Leadership vital for efficient multicenter clinical trial, according to study

Leadership, clear protocol and careful site selection are critical in running a multicenter clinical trial, according to new analysis.

The research sought to identify elements common to successful multicenter studies in a bid to give sponsors and contract research organizations tools to make drug development efforts more likely to succeed.

“Multicenter research can be applied to most study designs, from purely observational to randomized clinical trials. However, not all research questions require a cooperative study to be answered,” the authors wrote.

“Although with definite advantages, multicenter studies are obviously more complex and costly than studies in which only one site is taking part. It is therefore necessary to be clear when, how, and why we should conduct this type of study.”

Leadership – ideally by an experienced principal investigator – that has overall control and responsibility for the trial is one of the success criteria highlighted by the research.

“A multicenter trial has to have an identifiable leader, a principal investigator, who must be able to effectively direct collaborators and keep the project on track and under control.

“Some might think that the best way to lead a multicenter study is to have a large group of people, to form a large committee. However, experience shows that this strategy tends not to be very successful. Concrete and solid leadership is essential,” the authors wrote.

The research also underlined the value of having clear objectives for a multicenter study, particularly for the investigator in charge of the program.

According to the authors, “The objectives are one of the most important parts of a research proposal. They are goals that the investigator sets in relation to the aspects they wish to investigate and learn about.

“The objectives act as pillars that guide the research and direct the search for answers throughout the journey. Properly defining the objectives in a multicenter study is fundamental in ensuring that the results are relevant, and the impact of the research maximized.”

Site selection

The other main success metric identified in the research was appropriate site selection which, according to the authors, should be a focus for the principal investigator.

“One of the most important decisions a principal investigator has to make concerns which investigators are going to participate in their multicenter study, as reaching recruitment targets and maintaining quality standards and, hence, obtaining valid results sufficient for making rigorous conclusions, will all be dependent on the people selected. Choosing the right investigators in a multicenter study is therefore one of the most important factors for a project.”

Unsplash/Markus Spiske