NYU Cancer Institute is an NCI designated cancer center, serving the population of NYC with ... As with many cancer centers, achieving and maintaining high.
Effects of Enhanced Organizational Efficiency upon Accruals Yelena Novik, Aditya Malankar, Anne Martocci, and Lisa Gaynes Background/Purpose: NYU Cancer Institute is an NCI designated cancer center, serving the population of NYC with major venues of a large teaching hospital and the largest NYC public hospital with 3000 new cancer cases treated yearly. As with many cancer centers, achieving and maintaining high percent accrual to therapeutic clinical trials is a constant challenge. Starting in 2006 we restructured our organization in order to streamline our process, improve the management and tracking of ongoing trials and expedite the opening of new trials. Our aim was to increase the quantitative and qualitative scope of our clinical trials program by improving overall productivity.
Figure 1. 2003-2009: Annual Adult Therapeutic Accrual and Percent Accrual
What we have done so far
Figure 4. Process Flowchart
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With a centralized approach to the management of clinical trials we were able to standardize processes to promote parallel activity and minimize redundancy.
• Feasibility process was enhanced to include representatives from multiple
departments- nursing, pharmacy, laboratory, finance, administration and the budget manager.
Objective: To evaluate the impact of the revised process upon accrual.
• Feasibility and scientific review were to be conducted simultaneously, not in
Methods:
• Budgeting process was to be initiated as soon as a study was deemed
tandem. feasible
We examined data from 2003 to 2009 to see the annual trends in total accrual to therapeutic trials and percentages of therapeutic accrual. We then compared mean values of accrual and percent accrual between two groups: 2003-2005 vs. 2006-2009. We also examined the accrual to investigator initiated adult therapeutic trials (IITs). Lastly, we reviewed the proportional minority accrual to therapeutic trials and tissue based non-therapeutic protocols from 2007, 2008 and 2009.
• We were able to prioritize accrual to IITs We implemented software solutions to improve efficiency, institute standardization and improve communication during the administrative process.
• InfoEd (CTMS) has enabled the CTO to track old and new protocols more efficiently.
Results: We noticed a substantial increase in accrual and percentage of accrual to therapeutic trials when we compared 2006 (400, 16.49%), 2007 (433, 15.07%), 2008 (531, 19.8%) and 2009 (547) to 2003 (298, 9.38%), 2004 (290, 8.80%) and 2005 (286, 9.32%). On account of lack of availability of data we were unable to determine the accrual percentage for 2009. When comparing the mean values between the two groups 2003-2005 (291.33, 9.16%) vs. 2006-2009* (447.5, 17.10%* not including 2009), we noticed an increase of 53% in our total accrual. There was also an increase in the percentage of accrual by a factor of 1.87. There has been a steady rise in accrual to therapeutic IITs since 2003. The mean accrual has gone from being 119 for (2003-2005) to 273.5 in (20062009). The proportion of minority accrual has remained stable.
• Knowing the real time status of a trial in progress or in the pipelines reduces non value adding steps.
*2009 data not yet available
Figure 2. 2003-2009: Annual Accruals to Investigator Initiated Trials
• Obtained a standardized platform to upload and track documents from multiple •
In order to evaluate the impact of the restructuring process initiated in 2006, data was compared between group I (2003-2005) and group II (2006-2009) [Fig 1]:
• Oracle Clinical has enabled standardization of data capture tools for IITs. • Content management system such as Sharepoint, enables effective information
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Increasing efficiency through effective leadership and streamlined processes increased accrual. We believe these measures combined with other initiatives aimed furthering the parallel regulatory review processes and selecting trials with a greater potential for recruitment will further impart a positive influence upon accrual.
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Introduction:
We observed that accrual to therapeutic IITs have steadily increased since 2003. The mean accrual for IITs have increased from 119 in Group I to 273.5 in Group II Mean Percent accrual to IIT from total TT subjects increased from 41.21% in Group I to 56.4% in Group II
As a leading cancer center located in NYC, minority recruitment is a priority. Our data showed that between 2006 and 2009 while there was an overall increase in accrual, the representation among Asian, Hispanic and African American/Black subjects remained strong. [Fig 3].
Our restructuring goals were to: Identify and minimize administrative barriers resulting in delays to the activation of clinical trials Streamline regulatory and financial processes involved in activating and/or maintaining trials Implement new technological solutions to facilitate management and tracking of ongoing trials Implement an organized auditing process to maintain quality control To improve overall productivity
We observed an increase in accrual and percentage of accrual to TTs in Group II. A 53% increase in the mean accrual in Group II An increase in the mean percentage of accrual by a factor of 1.87.
