Sponsor-Site Communication in Device Trials: Evolution of a Dedicated Field Clinical Organization Throughout Study Execution

Clinical Researcher—September 2018 (Volume 32, Issue 8)

PEER REVIEWED

Jennifer Krueger, MACPR; Carolynn Jones, DNP, MSPH, RN; Marjorie Neidecker, PhD, MEng, RN, CCRP

Successful study execution is essential for sponsors and physician investigators. A quality study ensures timely collection of study data to ensure accurate measures of safety and efficacy. This impacts current patients and, of course, future patients as a new drug or device is marketed and used.

Today’s clinical studies are “costly, complex, and time-consuming.”{1} Efforts toward streamlining the clinical research process are desperately needed.{2–4} While much attention has been given to simplifying the regulatory system,{5} sponsors themselves must be responsive and commit to internal organizational and process improvement to maximize study efficiency.

Device clinical trials are similar to drug trials, but with the added dimension of complex biomechanical and, as required, implant instructions. For instance, in the case of implanted pacemakers, special imaging and output data are required to ensure proper placement and operation. As patients are enrolled, large amounts of data are collected which can lead to queries and delays in the final study report.

In keeping with new initiatives to streamline and bring efficiency to the clinical research process, the device manufacturing employer of the lead author of this paper changed the way it partners with study sites by creating a Field Clinical Organization (FCO) tasked with communication, relationship building, and provision to sites of a single point of contact across departments responsible for the study within the sponsor company. This paper describes the evolution of the FCO and results of a study site satisfaction survey for this new initiative.

The Roots of the Field Clinical Organization

In 1974, the medical device company of interest established the Field Clinical Engineer (FCE) role within the United States and Canada to be primarily responsible for technical support on Investigational Device Exemption (IDE) studies being conducted by its Cardiac Rhythm and Heart Failure (CRHF) clinical division. The CRHF product lines include implantable cardioverter defibrillators, pacing leads, pacemakers, among other cardiovascular devices.

During device implantation or use, the FCE attended the procedure and provided the physician with technical support to ensure the protocol was being followed and the data collection was accurate. In addition, the FCE would attend follow-up visits with the coordinator to provide assistance should the coordinator have questions surrounding the protocol and data collection requirements and to monitor device function electronically.

FCEs were instrumental to the in-house study team, as they were the face of the sponsor at the site during implants to provide support to mitigate errors and violations of the protocol requirements. The other members of the sponsor side of the study team, consisting of data managers, safety officers, and clinical research associates (CRAs), did not travel to many implants or study visits.

In 2010, the company created another team of individuals known as Field Clinical Site Specialists (FCSSs). Each FCSS was responsible for the clinical sites within his or her territory and for all clinical studies being conducted within CRHF Clinical Operations. The FCSS was developed to ensure that documents and protocol-required tasks were followed according to regulations, Good Documentation Practices (GDocPs), and the company’s standard operating procedures (SOPs).

The FCSS provided support from the start of the clinical study (activation phase) through the end (closure phase). This would allow for a relationship to be built between site and sponsor that brought continuity and timely responses throughout the course of the study. In addition, the FCSS would manage the clinical trial management system (CTMS) to track and manage regulatory documents received for the clinical studies.

The Field Clinical Organization

Ultimately, the FCSS and FCE structures within the U.S. and Canada evolved into what is now known as the Field Clinical Organization (FCO). In this system, FCEs and FCSSs partner within their territories (a one-to-one relationship) to become the primary point of contact for their research sites for any questions, case and technology support, or assistance with query resolution, to name a few activities.

The FCSS/FCE pairs work together to ensure the timelines of their studies are being met. It is extremely important to activate studies quickly and enroll well, but it is also essential to have clean data and to be responsive. The FCO structure ensures the study sponsor team’s requests are being met by partnering with the research sites.

