Oncology

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The Oncology Clinical Trial Support Unit (O-CTSU) serves as the centralized core facility of clinical research trials conducted by investigators at the University of Michigan Rogel Cancer Center and Michigan Medicine community. This includes investigator-initiated, peer-reviewed clinical trials, NCI-CTEP approved protocols, pilot transitional institutional studies, cooperative group trials, and industry-sponsored trials.

The O-CTSU offers a broad range of expert services and experiences to investigators to help them facilitate the conduct of their studies according to federal regulations and Good Clinical Practice (GCPs). Within the entire O-CTSU, 44% of staff have over five years of experience with the department and 20% have over 10 years of experience.

The O-CTSU uniquely supports investigator’s reporting requirements for NCI's Cancer Center Support Grant (P30) and Clinical Trials Reporting Program. Through the O-CTSU, the Rogel Cancer Center provides free services to support U-M's NCI oversight obligations: single-site monitoring of investigator-initiated trials, auditing, informatics and database development, protocol editing and committee support. The O-CTSU has a sizable study coordinator pool specialized in-clinic support, specimen processing, data management, regulatory and multisite coordination; 55% of the staff are Certified Clinical Research Professionals. The Rogel Cancer Center may also subsidize these services through a Cancer Clinical Trial Award. For more information about our services, visit https://cto.med.umich.edu.

IS YOUR STUDY A CLINICAL TRIAL?

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.

If you answer yes to the following questions, then your study qualifies as a clinical trial:

  • Does the study involve one or more human subjects?
  • Does the study involve the use of one or more interventions?
  • Does the study prospectively assign human subject(s) to an intervention(s)?
  • Does the study have a health-related biomedical or behavioral outcome(s)?

Learn more about the NIH Clinical Trial Definition at nih.gov.

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HOW WE SERVE YOUR CLINICAL TRIAL NEEDS

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Feasibility Review Support
The Feasibility Review, conducted by the appropriate CTSU, looks at the whole picture of a potential clinical trial to prevent unexpected challenges in its execution and to open to accrual in a timely manner. LEARN MORE.

 

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Pre-/Post-Award Support
Clinical Trials Support Units keep studies on track during the pre- and post-award process. A CTSU portfolio manager follows a study along its lifecycle and assists teams on their path to study activation. LEARN MORE.



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Study Coordinator Support
Principal Investigators can ultimately find a smoother process and save time by taking advantage of our study coordinator pool, which can provide investigators with team members who are already on staff and fully trained. LEARN MORE.
 

METRICS

925 oncology studies          89 oncology principal investigators          1527 oncology study subjects

FACULTY AND STAFF

Medical Directors

Christopher Lao, M.D.
Scott Schuetze, M.D., Ph.D.

Lead Administrator

Mathew Innes, M.B.A.innesm@med.umich.edu, 734-763-4073 

 

Questions?

Contact us at CTSU.Oncology@umich.edu

University of Michigan Rogel Cancer Center, 1500 East Medical Center Drive, Ann Arbor, MI 48109

A list of Oncology CTSU contacts are available in the Oncology Personnel Directory.