Ken Fabianovicz

	In the last several years, the rise in digital technologies and voice recognition have enabled an artificial intelligence revolution, impacting organizations across all industries. Platforms like Google Now and Siri, along with others from IBM and Microsoft, have succeeded by simplifying the user experience of accessing information. Most recently, the Amazon Echo/Alexa platform has become the leader in the smart home market, making inroads into a variety of healthcare settings. For example, Lenovo is using Alexa to link patients to its care teams, while HealthTap has launched “Doctor A.I.,” an Alexa skill, which allows patients to query a wide range of conditions and ailments. Boston Children’s Hospital has even 

 that allows anxious parents to ask Alexa about child-related medical symptoms.

	Given this growing range of health-related, voice assistant applications, healthcare and life sciences organizations are increasingly starting to design a range of scenarios for deploying voice assistant platforms, such as Alexa, in the clinical trial setting. These four scenario-based user-experiences each demonstrate how Alexa’s powerful voice recognition technology, when paired with a connected ecosystem, might be harnessed for addressing specific challenges in the current clinical trial environment. In this context, four separate use-cases have been developed:


	 Typically in the clinical trials process, keeping patients enrolled in a trial through completion is difficult. A common reason for early withdraw is subjects are overwhelmed by the number of visits, which prompts them to forget or skip appointments. This results in inadequate data. Rather than having the patient call the site to reschedule appointments or receive reminders, Alexa can be used to help keep patients on schedule. For example:

	·       A patient asks Alexa the time of his or her next scheduled visit

	·       Alexa accesses database and returns result

	·       The patient can confirm the appointment, set Alexa reminder(s) or reschedule

	·       If prompted to reschedule, Alexa will access the database for rescheduling or notify the clinical trials site to call the patient to reschedule

	Utilizing voice recognition technology during the patient appointments phase of the clinical trials process allows organizations to enhance the user experience. Specifically, providing a simple, central point of contact for scheduling and making appointments results in minimal disruption. This benefits the overall trials process by improving adherence to schedule visits and assessments, as well as providing better quality patient data.


	About 25 percent of clinical studies require patients to maintain a study diary, and in most cases, these are paper-based entries. In recent years, electronic diaries have become more common via a patient portal or telephone Interactive Voice Response (IVR). These methods have resulted in improved data quality and integrity; however, there is room to improve patient adherence in submitting the information. With this in mind, Alexa can be used in place of IVR to gather this data. For example:

	·       A patient tells Alexa they are ready to complete the diary

	·       Alexa accesses the database and asks questions related to completing the diary

	·       The patient is prompted to reply

	·       Alexa notifies the patient when his/her entry is complete

	In this case, voice recognition technology can improve the overall clinical trials process by providing minimal disruption to the patient’s schedule, and allowing them to input/record their diaries using a single communication method. As a result, this improves adherence to data collection, resulting in better quality data overall.

3). Collaboration between Site Investigators and Sponsors


	Site management by the sponsor and/or the Contract Research Organization (CRO) is an essential element in ensuring trial success. The appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, and overall management of subjects. As such, it can be difficult to maintain regular communication with the sponsor and/or CRO. Improving the communication flow will often reduce protocol violations and deviations and address data issues and questions, thereby increasing the quality and integrity of clinical trial data. For example:

	·       The site asks a question to the sponsor or the Clinical Research Associate (CRA)

	·       Alexa requests the CRA or sponsor call back, or Alexa accesses the database for the site’s FAQs and can provide an immediate response for any common questions

	By looking to new, digital technologies such as Alexa, clinical site investigators and sponsors can experience minimal disruption to the investigator schedule by improving the overall communication flow through a simple, central point of contact.

