Clinical Trials: The Regulatory Process: Ensuring Safety and Efficacy скачать в хорошем качестве

Clinical Trials: The Regulatory Process: Ensuring Safety and Efficacy

"Clinical trials are essential for advancing cancer treatment" "Measuring the disease, liquid biopsies, emerging biomarkers" "Immunotherapies and CAR T-cell therapy" "We sort of always have to balance that even as we go through the drug, drug investigational process and approval process." "Observations we see in clinical trials are not always predictive of the real world." "There's inadequate demographic representation in clinical trials." "Peritoneal disease may not be able to be detected on cross-sectional imaging" "The peritoneal microenvironment is very immunosuppressive" "Hyperthermic intraperitoneal chemotherapy may be a therapeutic alternative" Chapters 00:00 Introduction and Housekeeping 02:36 Patient Story: Treatment Response and Clinical Trial Eligibility 07:15 Overview of Clinical Trials and Phases 13:42 Types of Clinical Research Studies 21:48 Phase 2 Clinical Trials: Efficacy and Biomarker Specificity 25:29 Phase 3 Clinical Trials: Comparing New Treatments to Standard of Care 28:03 Phase 4 Clinical Trials: Real-World Effectiveness and Safety 29:29 Introduction to FDA and Oncology Center of Excellence 36:22 Challenges in Cancer Drug Development 38:14 Ethical Concerns and Trial Design 39:12 Conclusion and Q&A 39:42 Limitations of Clinical Trials in Predicting Real-World Outcomes 42:00 Importance of Demographic Representation in Clinical Trials 45:14 Phases of Drug Development and FDA Review Process 51:53 Different Endpoints for Assessing Drug Efficacy 01:11:42 Challenges in Managing Peritoneal Metastasis in Gastric Cancer 01:19:13 Challenges and Barriers in Peritoneal Carcinomatosis 01:21:58 Diagnostic Laparoscopy and HIPEC as Treatment Strategies 01:22:27 Immunotherapy in Gastric Cancer Treatment 01:24:18 Oncolytic Viruses and CAR-T Cell Therapy 01:49:54 Genetic Testing for Stomach Cancer