The process involves several key steps: 1. Study Design: Developing a robust protocol that outlines objectives, methodology, and endpoints. 2. Site Selection: Identifying and qualifying research sites that have the infrastructure and patient population to conduct the trial. 3. Patient Recruitment: Enrolling eligible patients while ensuring ethical standards are met. 4. Data Management: Collecting and analyzing data to assess the efficacy and safety of the treatment. 5. Regulatory Submission: Preparing and submitting documentation to regulatory authorities for approval.
