Organizing a clinical trial for the new investigator

Abstract

Background and purpose: Clinical trials organization can be daunting especially when orienting to a new system. The steps to a successful clinical trial are not concrete and vary based on the system.

Methods: In this section the discussion centers on how to shape the question for the clinical trial which is rational and feasible to answer within the planned study design.

Findings: Senior mentorship, collaboration and early involvement of stakeholders can help shape a successful clinical trial. Keeping in mind ethics and the processes within a system will make planning easier. Questions about key elements of the trial should be answered early to prevent delays of study initiation.

Conclusion: Clinical trial development and implementation can be very rewarding, but successful outcomes require careful planning and considerations.

Keywords: Clinical trials; Phase I trial; Phase II trial; Phase III trial; Randomized control trial.