At present, there is no centralized resource at RPCI that specializes in facilitating and improving the quality of research data collected from clinical and population-based samples, although other comprehensive cancer centers including the Mayo Clinic Cancer Center, the University of Wisconsin Comprehensive Cancer Center, Fox Chase Cancer Center, and the University of North Carolina Chapel Hill do have such core services. Having an in-house capability with this collaborative resource will allow for centralized data collection with built-in checks and balances with study logistics. In addition, in house service allows for more flexible project scheduling as well as ease in facilitating protocol implementation and amendments with Clinical Research Services. Consolidating all these capabilities under a single umbrella will reduce operational costs.

Reliable, cost-effective modalities for collecting data from both clinical and population-based samples are necessary for many research projects that span across multiple disciplines and research program areas. Examples of such transdisciplinary data collection efforts include clinical patient follow-up and surveillance, measurement construct validation, and biospecimen collection from large population-based samples.

The initial motivation for developing an RPCI data collection resource was the observation that in just one department (Health Behavior) over $3 million dollars has been spent on outsourced data collection subcontracts in just the past 4 years, the bulk of which is from NIH supported grants. Given our experience in managing contracts for data collection efforts, we felt we could do the work with comparable quality and greater oversight for much less money. On a pilot basis we implemented some initial data collection work, and this proved to be successful, resulting in more monetary resources for RPCI investigators. Therefore, the major goal is to expand the scope of this initial work to cover a more diverse pool of investigators with the aim of promoting inter-disciplinary peer-review funded research.

Background to Date

SRDAR originated in the summer of 2004 initially working on one project from a funded grant to Dr. Hyland in the Department of Health Behavior. This created the opportunity to hire staff and to create the necessary infrastructure for SRDAR. Given the success of that initial project, additional collaborations evolved within the Cancer Prevention Research Program, the Genetics Research Program, Clinical Research, and several outside organizations.

In just over 24 months, SRDAR has grown to have a large staff. SRDAR is led by Andrew Hyland, PhD and he is responsible for the overall scientific direction of the resource and for generating resources. Amy Van Deusen is the Scientific Director who is responsible coordinating the scientific design, implementation, and reporting of projects. Lisa Hatch is the Administrative Director who is responsible for coordinating and training staff as well as ensuring maximum quality. Barb Battistella is the Informatics Director who is responsible for information transfer and database management.

A total of 39 projects have been undertaken including 8 supported by peer-review grants and 7 that involve other research programs outside of Cancer Prevention. A total of $1.1 million in chargebacks have been generated to SRDAR of which 40% comes from NIH grants. A complete listing of SRDAR projects, the investigators and research programs collaborated with, chargebacks billed for, and current status of that project is given is the Appendix.

In addition, because SRDAR is housed within RPCI, it facilitates rapid project development and field work that is typically not possible when identifying outside vendors to subcontract with. For example, a Cancer Prevention member (Gary Giovino) submitted an R01 and received a good score but outside the fundable range. A major comment that needed to be addressed was to collect some pilot data to support the feasibility and reliability of obtaining the necessary survey data. These data needed to be collected in a very short time window due to the time sensitive nature of the project – delays would have made the research hypothesis moot. Drs. Giovino and Hyland developed a study plan and within weeks a large scale pilot survey and a series of reliability studies were performed in time for the next resubmission at a discounted cost. The grant subsequently a (0.2 percentile) and was funded forTDC. Without SRDAR, these data would have not been collected and the grant would not have been obtained.

Personnel

CCSG support is needed to provide some stability to the Resource for higher level administrative staff. Because the nature of the work flow typically involves periods of heightened activity as well as periods of reduced activity, it is necessary to have some staffing flexibility. However, a minimum level of dedicated support is needed to maintain highly trained and specialized managerial staff to perform core administrative functions during periods of resource scarcity. To date we have been able to keep SRDAR near maximum capacity since its inception, and we will strive to continue to do so. However, at present without additional administrative support a funding lapse of even a few weeks cannot be tolerated and core staff would have to be let go. The proposed CCSG budget request is at a level to provide some stability for core SRDAR staff. Chargebacks will be used to supplement the remaining personnel needs for SRDAR administrative staff as well as to cover 100% of all hourly data collection personnel.

