SUCCESSFUL EXECUTION OF CONSOLIDATED SERVICES FOR A GLOBAL RHEUMATOID ARTHRITIS STUDY
The Imperial Family of Companies was contracted to provide recruitment support for a rheumatoid arthritis clinical trial spanning nine countries and 51 research sites, with a total enrollment goal of 250 randomized patients. The sponsor sought efficiencies and cost savings in the planning and execution of the study, with risk mitigation and management and return on investment being additional critical aspects of the overall objective.
At the time of contract signing, Imperial had successfully completed 25 Phase Ib-III rheumatology projects spanning 34 countries; 4,544 patients; and 1,113 sites. Each study was completed with 100 percent of clients returning for add-on business. Imperial strategies for one study doubled enrollment within one month. That momentum was maintained throughout enrollment with the client goal of 1,050 patients achieved ahead of schedule. This level of international experience within the rheumatology field provided the necessary insight to develop a successful recruitment campaign targeting this patient population. As added value, Imperial has a core database of 277 (ROW) board-certified rheumatologists, with an additional 428 rheumatologists whom the company supported throughout the world. These physician databases represent over 40,000 rheumatology patients.
The onset of rheumatoid arthritis (RA) typically occurs between 30 to 60 years of age, and 70 percent of those affected are women. Based on this patient profile and our experience in managing global RA programs, Imperial recommended the implementation of site support materials, community outreach, and targeted radio and/or print advertising.
The complexity and reach of the recruitment campaign necessitated bundled services offered via the unified Imperial Family of Companies comprising DAC Patient Recruitment Services, Imperial Graphics and ClinicaLingua Translation Services.
SITE NEEDS ASSESSMENT AND ANALYSIS
To develop highly customized, site-specific recruitment plans, DAC conducted site needs research and analysis with all participating sites to determine their recruitment experience and needs.
COMMUNITY OUTREACH AND GRASSROOTS NETWORKING
DAC worked with country-specific local trial managers (LTMs) to develop community outreach plans to optimize recruitment opportunities. To that end, DAC developed study awareness materials for distribution at special events and for posting on RA advocacy websites.
To evaluate the outcome of the community outreach efforts, DAC conducted phone interviews with the LTMs mid-way through the recruitment period and wrote a summary response for further discussion with the client.
DAC provided two customized recruitment and retention workshops at each of the three investigator meetings held in the Europe, Latin America and Asia. One workshop specifically targeted study coordinators and PIs. The other addressed LTMs specifically. These trainings were 2 ½ hours in length, and the content focused on key recruitment concepts, including patient motivation, decision making factors, recruitment challenges, good customer (patient) service, and relationship building.
Two interim study webcasts were held at 6-month intervals to reinforce principles learned at the workshops.
As an approved provider of nursing continuing education through the California Board of Registered Nursing (Provider Number 15822), DAC offered U.S. attendees the opportunity to receive 1.2 continuing education credits for participation, while rest-of-world attendees received certificates of completion.
In support of the project, DAC developed targeted materials to: Inspire patient participation, promote physician awareness, and generate a steady flow of quality patient referrals.
Professional Materials (Provided by Imperial Graphics)
Subject Identification Tools
• Inclusion/Exclusion Card—a laminated card with full inclusion and exclusion criteria for physicians’ easy reference when evaluating patient eligibility
• Mini-Protocol—a pocket-sized version of the full protocol
• Chart Flags—used by clinical staff to flag patients’ charts, indicating their potential eligibility (or ineligibility) for study participation
Physician Awareness Materials
• Professional Information Flier—8 ½” x 11” flier with high-level study details that physicians require to consider referring patients for study participation
• CD with Templates for: physician journal ad and physician referral letter
Time & Events Schedule, Full Size
• Schedule of study events with special icons denoting what assessments must be performed at each visit
Visit Schedule Wheel
• Novel tool for physician use in mapping study visits
• Included 3 levers which aligned to reveal the next appointment date
• 11” x 17” poster for mounting in waiting and exam rooms to generate interest in study participation
• Included study objective, key I/E criteria and site contact information
Subject Recruitment Brochure
• Tri-fold brochure for referring physicians to give to prospective participants during routine visits
• Generates interest in the study and invites further inquiry
• Provides a general overview of the study and includes site contact information
Appointment Reminder Card
• Supported study compliance by helping subjects remember upcoming appointments
• Included checkboxes to indicate when pre-visit fasting was required
Subject Emergency Card
• Included the names and phone numbers of the subject’s emergency contacts
Study Participation Guide
• 12-page booklet created as a comprehensive information source for newly enrolled study participants and their caregivers
• A study-branded box is provided for convenient storage of all patient and professional materials.
• Constant brand visibility promotes top-of-mind awareness among site staff.
TRANSLATION (Provided by ClinicaLingua, an Imperial Company)
ClinicaLingua’s translation project management team and linguists offered synergistic solutions to off-load the sponsor’s project management support time significantly. All materials requiring translation were streamlined and fast-tracked through our integrated design, translation, print and fulfillment service package. International Organization for Standardization (ISO) certification ensured our translation services met the highest global standards. Further, our efficiency as a single-source provider in this area yielded significant cost savings.
Through its vertically integrated FSP (Functional Service Provider) model, Imperial drove increased project management efficiencies in the following manner:
• Single point of contact (Three Imperial companies through one project team versus managing multiple vendors)
• Regulatory experience (assistance with country-specific approvals)
• Reduction in translation and production times
• Improved management information systems (DACTracks and Imperial Marketplace)
• Robust global compliance and fulfillment
• Advanced site close-out support
PRINTING AND FULFILLMENT (Provided by Imperial Graphics)
Imperial Graphics leveraged its extensive knowledge of global shipping regulations and risk mitigation to provide printing and global fulfillment, including recruitment kit assembly, for the trial.
As a Functional Service Provider that can execute on a tactical and strategic level, the Imperial Family of Companies has a definitive clinical trial focus, operates and delivers on a global scale, and boasts the metrics to demonstrate a 19- to 25-day time savings on first patient in.
Beyond our core companies, our extended family includes over 400 clients in biotechnology, biopharmaceutical, medical devices, and CRO space.
The Imperial Family of Companies
Imperial is a clinical research support organization comprising a family of three companies: DAC Patient Recruitment Services,www.dacprs.com; ClinicaLingua Translation Services, www.clinicalingua.com; and Imperial Graphics, www.impgraphics.com. The organizations’ combined highlights include 4,000 active protocols under management, translation into 100+ languages and locales, experience in 40+ therapeutic areas, and 50,000+ shipments annually to 100 countries. Imperial has 7 locations across the United States and Europe. For more information, visit www.imperialcrs.com or call (800) 777-2591.