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«11-18-2012 An Organizational Diagnosis Of A Centralized Investigational New Drug Core Within A Large Academic Health Center Kathleen M. Thomas ...»

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Over the past two years, I have listened to and dealt with numerous complaints and concerns from the staff about the operations within the IND core. These complaints included: not fully understanding their role, feelings of being overwhelmed by the number of tasks associated with job functions, and feeling unsupported by senior leadership.

In addition, I have observed a lack of monitoring protocols. Monitoring is one responsibility associated with being a Sponsor.. As described in Chapter 2, the Sponsor is responsible for monitoring research protocols conducted under an IND. The lack of monitoring has often been discussed among all staff members over the past two years.

These frustrations and concerns of the staff members have left me feeling helpless. As the Operations manager, I do not believe I am giving them the support and direction they need to feel successful in their roles. About a year ago, I made the decision to perform an organizational diagnosis of the core and determine the root cause of the problem.

Controlling for bias “Reducing diagnostic bias should begin with an understanding of its cause” (Armenakis, Mossholder, and Harris, 1990, p.563). As an insider of the core, I need to be aware of things that can cause me to have a narrow perception of the ineffectiveness of the core. There are a few factors that may cause bias in this capstone. The first is, I have been an employee with the department for ten years and indirectly heard stories about the implementation of the core. The second way bias may be present in this capstone is my selection of participants and the third is my relationship with each participant..

I always assumed the core was set-up as a result of hiring a new division chief. I based this assumption on previous off-line conversations I have had with members of the department. In realizing this may not be the full story, I decided to incorporate background interviews into this capstone. Understanding the history of creating and implementing the core from several key stakeholders within the department is important because it will provide me with knowledge of operations I was not aware of previously.

In addition, I will cross reference these interviews with documentation describing the reason for implementation. Cross referencing will help eliminate bias as I will be checking against another source.

The second factor of bias is the selection of participants. I selected these participants based on my knowledge of their involvement with the core. The information I gather will be limited to the view of insiders. I wanted to gain a more global perspective of centralization by including members from the research support office, whom were involved in the development, but I was unable to do. The member who was involved in the centralization is no longer with the University and I was unable to get in contact with this individual. I tried to control bias by evaluating the role of each participant and reviewed previous documents outlining personnel within the core.

The third factor of bias is my relationship with each participant I will interview for the current state of the core. Over the past two years, I have had many discussions with each of these participants; I may have a predetermined mindset of how they will answer each question asked. In order to minimize this, I will tape record each interview conducted. This will allow me the opportunity to spend time listening to the interviews prior to my data analysis and notice if there were points I missed.

My goal with the information I gather from this capstone is to determine the best way to improve the effectiveness of the core. In order to fully do this, I believe it is important to highlight all of the issues I may uncover. I do not want participants in these interviews to feel they could be the problem, based on their performance. These participants may feel defensive and worry about the security of their job if these feelings arise. This concern may cause me to cover over some performance issues as I analyze my

data. As you read this paper, I ask you to consider the following:

• Did I miss specific history because non-departmental stakeholders were not

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• Did I ignore performance issues of certain staff members?

In summary there are two sets of data collection for this diagnosis: background and current state. Both sets of interviews and review of relevant documentation will occur over the course of three months. After all data is collected, I will review and analyze the results. I will specifically look for themes throughout the data and confirm or disprove the hypotheses outlined above. The results are presented in the next chapter.

–  –  –

Data summary In order to obtain the information to confirm or disprove my hypotheses, I conducted two sets of interviews: background and current state, and reviewed audit reports, job descriptions, regulatory files, and email communications. The data collection process was conducted over a total of eight weeks. I will begin this section with the results of the background interviews and identify the themes which emerged during data collection. Then, I will summarize the current state interviews and the themes which emerged. I will conclude this section with a summary of the data in relationship to my hypotheses.

Summary of background interviews I began the data collection process by conducting background interviews with several key stakeholders within the organization. The background interviews were conducted over a course of four weeks. The purpose of these interviews was to learn the rationale of creating a centralized IND core and to determine if clear objectives were developed for the operational structure of the core. As described in the methodology section of the paper, I selected individuals with active roles within the core to participate in the interview process. My goals for selecting these individuals were to understand the decision process for centralization and learn about the perception of those who were charged with outlining the infrastructure of the core, as well as those who were managing the core in its infancy. I contacted each individual via email requesting their participation in the interview. Details of the purpose of the interview and capstone topic were included in the body of the email and I asked if they were willing to participate. Confidentiality and privacy were assured. As a result, participant's names and titles have been removed and the interviewees have been randomly assigned numbers ranging from 001-006.

Potential participants were requested to respond directly to me via email with their decision. All five participants responded quickly with their willingness and desire to participate in the background interview process The data collected from conducting the background interviews included the opinions of staff members about the history influencing the development and implementation of a centralized IND core. Five individuals were interviewed on the basis of their role within the core at the time of implementation. Three of these interviews were conducted in person while two were conducted via telephone. The results of the interviews are presented below in relationship to each question asked.