Total staffing requirement for SRDAR to maintain its function at its current level as well as more details on each staff member is given below:

Andrew Hyland, PhD, Resource Director, 20% effort
Amy Van Deusen, Scientific Director - 100% effort
Lisa Hatch, Administrative Director - 100% effort
Barb Battistella, Informatics Director – 100% effort
Data Collection Staff – 20 FTE

The current Personnel structure of SRDAR is as follows:

Click here to see the SRDAR Organizational Chart

Andrew Hyland, PhD is the Director of the Resource and is responsible for its management and operation. Dr. Hyland is an Associate Member in the Department of Health Behavior and a member of the Prevention program. He is an epidemiologist by training and also has a masters degree in statistics. Before Dr. Hyland developed his own research program, he was a member of the Biostatistics Core Resource and he is familiar with the necessary components in order to make a core resource successful.

Amy Van Deusen, MPH is the Scientific Director of the Resource and is responsible for developing data collection protocols for specific projects. Ms. Van Deusen has a masters degree in public health and has extensive experience implementing complex data collection logistical protocols not only from her current role in SRDAR but also from her previous work at the Center for Health and Social Research at Buffalo State College. Ms. Van Deusen operationalizes the data collection procedures and her skill and experience are critical to the successful operation of the Resource. She collaborates with various other entities on campus such as Creative Services, the Print Shop and the mailroom to coordinate and meet various project needs. Ms. Van Deusen works closely with Clinical Research Services staff throughout all stages of protocol development, submission, review and termination to ensure compliance with Institute policy and procedure, science and ethics. She has developed positive working relationships with valuable resources outside the Institute which she works with to meet survey sampling needs, tracking services and specific database access. Ms. Van Deusen monitors all project stages to maintain the scientific design and protocol procedures and to ensure the integrity and value of final deliverables.

Lisa Hatch is the Administrative Director of the Resource. In addition to being responsible for the day to day activities, her focus is on implementing the data collection protocols. With a staff of 37employees, Ms. Hatch recruits and trains staff and implements measures to ensure the highest quality of data collection. With 15 years of health care experience, including upper level management positions at both Kaleida Health and Univera Health Care, she brings with her a great deal of knowledge and experience in finance, customer service, sales and marketing, and operations. She has a reputation of finding "out of the box" solutions to obstacles and ensuring that the customer's needs are met beyond their expectations.

Barb Battistella is the Informatics Director of the Resource and is responsible for managing the data flow for all projects. Ms. Battistella has 15 years previous experience in this capacity in call centers at the Research Institute on Addictions and Buffalo State College. She develops and troubleshoots programs for survey implementation, reports to monitor study and staff progress, and databases for investigators.

A staff of 37 employees performs the necessary data collection work. SRDAR has conducted several different types of data collection activities and staff are trained accordingly. Examples of different data collection efforts include random population-based telephone based phone surveys, clinic follow-up telephone surveys, web-based data collection, in person school based data collection, biologic sample collection through the postal service, and focus groups.

Facility Location and Future Site Projections

The main SRDAR data collection activities occur in Carlton 145. This room is approximately 893 square feet and accommodates 16 telephone interviewing workstations in addition to office space for Ms. Van Deusen and Ms. Hatch (for a total of 18 workstations). Data-oriented activities take place in shared space in Carlton 112, in which SRDAR occupies approximately 187 square feet and houses 4 computer workstations which are used for data entry and telephone interviewing activities, in addition to office space for Ms. Battistella (for a total of 5 workstations). In addition, Dr. Hyland’s office is located in Carlton 320.