4). Increasing Trial Awareness Among Physicians

The Center for Information and Study on Clinical Research Participation

 (CISCRP) found that 46 percent of clinical trial participants discovered clinical trials from the internet, while only 23 percent were referred by their physicians. In fact, patients are more likely to enroll in a trial when their physician recommends it;  however, physicians are typically overwhelmed by their daily workflow, and often have limited time to research and refer patients to trials. In this case, Alexa can be used to increase overall physician awareness of open trials. For example:

	·       A physician queries Alexa on open trials for a condition or diagnosis code

	·       Alexa accesses Clinical Trial databases (Clinical Trials and Me or ClinicalTrials.gov)

	·       An additional data layer associates a text shortcode to each open trial

	·       The physician or patient then sends the shortcode to a predefined number (i.e. 4325 to AbbvieTrials)

	·       A link to the site with trial information is then returned

	On the other hand from the patient perspective, voice recognition technologies enhance the user experience by providing an easy way to search the clinical trial database. The end result is increased awareness and patient engagement in discovering clinical trials, acerbating recruitment for the site overall.

As Alexa and other voice recognition tools gain wider adoption in the industry, organizations will start to see an increasing use of voice-driven tools within the healthcare space. The potential impact on the clinical trial process is very powerful across a range of different use cases. To drive success, organizations should identify areas that hold the most potential for process improvement, begin piloting/testing voice driven solutions as part of the technology ecosystem, to ultimately improve efficiencies and accelerate clinical trials overall.

, Director of Commercial Strategy & Innovation at Cadient, a Cognizant Company

Articles

Because of the growing rate of voice assistant applications, such as Alexa, healthcare and life sciences organizations are beginning to design a range of scenarios for deploying these voice assistant platforms in the clinical trial setting.

How Voice Recognition Technologies Can Be Used to Accelerate Patient Trials

Like so many other aspects of the pharmaceutical industry, digital tools, platforms and processes are transforming clinical trials in dramatic ways. This includes recruiting and engaging patients, streamlining data management, enhancing overall stakeholder communications and coordinating investigators and investigator sites.	 	As digital innovation continues to accelerate, new opportunities will arise that improve the clinical trials process even further. Faced with this wave of innovation, teams need to develop systematic processes for evaluating new technologies, and determine if and how these technologies can help to streamline their particular trial experience. When innovatively applied, these new technologies can benefit study sponsors, investigator site staff, subjects and their care-givers.	 	

	 	First of all, the protocol development process itself is an area where technology has promising potential. By building collaborative tools and platforms, clinical teams can effectively break down silos across the organization and streamline the process of gaining input from a broader range of internal and external stakeholders. This input ensures that the protocol is effective both in terms of final outcomes, as well as in the day-to-day logistics of trial execution. These real-time collaboration tools also have the potential to reduce costly and time consuming amendments.	 	Once the protocol is initiated, the investigator meeting itself can dramatically benefit from the strategic use of technology. Infographics and tablets can make it easier for investigators and their staff to understand study protocols, while interactive displays and virtual simulations can help to reinforce key aspects of the study design. These tools help investigators find better suited subjects, and also help equip them to respond to issues to improve completion and retention rates.	 	

Digital Tools to Enhance Trial Experience

	 	As the investigators return back to their respective study sites, digital tools can also help transform the subject onboarding process, making it easier for subjects to understand informed consent and help to set realistic expectations around the overall trial experience. Once patients are enrolled in a well-designed study, another area that is particularly rich for tech-driven innovation revolves around behavior modification and patient compliance. Motivation can be difficult to generate on its own, but if technology is aligned with the patient’s existing motivations and predispositions, then the trial processes can make it easier for patients to do what they are already inclined to do, thereby improving retention.	 	

	 	With the rise of powerful social networks and smartphones, technology can also be used to enhance the patient recruitment process, helping to geo-target around key study centers, while also providing digitally based infographics and videos that can easily be shared across various social platforms.	 	Risk-based monitoring, driven by Big Data analytics, is a digital endeavor at its core, with data streams that can be supplemented by digital tools, such as real-time chat/live video chat, and artificial intelligence algorithms which can help study sponsors anticipate and quickly identify issues before subject drop-off.	 	Voice activation, powered by devices like Amazon Echo and Apple Siri, combined with distributed sensors, also hold promise for providing a framework of in-home compliance, patient support and real-time contact with both the local study site, as well as national sponsor representatives.	 	As technology continues to accelerate, there will be countless opportunities to improve all aspects of the clinical trial process. In this environment, trial teams need to consider technology trends, but more importantly - focus on patient care and behavior change – systematically applying the appropriate technologies that will drive a successful trial for sponsors, investigators and patients alike.	 	By 

Digital innovations are enhancing clinical trials in several ways including recruiting, patient engagement and streamlining data management. Clinical teams will need to develop systematic processes for these new innovations in order to improve their particular trial experience.

