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The Complexity of Conducting a Multi-Center Clinical Trial: Taking it to the Next Level Stipulated by the Federal Agencies.

Randomized controlled trials (RCTs) are becoming increasingly difficult to organize and conduct efficiently. This, in turn, hinders the ability to derive highest level of evidence. Often investigators forget or remain unaware of essential practices that will help them fulfill their study goals. This manuscript emphasizes the common issues that a study team experiences during the planning and conducting of RCTs. We sought to share remedies to overcome these issues with the experience garnered in conducting several multicenter clinical trials and observational studies. Additionally, we list resources from sponsors like the National Institutes of Health and the United States Food and Drug Administration that study teams can apply to undertake studies effectively.