ABSTRACT

1. Challenges in Conducting Multi-Center Clinical Studies: Results from the Rapid Empiric Treatment with Oseltamivir Study (RETOS) Kendra Thompson, Kelly Carrico, Tiffany Lindeman, Amy Holloway, Greg Whittington, Paula Peyrani, Ruth Carrico,   Division of Infectious Diseases, University of Louisville, Robley Rex VA Medical Center MATERIALS AND METHODS (Cont’d) ABSTRACT RESULTS (Cont’d) Background: Multi-center clinical studies are becoming the standard approach for the study of new medical interventions. Although using multi-center trials have the ability to enroll a large number of patients, coordination of a clinical trial across various hospitals has generated new challenges in clinical research. Understanding these challenges from the perspective of quality improvement is critical for the success of the trial. The objective of this study was to describe the challenges encountered while implementing a multi-center study and to describe their causes and solutions. Methods: RETOS is an ongoing, randomized, prospective clinical trial to evaluate the impact of rapid empiric treatment with oseltamivir on the outcomes of hospitalized patients with symptoms of a lower respiratory tract infection (LRTI). All patients admitted to 8 hospitals in Louisville, KY from December 2010 to March 2012 with symptoms of a LRTI were invited to participate in the study. A focus group was established to determine challenges as well as causes and solutions for each. Results: A total of 12 challenges were identified. Nine of these challenges were considered related to study team issues, while 3 were considered related to hospital issues. The scope of these challenges ranged from physician refusal of patient enrollment to navigating various medical record systems in each participating institution. Conclusions: This study indicates that during the implementation of a multi-center clinical trial, investigators will identify important challenges. A system based on quality improvement methods should be integrated into the clinical trial process in an attempt to identify issues early in the study in order to rapidly implement appropriate solutions. Figure 3: Stop light card listing physician agreement Figure 1: 8 Participating Hospitals Figure 2: Focus Group RESULTS Throughout the study a total of 12 challenges were identified. These challenges were discussed and categorized into two groups: study team or hospital. Nine of these challenges were considered related to study team issues, while three were considered related to hospital issues. Challenges and solution for hospital and study team are shown in Table 1. Stop light card listing physicians names and enrollment agreement is shown in Figure 3. Training processes are shown in Figure 4. Table 1: Challenges and Solutions INTRODUCTION • If clinical trials are to be successful, it is pertinent that a quality improvement system is integrated into the clinical trial process to identify challenges and improve processes. This becomes particularly significant when conducting multi-center studies. • In most cases, multi-center studies have the ability to enroll a large number of study participants. This allows for a larger data set to analyze, often resulting in better generalizability.1 • Since multi-center studies are becoming the standard approach in research, it is important to understand that new challenges can surface. • The objective of this study is to describe the challenges encountered while implementing a multi-center study and to describe their solutions. Figure 4: Training Diagram CONCLUSIONS • In our study we found that many challenges will surface during the execution of a multi-center clinical trial. • Identifying these challenges and finding the primary issue within each challenge by using a system based on quality improvement methods, should be integrated into the clinical trial in order to rapidly implement appropriate solutions to the challenges. • The resolution of these issues, such as those relating to training, communication systems and auditing processes are very important and should be Implemented throughout the study MATERIALS AND METHODS • RETOS is an ongoing randomized prospective clinical trial to evaluate the impact of rapid empiric treatment with oseltamivir on the outcomes of hospitalized patients with symptoms of a lower respiratory tract infection (LRTI). • Adult patients admitted to 8 hospitals in Louisville, KY (Figure 1) from December 2010 to March 2012 with symptoms of a LRTI were invited to participate in the study. • A focus group was created to determine the challenges encountered during the study as well as solutions to those challenges. • The focus group included the principal investigator, sub-investigators, co-investigators, study coordinators and research associates as shown in Figure 2. 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