Statistical Support for Large-Scale Clinical Trials

Statistical ResourcesThe transformation of clinical trials at Michigan Medicine is one of the top five goals for the Great Minds, Greater Discoveries strategic research plan.

To support the growth of multidisciplinary and multi-site clinical trial opportunities, the Medical School Office of Research has partnered with the School of Public Health to expand service offerings, allowing investigators to tap into the expertise of the Statistical Analysis of Biomedical and Educational Research (SABER) Group, a unit of the Department of Biostatistics.

SABER offers a variety of support options for investigator-initiated multi-site trials, including study design, data and project management, clinical monitoring, and even development of customized apps for clinciat studies. This complements the menu of support that MICHR provides for single-site trials.

Questions can be directed to Rex Edwards, SABER’s Research Manager, at rexa@umich.edu.

Informational Event

Click here to view a recording of
the November 30 informational event. 

SABER webinar

 

 

 

 

 

FAQs

What services does SABER provide?

CLICK HERE for a comprehensive description of SABER services, including:

  • Statistical expertise
  • Data management
  • Project management
  • Clinical monitoring
  • Software development
  • Clinical research administration

How do I connect with SABER? How do I know whether to work with them or MICHR?

As with any clinical trial, investigators should complete the Clinical Trials Support Office's CTSU Intake Form. Information provided on this form will help that team determine whether your project data and statistical needs are a better fit for SABER or MICHR, and an introduction will be sent to the appropriate units.

Does SABER support single-center investigator-initiated studies or just multi-site studies?

SABER’s focus is on multi-site studies and it works most efficiently when handling those; however, SABER is capable of supporting, and currently supports several, single-center studies. As part of the partnership with MICHR, we have increased our focus on supporting those single-center studies that require a 21 CFR Part 11 compliant data collection system.

How much does SABER cost? What about MICHR?

Through the partnership between the School of Public Health and the Medical School, SABER can provide core administrative functions for Medical School investigators, with free initial consultations on study design and proposal development. All program-related activity is funded by sponsored programs (grant awards). SABER would partner with the investigative team and be supported on the submitted grant for the personnel and effort required to manage the roles that SABER has agreed to manage for the study.

As a part of its CTSA award, MICHR offers the following free services:

  • Regulatory support consultation and training
  • Research development consultation and grant editing services
  • Consultations on data management, partnership development, and biostatistics support
  • Connect U-M faculty with national Clinical Research Networks (CRNs) multi-site trial opportunities
  • REDCap training and software hosting

MICHR also provides other research support services priced on an hourly basis, including regulatory support, statistical support, and study monitoring. CLICK HERE for a more comprehensive list of MICHR services for clinical trialists.

What information does SABER need to provide a quote for my proposal?

Much of the information that SABER will need is collected on the CTSU Intake Form – the type of study, the program period, and the services needed. Other data that SABER will collect will be details about the number of patients and sites involved, the scope and type of the data collection, requirements for the Observational or Data Safety Monitoring Board and regulatory and safety reporting, and types of ancillary activities that may be involved, such as biorepository support or central pharmacy management.

Will SABER help me write my protocol?

SABER can definitely assist with developing a protocol. We encourage investigators to reach out to us as early in the process as possible. If we work together, part of our role will be to help prepare your study protocol, from helping to draft one from scratch to reviewing and commenting on an existing one. However, this service is not available as stand-alone support for a grant that would not include SABER's services. 

I don’t have a statistician, does SABER have one I can use for my research project?

SABER can provide statistical services for a research study, separate from other operational support. It is not our normal approach, but in some cases, it can be a good fit. The Clinical Trial Support Office can help determine if our statistical support is right for the project and, if there are additional questions, you can contact Giselle Kolenic (gkolenic@med.umich.edu) at SABER to discuss your project.

Does SABER have a Data Safety Monitoring Board (DSMB) I can use for my study?

SABER does not have an empaneled DSMB available for use as needed. As part of study development with partners, SABER will help identify DSMB members to impanel a Board that meets the sponsor’s requirements. SABER will also help contract and manage that DSMB during the course of the study if awarded.

Questions?

Contact us at CTSOgroup@umich.edu

1600 Huron Pkwy, Building 400, Ann Arbor, MI 48109

A list of CTSO-CTSU contacts are available in the Personnel Directory