ERIC EJ1134105: Collaboration in Action: Measuring and Improving Contracting Performance in the University of California Contracting Network

2017·0.8 MB·English

by  ERIC

Research Management Review, Volume 22, Number 1 (2017)

Collaboration in Action:
Measuring and Improving
Contracting Performance in the
University of California
Contracting Network

Tam Tran Hillary Noll Kalay
University of California at Irvine University of California
Office of the President
LeeAnna Bowman-Carpio

University of California at
Terry Nakazono
Los Angeles
University of California at

Los Angeles
Nate Buscher

University of California Biomedical
Helene Orescan
Research Acceleration, Integration,
University of California at
and Development
Los Angeles
Pamela Davidson
Rachael Sak
University of California at
University of California Biomedical
Los Angeles
Research Acceleration, Integration,
Jennifer J. Ford and Development
University of California at
Irene Shin
San Diego
University of California at
Erick Jenkins San Francisco
University of California at Davis

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Research Management Review, Volume 22, Number 1 (2017)

ABSTRACT

In 2013, the University of California, Biomedical Research, Acceleration, Integration, and
Development (UC BRAID) convened a regional network of contracting directors from the five
University of California (UC) health campuses to: (i) increase collaboration, (ii) operationalize and
measure common metrics as a basis for performance improvement efforts, and (iii) identify and
implement best practices to maintain a competitive edge in the field of biomedical research.

This article summarizes an 18-month examination of performance metrics across the five campuses,
including methods for data collection and harmonization agreed upon by the UC contracting offices.

Some of the most striking, and previously unmeasured, results demonstrate that master agreements
are a highly effective and successful strategy for significantly shortening the average time to
completion of contract terms. Interestingly, clinical research organizations (CROs) significantly
increase the time required to negotiate a contract. Results also point to the intra- and inter-
organizational dependencies affecting time to contract execution.

Systematic and transparent data collection among UC stakeholders is necessary to continue
improvements to the system. However, data collection is only one component of the larger need to
develop shared technology both within and between institutions. This study demonstrates that
collaboration and sharing of contract terms is an effective way to reduce study activation time, but
the greatest improvements will be driven by the sharing of data and technology tools.

INTRODUCTION convened the Contracting Network (the
Network), comprised of the contracting
Sponsored projects offices face
directors from five University of California
increasing internal and external pressure to
(UC) academic medical campuses (UCs
improve turnaround times for clinical trial
Davis, Irvine, Los Angeles, San Diego, and
contract execution—a critical measurement
San Francisco) to create an adaptive system
when interfacing with industry sponsors
that shares terms and best practices and
and funding agencies. At the same time, the
leverages resources.
proliferation of multisite clinical trials
The Network’s charter led to an 18-
provides opportunities for affiliated
month effort to achieve several aims:
institutions to harmonize and align contract
(i) measure and improve industry-
negotiations. The University of California
sponsored clinical trial contracting
Biomedical Research, Acceleration,
performance, (ii) increase collaboration for
Integration, and Development (UC BRAID)

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multisite clinical trial agreement (CTA) UC to quickly respond to a changing
negotiations, (iii) mitigate redundant efforts contracting landscape, identify and
and conserve resources, and (iv) share best implement evidence-based best practices,
practices and lessons learned with internal and maintain a competitive edge in the field
stakeholders and the larger research of biomedical research.
administration community. Affirming the METHODS
importance of such examination, the
The objective of this study was to collect
National Center for Accelerating
data on industry-sponsored clinical trials
Translational Science (NCATS) recently
related to: (i) contract negotiation duration,
launched a similar performance
(ii) the frequency of delays related to
improvement initiative for the Clinical and
ancillary approval processes (e.g., IRB,
Translational Science Award (CTSA)
coverage analysis, financial interest review),
Program and views such improvement in
and (iii) overall duration: from the receipt of
administrative and clinical research
the minimum documents required to
processes among its top priorities (Dilts et
negotiate the contract to contract execution.
al., 2012; NCATS, 2014; UC BRAID, 2012).
Because the scope of responsibility varied
Led by the contracting directors, the
for each contracting office, the directors
Network also included BRAID leadership,
each identified their essential minimum
CTSA evaluators, and a policy manager
documents necessary to begin a negotiation
from the UC Office of the President. The
and agreed that this would be the starting
directors agreed upon a common set of
point for assessing the overall duration of
metrics applicable across sites and collected
contract negotiation. The group assigned
standardized data on more than 1,000 new
the phrase “Minimum Documents” to this
clinical trial contracts and amendments.
starting point, which generally included:
Although the contracting offices at each
 Campus intake forms
campus vary in size and scope of
 Study protocol
operations, electronic systems, and
 Draft budget and contract
resources, the directors were able to
 Draft consent forms
develop a rich, metrics-based foundation
 University economic interest
and a performance improvement initiative
disclosures
worth pursuing by all members. Ultimately,
Inclusion criteria for the contracts in this
this platform of close collaboration allows
study were: (1) industry-sponsored trials;

