REDUCING THE RISKS INHERENT IN EMERGENCY MEDICAL CONTACT AND UNBLINDING

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1 white paper REDUCING THE RISKS INHERENT IN EMERGENCY MEDICAL CONTACT AND UNBLINDING All sides agree that patient safety is paramount in the conduct of clinical trials. While focused on patient safety, investigators and sponsors are also mindful of the need to maintain study integrity, to the extent possible. In those instances during a clinical trial when patients require emergency treatment and the treating physician requires information about the study drug, the Principal Investigator is expected to be available to respond to relevant questions at any time. However, it s not realistic for one individual to be available 24/7/365.

2 The challenges to be addressed here are: 1 2 Availability of physicians with access to protocol specific information. Accessibility of these physicians to emergency room staff and other treating healthcare professionals in order to discuss and obtain medical information to effectively treat the patient. This paper outlines a global 24/7/365 solution to ensure that medical information is given accurately and timely so that care of the patient can be administered immediately. This solution incorporates elements that ensure immediate response to enquiries and identification of compounds and randomization information, and enables interaction with physicians who have access to the protocol and the investigator s brochure. When completed, the interaction is documented and facility to unblind (if necessary) is available. This global solution addresses the challenges typically encountered while offering a system that places patient safety at the forefront. It also increases efficiency while reducing the incidence of unnecessary unblinding. This paper will explore the four key elements of this global solution: A universal global subject card that details the compound, protocol number and subject number. A centralized call center available 24/7/365. Call center technology that includes dedicated client phone numbers, with backup, and a secure, redundant database of information for each trial so that call center can quickly identify the correct compound, randomization and patient information. Global rotations that mean two PAREXEL physicians a primary and a backup are available 24/7/365 to speak to investigators or non-study heath care providers in case of emergency. Your journey. Our mission ṭm 2

3 INTRODUCTION Biopharmaceutical companies conducting trials around the world are seeing increased scrutiny in the area of patient safety. Investigators have specific delineated responsibilities as outlined by ICH GCP 4.3 as well as U.S. Food and Drug Administration guidelines. In addition, those trial participants must clearly understand in writing how to reach that investigator should the need arise. Sponsors have a parallel responsibility. They must have designated, readily available, qualified medical expertise to advise on trial-related medical questions. Should a problem arise, sponsors must provide a mechanism so that the study product can be properly identified and, in a blinded trial, the ability to unblind that product, if necessary. Patient safety is a primary responsibility that all stakeholders in clinical research share. In speaking with groups in the pharmaceutical sector, we have found that in the majority of requests to unblind, once information is provided about the study compound, the caller no longer needs to know the actual treatment assignment. A clinical trial may go for years without a request. So when such a situation arises, it can raise issues and concerns: Delays can be encountered trying to contact the designated Principal Investigator. Emergency room physicians may experience difficulties reaching the appropriate individual to seek medical advice from, delaying treatment of the patient. Outside of normal office hours, the Principal Investigator may be required to return to the office to get access to records. Accessing locked, infrequently-used files can be a challenge. Confusion over getting the appropriate compound, protocol number and randomization number can also arise. Finally, at the end of the trial, all of these individual patient interactions must be documented, and companies often find it difficult to retrieve all of the paperwork necessary for documentation. To address these challenges PAREXEL has assembled a global Emergency Medical Contact and Unblinding service that centralizes the solution with a call center available 24/7/365, a physician rotation to ensure primary and backup physicians are available, and resilient technologies. Based on the company s experience with a variety of pharmaceutical partners, we have found that this global solution requires a global clinical call center with trained representatives who can conduct the emergency unblind, if necessary. In more than 200 studies, PAREXEL s solution enables the patient s emergency room physician to reach the appropriate medical contact within five minutes of placing their call to the contact center. The following case study describes how our client, Merck, decided to respond to these challenges by centralizing a solution. In reaching that solution, Merck examined the issues that global pharmaceutical companies face and arrived at the parameters of a solution that would focus on patient safety while reducing regulatory risk. Your journey. Our mission ṭm 3