Charge-Back Plans, Identified Billable Services and Fee Structure

Because of the diverse nature of the SRDAR data collection projects, a single fee structure is not possible and each project will need to be priced individually. However, for most projects the following chargeback guidelines are fairly accurate, which is based strictly on the estimated number of data collection hours required for the project. Below are some overarching categories of expenses that will be used to generate

Data Collection Expenses: This is based on the estimated number of hours required to complete the data collection. The rate in 2006 is $12/hour, which covers staff wages and fringe benefits.

Management Expenses: For each project, management expenses are required to develop the study plan, acquire IRB approval if needed, program data collection instruments, recruit, train, and monitor staff, and produce a report. The charge for management expenses is equal to the cost for data collection expenses.

Fixed Expenses:, This is based on fees, which we incur in order to collect the data and include items such as long-distance calling, advanced letter or postcard printing including supplies, postage charges, address hygiene services, incentives, and telephone list purchases. These charges will be passed onto the investigator without markup.

Overhead Expenses: In order to maintain and grow SRDAR, resources are needed to upgrade hardware/software and to pay key management staff during lulls in data collection activity. These resources will come from overhead expenses charged to projects. A 3-tier overhead system is proposed:

1. RPCI investigators with a peer-reviewed project will be charged an overhead rate of 10%

RPCI investigators without a peer-reviewed project will be charged an overhead rate of 25%
Non-RPCI investigators will be charged an overhead rate 50%.

Like all other CCSG core resources, priority will be given to investigators that have peer-reviewed grants.

Current and Potential Users (if feasible, group by service categories)

A total of 40 projects have been completed with a total income of $1.1 million. Initial projects have focused on the Prevention program reflecting the source funding for SRDAR, although there are projects that have involved the Genetics program, Clinical Research, and outside collaborators. Nine completed projects are from peer-reviewed grants representing 40% of SRDAR’s income.

The initial development of SRDAR has proven successful as we have demonstrated that the resource can be created to service the limited pool of investigators in the Prevention program. The plan over the coming 12 to 24 months will be to maintain these strong ties to the Prevention program and to expand to other science programs and to clinical areas.

One area we see tremendous potential for growth into other research programs is through the collection of biospecimens from large, population-based samples. For example, SRDAR is currently collecting saliva samples from thousands of smokers who have been tracked since 1988 but are scattered throughout the country for DNA analysis on an R01 examining the genetics of smoking cessation. Plans exist to apply this data collection technique to facilitate large scale studies of the genetics of cancer in pre-existing cohorts and to look at changes in immunologic markers of disease progression obtained from buccal scrapings. Currently SRDAR is implementing a pilot study to supplement the P50 TTURC grant of Dr. Cummings to further refine the methods needed to do studies like this in the US as well as in international cohorts of participants in Australia, the United Kingdom, Canada, Mexico, and Uruguay.

We are also developing stronger collaborations with members of the clinical staff at Roswell Park Cancer Institute. For example, SRDAR has served as the data coordinating center for a phase II study of a novel therapeutic agent for smoking cessation led by Dr. Mahoney. This experience has subsequently led to similar roles in another smoking cessation trial and a clinical study of the effects of secondhand smoke exposure. Expansion of SRDAR into the clinical area will involve similar sorts of collaborations and it could also take the form of assisting with patient follow-up data collection for ongoing clinical studies.

A third area of growth will come from investigators at the University of Buffalo and at other institutions. We have made little effort to market SRDAR outside of RPCI, although there is a tremendous opportunity. In Western New York, there are a few marketing research firms, there are not really any academically and scientifically grounded data collection groups; however, there are many investigators at local hospitals and universities that have data collection needs. In addition, SRDAR can offer very competitive pricing relatively other data collection firms nationwide because of WNY’s large available pool of service workers and low cost of living, which translates into lower labor costs.

Once given the support of the Roswell Park Cancer Institute to support SRDAR as an Institute Resource, we will embark on a focused marketing program to let other investigators know about SRDAR and the services it can provide. We will develop a brochure describing SRDAR that will be widely disseminated and also set up individual appointments to key investigators in other research programs to determine if SRDAR can add value to ongoing or planned studies in other research areas. A more formal marketing plan will be developed as the need to expand to other programs increases.