The Importance of Principal Investigators as Leaders

Principal Investigators (PIs) have to juggle a lot in their day-to-day roles. The globalization of organizations has led to rapid changes in the work environment due to the cultural diversity of teams and the revolution in information and communication. PIs need to consider ethical and regulatory requirements, compile written procedures such as the description and responsibilities of jobs, train staff as well as ongoing monitoring and supervision. This inevitably means that the PI exercises their role as leader, influencing the outcome of protocol execution.

In the ICH-E6 Good Clinical Practice (GCP) Guideline, the Principal Investigator's leadership appears as an explicit growth competency: “Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator“(1.34).

To meet the demands of the sector's complexity and avoid the error of over-managing and under-leading the site, leadership develops as a skill that improves management. Its growth is crucial.

Although the PI has authority over their staff, leadership does not necessarily follow from talent. Creating a shared vision for the team and guiding them towards achieving common goals is the act of leading. People can therefore anticipate a range of leadership impacts, such as satisfaction, motivation, encouragement, adherence, and retention.

Duties and Qualities of a Leader Versus PI

We can observe that the work of the leader and that of the PI is very similar if we define the duties and qualities of a leader and contrast them with the duties of a PI:

Regardless of the authors we consult or even our personal experience, leadership characteristics are frequently mentioned. Early social psychology and organizational behavior psychology both found common traits of leaders that may be developed to different degrees, such as honesty, motivation, creativity, flexibility, and cognitive skills.

Seven Key Attributes of the PI

We conducted a survey of about 20 attributes with weights ranging from 1 (low) to 7 (high) to better understand how the various research team members perceived PI competencies. We selected the seven attributes they felt were most important and quantified them. Following a survey of 33 sub-investigators, study coordinators, nurses, and pharmacists, the following findings were obtained:

Natural Versus Born Leaders

"There may be too many born leaders, but there are definitely too few to count on them," said Peter Drucker in 2006. This quote shows that it is possible to learn and develop the skills needed to exert leadership in knowledge-intensive businesses. So, as the team leader for clinical research, PIs are in a position to lead even if they perceive themselves as not being natural leaders.

Likewise, leadership qualities in clinical research must be experimentally discovered and developed in response to the sector's increasing complexity, the speed of change, multicultural networks, and the social responsibility of clinical research. For many years, there have been considerable academic options geared at acquiring, developing, and optimizing general leadership qualities. Surely it would be better if all formal clinical research training included instruction in leadership skills for investigators?

In large organizations, the success or failure of their projects often depends on the leadership skills of those who lead them. Can we say the same in clinical research? Can the leadership attributes of a PI influence the success or failure of a clinical study? This is an attractive hypothesis, particularly when the clinician does not have formal leadership training.

Finally, we must emphasize the importance of exploring and investigating the impact of these skills on research sites. The potential findings and recommendations could help PIs work more effectively with their team, sponsors and with society. This would open a universe of possibilities such as reducing site turnover, improving subject recruitment and study compliance – as well as increasing the social awareness of all those involved in clinical studies.

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Dr. Jorge Velasco Zamora

Site Manager at CER Instituto Médico

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Jorge Velasco Zamora, MD, MBA, CPI is site Manager at CER Instituto Médico and graduated from the Faculty of Medicine of the UBA. He specialized in internal medicine, rheumatology and strategic management of technological innovation.

Monica Coronel

Operations Director at CER Instituto Médico

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Mónica Coronel is Operations Director at CER Instituto Médico