START Midwest Phase I clinical trials program consists of a team of leaders in research and support personnel with extensive experience in oncology-drug development and patient care for cancer. We are guided by the highest standards and a genuine commitment to ensuring the utmost integrity and quality. This includes an uncompromising dedication to patients’ needs and safety.
OFFERING NEW HOPE WITH THE CANCER TREATMENTS OF TOMORROW.
START Midwest is the largest non-academic-institution Phase I medical oncology programs in the Midwest. START Midwest is involved in the investigation of many promising new anti-cancer drugs. This means people who are not responding well to other medications or forms of treatment can be given new alternatives… and the hope they need in their battle against cancer.
Investigational Drug Section
START Midwest Investigation Drug Section (IDS) provides pharmaceutical services for Phase I investigational study treatments as well as for conventional chemotherapy treatments. The IDS is run by a board certified oncological pharmacist and staffed by highly capable pharmacists and pharmacy technicians. Our IDS team works with pharmaceutical companies in the development of new anti-cancer agents, including determining methods for administering new medications and conducting extensive medication screenings for all patients enrolling in our Phase I clinical trials. They also assist our physicians in providing supportive care, including pain management.
Phase I Clinic
Our Phase I clinic is staffed by a variety of specialized team members, from registered nurses and research nurses to study coordinators, clinical research assistants and medical records specialists. Our clinic staffers are all dedicated just to our Phase 1 program, and are trained and experienced in good clinical practices in the field of oncology. In our dedicated exam rooms, our doctors assess patients carefully to document, grade and attribute adverse events, ensuring accurate assessment at the point of contact with immediate data entry. The clinic also features a dedicated research treatment room, where we administer IV infusions and oral drugs, and we collect pharmacokinetics, pharmacodynamics and other specimens. START Midwest’s experienced data-management team diligently coordinates all aspects of monitoring patient visits and maintaining impeccable, reliable scientific data.
Regulatory Affairs Department
START Midwest’s Regulatory Affairs Department exists to gain necessary approval from the Institutional Review Boards (IRBs) to enroll patients appropriately in investigational studies at START. The department ensures compliance with all regulatory and industry requirements, following FDA guidelines and good clinical practices for every study. Regulatory Affairs also maintains the database of all pertinent information about and for each study. Regulatory issues are centrally important to clinical trials and essential for ensuring the safety of every patient enrolled in a study, and there are numerous details and obligations, all of which our RA team handles with experience and dedication to excellence.