. Ease patient access and reduce the burden of trial participationTravelling to clinical sites for assessments, sometimes several times a month, is a major burden for trial participants. In fact, 70 percent of potential participants in the United States live more than two hours away from the nearest study center, which often impacts their willingness and ability to participate.2Virtual trials make it possible for patients to participate in studies from the comfort of their homes, reducing or even eliminating the need to travel to sites. Such trials leverage social media, e-consent, telemedicine, apps, and biosensors to simplify recruitment, communicate with patients, and support both passive and active data collection (see case study 1).
    1. Transform patient care during a clinical trialDigital technologies can provide more comprehensive tools to patients and clinicians than are available today. They can help engage patients continuously throughout the clinical trial experience and help improve patient care management during clinical trials.For instance, text messaging and smartphone apps can remind patients to take their medication, record health data, answer patients’ questions in real time, and schedule their visits.

    Innovate: Drive greater product value through new approaches and insights

    Digital technologies can help companies develop a better value proposition by operationalizing the drivers of patient value and achieving significant advances in study methods that traditional approaches cannot deliver.

    1. Improve adherence to therapyAdherence to therapy ensures that the effect of an investigational drug is fully reflected in the data. However, high adherence rates can be hard to achieve and verify using traditional methods. A senior scientific director at a midsize biopharma companydescribes the problem:“We found that based on blood samples on the pharmacokinetic monitoring, 35–40 percent of patients had no drug on board. This drug had a half-life of 5.5 days. This meant those patients didn’t skip just one dose, they hadn’t taken the drug for up to two weeks.”

      Adherence tools such as AiCure use facial recognition to confirm that the medicine has been ingested and generate nonadherence alerts to investigators.4 Case study 2 describes another example of an adherence solution.

    2. Increase the statistical power and sensitivity of clinical studiesMore frequent data collection (daily, hourly, or continuously) via sensors and wearables can generate much more data and produce more sensitive measurements than periodic standard clinical assessments. As a result, the effect of therapy can be demonstrated with shorter studies and fewer patients, requiring less effort and cost for recruitment and retention (see case studies 3 and 4).
    3. Capture patient-centered endpoints and support product value propositionsSome interviewees note that the ability to measure endpoints important to patients, such as quality of life or the ability to perform specific daily activities (such as getting up and down the stairs), will help drive market access and adoption.Many endpoints used in trials today only offer a glimpse into a patient’s physical and mental functioning at a given point in time. Advances in sensors and mobile technologies have made it easier to continuously collect patient-generated data, also referred to as digital endpoints (see case study 4). Additionally, new technologies make it possible to collect patient-reported outcomes electronically, including the ways in which an intervention impacts a patient’s quality of life. Analytical insights on clinical and patient-reported outcomes can provide competitive advantage and support the case for reimbursement.

      In the future, digital endpoints and health outcomes captured in a real-world setting could also support value-based contracting. This data could demonstrate to patients, providers, and payers that the expected therapeutic and economic value defined in clinical trials is being delivered.

      1. Get new insights from existing dataAs companies apply artificial intelligence and advanced analytics to data assembled from different sources (real-world evidence, claims, and completed and ongoing studies), they can begin to uncover new insights. These insights may suggest potential new indications, a different safety profile or response to treatment in certain patient subgroups, or predictions around the likelihood of compounds to succeed in trials.
      2. Reduce the number of patients needed to study investigational treatmentsNovel approaches to study design, such as synthetic trial arms or master protocols, can reduce the number of patients required to test investigational treatments.A synthetic trial arm uses data from previously completed trials or real-world evidence to create a “control” study group that receives a placebo or standard of care treatment. This approach is particularly useful in rare disease trials or when a placebo approach is not appropriate or ethical, as is often the case in oncology.

        Master protocols—where several companies or teams study competing treatments for a similar patient population in an umbrella or a platform trial*—can achieve a similar goal.

        In-silico trials can eliminate the need for phase 1 trials that test the safety of compounds in healthy subjects. Instead, safety is evaluated using advanced computer modeling.

      Execute: Gain efficiencies, optimize time and cost

      As clinical trials grow in scope and complexity, digital technologies can optimize trial operations. Some companies are starting to use these technologies and realize the benefits described below. These are just a few examples from our interviews; digital can give rise to many other operational efficiencies.

