IMPROVE CLINICAL TRIAL OUTCOMES BY BOOSTING PATIENT EXPERIENCE

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SMARTER DRUG DEVELOPMENT IMPROVE CLINICAL TRIAL OUTCOMES BY BOOSTING PATIENT EXPERIENCE Shifting from Subjects to Customers We are in the Experience Era. Consumers are drawn to organizations that consistently deliver high-quality and engaging experiences. As a result, organizations across industries and around the globe are changing the way they interact with customers. Those that do it well see higher customer satisfaction, loyalty and financial return. Customer experience is the paramount source of corporate differentiation in today s economy: 89% of senior marketing executives expect to compete primarily on the basis of customer experience this year. 1 From 2007 to 2014, customer experience leaders cumulative returns were 49% greater than the S&P 500 Index, while laggards underperformed the index by 162%. 2 Customer experience leaders have an average Net Promoter Score rating that is 24 points higher than laggards. 3 89% OF SENIOR MARKETING EXECUTIVES EXPECT TO COMPETE PRIMARILY ON THE BASIS OF CUSTOMER EXPERIENCE THIS YEAR. 1 The Life Sciences industry in general, and the clinical trials space in particular, can benefit by identifying and implementing changes that enhance patient experience. While long-term studies to measure the impact of patient-centricity in clinical trials have not yet been completed, there is significant momentum in the industry towards a patient-centric approach. Anticipated benefits include faster enrollment, higher levels of patient engagement and retention, increased compliance, and improved patient loyalty. Given that the average cost to recruit and retain one enrolled subject is $7,600 and the loss in revenue due to a delay in clinical trials is estimated to be $40 million per month, even modest improvements due to a patient-centric approach should translate into significant savings. 4 1. Gartner Surveys Confirm Customer Experience is the New Battlefield. October 2013. 2. The 2015 Customer Experience ROI Study. Watermark Consulting, 2015. 3. ROI of Customer Experience 2015. Temkin Group, October 2015. 4. Tufts (2011, April 26), Mintz, C. (2010), Beasley, D. (2006).

In response, companies are testing new models and techniques for patient-centricity to identify approaches that add value and positively impact trial outcomes. Examples include targeted recruitment strategies, patient-influenced protocol design, and return of individual trial results directly to patients. The industry is still on the early part of the learning curve and trying to build the critical mass needed to drive toward widespread adoption. To accelerate efforts, companies should build a patient-centricity program on a central foundation of providing a world-class patient experience. This requires a shift away from the traditional classification of trial participants as subjects who serve as a means for data collection towards one that considers participants as customers. Sponsors can achieve competitive advantage in areas such as recruitment and retention by providing customer-centric experiences similar to leading organizations in other industries. Furthermore, an enhanced patient experience, with higher levels of engagement and motivation, will support the current trend toward greater use of patientreported outcomes. THE EXPERIENCE TOOLSET: PERSONAS AND JOURNEY MAPS IN A RECENT STUDY OF 400+ CLINICAL TRIAL PROFESSIONALS, 75% SAID PUTTING THE PATIENT AT THE HEART OF THE CLINICAL TRIAL IS A TOP PRIORITY. YET, ALARMINGLY, ONLY 21% SAID IT WAS A COMPANY- WIDE PRIORITY, AND 17% REPORTED, NO ONE IS SPEARHEADING THE EFFORT. 5 Providing a high-quality patient experience requires understanding and navigating a complex landscape composed of multiple partners and stakeholder groups. For global trials in particular with varying regulations, compliance procedures and cultural norms delivering a consistently high-level patient experience can pose numerous challenges. With primary responsibility for the conduct of the trial, the sponsor is best-positioned to spearhead efforts to build a patient-centric approach. This requires a deep understanding of the patient and the trial journey. Personas and journey maps are two powerful tools used in the customer experience discipline that can be applied to patient-centricity efforts. Adopting these methods will help trial sponsors and partners better align around a patient-centric strategy. 5. Patient-centric clinical trials becoming a higher priority for biopharmaceutical, CRO management. CenterWatch, January 2015 2 North Highland Patient Centricity Perspective

