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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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The University of Minnesota established the program as a result of leadership concerns about the familiarly Investigators had about research regulations. “Unfamiliarity with the required regulations places the researcher and the university at risk of noncompliance. Research participants’ safety is of course, the primary concern. Attempting to learn the regulations and how to apply them took valuable time away from conducting the clinical trials” (Arbit &Paller, 2006, p. 148). Arbit and Paller did not provide further explanation as to why learning research regulations stood in the way of conducting the clinical trials. I think it would have been interesting to learn about the training physicians underwent prior to becoming Investigators. Perhaps, providing a more comprehensive training program for Investigators may have been an option.

The University of Minnesota documented the successes and failures of establishing the IAP. The program successfully established a system to guide Investigators in determining if an IND/IDE is applicable for their research. This is often a tedious task for Investigators and the additional level of support demonstrated a helpful tool for Investigators. In cases where an IND/IDE is required, Investigators often feel bogged down by the process. The establishment of the IAP proved to be a quick process

for the establishment of research protocols. Arbit and Paller (2006) reported:

One researcher delayed progress on a study of a new surgical device for more than 12 months because he had no idea where to begin or where to turn. Within a week of contacting the IAP, a draft of the IDE application was completed and within a month, the IDE application was submitted (p. 152).

These two services provided investigators with support from experienced regulatory personnel, who contribute full time efforts to understanding FDA regulations.

Other report successes with the establishment of the IAP include: development of case report forms, monitoring plans, and drug accountability logs, working with external drug vendors, Coordinator training, and assisting Sponsor-Investigators with reporting.

Along with the successes, there was some learning. The biggest challenge faced by the staff of the IAP was resistance from some Investigators, who managed and submitted their own INDs/IDEs successfully. “These individuals were reluctant to change and to accept regulatory assistance and guidance” (Arbit and Paller, 2006, p.152).

To my knowledge (Arbit & Paller, 2006), when a new program is established without buy-in from all stakeholders, resistance is met. This was a key lesson learned from the University of Minnesota. On several occasions the FDA refused to provide information to the IAP regarding an IND because the IAP director was not the IND Sponsor. In turn, the IND Sponsor wrote a letter granting permission for the FDA to communicate to the IAP director.

Overall, the IAP program provided much needed support to the SponsorInvestigators across the University of Michigan. The article did not specify if the successes and lessons learned were noted by the IAP staff or Investigators. The program was set-up to be a support for Sponsor-Investigators rather than take on the full responsibilities of a Sponsor. Is this the best type of office? Or would it be of more benefit to have a centralized Sponsor?

“In 2004, the National Institute of Health (NIH) launched the “NIH Roadmap for Medical Research” to address roadblocks to research and to transform the way biomedical research is conducted by overcoming specific hurdles or filling defined knowledge gaps” (Berro et al, 2011, p.2). One of the objectives of this program was to enhance translational research. The IND/IDE task force was put together to evaluate the support for Sponsor-Investigators. In 2008, the task force developed a pilot study to evaluate the current system for Sponsor-Investigator support at AHCs. The study consisted of surveying twenty-four AHCs that provide regulatory support. The survey was administered to the regulatory representative at each AHC. The questions were developed to assess the level of support offered at each AHC.

The results demonstrated a wide range of regulatory support provided at each AHC. The various models used to support AHCs include: Independent, Consultation and Full service (see Figure 2). These results evaluate three different types of support models within AHCs. As you noted in the figure below, there are positives and negatives to each model. Department A appears to be a full service model type. I wanted to highlight the research evaluating these various models to highlight the importance of being aware of the positives and negatives associated with each. “ The NIH Roadmap for Medical Research and the CTSA initiative have contributed to increased recognition of the complexities introduced by innovative clinical research conducted at AHCs” (Berro et al, 2011, p. 6). Overall, the survey reinforced the need for regulatory support programs at AHCs. The programs will continue to provide a level of relief that professionals with solid regulatory experience are overseeing the conduct of clinical research.

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Illustration 1: Figure 2: Berro et. al, 2011, p.6 Again, there is a gap of literature evaluating the successes and failures of implementing regulations and rules within the field of clinical research. The purpose of presenting the above literature was to validate the need for some level of regulatory support within an AHC. In addition, the gap within the literature validates the importance of this capstone.

The literature for this capstone is very sparse; however, the lack of literature highlights the need for future research to be conducted within the field of clinical research. The literature I did present within this chapter highlights the importance of learning the history of an organization, understanding underbounded systems, planning and review of clinical research support programs.

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The centralized IND core was developed and implemented to resolve noncompliance issues among Sponsor-Investigators; however, non-compliance issues were still noted on audit reports after the implementation of the centralized IND core. There are several assumptions I have developed over the past two years leading to my interest in exploring the hypotheses outlined below.

The first assumption is, due to a lack of planning, the core is not fulfilling all Sponsor obligations. Over the past two years I have been concerned with the lack of Sponsor responsibilities remaining unmet by the centralized core. In addition to my observations, the lack of fulfillment has been documented as major findings by the research services office. The three responsibilities not being fulfilled by the centralized core include: monitoring, drug accountability, and training.