4 Case Study: Merck Merck senior management engaged PAREXEL to establish a process that utilizes the best, world-class operating processes and procedures for a 21st century pharmaceutical manufacturer. The previous process Merck had in place was decentralized, and implementation varied from country to country, which presented potential regulatory risk. Merck recognized that these problems arose because of the infrequency of requests. Everyone using the same approved solution would lower the regulatory risk, and everyone should know the process. The centralized record-keeping would take all of the paper out of the system. As for the contact process, Merck chose as a goal: one phone call gets the emergency medical professional to the appropriate person. Finally, the solution needed to be scalable to handle the growing number of studies performed by Merck. PROBLEMS TO BE ADDRESSED Merck decided that the solution called for a centralized process that presented efficiencies and lowered regulatory risk. Merck personnel had trouble recalling the expected process because the unblinding events rarely occurred. Procedures were not uniform around the globe; each country had a slightly different process. Weaknesses in the system were not evident until one of those rare phone unblinding requests came in from an emergency medical professional. In addition, Merck found that with non-ivrs (Interactive Voice Response System) trials, the mass randomization schedules distributed to worldwide Merck offices and to people responsible for unblinding coverage represented a substantial amount of paper. When trials ended, Merck had trouble retrieving all of those paper records. With IVRS trials, the issue involved the multiple user IDs and passwords. When calls came in, often the designated responder could not remember where those IDs and passwords were kept or how to get into the records system. If those persons were at home, they had to get back to the office. Merck determined that these impediments needed to be minimized in a new process. SOLUTION ELEMENTS FOR CENTRAL CALL CENTER Merck engaged with PAREXEL to establish a solution that utilized a call center staffed by personnel whose full-time job was responding to questions about study drugs. The center maintains the technology, and staff has access to study protocols, investigator s brochures and randomization schedules so that one phone call would seamlessly result in connecting the emergency physician with a PAREXEL physician who could answer questions about the drug and potential interactions. The center needed translators and the ability to respond 24/7/365 efficiently and quickly, and be ready to service more than 100 trials. The key component of the global solution, Merck learned, was a universal subject card for all locations that had three key pieces of information: the compound, the protocol number and the randomization number. With the appropriate contact numbers in the same area on the card and the same general wording, regardless of location or language, call center staff would have confidence that it could obtain the correct information for each call. These subject cards had to be approved by the regulators in each country. REQUIREMENTS FOR A SOLUTION Ultimately, the Merck team determined that a centralized operation was needed for an efficient global approach. One process and everyone follows it. The process should include IVRS, non-ivrs, open label and in-house studies as well as the growing number of outsourced trials. ADDITIONAL LESSONS LEARNED Merck learned that communication and training is important throughout these changes. Since the central call center involved changing the process and, in some cases, slightly modifying roles, clinical staff around the Your journey. Our mission ṭm 4

5 world needed to be informed about what was happening and trained in the new process. Continued communication was required for staff buy-in and to educate staff about the changed processes and roles. The company conducted more than 20 training sessions that reached more than 2,000 staff. elearning training developed during the sessions is available for future clinical staff. In addition, no one toll-free number serves the entire world, particularly in some areas of the globe. Because hospitals in some areas do not allow phone calls out of the local country, Merck needed to arrange for local phone numbers in each country where trials were conducted and those where new trials were contemplated. In addition, Merck included as back-up two international contact numbers one in the United Kingdom and one in the United States. Because of changing regulations, Merck also concluded that medical professionals at the call center needed to be enabled to action the unblind during the phone conversation with the treating emergency medical staff. Because Merck approvals were no longer required in these unusual cases, the entire company needed to understand this cultural change. The treating physician is making the medical decision about whether an unblind is performed or not. The Four Elements of a Global Solution That Enable Reduced Regulatory Risk in Emergency Unblindings 1. The Universal Subject Card Standardizing the subject card for all countries and languages drives the improved process of medical contact. It ensures a swift and sure connection with a trained, on-call medical physician. The standardized card also informs the local emergency physician that the patient-subject is participating in a clinical trial. The elements contained on each card, in language appropriate to that country, allow efficient contact to be made with the call center. Most important, the compound name, randomization number and subject number need to be in the same relative place on each card, regardless of country or language. That ensures accuracy in communicating the correct information. Should the Principal Investigator not be available at the time of the medical emergency, Your journey. Our mission ṭm 5