Digital Innovation in Enhancing Clinical Trials

Over the last 30 years, the process of clinical research and clinical trials have undergone a revolution, one that has expanded the complexity, global reach and sheer quantity of trials. Despite these changes, investigator meetings have not evolved. The majority of these meetings are still centered on a series of PowerPoint® presentations with limited participant interaction. While investigators are certainly familiar with this communications approach, it is far from optimal. Not only are PowerPoint lectures an outdated and ineffective way to review the details of a trial protocol, but also are ineffective when it comes to accommodating a variety of learning styles. Following the presentations, attendees are typically given follow-up materials in print with the expectation that they travel back home and communicate these learnings with their staff.	 	These are all factors that are hindering clinical trial investigators’ ability to drive deeper understanding about patient identification and enrollment. Fortunately, digital technologies and strategic design approaches are beginning to dramatically reimagine the investigator meeting experience, enabling more open discussions on scientific background or studying drugs and their key inclusions/exclusions.	 	

	While at first glance, there is little in common between an investigator meeting and today’s digitally driven consumer culture, consumer brand experiences have raised the bar for meetings and experiences of all types. 	 	In this context, crafting a great investigator meeting experience begins by “thinking beyond the meeting,” or discerning how attendees can be reached with meaningful content and experiences before, during and after the event. By concentrating on the following key concepts, investigators will be able to create more powerful meetings, help ensure successful trials and drive engagement, accuracy, long-term retention and social interaction among investigators:	 	

	While it is important to make a meeting as productive as possible, investigators should not overlook the chance to engage attendees before and after the live event. Password protected portals are a powerful platform that can engage investigators prior to them arriving onsite, allowing them to review basic materials before the meeting, as well as begin to network with fellow investigators and staff. When they arrive onsite, this spirit of collaboration can be further enhanced and amplified through a series of activities and digital experiences such as quizzes, trial simulations, and the use of interactive tablets. The portal can also remain active after the meeting to provide a central point for communication and dissemination of information.	 	

	Simple ice breaker tactics, including interactive protocol recall quizzes, maps of study sites and sponsor and contract research organization study team biographies can liven up welcome dinners and receptions by facilitating connections and building camaraderie amongst team members. Building this type of social capital while attendees are gathered in person pays strong dividends as the trial progresses.	 	

	Trial protocols can often times be extremely complicated, even for experienced clinicians. In a work environment marked by data overload, infographics are another powerful tool for condensing complex protocol data into meaningful and memorable takeaways. This visual approach caters to a variety of different learning styles, and – with minor modifications – also enables flexibility across different roles, from investigator to coordinator.	 	

	While investigator meetings provide tremendous opportunities for attendees to access a deeper understanding of patient identification and enrollment in the clinical trials industry, it is also a significant investment. As a result, it doesn’t just stop at the event, and is essential to continue the meeting momentum by maximizing the rate and quality of personal communication and feedback. For example, providing tablets for all attendees during the meeting can improve dissemination of information. It has also shown to increase the number of questions asked due to the fact that attendees can remain anonymous. Additionally, tablets and other wireless technologies also aid as a mechanism for measuring investigators’ real-time comprehension of the event. 	 	

	Another crucial component of driving a successful investigator meeting is to engage participants over the course of the event. For example, breakout groups are an effective tactic for driving communications and heightening the meeting experience, as immersive learning and digital interaction experiences like a trial run simulation, can lead to much deeper engagement, compared to a PowerPoint presentation given to larger groups. Interactive patient identification activities can also enhance and improve the understanding of inclusions and exclusions, as well as forces participants to think about “real world” patients. As mentioned above, a trial run simulation provides the opportunity to dramatically improve retention and completion by taking participants through difficult issues that they may encounter, or by providing strategies on how to overcome and improve industry challenges. 	 	Live investigator meetings remain a key milestone in the clinical trial process, and represent a significant investment of time, attention and money for everyone involved. To create more effective meetings and receive a greater return on this investment, organizations should put strategies into place that focus on these five key strategies, as well as ensure all key protocol information is delivered in an engaging and memorable manner. The end result will provide participants with increased opportunities to interact with the content and each other, and ultimately elevate the investigator meeting experience to new heights.	 	 	Ken Fabianovicz is Director of Commercial Strategy & Innovation at Cadient, a Cognizant Company.