Roles and Responsibilities

From the site perspective, one valuable aspect of the FCO pairings being responsible for a territory is that it helps develop a relationship and familiarity with the sponsor representatives for all studies the site and sponsor complete together. It creates a bond where each is responsible for executing a clinical trial successfully because they own all phases of the study lifecycle. Thus, in the case of a site conducting more than one of the sponsor’s studies within the CRHF Clinical Organization, the FCO remains the primary point of FCSS/FCE contact for that site. In addition, each FCO pairing is responsible for developing relationships with new clinical sites with which the sponsor becomes engaged in its territory.

The FCE is responsible for networking within the territory to better understand which sites and physicians are interested in clinical research with the sponsor. Because this role is territory-based, the FCE gains local knowledge about the sites and research personnel.

As clinical studies become available, the FCE/FCSS pairs are able to nominate suitable sites based on past experience in enrollment and quality and the investigator’s interest in participating. In addition, the FCE trains clinical site personnel on the protocol prior to activation. The FCE can also assist with the collection of documents or ask questions while onsite to help ensure study start-up is progressing.

Once a site is activated, the FCE attends implants and provides technical guidance to the investigator during the case (the FCEs are technically trained on the programmer, devices, etc.). In addition, the FCE works with the coordinator throughout the course of the study to answer protocol or query questions. The FCE remains the face of the sponsor throughout the lifecycle of the study.

The FCSS is also responsible for networking, but the FCSS’s role is complementary to the FCE. Many FCSSs live within their territory; however, it is not required, as they can travel onsite when needed.

The FCSS partners closely with the FCE during the initial phases of the study, but the FCSS is instrumental in ensuring all components of activation are met as quickly as possible and are accurate per the regulations and internal SOPs. The FCSS communicates with the site when all activation requirements are met, and continues to provide support to the site by answering enrollment questions, supporting query resolution, and fielding protocol-related questions, to name a few activities.

When questions arise, it is not uncommon for the principal investigator or coordinator to contact both the FCE and FCSS by e-mail. Since the FCE has a technical background on the devices, questions pertaining to device implant or programming may go specifically to the FCE. However, questions related to data collection or the database may go to the FCSS because of his or her familiarity with the queries. Overall, it is beneficial for both the FCE and FCSS to be copied on all communications with sites, as it provides a broader awareness of discussions and decisions.

Figure 1 displays an example of the previous sponsor-site model in which each member of the sponsor’s study team was responsible for contacting the site for requests and queries, which led to multiple points of contact and significant inconsistency amongst study teams in their communications with the site. Figure 2 illustrates how, in the current model, the FCO partners closely with in-house personnel and in turn transfers the information to the site. Because of this, communications to site personnel are streamlined and focused. Table 1 displays the responsibilities of the FCSS and FCE.

 

Figure 1: Traditional Sponsor-Site Model with Multiple Points of Contact

 

Figure 2: Field Clinical Organization Model (one primary point of contact at the sponsor organization)

 

Table 1: Roles and Responsibilities of the FCE and FCSS (“X” denotes primary responsibility, but support is provided by both)

Research Site Perspective

Metrics that the FCSS and FCE track include time to study activation, enrollment rate per month at the site(s), monitoring action items, and query resolution days.

While the FCO consistently strives to improve the days to activation, the number of days can vary from year to year, depending on the type of study (Investigational Device Exemption vs. postmarket) in the activation phase. From May 2017 until April 2018, the average number of days for the FCO pairs to activate their sites in the U.S. and Canada was at an all-time low of 133 days, largely attributed to the FCO model structure.

Data on enrollment rate per month are tracked, but vary depending on site activations and number of active studies, and therefore enrollment outcomes are difficult to attribute to the FCO structure. This system supports the sponsor’s query resolution goal of less than 30 days.

While the FCO method seeks to be both functional and efficient within the sponsor organization, its ultimate success is better judged by cooperating sites. The FCO pairs are responsible for partnering with both new and old sites, and in 2018, the FCSSs and FCEs were asked to circulate a satisfaction survey to their primary study coordinators in the U.S. and Canada who were supported by the FCO structure in June 2018.

