Spotlight on MCRU
Part 1: Building Resources to Complete More Clinical Research Studies at U-M
Clinical research is an essential part of translating research from the lab to the patient bedside, and the pool of volunteers who are willing to participate in research trials is critical. To support clinical research studies at the University of Michigan, UMClinicalStudies.org has registered more than 10,300 potential volunteers and the Michigan Clinical Research Unit's (MCRU) extensive population of participants are actively associated with over 300 studies. In spite of these resources, the engagement and then the retention of the highly specific populations needed for clinical trials remains a challenge. Many PIs who initiate clinical research studies still face a "valley of death," where they either cannot recruit enough participants or cannot retain participants until the end of the study.
In collaboration with the MICHR Participant
Recruitment and Retention Group and the MICHR Evaluation Group, MCRU is
launching a study involving a survey of 1,000 participants along
with study coordinator and principal investigator focus groups to support the
successful completion of clinical studies. This will identify strategies to
combat the biggest challenges, including:
a) What does our current participant pool
look like? We cannot determine what populations are underserved until we know
who we are serving, so we will compile a detailed overview of our volunteers to
find out whether different age groups, genders, races and socio-economic groups
are represented fairly and, if not, how we can target our marketing to address
b) What factors motivate participants to
enroll and then, more importantly, stay on a research study and what could we
at U-M do to support them further?
c) How much of what is involved in their
study does a participant actually understand and how important is this in their
decision to complete the study or to volunteer again?
d) What factors contributed to the decisions
of participants who started and then dropped out of a clinical research study,
and what measures can we put in place to reduce the probability of it happening
MCRU is planning to have a preliminary report
available in June 2012 and a final report by October 2012. These will both be
available on the MCRU website.
Part 2: MCRU Biorepository
The MICHR Biorepository has enjoyed continued success and growth in the use of its services. Currently, the Biorepository is serving 20 unique studies, which average about 350 sample submissions per month.
The MICHR Biorepository and the Specimen Processing Core Lab offer seamless specimen management and controlled transfer to the Biorepository facility via twice weekly Metrocourier deliveries. Please visit the MICHR Biorepository homepage for more information.
Part 3: Bionutrition Core
Here are a few fun facts about our MCRU Bionutrition Core:
- Michigan tart cherries, two bags of 90 per day for 30 days, were delivered to and consumed by participants in Dr. Warber's "Pilot Study of Daily Tart Cherry Consumption in Humans with Metabolic Syndrome."
- 400 weighed bottles of water and 400 weighed containers of sugar are prepared for protocol 2799, "Taste Preference and Intensive Medical Weight Loss Intervention: Sweet Taste Study II."
- The bionutrition team telephoned 150 families more than 400 times to gather 24-hour dietary recall data in just six weeks this last fall for protocol 2744, "Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers."
- The bionutrition core is an integral resource for the Human Phenotyping Core,U-M's Nutrition Obesity Research Center
As a reminder to all faculty performing nutrition-related studies, the bionutrition core has research dietitians, a technician, and food service supervisors equipped to handle all aspects of clinical research. Our services include calculated diets and meals; body composition measurement via DEXA; diet analysis using 24-hour recalls, food diaries and NDSR analysis; and diet/nutrition counseling.
Part 4: MCRU is Developing New, Collaborative Business Models With Clinical Research Resources Across U-M and Across the U.S.
With funding bodies increasingly feeling the pinch financially, MCRU is reaching out to find new ways to streamline our business model without affecting the support available to our PIs or reducing the competitive advantage that an in-house clinical research facility brings our funding applications.
In collaboration with the U-M Comprehensive Cancer Center (CCC), we have initiated an analysis of 35 National Cancer Institute-accredited Cancer Centers across the U.S. to identify CTSA-CCC business models that work, synergies that delete repetition, and alliances that grow novel research partnerships. With a focus on Phase I centers, this research will identify areas of overlap, best practices, and lessons learned by experience, with particular regard to the different levels of clinical care and research experienced in CTSA and CC environments. These findings will be available to U-M staff and faculty in August 2012.
We are also co-chairing a nationwide committee, encompassing all 60 of the CTSA institutions, to examine business models for resource sharing and to improve and optimize the services we offer, ensuring we remain leaders among our peers. This report will be presented to the CTSA leadership in early summer and MCRU plans to have the final report available to U-M staff and faculty by the end of summer 2012.