6 the card clearly instructs the treating physician to contact the call center. A country-local telephone number is provided, along with international numbers terminating UK and US. Once the emergency contact is received in the call center, the detailed protocol number and subject number codes enable the call center to correctly triage the treating physician and connect through for medical assistance. The representative who answers the phone follows a pre-defined script that identifies the correct trial in which the subject is participating and the appropriate medical professional to whom the caller needs to be referred for medical assistance. The call center remains on the line (muted) throughout the discussion between the emergency medical staff and the PAREXEL clinician. Should an unblinding be required, the call center staff has the information available to take immediate ownership of the unblinding without further delay. Subject Card Example Dear Doctor, This subject is currently enrolled in a blinded study in which they are receiving treatment with either an ACTIVE DRUG NAME or COMPARATOR DRUG/PLACEBO NAME Please contact the primary investigator for any circumstances listed below. 1. When treating this subject for any adverse events or if the subject is hospitalized. 2. If you have any questions about this subject s participation in this study. Contact Information: Primary Investigator: Name: Telephone: Clinical Research Coordinator: Site Number: Telephone: Hospital: Department: Subject Number: For Health Care Professionals: If the primary investigator is unavailable and there is a need for information about the product, clinical trial or emergency unblinding please call: (insert dedicated number) Dear Subject, Please show this card to doctors or nurses if/when: Visiting any other medical facility or department other than the study site. You are hospitalized. Please contact the primary investigator before taking any new over-the-counter medication including vitamins (other than those given to you by the primary investigator) or herbal remedies. Upcoming Study Visits Or Study Phone Calls: Subject ID Card: This subject is participating in a clinical research study (Protocol No:XXXYYY123) for the treatment of X. Study medication: ACTIVE DRUG NAME or COMPARATOR DRUG/PLACEBO NAME Treatment period*: From: To: * Subject may discontinue treatment period earlier than indicated on this card. Your journey. Our mission ṭm 6

7 2. The Global Clinical Call Center The Call Center is at the center of this global solution to potential emergency unblinding. Available 24/7/365, it contains the professionals and the core information necessary to take immediate action needed to handle each emergency situation. In addition to dedicated client country-specific phone numbers, PAREXEL provides and recommends two additional international phone numbers one from the United Kingdom and one from the United States as a backup if free country-specific phone numbers are not operational. Skillset call routing ensures that any incoming emergency medical phone calls are placed on top of all other incoming calls to the center. All representatives are fully trained with a set script and familiar with the service so that the initial conversation typically takes less than five minutes. In the event that the caller is not an English speaker, the center has immediate access to translators for more than 150 different languages. For sponsors, full call recording and an audit trail are maintained. In order to ensure that the center staff continues to be accurate and responsive, monthly testing and training is conducted to ensure top-level performance. That includes mock call scenarios and testing so that all participants are confident that the agents are familiar with the service. 3. Resilient Call Center Technology Infrastructure Multiple layers of redundancy mean that, short of global catastrophe, the call center services are virtually assured of providing full-service continuity. At its core is a global electronic document repository that provides immediate access to each trial s current protocol and investigator s brochure. These documents Your journey. Our mission ṭm 7

