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Clinical Researcher The Authority in Ethical, Responsible Clinical ResearchMay 2019 (Volume 33, Issue 5)Mapping the Way to Site SuccessAll contents 2019 ACRP. All Rights Reserved (The Association of Clinical Research Professionals)1 Page

Clinical Researcher Association of Clinical Research ProfessionalsEditor-in-ChiefJames Michael Causeymcausey@acrpnet.org(703) 253-6274Managing EditorGary W. Cramergcramer@acrpnet.org(703) 258-3504Editorial AdvisorsSuheila Abdul-Karrim, CCRA, CCRT, FACRPFreelancerJohannesburg, South AfricaVictor Chen, MScPrincipalThe CK Clinical GroupDirector, Clinical AffairsAlign Technology, IncMountain View, CAFraser Gibson, CCRC, CCRA, CCRPPresidentAdvantage ClinicalLondon, Ontario, CanadaJerry Stein, PhD, ACRP-CPPresident/OwnerSummer Creek Consulting, LLCFort Worth, TXShirley Trainor-Thomas, MHSAPresident and Principal StrategistPhase Up ResearchMount Pleasant, SCHeather Wright, CCRCResearch CoordinatorTampa Bay Clinical Research CenterBrandon, FLStefanie La Manna, PhD, MPH, ARNP, FNP-CAssistant Professor and Advanced Registered NursePractitionerNova Southeastern UniversityLake Worth, FLChristina Nance, PhD, CPIAssistant ProfessorBaylor College of MedicineHouston, TXPaula Smailes, DNP, RN, MSN, CCRP, CCRCVisiting ProfessorChamberlain College of NursingSenior Systems ConsultantThe Ohio State University Wexner Medical CenterColumbus, OHAdvertisingTammy B. Myers, CEMDirector, Advertising & Exhibition Sales(703) .org/advertising/For membership questions, contact ACRP atoffice@acrpnet.org or (703) 254-8100.2 Page

Clinical Researcher—May 2019 (Volume 33, Issue 5)Table of Contents4 Executive Director’s Message—Thank You, James Lind!Jim KremidasPEER REVIEWED6 Three Times the Charm—Transforming Patient Centricity with eConsent, eCOA, andPatient EngagementJeff Lee17 Trial Complexity and Coordinator Capacity: The Development of a Complexity ToolAlexa Richie, DHSc; Dale Gamble, MHSc; Andrea Tavlarides, PhD; Carol GriffinCOLUMNS24 Site Strategies—Welcoming Technology into the World of Clinical TrialsMark Hanley28 Good Management Practice—Extracting Scientific and Economic Value fromClinical RemnantsChristopher J. Ianelli, MD, PhD; Andy Olen, MBAClinical Researcher is your platform. Interested in writing a peer-reviewed article or guest column?You’ll find our submissions guidelines at her/.Credit-granting Home Study tests based on Clinical Researcher articles are available for purchase athttps://www.acrpnet.org/home-study/, along with downloadable PDFs of the relevant articles andquestions from each issue. The test based on this issue should be activated online in June.3 Page

Clinical Researcher—May 2019 (Volume 33, Issue 5)EXECUTIVE DIRECTOR’S MESSAGEThank you, James Lind!Jim KremidasTwo hundred and fifty years ago, when the British empire ruled theAtlantic Ocean, Scottish physician James Lind was tasked withfinding out why scurvy was killing more sailors than Spanish andFrench enemies. Like a few others, he had a theory that addingfruit to the military diet might do the trick. For proof, in 1747 heconducted one of the first documented clinical trials.After eight weeks at sea as surgeon of the HMS Salisbury, as scurvy began to take its toll on thecrew, Lind decided to test his idea that the putrefaction of the body caused by the disease couldbe prevented with acids from fruit. On May 20, he divided a dozen sailors into six pairs, andgave each a different supplement in their diet: cider, vitriolic elixir (diluted sulfuric acid),vinegar, sea water, two oranges and a lemon, or a purgative mixture.As a result of what some have considered the first clinical trial in history, only the two sailorswho took the fruit improved. “The most sudden and visible good effects were perceived from theuse of oranges and lemons,” Lind wrote in 1753 in his historical work A Treatise of theScurvy. “One of those who had taken them being at the end of six days fit for duty The otherwas the best recovered of any in his condition; and being now deemed pretty well, was appointednurse to the rest of the sick.”4 Page

We’ve come a long way since the days of Lind, and while every day is clinical trials day in ourindustry, we like to call May 20 a special “Clinical Trials Day” and promote its celebration bystakeholders in the clinical research enterprise through events around the country, and the world.This day of celebration also provides our community with a unique opportunity to raiseawareness of clinical trials—and of clinical research as a career option—among the greaterpublic.This year we are excited to partner with PopUp Star to kick off a contest to bring clinicaltrials awareness to the masses starting on Clinical Trials Day. From San Antonio to Miami,from Las Vegas to Australia, innovative, and fun, events will educate the public about thevalue of clinical trials and the work you do every day.If you’d like to share how you celebrate Clinical Trials Day with us, please check out theACRP Facebook page at https://www.facebook.com/ACRPDC/ for details as the big dayapproaches.Jim Kremidas (jkremidas@acrpnet.org) is Executive Director of ACRP.5 Page