As with any NCI designated cancer center, IITs are a priority. The evaluating criteria we used to assess the impact upon IITs were: annual accrual and percentage of all patients on TTs who were enrolled in IITs. We additionally analyzed mean values between Group I (2003-3005) and Group II (2006-2009) [Fig 2]:
NYU Cancer Institute is an NCI designated cancer center, serving the population of NYC with major venues of a large teaching hospital and the largest NYC public hospital with over 3000 new cancer cases treated annually. As with many cancer centers, achieving and maintaining high percent accrual to therapeutic clinical trials is a constant challenge. In order to increase the qualitative and quantitative scope of our clinical trials program, starting in 2006 we established an enhanced organizational structure with a special emphasis toward investigator initiated trials (IITs).
Figure 3. Distribution by Race for All Trials at NYUCI
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1. Shortened duration required to open up trials 2. Enabled activation of a greater number of trials [Fig 5]
Accrual to Therapeutic Trials (TT) Accrual to Therapeutic Investigator Initiated Trials (IITs)
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We examined data from 2003 to 2009 to observe annual trends: Compiled annual accrual data for TTs from 2003-2009 Calculated the percentage of therapeutic accrual per annum based on the new cancer cases at NYUCI compiled in the NCI Summary 3 reports. Compared mean values of accrual and percent accrual between Group I (2003-2005) and Group II (2006-2009). Compiled accrual data for IITs and calculated percentages based on total annual accrual to TTs Examined proportion of minority accrual per annum for all trials from 2007 2009.
Our study had limitations because we: • Relied only upon accrual numbers and percent accruals • Need to establish and obtain more detailed metrics to examine specific correlation between improved management and increased accrual.
Trial performance remains another issue:
• Non accruing trials are an administrative burden and consume valuable resources
• There is a disparity in the total number of trials open and ones that accrue. A recent survey indicated that approximately 28 percent of the trials are responsible for approximately 90 percent of accrual to adult industry and cooperative group therapeutic clinical trials4 .
many trials accrue in a given year. Clearly more needs to be done to improve the selection process whereby resources are utilized to open trials with a greater potential to accrue. [Fig. 5]
The restructuring process has had a positive impact upon accrual to TTs and IITs. We believe this is because by reducing non value adding steps in the regulatory and financial process it has:
To evaluate the impact of the structural changes upon:
Methods:
dissemination when coordinating with committees which only meet periodically.
• There has been no remarkable change in the percentage of accruing trials • This indicates that our structural changes so far have had no impact upon how
Discussion:
Objectives: • •
sources (regulatory, IRB, contracts/budgets etc.) Intranet accessibility ensures instant availability of up to date documents for all members of the staff
Results:
Conclusion:
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Figure 5. 2007-2009: Open Adult Therapeutic Trials vs. Accruing Trials Peer Reviewed
Starting in 2006 we consolidated research activity and restructured the CTO to comprehensively manage all aspects of clinical trials at NYUCI [Fig.4].
What we know • •
Trials which take a long time to activate tend to accrue poorly. Exceptionally long activation periods result in trials that are either fully or partially obsolete1 Redundancies in the administrative process contribute significantly to delays.
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In one study it was observed that within the approximate 199 days required to take a protocol from concept to IRB review, 174 days were considered as non value adding2 . Parallel processes reduce delays compared to a sequential format2 Budgets and contracts are the rate limiting step in the initiation of trials3 .
Conclusion: Increasing the efficiency of the regulatory and financial process:
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Reduces the time required to open new trials Provides the ability to open more trials Exacts a positive impact upon accrual. With a special emphasis on IITs it results in increased accrual We believe that accrual can be further improved if these measures are combined with other initiatives aimed at: Further improving parallel regulatory and financial processes Selecting trials with a greater potential to accrue which enhance the treatment portfolio.
References: 1. Kurzrock R, Pilat S, Bartolazzi M, et al: Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials. J. Clin. Onc. 27: 4433-4440, 2009. 2. McJoynt T, Hirzallah M, Satele D, et al: Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center. J. Clin. Onc. 27: 3855-3860, 2009 3. Dilts David, Sandler Alan: Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and procedural Barriers to Opening Oncology Clinical Trials. J. Clin. Onc. 24:4545-4552, 2006. 4. Durivage H, Bridges K. 2009, “Clinical Trial Metrics: Protocol Performance and Resource Utilization from 16 Cancer Centers”, AACI- CRI Chicago, IL, pp. 11.