8 along with the randomized lists are backed up across all locations in order to eliminate all potential points of failure. This integrated technology ensures that center staff can process all calls, as well as provide remote, secure office access technology if any remote location office is not accessible. Randomization listings are backed up across UK and US data centers. During each call, contact center staff remain on the phone to facilitate unblinding, if required. The process is simple, quick and reliable. The database is able to host and access randomization list information, regardless of vendor, or whether IVRS studies, non-ivrs studies, and whether paper or electronic. In the event that an unblind is performed, the desktop application using the protocol, site and subject number is able to generate an output file that is sent to the treating physician by either fax or . Sponsor companies have full visibility over all activities received or processed. At the end of every phone contact whether unblinded or not a consolidated log is provided which details who contacted, when and what actions were taken. At the end of each trial, these information files are available to sponsors. 4. Global Physician Rotation Redundancy and reliability are just as important at the medical expert level to ensure the highest response to patient safety issues. A two-level (primary and backup), the classic call scheduled rotation, means that trained physicians are always available to speak to investigators or non-study health care professionals. These physicians are experienced in clinical trial conduct. That allows them to focus on the appropriate information for the treating physician and, ultimately, for the patient. This single point of contact minimizes the confusion about who is on the call. Staffing the center with physicians with clinical trial experience allows us to focus our training and capability on a small number of responsive and dedicated medical professionals. Each knows how to access documents, and they can provide a pre-specified report to the Sponsor s medical operations team in real time. Based on our experience in more than 200 studies, we have a host of experience on what kinds of situations arise. In most cases, it is not necessary to unblind the patient treatment assignment following a thorough discussion with the caller, whether an investigator or a non-study medical professional. The result: better decisions, faster resolution and fewer instances of unblinding and lower regulatory risk. Your journey. Our mission ṭm 8

9 Conclusion All parties involved in the conduct and supervision of clinical trials understand that patient safety is paramount. The global call center solution outlined here provides a robust example of how to both protect patients and protect study integrity. Because they occur so infrequently, emergency medical unblinding requests present larger potential risks. The streamlined solution outlined means simply that anywhere in the globe, an emergency room physician has access to a universal subject card with a global number that allows contact with a call center. Within minutes, emergency personnel are connected with a physician on a global rotation who is able to access both the protocol and the investigator s brochure. In the background, the technology ensures that appropriate documentation is made. In most cases, this interaction can be accomplished in less than 30 minutes. Approximate Timeline 5-10 minutes to initiate call with Emergency Physician 20 minutes to break blind and generate confirmation Client Monitors frequency of medical escalation requests and blind-breaks utilizing reports Site Investigator Scenario ends Yes Investigator presents need for medical support regarding Clinical Trial Treating Physician (non-study investigator) Patient presents need for medical support regarding Clinical Trial Is investigator available? No Call PAREXEL Customer Care on dedicated number (24/7 first line support) Treatment group notification issued Customer Care Services Medical escalation request Customer Care first line support logs customer enquiry, accesses on call-rota and escalates call. Follow-up is sent to pre-defined CLIENT team. Translator service is fully available Yes CCS representative accesses patient information to break blind. Generates fax or confirmation with unblinding treatment details. Forward unblinding confirmation by fax or to pre-defined CLIENT team and caller. Blinded version of notification is also available Consolidated report generated highlighting Medical Escalation and Blind Break activities PAREXEL Medical Services Warm transfer caller to PAREXEL medical contact Is codebreak required? Follow-up is sent to pre-defined CLIENT team. No Scenario ends Your journey. Our mission ṭm 9

10 For more information about clinical and technical support services from PAREXEL or to discuss your organization s specific challenges and needs please contact: Joanna Gutkowski Director, Business Development PAREXEL International +44(0) Or visit the Customer Care Services: References: PAREXEL Webinar: Emergency Medical Contact and Unblinding, September Available on-demand. Your journey. Our mission ṭm 10

11 WHEREVER YOUR JOURNEY TAKES YOU, WE RE CLOSE BY. Corporate Headquarters 195 West Street Waltham, MA USA Offices across Europe, Asia and the Americas PAREXEL International Corporation. All rights reserved.

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