Recently, we sat down with two of our experts here at Clinipace, Dr. Jurgen Frisch, MD, Chief Medical Officer, European Operations & Jo Ann Proper, Senior Clinical Research Associate and member of the Oncology Nursing Society and an Advanced Oncology Certified Nurse, to discuss the oncology clinical trial landscape. This Q&A looks at a few of the most commonly asked questions about the ever-changing clinical development landscape.
Q&A with Clinipace Oncology Experts
How has the integration of technology into early phase oncology trials changed the drug development landscape?
According to Dr. Frisch, “Targeted therapies typically come up based on mostly genomic diagnostic tools out of tumor samples, so today a specific genomic diagnostic evaluation of tissue is nearly standard in early phase oncology trials. In addition, the population analysis already included in Phase 1 becomes more important than in former times, perhaps even decisive (e.g., cancer vaccine development).”
Based on your experience, despite having the worst drug approval rates, why are high-performing sites and personnel critical for keeping Phase 1 oncology studies on track and streamlined?
Based on Jo’s extensive experience, “By supplying a large number of subjects quickly, trials are completed faster and, therefore, less money is being spent. Having experienced personnel is also key, as they are able to effectively run the trial with little diversion.” Dr. Frisch commented on the fact that oncology patients demand highly specialized and trained personnel with special knowledge on disease, drug induced effects and adverse effects. Highly trained personnel also likely have special knowledge of how to handle special diagnostic and therapeutic tools. Experienced sites have been trained on therapeutic-specific protocol, which is often more complex than other therapeutic areas.
As we look 5 years out, what does the early phase oncology trial landscape look like?
Dr. Frisch predicts that, “Five years from now there will be more targeted oncology therapies and that diagnostic tools will become more focused on the targeted tumor entity in the trial already in Phase 1.” In addition, Jo predicts almost all therapies under development will be targeted and that genomic testing will be standard of care. “Combination therapies will be developed based on tumor testing in vitro.” Finally, Jo feels there will be a greater focus on treating side effects and long-term complications.
To learn more about how developing a solid trial design, integrating technology and selecting high-performing sites and personnel can help streamline the conduct of your Phase 1 oncology trial and improve the quality of your trial data, download a copy of our whitepaper entitled, “Ensuring Success in Early Phase Oncology Clinical Trials,” at http://bit.ly/NyzYzl.