Clinical Researcher—May 2019 (Volume 33, Issue 5)PEER REVIEWEDThree Times the Charm—Transforming Patient Centricity with eConsent,eCOA, and Patient EngagementJeff LeeImagine seeing a product you want to buy, but whenyou go to the website, it asks you to print an orderform and mail or fax it in. Would you trust thatprovider or system with your credit card information?Probably not. And yet, that’s what we are askingpatients to do with something far more important—their health—when it comes to clinical trials. Peopleare used to technology, apps, and accessibility in theirdaily lives, so it is no surprise that a 2016 surveyshowed 31% of 137 responding patients reportedthemselves as more likely to participate in a clinical trial if it has a mobile app.{1}6 Page

In fact, Deloitte reports there are more than 260,000 health apps worldwide and the members of70% of patient groups are using at least one app to manage their condition.{2} By utilizingdigital solutions, pharma companies can tap into these progressively health-aware consumers.However, those working in the industry, specifically within clinical trials, often feel that thepatients in their studies receive a mixed experience of technology, and many simply feeloverwhelmed by too many systems.So why isn’t the pharmaceutical industry moving more quickly to adopt solutions that patients—and sites and study teams—want? Barriers to digitally focused patient centricity includeuncertainty over regulators’ expectations and requirements, and data safety and privacy concernswith the rise of medical apps and other digital technologies. Such trust issues can result inpatients being unwilling to engage with pharma, while low levels of health and digital literacyalso affect the ability to engage with patients effectively. Attracting the right talent to support apatient-centric ecosystem can also be a stumbling block, with a traditional product-based culturecausing barriers to an agile, patient-centric approach.Increased willingness to take a patient-centric approach to technology adoption to improve datacapture, patient understanding, and patient engagement is needed to drive real return oninvestment for retention, compliance, protocol adherence, and overall study timelines. The firstimportant step is improving adoption, but equally important is seamless integration and a single,unified user experience for the patient and sites. It is not enough to give them technology—itmust blend into their daily lives so that it doesn’t get in their way. In other words, we seek easyto-use solutions built with patients (and how they will actually use the tech) in mind. This articlewill therefore outline how electronic clinical outcome assessment (eCOA), electronic informedconsent (eConsent), and patient engagement apps can work together in one solution to combineto transform the patient experience in clinical trials.As an aside for readers who are concerned that their patients may lack the technologies necessaryfor the purposes described in this article, eCOA and eConsent are commonly offered usingprovisioned devices, so that all patients can utilize them, without regard to their personal mobilephone usage. Patient engagement is typically offered to patients on their personal devices, witheither mobile app (for smartphone users) or SMS (text messages) for non-smartphone users.7 Page

SMS works on any mobile phone, so this ensures that patient engagement can be provided tovirtually any patient.Creating a Seamless Patient ExperienceIn clinical studies, it is important to employ approaches that enable the optimal assessment of thestudy concepts of interest. Where this involves use of a technology solution, the aim is tosimplify processes, make participation easier, improve quality, facilitate decision making, andcollect reliable, honest data.Patients and their families are understandably impacted by technology as they are going througha trial. In a typical study, for example, one patient may experience four devices, such as awearable, a reminder app, eConsent, and an e-Diary. It is not uncommon for a trial participant toalso use a payment and reimbursement website, all accessed via different systems and devices.As new technologies emerge, they appear via specialist vendors, so for each software and device,patients have a learning curve, different access points, and compliance requirements. As a result,the patient is faced with a dizzying array of disparate communications, devices, and systems, andif the process is too complex, the patient is more likely to quit the study and deviate off protocol.Seamless integration and a single, unified user experience are again the key to makingparticipation as easy as possible without overburdening the patient. It might seem obvious, butthey only need the tools that they need.Sites today are leaning on technology help desks more than ever in their struggles to providepatients all the training they require. Fortunately, by combining these technologies into a singleproject delivery team, sites receive streamlined and coherent training, which makes them moreeffective educators to patients.However, it is not just the patient who needs to be considered, as technology has an impact frommultiple perspectives. Improving the clinical trial experience for all involved is a priority. Forstudy teams, enabling them to see real-time study progress and improve efficiencies is the toppriority for managing the complexities of a trial and not adding to it. Transparent, real-timeinsight is the key here. Meanwhile for management, any solution should improve oversight,efficiencies, and successful outcomes for return on investment.8 Page

Less Vendor Focused, More Solution FocusedAs mentioned, seamless patient experience requires successful collaboration across manydifferent areas of a trial—outreach, recruitment websites, screening, verification, eConsent,registration, data collection, data return, and incentives. How to bring all these elements togetherneeds to be considered carefully, especially in a virtual trial where there may be no physical site.Figure 1 demonstrates what successful collaboration could look like.Figure 1: Coordination Among Multiple Systems Sets a Higher Bar for a Seamless PatientExperienceeConsent, eCOA, and patient engagement solutions are the cornerstones of a dependable,patient-centric technology solution to help improve the speed, reliability, and insight of clinicalresearch. Combined into an integrated solution, it makes for a powerful approach.9 Page