Personas Creating patient-centric experiences requires a well-articulated understanding of the patient population, and the meaningful differences within it. Personas are representative portraits that serve to categorize and describe a customer base. For clinical trial organizations, patient personas would typically capture a combination of: Demographic factors (such as age, ethnicity and gender) Health-related factors (including disease state/therapeutic area, medical history and familiarity with clinical trials) Psychographic factors (for example motivations for participating in trials, trial expectations, dependence on caregiver, communication style and channel preference) Personas may also be created for stakeholders such as caregivers and family members who experience the clinical trial process through their relationship with the patient. Journey Maps Journey mapping tells the story of a representative patient s experience and provides insight into needs, motivations and expectations using ethnographic research techniques and data analytics. To more fully understand and articulate the patient s journey, experience it. Have key teams and company leaders role-play as participants in a trial to build empathy and understanding around the actual experience as it is delivered. Document the experience, compare it against expectations, identify gaps and prioritize improvement opportunities. Highlight the key interactions that add value or have the most impact on patient engagement (the moments that matter ) to align teams on improvement efforts. During this process, adopt the patient s perspective and language as much as possible. This will go a long way to reinforce a patient-centric vs. company-centric mindset. Many customer journeys suffer due to handoffs from one department, channel, entity or owner to the next. Closely examine these handoffs for potential gaps or failure points and identify solutions. For clinical trials, focus on ensuring a consistent patient experience is delivered across interactions with the Study Coordinator, Physician/Investigator, Lab Personnel and the rest of the clinical team. Remember to include technology interactions that will be required of the patient and design solutions that address the high degree of variability in patients ability to use technology and master new tools. BUILT ON A FOUNDATION OF QUANTITATIVE AND QUALITATIVE RESEARCH AND BROUGHT TO LIFE THROUGH COMPELLING NARRATIVES AND VISUALS, WELL-CRAFTED PERSONAS PROVIDE ORGANIZATIONS WITH DEEP PATIENT UNDERSTANDING AND A LIVING ROADMAP FOR ALL ASPECTS OF DESIGNING THE PATIENT S EXPERIENCE. READ MORE IN OUR PERSONA DEVELOPMENT OVERVIEW 6 PUBLISHED BY SPARKS GROVE, THE EXPERIENCE DESIGN DIVISION OF NORTH HIGHLAND. 6. http://blog.sparksgrove.com/personas-an-experience-design-tool/ 3 North Highland Patient Centricity Perspective

FROM FAILURE POINTS TO OPTIMIZED MOMENTS THAT MATTER By understanding patient needs, motivations and expectations at each phase of the trial lifecycle, sponsors can enhance the patient experience and improve on important outcomes such as speed and quality. Since every trial and circumstance is unique, documenting individual patient journeys can be useful to make real-time assessments and adjustments, while aggregating such data can highlight pain points and areas requiring particular focus. The hypothetical and highly simplified patient journey map in Figure 1 helps illustrate how key interaction points can be visually captured. Adding additional layers of data (such as specific clinical and non-clinical touch points, internal/external influencers, etc.) will reveal insights and opportunities to strengthen the patient experience. Discovery / Recruitment The initial phase of a patient s trial journey is characterized by emotional adjustment to a diagnosis along with information gathering. Newly aware of a diagnosis, patients seek to understand all options, from lifestyle changes and FDA-approved treatments to clinical trials. Learning about a trial from a physician or sponsor advertisement is often the first step ideally this is positively reinforced by interactions with a patient advocacy group or another trusted party. In this phase, provide information and resources that help patients quickly assess eligibility, understand the protocol, ask questions and begin a dialogue. Patient education is critical forty percent of adults report they do not understand the idea of a clinical trial. 7 In addition, set clear expectations with each patient. Experience is a perception one that is grounded in expectation. When establishing and communicating expectations, address patients needs for emotional support as well as for clear information on trial details. 7. Patient-centric clinical trials becoming a higher priority for biopharmaceutical, CRO management. CenterWatch, January 2015 4 North Highland Patient Cantricity Perspective

