By Dawn Anderson and Matthew Hefner, Deloitte Consulting LLP
The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the first of two articles that shares interview findings and insights published in the new Deloitte Center for Health Solutions report Digital R&D: Transforming the future of clinical development.
During the last decade, biopharmaceutical companies have successfully brought many breakthrough treatments to market. Still, industry stakeholders often say the current high-risk, high-cost R&D model is unsustainable. A Deloitte 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
Many clinical trials still rely on 1990s-era processes, and many R&D functions are yet to fully leverage real-world evidence (RWE), genomics information, and emerging data sources such as the Internet of Things (IoT), wearables, mobile apps, and more. Digital technologies may have the potential to transform the way biopharma companies engage, execute, and innovate during the clinical trial process by addressing many of the pain points faced by sponsors, investigators, and trial staff, including those impacting patient identification, recruitment, and retention throughout the life of the trial.
As patients’ (e.g., trial “consumers”) expectations evolve, they will likely demand a more inclusive and personalized trial experience. Digital technologies can radically improve the patient experience and support other patient-centric objectives by making trial participation less burdensome and redefining how patient care is delivered during clinical trials.
1. Fewer empty seats: Digital technologies can expedite patient recruitment and increase population diversity.
Recruiting patients to fill clinical trials has become increasingly difficult. Almost 15 to 20 percent of trials never manage to enroll a single patient, and more than two-thirds of trial sites fail to reach their original enrollment goals for a trial.2 In addition, traditional recruitment approaches have largely failed to garner study participants who reflect real-world patient cohorts — in the United States, for instance, only 10 percent of clinical trial participants are non-white, although increasing evidence suggests that factors such as ethnicity and gender can impact drug performance and healthcare outcomes.2 Digital technologies can reduce the effort and cost involved in patient identification and help recruit a more diverse and representative study population. Technology-aided approaches can include advertising on websites and online patient communities, targeting patient opinion leaders through social media, and mining unstructured patient data (e.g., social media, electronic health records, lab results). Some solutions help patients find trials, while others help investigators find patients.
Antidote, through its platform, Antidote Match, culls data from clinicaltrials.gov and uses machine learning along with minor human intervention to create structured eligibility criteria for single or multiple studies. The platform automatically generates a pre-feasibility questionnaire that translates complicated medical terms into easy-to-understand language for patients. Completing the questionnaire can enable patients to easily sift through hundreds of studies and find the ones they are eligible for. As of September 2017, Antidote had allowed patients in the United States to search close to 14,000 trials and plans to extend coverage to all U.S. trials in the coming year.3
2. From subjects to collaborators: Digital tech can increase patient engagement in the research process.
Biopharma companies could gain greater insight from trial participants by treating them as collaborators instead of subjects and by seeking their input on issues such as overcoming research mistrust and addressing patient-specific concerns related to study design.4 Many forward-looking clinical teams are using digital technologies to measure patient-centric endpoints — such as quality of life or the ability to perform specific daily activities — and incorporate patient feedback into the trial process through, for example, online surveys and focus groups, study pilots, and crowdsourcing. In addition, many of these teams are using patient feedback on their trial experience to shape the final treatment.
3. Less travel time: Digital technologies can make trial participation more convenient.
Traveling to clinical sites for assessments, sometimes several times a month, is a major burden for some trial participants. In fact, 70 percent of potential participants in the United States live more than 2 hours away from the nearest study center, which often impacts their willingness and ability to participate. Virtual trials can make it possible for patients to participate in certain 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 communicate with patients and support both passive and active data collection. The individuals we interviewed for this research estimate about half of all clinical trials can be conducted either partially or completely on a virtual basis.
Roche used an app connected to smartphone sensors to remotely monitor participants in a multiple sclerosis (MS) study and compare readings with in-clinic assessments. The app directed patients to perform tasks such as hand and wrist turning, gait and balance exercises, and cognitive tests to assess their neurological activity. The data from the sensors created a continuous picture of a patient’s disease progression. Analysts found that results from remote patient monitoring were comparable to in-clinic assessments and, in some instances, were even more sensitive.5
4. More consistent treatment: Digital tools can improve clinical trial patient care and treatment adherence.
Today, patient adherence is measured primarily through self-reporting: researchers ask patients whether they are taking the prescribed drugs and review their diaries (if there are diaries as part of a protocol). Blood tests to validate self-reported data are another way to measure adherence, but they’re not always practical or affordable, and may require additional site visits. Digital technologies can improve patient care and increase treatment adherence throughout the length of a trial. 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. Digital adherence tools that use facial recognition can confirm that medicine has been taken and generate non-adherence alerts to investigators.6
Transforming the future of clinical trials
While digitalizing clinical development can be a complex, resource-intensive, and lengthy undertaking, the rewards can be significant. Digital technologies can radically improve the patient experience, create efficiencies, and lower costs throughout the entire clinical development process and can increase the amount and quality of data collected in trials. In addition, digital technologies can facilitate participation by clinical research staff, investigators, and study nurses and help enable faster cycle times for products in development.
The first big shift has already taken place – many in the biopharma industry realize the importance of patient engagement and the need to design trials that put the patient front and center. Now, it’s a matter of using digital technologies to make that happen — and quickly. Given the complexity of operationalizing a digital strategy and the industry’s relatively slow pace of digital adoption, this should be the time to be a leader, not a fast follower, as undue delay could put biopharma organizations at a competitive disadvantage.
About The Authors:
Dawn Anderson is a managing director in Deloitte Consulting LLP’s life sciences consulting practice. She has more than 30 years of industry and consulting experience in pharmaceutical, biotechnology, CROs, and technology companies. She works with biopharma and CRO clients to design and deploy global operating strategy, performance improvement, and technology implementations across drug development. Over the past 10 years, Anderson has led strategy and operations solutions including a focus on clinical transformation, clinical innovation, operating model optimization, organizational redesign, process re-engineering, insourcing/outsourcing strategy, vendor performance management, digital, advanced analytics, cognitive automation and artificial intelligence, and the design and implementation of enterprise clinical system solutions.
Matthew Hefner is a senior manager in Deloitte’s Life Sciences strategy practice. He helps large and small public and private biopharma clients grow, create value, increase productivity, and reduce risk through: cross R&D, manufacturing and supply chain, and commercial operating strategy development; large-scale business model and operating transformations; organization and process redesign; cognitive, digital, informatics, and information management initiatives; and collaboration and partnership design for discovery, pre-clinical/early development, clinical development, regulatory submissions, and pharmacovigilance. Prior to joining Deloitte, Matt worked in manufacturing process and design engineering roles in the biotech, automotive, microelectronics, and aerospace industries.