Question number one: Can you provide me with information on the operational structure of the IND core prior to implementation of the centralized model? The responses given by all participants were very similar. "There was no structure prior to the centralization" was the statement made by four of five participants. INDs could be held by Investigators, allowing them to take on the added responsibility of a Sponsor (Sponsor-Investigator). One participant even went as far as to describe the structure as a "free for all.” Another participant named two individuals in the department that often filled the role of Sponsor-Investigator.

Question number two: When did the idea of a centralized core come about? One participant was able to provide me with the specific time frame that the idea of centralizing was discussed—September 2006. The other participants were not clear on the specific time frame, but seemed to have an idea it was around 2006/2007. Two participants explained the idea came about as a response to non-compliance. This date correlated with the time frame provided by the participants and documents within the core. I cross-checked the dates with reports of the audit findings.

Question number three: What was the rationale for creating a centralized core?

Through the responses to this question I learned about a significant tragic event within the AHC, which led to the redesign of the IND model within Department A. All interviewees identified non-compliance as the major reason. One participant explained “the rationale for creating the core was for efficiency, to minimize errors, and quality control. In addition, the core was developed to prioritize the importance of specific INDs.” Another participant specifically stated “the idea came about after OHR audited IND related protocols. Leadership of the AHC decided to implement a centralized office and asked Department A to be the pilot.” A third participant stated “senior leadership at the AHC approached senior leadership within Department A with the problem of noncompliance and asked them to determine the best solution. With that, Department A decided it was best to implement a centralized office.” Two participants provided a more thorough background as the reason the core was developed and implemented. Jessie Gelsinger’s case - - death of a research participant in a gene therapy trial-- was the primary factor in the structure change of managing INDs.

This incident occurred in September 1999. The death of this research participant put the University in the spotlight throughout the research community.

The death of this research participant sparked changes throughout the AHC. While many individuals may not see this at a national level, the changes are noticeable at the AHC. Shortly after the tragic incident, the AHC developed OHR, a centralized office to oversee the conduct of human research. One of the goals of this office was to audit all research protocols considered high risk. “The AHC addressed the problem head-on and took aggressive steps to create and implement the Office of Human Research.” (Zhou, J,

2003) The members of OHR took their roles very seriously and began developing a process for auditing high risk protocols.

Department A was one of a few departments throughout the University with high risk protocols--protocols using non-FDA approved agents-- and a production facility.

Compliance issues were noted on eight protocols. OHR personnel shared their findings with departmental senior leadership and requested they implement a corrective action plan. Senior leadership agreed upon a centralized model to control compliance. "One participant noted the additional reasons behind centralization were to improve efficiency, and quality control.” Question number four: Who led the redesign of the core? The responses from the participants varied. Two of five participants identified two groups involved in the development of the centralized core: senior leadership from OHR and senior leadership from Department A. One participant indicated the Compliance Director within the department was also included. Another participant also indicated the newly appointed authorizing representative was involved in the redesign as well. One participant was not sure who was involved in the redesign of the core.

Question number five: How did you envision the structure of the IND core? This question was designed to learn how each member imagined the core would operate. The responses had a mix of similarities and differences. One participant responded with “I can tell you my ideal vision, but I will tell you my vision based on the resources provided by the AHC. My vision was to build an organized regulatory submission process between Investigators, the core, and the FDA. This was the only thing the centralized core could handle with the limited resources.” Another participant explained “I hoped the core would limit the number of active INDs and protocols. I imagined there would be more resources.” A third participant stated “Not much changed from my perspective.” The remaining two participants had similar responses. They both indicated they imagined the core as being one single point person to manage all regulatory responsibilities and monitoring.

Question number six: What mechanism did you use to inform Investigators of the redesign of the core? All five participants were uncertain of the exact method of notification. Two stated they were unsure, two thought the Investigators were notified via email, and another participant thought the notification was announced at a departmental research meeting and then disseminated to collaborators.

Question number seven: Do you have any other additional information you would like to share? Four out of five participants responded with “no. I do not have any additional information.” One participant added their opinion on the positives and negatives to centralization. The participant stated “The disadvantage to a centralized model is the lack of expertise per radio-pharmaceutical. In a decentralized system, the Sponsor-Investigator has all of the knowledge needed to run the protocol.” Follow up questions I did not ask follow up questions during the background interview portion of this diagnosis.

Current state interviews The second set of interviews I conducted was with four of the staff members of the IND core. These interviews were conducted over the course of two weeks. My goal with selecting these participants was to gain insight about their perception of the operational structure of the core. I emailed each staff member informing them of the purpose of this thesis and requested their participation in the interview process. I contacted each individual via email requesting their participation in the interview. Details of the purpose of the interview and capstone topic were included in the body of the email and I asked if they were willing to participate. Confidentiality and privacy were assured.

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