Developmental Therapeutics for Providers/Pharma

What should providers know about Phase I clinical trials?

Siteman specializes in first-in-human studies that are typically very small (20-50 patients). We also conduct a great deal of investigator-initiated trials (IITs), where one of our doctors works with a drug company to initiate their own protocol. Siteman is a highly sought-after partner for trials, with studies coming from smaller companies, non-American companies, and large pharmaceutical companies.

Leadership in Siteman’s Phase I clinical trial program

• Brian Van Tine, MD, PhD: Co-Director, Medical Oncologist
• Katlyn Kraft: Acting Manager/Clinical Research Specialist (Clinical Operations)
• Jessica Porzel: Clinical Research Specialist (Data Operations)
• Katie Navo: Nurse Practitioner

Drs. Park and Van Tine are working to create a new direction of focus on first-in-human studies and to develop Siteman’s IITs.

What makes Siteman in particular such a coveted destination for patients in search of a Phase I clinical trial?

Washington University Physicians at Siteman are repeatedly recognized as some of the best in the world. They provide patient care that is thorough, and a level of attentiveness that is unmatched. Additionally, Siteman is centrally located for the entire country, making it easily accessible. We have many resources that community hospitals and physicians in private practice may not; combined with our central location, this means that we can provide first-rate care that might not otherwise be available to people in rural areas.

Is there ever a reason why a patient should not take part in a Phase I clinical trial?

Patients must be well enough to receive investigational drugs, so someone who should be going on hospice wouldn’t be able to tolerate them. It is also difficult to determine if the side effects such a patient might experience would be due to the end stage of their cancer or due to the drug, making it hard to discern what effects the drug actually produces.

What clinical trial resources are available at Siteman that providers should know about?

Washington University Physicians at Siteman have outstanding clinical expertise and experience in conducting clinical trials. Our faculty are collaborative: they keep providers engaged and are willing to send patients back to their referring physicians after the trial or if the trial is no longer providing benefit. Additionally, our faculty are willing to speak with referring physicians about their patients’ care to ensure that their patients receive the treatment they need.

How do those resources apply for those in the pharmaceutical industry?

Siteman is one of the highest-accruing institutions in the country for clinical trials because we have great access to many patients. We also have scientists who are closely engaged with our physicians, providing a wealth of knowledge in both clinical care and research.