Clinical trials of new cancer treatments have historically focused on disease type by tumor location: breast cancer, brain tumor, colon cancer and so on. With advances in medical oncology and genomic characterization of tumors, we are now able to test new therapies that target a single biomarker in multiple tumor types by conducting “basket trials.” This ability has created a paradigm shift in oncology trials.
In basket trials, cancers with differing histologies are pooled and the common element is a singular genetic mutation or protein alteration. The biomarker may be a protein or a DNA alteration. The tumors of interest are grouped in baskets for the analysis. The basket trial tests a drug that targets a common biologic process. Because of the different tumors involved, the recruiting physicians may represent many different areas of specialization.
In choosing participants for basket trials, there are certain key parameters that should be taken into consideration. This webinar will help attendees understand the differences between these trials and historical oncology trials, will shed light on key basket trial considerations and will use specific examples to help attendees gain knowledge.
Julia Lawrence, DO, Senior Medical Director and Head Oncologist, Synteract
Julia Lawrence, DO is a medical oncologist with over 20 years of clinical oncology experience and three years of experience as a medical monitor and medical advisor in a clinical research organization. She has worked on clinical trials in malignant hematology and oncology. Julia’s responsibilities for projects include aspects of team therapeutic training, strategic and scientific oversight and support, including assistance in study start-up activities as well as assistance in the analysis and clinical interpretation of trial results. Julia was trained in medical oncology at the National Cancer Institute where she remained on faculty for three years followed by academic oncology for 15 years.Message Presenter
Who Should Attend?
VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
In this free webinar, attendees will:
- Learn the clinical significance of the biomarker on prognosis and the impact this can have on potential trial participants’ motivation to participate in the basket trial
- Understand the biomarker and the methodology used to test for it
- Learn strategies for selecting and managing sites for basket trials that ideally include multiple medical specialists who can collaborate on one clinical trial
- Gain insight on how adaptive and flexible operational conduct from an experienced CRO study team allows for critical readiness to respond to inevitably shifting outcomes
With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. It has contributed to more than 240 product approvals. Synteract offers a notable depth of therapeutic expertise in oncology, dermatology, and neurodegeneratrive indications, as well as rare and orphan, pediatric, and immunotherapy studies.