Abstract

Clinical Trial of a Targeted Therapy in Patients with Advanced Cancer

Author(s): Ali Mohammed

Clinical trials play a crucial role in the development and evaluation of new medical interventions, including drugs, therapies, and medical devices. These trials are carefully designed research studies conducted on human subjects to assess the safety, efficacy, and potential side effects of these interventions. The results obtained from clinical trials are essential for regulatory approval, clinical practice guidelines, and informed decision-making in healthcare. Phase 3 trials involve larger sample sizes and compare the new intervention with standard treatments or placebos to establish its efficacy and monitor adverse events. Phase 4 trials, also known as post-marketing surveillance, occur after regulatory approval and involve monitoring the intervention’s long-term safety and effectiveness in a broader patient population. Patient safety and ethical considerations are of utmost importance in clinical trials. The trial design must adhere to ethical principles, such as informed consent, privacy protection, and minimizing harm to participants. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States, closely oversee clinical trials to ensure compliance with ethical guidelines and regulations