Over the last 30 years, the process of clinical research and clinical trials have undergone a revolution. However, despite these changes investigator meetings have not evolved.

Five Untapped Opportunities for Elevating Investigator Meetings

	The number of clinical trials is increasing, from approximately 35,000 trials in 2006 to more than 200,000 clinical trials underway in 2016. Given the pace of discovery and innovation in the biopharma industry, there is no end in sight for this trend, and it is making patient recruitment and retention more important than ever.

	Unfortunately, there is a persistently low level of patient trust in pharma, and positive patient engagement is crucial for improving long-term trust for companies to achieve business results and the completion of trials. To effectively engage patients and build their confidence in an increasingly digital and mobile environment, the pharmaceutical industry needs implement a “CLEAR” method that leverages: credibility, literacy, expectation management, accessibility and that relates to patients.

	One of the most important factors for engaging patients in the clinical trial process is to build credibility, and speak to patients in a trusted voice. For example, the industry has seen great results when recruitment materials include testimonials from patients or caregivers, who have participated in a trial. In addition to testimonials, there are several other ways to build credibility:

		Taking compassion into account to build trust while shaping the tone of patient communications is a key consideration. While med-legal requirements are a fact of life, it does not mean that content should be needlessly complicated and obtuse.

		Creating and providing tools to make it easy for a patient’s circle of care to be more involved in their loved ones journey, can further expand a sense of compassion and engagement.

	According to the Department of Health & Human Services, only 12%  of U.S. adults possess proficient health literacy. This is a critical factor to keep in mind, especially when designing recruitment and educational materials. One approach that is effective in addressing the challenge of health literacy is creating interactive infographics of trial protocols. These infographics provide a simple visual depiction of often complicated schedules that make the information easier to understand. These infographics are not only useful for patients, but also for site staff and investigators.

	Literacy alone is not enough. Pharma and life science organizations also need to design experiences that are predictive, organized and optimized for a positive user experience. We’ve seen trial enrollment and completion rates improve by presenting patients with the ability to take a “trial run.” This is a virtual experience that allows patients to walk through a trial protocol and familiarize themselves with the expected schedule of visits and assessments. There has also been positive feedback when FAQ responses are written and presented by nurses or other patients.

	Often times, clinical trial materials are poorly designed and distributed across limited channels. As a result, it is essential to create tools and content that are age appropriate, shareable and supported by multiple devices. For example, providing large text views for seniors, mobile options for millennials, email messaging for baby boomers and more makes trial communications more accessible. In addition, a strategy for broad recruitment and SEO is also often overlooked. In order to make a trial accessible to as many patients as possible, organizations need to invest in professional SEO and geo-targeting.

	It is important to design familiar experiences into trial communications. Organizations should not limit themselves to the assumption that health and science communication should be dry and boring. It is also important to present information that is sensitive to cultural and gender nuances, as well as avoiding imagery and design approaches that are out of touch with the patient population. For example, stock photos of smiling, happy patients may not be appropriate for several types of trials, especially when addressing serious conditions.

	Clinical trials are a critical piece in driving medical advances, and it is imperative to effectively engage patients in these trials. By building credibility, focusing on health literacy, managing expectations and creating content that is accessible and relatable, pharma and life sciences organizations can position their clinical trials for “CLEAR” success.

	Ken Fabianovicz is the director of commercial strategy and innovation at Cadient, a Cognizant Company.

Use the “CLEAR” path to effectively engage patients and build their confidence in an increasingly digital and mobile pharmaceutical environment.

Ken Fabianovicz

Articles

How Voice Recognition Technologies Can Be Used to Accelerate Patient Trials

Digital Innovation in Enhancing Clinical Trials

Five Untapped Opportunities for Elevating Investigator Meetings

5 Proven Strategies for Driving Patient Engagement