Figure 1 Simplified Hypothetical Clinical Trial Patient Journey Discovery / Recruitment Enrollment / Participation Completion / Follow-Up PATIENT EXPERIENCE Pre-diagnosis Learns More About Trials From Patient Advocacy Group Welcoming Site Enrollment Confusing Consent Documents Invasive Procedures Patient Support Program Initially not Informed of Trial Results Learns Trial Results, Gets Formal Thank-You From Sponsor Diagnosis Learns About Trial on Sponsor Web Site CLINICAL TRIAL PATIENT JOURNEY KE Y: Positive frame of mind Neutral frame of mind Negative frame of mind Sponsors can overcome this awareness barrier using innovative outreach tools to educate patients and by simplifying the screening process. For example, some companies have developed websites designed specifically for patients enrolled in a clinical trial or considering a trial. These sites include features such as educational resources (disease-specific or general info on clinical trials), links to find out more about active trials, tools to document a patient s individual journey, or forums to provide feedback. Conversely, be sure to develop a good understanding of patient motivations for participating in clinical trials. The persona development process along with third party resources such as the Center for Information and Study on Clinical Research Participation (CISCRP) can be very useful in this regard. Interestingly, a survey conducted by CISCRP 8 revealed that patients more frequently mention altruistic benefits (advancing science and treatment, helping improve or save lives) for participating in a clinical trial than they do direct personal benefits, such as treating or curing their own condition. Other reasons cited include monetary compensation, free medication, and doctor recommendations. 8. 2013 Perceptions & Insights Study. Center for information and Study on Clinical Research Participation 5 North Highland Patient Centricity Perspective

Enrollment / Participation Understandably, patients may struggle with information overload, confusion and uncertainty leading up to a decision to enroll in a clinical trial. Even after enrollment, ongoing uncertainty can lead to a patient dropping out of the trial. Counter this by putting the patient at ease and building confidence, starting with the first interaction at a clinical trial site. Convey understanding of the patient s situation and help patients understand how the trial will be conducted and what will be expected of them. Further, demonstrate credibility through informative and easy-tounderstand content. For example, the current trend toward simpler and shorter informed consent documents is very positive for patients. When a trial requires several site visits and/or procedures, consider offering patient support programs that help with the logistics and cost of travel. This can make a real difference for certain patients allowing more individuals to participate and boosting enrollment rates. Also, consider using technology that alerts patients of upcoming visits to help ensure trial completion. Trial Completion / Follow-Up Trial completion provides an opportunity to recognize patient accomplishment and provide clear communication about what comes next. Where feasible, share data with the patient and ask for feedback. Find ways to incorporate proven customer experience measures such as Net Promoter Score and Customer Effort Score, and link results back to continuous improvement plans and incentives. This approach should be supplemented by more open-ended dialogues with patients to understand the trial experience and gather deeper insight into improvement opportunities. FIND WAYS TO INCORPORATE PROVEN CUSTOMER EXPERIENCE MEASURES SUCH AS NET PROMOTER SCORE AND CUSTOMER EFFORT SCORE, AND LINK RESULTS BACK TO CONTINUOUS IMPROVEMENT PLANS AND INCENTIVES. CUSTOMER EXPERIENCE MEASURES Net Promoter Score is an index ranging from -100 to 100 that measures the willingness of customers to recommend a company s products or services to others. It is used as a proxy for gauging the customer s overall satisfaction with a company s product or service and the customer s loyalty to the brand. Customer Effort Score measures customer service satisfaction with one single question (typically, the company made it easy for me to accomplish my task ). The underlying thought is that service organizations create loyal customers primarily by reducing customer effort. 6 North Highland Patient Centricity Perspective

IN SUMMARY Achieving patient-centricity requires shifting mindsets along with processes. It means abandoning the old patient as subject model in favor of a new approach based on proven customer-experience techniques. Sponsors can strengthen capabilities to deliver a positive patient experience by using powerful tools such as journey maps and patient personas. As they continue to build insights around the critical interactions that impact patient experience, sponsors will refine policies, procedures and practices around clinical trials and convert failure points to optimized moments that matter. Ultimately, organizations that boost customer experience will improve clinical trial outcomes and drive greater patient satisfaction and loyalty. ABOUT NORTH HIGHLAND North Highland is a global management consulting firm known for helping clients solve their most complex challenges related to customer experience, transformation, performance improvement, and technology and digital. We add value and support our clients across the full spectrum of consulting, from strategy through delivery. We bring the big ideas, then we make them real. North Highland is an employee-owned firm, headquartered in Atlanta, Ga., with more than 3,000 consultants worldwide and 60+ offices around the globe, and has been named as a Best Firm to Work For every year since 2007 by Consulting Magazine. The firm is a member of Cordence Worldwide (www.cordenceworldwide.com), a global management consulting alliance. For more information, visit northhighland.com and connect with us on LinkedIn, Twitter and Facebook. For more information, please contact: Alan Susser +1 215-207-0796 Alan.Susser@northhighland.com Copyright 2016 The North Highland Company. All Rights Reserved.