According to the ICH-GCP definition “The investigator is the responsible leader of the team and may be called the principal investigator (PI)”. And should be, without any doubt.
Confronting the demands of one of the most exigent areas in modern medicine that is full of norms, requires much more from the PI than simply knowing the pathology-protocol-brochure trilogy. The increasing complexity of the clinical trials confronts the investigator with a growing number of human resources trained in the framework of high performance equipment, optimum and responsible budget management and designs of processes and procedures, to mention just a few of them. Leadership is then transformed into an essential development ability in order to be measured up to the demands of the community preventing the studies from being over managed and under-leaded.
As in many organizations, many times, the success or failure of their projects depend on the leadership skills from those who carry them out. Could we assert the same in clinical trials? Will the success or failure of a clinical trials also depend on leadership attributes of their PIs? This is an interesting hypothesis, most of it when the Doctor does not possess formal leadership training. If this is really the case, we would be facing potential consequences in the results of the studies; consequences that could be larger than expected.
When checking English literature through PubMed, we have not found information about leadership in clinical trials. Then, we are dealing with a breach between the needs to develop leadership skills and the scarce or null exploration of the subject.
Leadership is an influential interpersonal attempt, directed by the communicational process, aimed at fullfilling one or many goals. Leadership can be learned: it can be exercised and developed. According to Kouzes and Posner after studying thousands of successful leaders, they concluded that the skills to be developed are: defying the process, inspire a shared view, enable others to act, serve as a model and give support. These authors also point out that the employees of different enterprises identify: honesty, the fact of being progressive, inspiring and competent, among the most important qualities that their leaders have.
As we can see, some attributes are values that are inherent to the persona-lity of the individual, on the other hand there are others that can be developed. With regards to the high impact that leadership capacities would excerpt on the required results of a clinical trial , the chances to acquire them and the absence of studies on the matter are the reasons why the subject is presented as a must to be considered in the whole formal training in clinical trials.
Jorge Velasco Zamora MD MBA CPI
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