A total of 65 surveys were distributed; 43 were completed and returned. Satisfaction scores were measures on those surveys that were completed. Overall satisfaction with the FCO was 97.6% by all research coordinators who completed the survey (90.20% extremely satisfied and 6.98% somewhat satisfied). For the FCSSs, 100% of those research coordinators were satisfied with their FCSS, while 87.8% were satisfied with their FCE. When asked if the research coordinators would prefer the FCSS/FCE model (one primary point of contact) as opposed to being contacted by each member of the sponsor study team, 90.2% chose the FCSS/FCE model.

These data validate confidence in the site satisfaction for this model. One survey respondent commented, “I feel that going to one point of contact was the best way for the organization to provide support to our study staff! We really appreciated this change!”

Challenges

While the attitude toward the FCO structure within the sponsor and with cooperating sites is overwhelmingly positive, the system is not perfect. One FCSS/FCE team may concurrently support 10 or more studies, which can lead to less familiarity with protocol requirements for specific studies. Therefore, the FCSS/FCE pairings can become the “middle man” as they ask members of the study team (including CRAs, data managers, safety specialists, etc.) questions on behalf of the sites and vice versa. However, a primary point of contact prevents sites from becoming frustrated by wondering who to contact at the sponsor. As long as an answer is received in a timely fashion, the research coordinator and site personnel are satisfied, while the primary goal of providing exemplary service is upheld. In addition, the FCO is heavily focused on training to ensure team members are comfortable with delivering answers to questions to the sites.

Another challenge is that not all sites received the survey due to vacations or other unknown reasons. Therefore, the data may not represent the entire set of sites, thus introducing potential bias. Moreover, since this was a convenience sample, results may be inherently biased (e.g., highly satisfied coordinators may have been more likely to respond than those less satisfied).

Moving Forward

As the FCO initiative looks to the future, continuous self-evaluation is important. For example, the FCO model is currently only implemented within the CRHF Clinical Division at the sponsor. A possibility would be to implement this model within other business units to drive consistency across the greater company. Due to the success within the CRHF division, we feel there would be value to implementing this organizational process company-wide.

As the FCO continues to provide support to the clinical sites, we can look back and be pleased with the evolution of the FCO model and the clinical study execution each team member has provided. Moving forward, we hope to provide more best-in-class support to more studies, therapies, and clinical sites.

 References

  1. Martinez DA, Tsalatsanis A, Yalcin A, Zayas-Castro JL, Djulbegovic B. 2016. Activating clinical trials: a process improvement model. Trials 17(1):106. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4765218/
  2. Schimanski C. 2013. Streamline and improve study start-up. Applied Clinical Trials 22(9). www.appliedclinicaltrialsonline.com/streamline-and-improve-study-start
  3. Lamberti MJ, et al. 2015. Outsourcing strategies and practices to improve efficiency and performance. Applied Clinical Trials. www.appliedclinicaltrialsonline.com/outsourcing-strategies-and-practices-improve-efficiency-and-performance
  4. Wechsler J. 2016. FDA looks to new technology, policies to streamline clinical research. Applied Clinical Trials 25(2). www.appliedclinicaltrialsonline.com/fda-looks-new-techology-policies-streamline-clinical-research
  5. U.S. Food and Drug Administration. 2017. Regulatory Science Priorities. https://www.fda.gov/MedicalDevices/ScienceandResearch/ucm467550.htm

Jennifer Krueger, MACPR, (jennifer.krueger@medtronic.com) is a Field Clinical Site Specialist with Medtronic plc in Minnesota.

Carolynn Jones, DNP, MSPH, RN, (Jones5342@osu.edu) is an Associate Professor – Clinical, and Lead Instructor, Online Master’s Program in Applied Clinical and Preclinical Research with The Ohio State University.

Marjorie Neidecker, PhD, MEng, RN, CCRP, (Marjorie.Neidecker@osumc.edu) is Assistant Professor – Clinical, and Director of the Online Master’s Program in Applied Clinical and Preclinical Research with The Ohio State University.