The first responsibility not being met is monitoring of research protocols. I have met with the IND core manager on several occasions to discuss monitoring. The core manager expressed her concerns with being over-worked with other obligations. She did not feel she could dedicate additional time to complete monitoring. We both brought this concern to the Sponsor-Representative, who in turn confirmed the importance of the tasks, but was comfortable with the lack of monitoring at this time due to the annual audits conducted by research services. While I accepted this answer, I am still concerned with the lack of monitoring. I began to question the clarity of our role as a centralized core. There are multiple responsibilities associated with being a Sponsor. Often times when an Investigator takes on this additional role, they are supported by multiple administrative staff members. The centralized model took all associated responsibilities away and only hired one full time administrative staff member. These actions left me wondering what type of model the core was designed to be. Was the core designed to be a full service IND core?

The second responsibility not being fully met is documentation of drug accountability. There is a lack of documentation between all working parts of the core (drug production, handling, and administration). To my knowledge, each sub-group is managing their own documentation; however, there is a lack of collective documentation of these records. I’m concerned with the lack of collaboration among the key groups of the core. Prior to centralization, these sub-groups managed their drug accountability separately. I would have assumed a collective area for managing documentation would have been put in place with centralization. I began to wonder if the goal of centralizing was to improve document management practices or possibly some other hidden motive.

The third responsibility not being met is training. A Sponsor is responsible for training Investigators on regulations and providing oversight. During my first year of managing the core, I noticed the Sponsor was not fulfilling the responsibility of training.

Training Investigators on regulatory requirements of protocols involving radiopharmaceuticals is important. The lack of training often has me wondering if these Investigators really understand the radio-pharmaceutical they are investigating and their obligations as an Investigator. I have often witnessed an Investigator submit a protocol to the IND core, without a fully written protocol, and the essential documentation needed to conduct an IND related trial. In these special circumstances, the IND core manager has taken time to work directly with the Investigator to ensure they fully understand the requirements of an IND application.

The second assumption is, due to role identification, the core is not operating effectively. I was asked to step in and help “clean up” the files after issues of noncompliance were still found on audits. Shortly thereafter, I was appointed an operations manager for the core. My role is to oversee, support, design processes, and supervises the core manager. My involvement with the other members of the core is in-direct. Over the past two years, I have worked closely with the core manager on brainstorming monitoring plans, drug accountability tracking, and training programs. We've developed templates, but we have not been able to implement any of them to date. Since, my involvement is limited; I haven't felt comfortable trying new plans. Furthermore, I’m not clear on the specific responsibilities of the indirect members of the core.

The core manager and I meet monthly with the Sponsor's authorized representative; however, the regulatory manager and cyclotron manager are absent from these meetings. I’m concerned that the absence of these key members is hindering the effectiveness of the core. Due to the lack of clarity with the delegation of roles and responsibilities, the core is not operating in the way it was structured to operate.

At the time the IND core was developed and implemented, the core supported four INDs and eight protocols. Over the past five years, the core has grown to manage ten INDs, and thirteen protocols. As previously mentioned, I supervise the IND core manager. I meet with this individual on a monthly basis to review tasks and to discuss issues (if any) that may have arisen within the monthly period. Our discussions are mainly centered on the document management process and development of operational processes. The core manager is expected to maintain complete files for INDs that were in existence prior to centralization. Attempting to locate historical documentation has been challenging and time consuming. These tasks are expected to be completed as well as maintaining ongoing documentation and communication.

My third assumption is the goals of the core have not been made clear. Initially, I had a very limited understanding of the IND core and the purpose it served within the department. I also had a very limited understanding of the role of Sponsors. I educated myself by reading section 312 of the CFR (regulations specific to INDs). Sponsors have specific responsibilities and per FDA regulations must be met. I do not believe leadership clearly identified if the centralized core was going to handle the full responsibilities of a Sponsor.

My goals for this capstone are to learn more about the rationale of developing a centralized core, and understand why the IND core is not functioning as a full service

centralized IND core. The hypotheses I will explore are:


• The centralized model was set in place without clear objectives.

• The IND core is not operating in the way it was structured to operate.

• The IND core is understaffed and unable to fully carry out the level of responsibility associated with being a Sponsor.

• Future expansion was not included in the planning when the centralized model

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Investigative methods

In order to fully explore these hypotheses, I will conduct two sets of interviews:

background and current state. The purpose of these interviews is twofold: to determine the key reasons for creating a centralized structure, and to determine if the IND is presently functioning effectively. In addition to conducting interviews, I will review audit reports, job descriptions, regulatory files, and email communications. I attempted to locate a documented vision, and business plan, but was unsuccessful.

Background interviews In order to fully understand the rationale for the development and intended structure, I will conduct five in-depth interviews with key stakeholders. The participants chosen for these interviews were key departmental personnel involved in the decision to centralize the IND core and those who were hired as support personnel for the core. I selected the departmental leaders so I could understand why the centralization was implemented and understand the intended operational structure. I selected the administrative personnel so I could fully understand how the IND core is operating.

Below is a description of the responsibilities associated with the participants I selected for the interview protocol.

Participant 001 was a member of the AHC for about five years prior to moving on to a new position. While he was at the AHC his responsibilities varied. He was hired to oversee the administrative aspects of research, as well as assist with laboratory duties.

Soon after his hire date, his duties were extended to administrative support for the IND core.

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