The Developmental Therapeutics Clinic (DTC) receives funding from the National Cancer Institute (NCI) through a U01 grant (Principal Investigator: Mark Ratain, MD). Trials are typically sponsored by industry or by the NCI's Cancer Therapy Evaluation Program (CTEP).
Unique strengths of the DTC include a dedicated weekly clinic with four attending physicians/investigators and a Pharmacology Core Facility for collecting and storing specimens and conducting onsite analyses.
Areas of Unique Expertise
Although we have conducted many kinds of trials over the years, we have unique expertise and interest in the following areas. Please click on each area to see a list of related publications.
- First-in-human studies (phase I trials)
- Combination and drug-drug interaction studies
- Food-effect studies
- Organ dysfunction studies
- Pharmacogenomic studies
- Innovative trial designs
- Pharmacodynamic biomarker studies
The three DTC attending physicians have a combined more than 40 years of experience conducting clinical trials in oncology patients. From 2008-2012, we enrolled 675 patients on DTC trials.
Institutional Policies and Procedures
New trials require a number of organizational steps before opening to accrual, similar to the process at other academic institutions. On average, new trials without delays from the sponsor can be opened in 8-12 weeks. The critical steps are:
- Identification of a principal investigator (PI)
- Completion of an institutional IND application (if necessary)
- Review/development of protocol by PI and research nurse
- Review/approval of protocol by Clinical Trials Review Committee (CTRC) and Institutional Review Board (IRB)
- Contract negotiation and agreement
Additional details are available through UChicago Office of Clinical Research.
Contact for New Trials
Please contact Manish Sharma, MD, at email@example.com to discuss potential future clinical trials in the DTC.