30 June 20 08 VIEW on Clinical Operations OUTSOURCING everaging pharmacy outreach services in clinical operations can improve the overall study life cycle by adding value and precision to a sponsor’s milestones. Companies can use an evidencebased resources enabling the study team to make advantageous informed decisions, including the ability to identify treated patients based on medications, dosing and delivery mechanisms, age, and location. How important is this? This information is the difference between success or distress. PreProtocol Feasibility The genesis of each clinical project is the preprotocol feasibility. By employing pharmacy outreach services, the study team can complete a thorough preprotocol analysis of the patient profile, indication prevalence, and population prevalence.This forerunner activity occurs prior to the pro tocol submission.The significance is the study team has empirical proof that the patient profile and prescribing physicians exist and where. Developing a sustainable study design at the inception determines overarching success of the study with many key objectives. The ability to determine if the patient population exists, in concert with the overall prevalence establishes the baseline for the protocol success. Evaluating the patient profile by stratification of characteristics, lifestyle, economics, diver sity, and residency can influence the randomization outcomes considerably. Utilizing pharmacy resources during preprotocol feasibility will impact the clinical and regulatory strategy overall marginalizing unforeseen points of failure. Site Selection Site strategy and feasibility are fundamental components of a clinical study.The attention and effort put into these are primary for study success. By applying pharmacy outreach services, the study team can leverage the interrelated results of the patient and physician population; examining both the prescribing behavior and the treated patient allows the study team to bracket the site selection with efficiency. Contracting with familiar sites is often the approach, but reusing low performing sites is neither conducive nor fair to the site or the study team. Mapping the integrated data from the pharmacy outreach services to the study team’s sites requirements prepares the study for a successful out come. Metrics and ROI knowledge assessments are done throughout the study for efficacy of the respective resource and decision. Patient Recruitment A directtopatient communication is principal in identifying, screening. and randomization.The key differentiator in pharmacy outreach services is the positive forum it encapsulates. The directtopatient relationship between the pharmacy, pharmacist, and physician, as well as the healthcare provider is the most powerful in the wellness life cycle. Pharmacy outreach services gain a unique access to the patient or caregiver via the pharmacy point of care. Pharmacy outreach services include realtime communica tions, referred to as patient messaging to present the study opportunity. When a prescription is filled, it triggers events that produce the patient’s filled prescription.There is plethora information exchanged between multi ple entities that is of merit to the respective parties and invaluable for clin ical research. There are several modalities that can be used to communicate directly to the patient, caregiver, guardian, and even the prescribing physician. Spon sors can directly message inbound or outbound. Interactive surveys or call scripts are used to further prescreen the patient candidate, all collabora tively prepared by the study team and sponsor. No patients are messaged if they have not signed the appropriate HIPAA compliance documentation at their pharmacy; privacy overrides all objectives. Relationship Management The value proposition for an exceptional relationship strategy exceeds the milestones that the industry often focuses on. Adapting an overarching plan to address all aspects of study relationships is integral — ranging from the site, patients and family, community and advocacy groups, investigators, coordinators, monitors, clinical research associates, and all service providers. Relationships that connect the entire study team and participants facilitate a stronger, successoriented environment. This becomes the catalyst for a transformative study atmosphere. Maintaining relationships means remain ing engaged throughout the study. Pharmacy outreach services can create a collaborative environment effectively. Partners that marry realtime data with longitudinal data explores a whole new paradigm that is exciting in clinical operations. Recruiting Physicians/Principal Investigators A key element of the pharmacy prescription transaction is knowing who the prescribing physician is, their contact information, and related reg Ateb, Inc. ATEB, INC., Raleigh, N.C ., provides pharmacy outreach services through its patient messaging solutions, an innovative approach to finding clinical research candidates with a double optin, HIPAA compliant, and realtime messaging opportunity. A Prescription for Change Sharen Godwin, Vice President L Leveraging pharmacy outreach services in clinical operations can improve the overall study life cycle by adding value and precision to a sponsor’s milestones. 0608 pvv layout FINAL 5/30/08 4:59 PM Page 30 31 VIEW on Clinical Operations June 20 08 OUTSOURCING ulatory information. Utilizing pharmacy outreach services allows sponsors to locate the high prescribers and physicians of interest. Messages can be created for the physician’s patient referrals or to invite them to participate in a study opportunity as an investigator. Patience and Retaining Patients Fostering the fortitude to move forward even when the patient candidates are dwindling can be difficult. Pharmacy outreach services, first target patients based on medications, age, and location, and they provide the flexibility to capture patients’ attention with either inbound or outbound communications. Having the confidence that the patient candidate has been prescribed a medication or has filled the prescription can alleviate study team frustration. A proper patient retention philosophy is to engage, recognize, and respect the per sonal commitment each patient makes. Retaining the pharmacysourced patients can be done by a show of gratitude for their efforts presented in the form of a pharmacy gift card for medications or consumer items. This creates a win/win for the pharmacy and patient; driving loyalty for both. The “wow” factor of using the retail pharmacy as a recruitment source is impacting drug development in the clinical recruitment area in a remarkable manner. When the clinical study contains an indica tion with a chronic condition, recruiting patient candidates through their trusted pharmacy is a win/win. It enhances the patient candi date’s trust in their pharmacy and reaffirms their loyalty to the phar macies pursuit of better healthcare.This is the single reason for drug development delay costing the industry millions of dollars per drug discovery. The patients, the study team, the pharmacy, the client and service provider consider this another victory in the ongoing race to find cures and improve quality of life through partnerships. Pharmacy Parity The pharmacy is often the first line of defense in healthcare when a patient does not feel well. The local pharmacy has become the standard for selfidentifying patients before they go to their physicians’ offices. The pharmacy provides many services that patients are becoming more acclimated to in this comfortable set ting, such as disease education, lifestyle changes, supportive pro grams, and medication information. Instrumental to this paradigm shift is the familial and caring environment the pharmacy and phar macist convey. Pharmacists know patients by name; they see patients often. This awareness of the patient’s needs has quickly positioned the pharmacy as the intermediary between the patient and the physician. The pharmacy is the link, physically and logically, between the patient and the physician. Pharmacists express a higher quality patientoriented focus. The equitable significance each entity — patients, physicians, and pharmacists — contributes to better health outcomes is changing healthcare. Patients have become their own wellness advocates, adjoining the pharmacists and physicians to make integrated deci sions.The protocols that best fit within a pharmacy outreach program are chronic conditions, those that can be identified by medication(s), adjunct therapy, specific demographic prevalence, and those using specialty pharmacies for critical disease states. Patient messaging solutions are not the magic bullet, yet they do tightly bracket the target thereby giving many protocols a key differ entiator for success. By nourishing the pharmacypatientphysician relationship and promoting the totality of both, there can be a strate gic and fundamental conversion of our healthcare vision now and beyond.This is a prescription for change. # Pharmacy Outreach Services Clinical Operations Patient Messaging Solutions: . Patient and Site Recruitment . PreProtocol and Site Feasibility . Honorariums — Pharmacy Gift Cards . Site Services . ROI and Metrics Tracking . Prescreening Contract Center 0608 pvv layout FINAL 5/30/08 3:27 PM Page 31

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