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(2) meeting the 2006 UC Definition of n=827, including n=581 new contracts and
Clinical Trials (http://www.ucbraid.org/ct); n=246 amendments.
and (3) where “Minimum Documents” were RESULTS
received by the negotiating campus from
Master Contracts Are Key to Reducing
July 1, 2013 through December 31, 2014. The Negotiation Time
Network collected data at all five sites using To date, the UC Office of the President
Vanderbilt University’s REDCap (UCOP) has successfully negotiated over 30
technology (https://projectredcap.org/) master clinical trial agreements with
coupled with a unified survey form industry sponsors. Such agreements were
(available at: http://www.ucbraid.org/rmr). used in 38% of the trials in this study
The Network then partnered with UCLA’s (n=218), but not in the remaining 62% of
CTSA evaluation team for statistical cases (n=362). While anecdotal reports
analysis. suggested a positive effect when using these
Data Cleaning and Normalization master agreements, the impact had not been
quantified until the Network’s study. Figure
Throughout and at the close of the
1 shows two metrics: (i) average days
collection period, the Network verified
between minimum documents received and
entries for accuracy and consistency, with a
first comments provided, and (ii) days to
final sample of n=981 contracts included in
contract terms finalized (n=581), both with
the database. The sponsor and clinical
and without master agreements in place.
research organization (CRO) names were

then normalized to eliminate
inconsistencies in data input. Incomplete or
withdrawn contracts were excluded from
this study, resulting in a sample size of

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On average, using a UCOP master participating in a clinical trial versus
agreement significantly reduced the time to receiving the standard therapy for their
complete the contracting process. Finalizing disease.
contract terms took 39 days on average with Industry Sponsors with/without UCOP
a master, versus 73 days without. This Master Agreements
represents a significant reduction of 47% Figure 2 compares industry sponsors
(p<.001) in negotiation time when UCOP with (n=36 sponsors/216 contracts) and
master agreements are used. without (n=224 sponsors/349 contracts)
The evidence from this study strongly UCOP master agreements. The scatterplot
demonstrates that the UCOP approach to in Figure 2 graphically displays the
negotiating master agreements with relationship among volume of contracts per
industry sponsors is a highly effective and sponsor, average days to finalize contract
successful strategy. Having master contracts terms, and having a UCOP master
in place equates with a reduction of almost agreement. Unsurprisingly, industry
50% in average days to finalize the contract. sponsors with master agreements had
Such a reduction can speed the launch of significantly more contracts on average (6
clinical trials, resulting in decreased costs compared to 2 contracts; p=0.0002), as well
for sponsors and institutions alike (DiMasi as significantly lower average days to terms
et al., 2003; Rijswijk-Trompert, 2012). For finalized (46 compared to 76 days;
patients, this reduction increases access and p<0.0001).
options to participate in clinical research,
and can mean the difference between

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Simply put, leveraging one contract intersects with contract execution and the
negotiation for multiple studies is most UC campuses are looking internally and
efficient. Having a master agreement in across their sister sites to identify
place is a strong positive factor when approaches to streamline this step.
analyzing study feasibility for the site, CROs Increase Negotiation Time
especially when considering multiple, and Contracting with Clinical Research
competing, trials. For this reason, the Organizations
Network plans to: (i) expand the number of The Network examined the average
master agreements through further time to finalize contract terms when a
collaboration with the UC Office of the Clinical Research Organization (CRO)
President and major sponsors; (ii) continue participated in the negotiations. Figure 3
to enhance collaborations in the contracting shows CRO participation in 34% of new
offices at the five UC CTSAs; and (iii) contracts (n=566), but the most notable
research benchmarks from other CTSA results in Figure 3 indicate that CRO
institutions to compare their results with involvement in the contracting process
those generated by the UC BRAID Network. significantly increases the time required to
Even with master agreements in place, negotiate the contract—65 days compared
budget negotiations may introduce a to 57 days without a CRO (14% increase in
significant time delay in finalizing contracts. duration; p< .01).
Budget negotiation is a key process that

