Knowledge ramp up on clinical trials & protocol A clinical trial is a research study conducted to evaluate the safety, and efficacy of medical interventions such as drugs, devices, or treatments on humans. These trials are often conducted in phases to progressively assess the intervention's safety, dosage, and therapeutic effect. The clinical trial protocol is a detailed plan that outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial. It ensures the trial is conducted consistently and ethically, providing a framework for how the study is carried out and how data is collected and analyzed. Following the protocol is crucial for the validity and integrity of the trial results. The two major reasons a clinical protocol gets delayed or causes delays in the clinical trial timeline are:
• Patient Recruitment and Enrolment Challenges: Stringent patient inclusion & exclusion criteria can lead to difficulties in identifying and enrolling the right patients can significantly slow down the trial process.
• Protocol Amendments: Unanticipated amendments to the protocol, often due to changes in trial design or new regulatory requirements, can lead to considerable delays.
