Winter 2016

Paul J. Martin, MD, is Medical Director, Clinical Research Support, at Fred Hutchinson Cancer Research Center, in Seattle and Chair of the AACI Clinical Research Initiative.

Commentary Overview

* At many cancer centers, the roles, responsibilities, level of effort and accountability of the clinical trials office (CTO) medical director has evolved to address specific institutional needs.

* An AACI Clinical Research Initiative (CRI) survey found that "managing concerns raised by investigators regarding the CTO and concerns raised by the CTO regarding investigators" is among the most important tasks performed by CTO medical directors, along with "providing input on day-to-day operations of the CTO in conjunction with the administrative director or manager of the CTO".

* In many ways, the CTO medical director can be most effective as a diplomat, working collaboratively with CTO administrative leadership, staff members, investigators, and cancer center medical and administrative leadership.
About AACI Commentary

As part of AACI's efforts to feature the work and views of its member centers, AACI publishes AACI Commentary, a quarterly editorial series. Written by cancer center leaders, each edition focuses on a major issue of common interest to AACI cancer centers.



The Evolution of the CTO Medical Director: Results from an AACI Clinical Research Initiative Survey

BY PAUL J. MARTIN, MD

In many AACI cancer centers, the organizational structure of the clinical trials office (CTO) includes a medical director. In most centers, the role of CTO medical director likely has evolved to address specific institutional needs and was not driven by any obvious external requirements or specifications. This evolution has led to variability in the roles, responsibilities, level of effort and accountability of CTO medical directors.

A recent survey conducted by the AACI Clinical Research Initiative aimed to learn more about these differences across cancer centers. The survey was intended to identify dedicated CTO medical director or other similarly titled positions at AACI member cancer centers and to gain information about these positions that could be shared with member centers that might consider creating a similar role. It was also anticipated that the results would allow current CTO medical directors to compare their reporting relationships, effort, responsibilities, and cancer center leadership support for these positions with those of other centers. The survey had nine items and was distributed in mid-2016 to 48 AACI cancer centers known to have CTO medical directors or other similarly titled positions. The survey yielded 23 responses.

The length of time that the role of CTO medical director had existed varied considerably across the 23 centers. Approximately 25 percent of the responding centers had established this role more than 15 years ago, and similar proportions have had CTO medical directors for 10-15 years, 5-10 years and less than 5 years, respectively.

Approximately 75 percent of the responding centers indicated that the current CTO medical director has served for less than 5 years, indicating some degree of turnover in staffing this role. Approximately 80 percent of CTO medical directors had more than 5 years of experience as principal investigator or co-investigator for cancer research trials. In some centers, however, it appears that CTO medical directors have relatively little experience as a clinical trial investigator.

In nearly all centers, the CTO medical director reports either to the cancer center director or to an associate cancer center director, and in approximately three-quarters of the centers, the CTO administrative director or manager reports at least in part to the medical director. The average effort devoted to the CTO medical director role is 20 percent. Individuals serving in this role have a typical academic mix of other clinical, research, teaching and administrative activities. Nearly all CTO medical directors receive financial compensation for their effort, approximately half have protected time for CTO-related responsibilities, and approximately 20 percent have additional staff resources for this role.

CTO Medical Director Responsibilities
The most informative item in the survey asked respondents to rank CTO medical director responsibilities from most important to least important in contributing to the success of the CTO. The rankings of 14 possible responsibilities were organized into three tiers. The top two tiers covered "managing concerns raised by investigators regarding the CTO and concerns raised by the CTO regarding investigators", and "providing input on day-to-day operations of the CTO in conjunction with the administrative director or manager of the CTO." These paired roles emphasize the paramount importance of the medical director in maintaining effective CTO services and in fostering cordial and mutually respectful working relationships between the CTO and the investigators it serves.

The lowest ranked tier of responsibilities included "closing slow accruing or non-complaint research trials, aside from the Protocol Review and Monitoring System (PRMS) and the data and safety monitoring committee (DSMC)" and "determining whether network sites are permitted to participate in trials." The National Cancer Institute's (NCI) guidelines for cancer center support grants (CCSG) clearly vest the authority to close trials with the PRMS for low accrual and with the DSMC for poor compliance. The survey's low ranking of these responsibilities emphasizes that, at most, the CTO medical director may refer concerns to the PRMS or DSMC but does not have independent authority to close trials. Similarly, the CTO medical director is viewed as having little responsibility for determining whether network sites should be permitted to participate in trials.

Even though the rank order of roles indicated that the CTO medical director should not have authority to close trials, the middle tier of responsibilities included "oversight of the PRMS," together with "responsibility for CTO quality assurance outcomes," which could be viewed as falling within the Clinical Protocol Data and Monitoring (CPDM) functions supported by NCI CCSG guidelines. These guidelines indicate that responsibility for the PRMS and CPDM should be organized as separate roles held by different individuals. In principle, this expectation could be satisfied by having a reporting arrangement between the PRMS director and the CTO director who is responsible for the CPDM.

The middle tier contained a variety of other responsibilities. With respect to clinical trials, these can include setting overall accrual goals for the center and assessing feasibility of individual trials independently of the PRMS. The medical director can assist principal investigators with protocol development and provide research training, which may be more effective than alternative training methods for physicians. The medical director can serve as a resource to address questions regarding eligibility or protocol compliance. At an organizational level, the medical director may be involved in engaging affiliate and network sites and in overseeing the conduct of clinical trials at these sites.

Finally, the medical director may have some financial responsibility for the CTO staff budget. Helping to secure commitment and budget support from cancer center administrators is a highly appropriate role for the medical director because it is extremely difficult to design a self-supporting structure for a CTO through charges for services.

Details of the CTO medical director's roles and responsibilities will surely vary by virtue of their historical development and evolution at any given cancer center, the intentions embodied by a formal job description, the CTO's organizational structure, and the personalities and interests of the individuals involved in medical and administrative leadership. In many ways, the CTO medical director's role can be most effective when it is viewed as having a major diplomatic component that involves working collaboratively with CTO administrative leadership, CTO staff members, investigators and their support staff, and cancer center medical and administrative leadership. Goals shared by all include cost-effective enrollment of patients in high-quality clinical trials conducted with excellent compliance and data collection, leading to improved care for patients with cancer.

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