      1. Expedite patient enrollment, improve retention, and increase the diversity of the study populationTraditional recruitment approaches have largely failed to garner study participants who reflect real-world patients. Regulators, treating clinicians, and payers stress the need for greater demographic heterogeneity in study populations. Digital technologies can support the recruitment of a more diverse and representative study population (see case study 5). This could also help sponsors better understand the benefits and risks of new therapies across different subpopulations before going to market.Furthermore, digital technologies can significantly improve recruitment efficiency by reducing the effort and cost involved in patient identification. Today, approaches range from simple advertising on the Web and online patient communities to targeting patient opinion leaders through social media to mining unstructured patient data (social media, electronic health records [EHRs], lab results, pathology reports). Some solutions help patients find trials while others help investigators find patients (see case studies 5 and 6).

Strategic and operational issues impede progress for major stakeholders

Who in the clinical development ecosystem will drive the adoption of innovation? We have found that given the constraints stakeholders in the clinical development ecosystem face, it may be difficult for any one player to be successful independently. For many organizations we interviewed, partnerships are central to the success of their digital programs.

Biopharma companies. Innovation is currently happening in pockets within biopharma companies; however, strategic and operational issues can limit progress (described in more detail later in this report). An inherently risk-averse culture steers organizations away from exploring technologies for high-priority and potentially high-value clinical programs for fear of slowing down trial execution. Many large biopharma companies are also saddled with complex and slow-moving organizational structures. Small biopharma companies, on the other hand, may be nimbler, but have limited resources, which constrains their ability to make larger technology plays.

CROs. Our research suggests that biopharma clients do not think of CROs as champions of innovation. Some interviewees point to a tension between preserving an existing CRO business model optimized for the current drug development process and the need to experiment, which can disrupt familiar processes, threaten job functions, and undermine the CRO revenue model.

“With a focus on operational effectiveness and efficiency, CROs operate like machines. The idea of a well-oiled machine is predicated on repeatability, doing things the same way, consistently. However, this created a system that is averse to making purposeful changes to these well-oiled processes: ‘We get things done, and reasonably fast.’ But what was reasonable in the past is not appropriate for the future. Somebody in my role asks to break the machine because we want to do things differently. We create tension and animosity. This is where culture has to adapt over time,” says the vice president of strategic operations at a CRO.

A few oppose this view, suggesting that CROs can gain the most from transformative digital innovation, as they will likely be pushed toward a capitated payment model that rewards efficiency. They expect CROs to choose to bring new technology through mergers and acquisitions and partnerships with technology players.

Technology companies. Technology companies focused on the clinical development space offer promising solutions, but many find it challenging to understand the heavily regulated biopharma environment. Biopharma companies are often reluctant to be the technologists’ “beta testers” for new, unproven solutions.

A few interviewed experts expect innovation to come from outside the industry, perhaps from large technology companies such as Amazon or Apple Inc. eyeing the health care space. These companies have access to ever-growing amounts of consumer health data that could prove valuable in clinical development, from understanding disease onset and progression to identifying early safety signals or food and drug interactions to engaging with patients for clinical trial participation and awareness. For most, working with these technology companies is new territory, but this could become an essential element of biopharma companies’ digital strategy.

Cross-industry collaboration can accelerate adoption

One way companies can experiment without incurring too much risk is through participation in industry consortia, and this is a key component of digital strategy for several interviewees.

The past few years have seen a large increase in R&D-focused partnerships through industry consortia such as the Clinical Trial Transformation Initiative (CTTI) and TransCelerate. Such partnerships have been instrumental in increasing our understanding of complex conditions and novel biomarkers, improving the ability to measure disease progression, and exploring the clinical benefits of combination treatments.11 Consortia are a good model for activities that require industry-wide consensus, such as standards development and presenting a collective voice to regulators in shaping regulatory guidance on new issues. Possible benefits of industry consortia to digital adoption in clinical development include:

  • Minimizing risks through shared investments in joint projects
  • Incorporation of multi-stakeholder perspectives (patients, investigators, treating clinicians, payers, regulators)
  • Access to interdisciplinary expertise around analytics, endpoint validation, and technology development
  • Data-sharing

SOURCE: https://www2.deloitte.com/insights/us/en/industry/life-sciences/digital-research-and-development-clinical-strategy.html?id=us:2el:3pr:4di3967:5awa:6di:MMDDYY

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