World leaders in Phase I Clinical trials
We have the know-how you need.
Phase I Trials
The START Center’s Phase I clinical trials program consists of a team of world-leader researchers 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
With one of the largest non-academic-institution Phase I medical oncology programs in the world, the START Center for Cancer Care is involved in the investigation of as many as 40 different 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. Our Phase I clinical trials program has helped bring 19 new anti-cancer drugs to market, and we remain committed to improving cancer care around the world with top-quality research. Here’s how:
Investigational Drug Section
START’s 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 with a combined 35 years of experience. 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. And START’s experienced data-management team diligently coordinates all aspects of monitoring patient visits and maintaining impeccable, reliable scientific data.
Regulatory Affairs Department
START’s Regulatory Affairs Department exists to gain necessary approval from the Institutional Review Board (IRB) to enroll patients appropriately in investigational studies at START. The department ensures compliance with all regulatory and industry requirements, following FDA, EMA, and GCP guidelines for every 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 regulatory team handles with experience and dedication to excellence.
Tumor Bank
As part of our Phase I clinical trials as well as our conventional cancer care, the START Center maintains a “tumor bank.” This is a cache of information and tissue that cancer researchers at START and elsewhere can use to help develop new anti-cancer agents.
To learn more about START’s world-class Phase I clinical trials program, or to enroll in a study, call 210-593-5700. You can also request an appointment using our easy online form.