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While billed as facilitating sites, there was considerable variation in
organizations, CROs can introduce throughput for clinical trial contract
complications in the negotiation process execution. Time (in days) from minimum
that may not exist with direct interaction documents received to first comments
between sponsors and contracting offices. provided was significantly different across
The Network recognizes this as an area for the five sites (p<0.0001), ranging from a low
concerted improvement and will devote of 6 days (campus D) to a high of 33 days
resources to that end, such as exploration of (campus A). Days from first comments
CRO master agreements. provided to contracting terms finalized was
Local Factors Influence Turnaround also significantly different (p<0.0001),
Time ranging from a low of 15 days (campus D)
Contracting Compared among the to a high of 59 (campus C). In both cases,
Five UC Campuses analysis of variance was used to test the
Owing to differences such as resources mean difference in days across the five sites.
or the scope of responsibilities between

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The Network’s performance other duties and obligations that affect
improvement study started with examining performance, such as budget development
minimum documents required for finalizing and coverage analysis.
contract terms for each trial. It also PI-initiated versus Sponsor-initiated
distinguished between documents collected Contracts
within the contract offices and those Historically, PI-initiated clinical trial
collected in other functional areas, within agreements accounted for less than 5% of
which the Network has no leadership the industry-funded clinical trial
authority or workflow control. The agreements received by UC. A PI-initiated
Network analyzed the variations in metrics clinical trial is led by a UC faculty member
among the campuses for informing the who has authored the protocol and holds
performance improvement priorities. the Investigational New Drug Application
Other institutional factors that influence (IND) or an Investigational Device
the Figure 4 results include volume and Exemption (IDE). That number has been
variability of contracts per campus, staffing increasing in part because UC has been
resources (contracts per FTE), knowledge, more involved in the development of
experience, and training of staff, and useful treatments, making UC the sponsor of these
and accessible reference guides for staff. projects.
Additionally, some contracting offices have

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Figure 5 shows that PI-initiated sponsor. This manifests in considerations
contracts (n=30) take longer to complete such as inventions and intellectual
than sponsor-initiated contracts (n=536). PI- property, data and publication rights, and
initiated contracts averaged 70 days to more complicated liability and
finalized terms, whereas sponsor-initiated confidentiality negotiations. Finally,
contracts took an average of 59 days. Due to sponsors are typically less motivated to
the paucity of PI-initiated contracts, this begin a PI-initiated study, as it is not theirs.
difference was not statistically significant. In some cases, and particularly with
However, PI-initiated studies are frequently early phase studies, sponsors may be
of greatest concern to faculty, despite their concerned about the openness of UC
small number. In addition, members of the research, postponing the negotiation to
Network note that PI-initiated contracts are conduct the study in a more confidential
rapidly increasing in number and setting before making results public. Given
importance. that these types of projects are becoming
PI-initiated trials require substantially more common, the Network is focused on
more time to negotiate for several reasons. developing resources, including master
First, only a small handful of PI-initiated agreements, to assist contract offices in
master agreements exist. Second, the reducing the overall burden of these
increased intellectual contribution from UC negotiations.
changes the dynamic with the funding

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Research Management Review, Volume 22, Number 1 (2017)

Intra- and Inter-Organizational liberate them from sequential or serial
Dependencies processing, allowing each functional unit
A common (mis)perception at research (e.g., IRB, coverage analysis, COI, etc.) to
institutions is that contracting processes move forward unrestrained. The gold
cause delays in study activation. Despite standard is clearly parallel processing
those perceptions, the study revealed that (Logan, 2002), and to increase its
this is rarely the case within UC. In fact, of application, UC must work collaboratively
the 581 new contracts executed, 86% to bring historically isolated departments
completed negotiation of the terms (i.e., together. The Network sees this as an
confidentiality, publication, intellectual opportunity to test and implement more
property) on the same day, or even before, efficient parallel processing procedures
approvals were secured for IRB, conflict of while breaking down silos.
interest (COI), and/or completion of budget The Need for Shared Technology
negotiation and coverage analysis. These Realizing the full benefits of parallel
results indicate that contract negotiation is processing and mitigating redundant effort
not the prevalent rate-limiting step. requires a range of technological capabilities
This is not to suggest that other to share information both within and
institutional approvals are the lone between campuses.
bottleneck in the complex and One real-world example of such a
interconnected march toward study shared technology is UC TrialQuest, a UC-
activation. Rather, these results highlight wide database of clinical trials in the
the need for parallel processing, process of, or having received, IRB approval
information sharing, and supportive over the past three years. Originally
technology. As evidenced by Anderson’s deployed in 2014, TrialQuest gives a
Project “Zero Delay” (Kurzrock et al., 2009), window into the UC clinical trials portfolio
dissecting interdependent processes can with up-to-date information from the five

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