The Significance of Training and Competence in Clinical Studies: Beyond Titles and Experience

The Significance of Training and Competence in Clinical Studies: Beyond Titles and Experience



In the realm of clinical studies, the successful conduct of research cannot solely rely on academic titles and years of experience. Beyond conventional credentials, the training and competence of professionals make a difference in the quality and validity of clinical trials. This article delves into the importance of specific training and the ability to apply knowledge,   emphasizing that actual competence surpasses the acquisition of titles that merely adhere to established rules. We will explore howclinical study management companies, aiming to enhance the quality of their services, have chosen to recruit professionals with medical degrees for critical roles such as Clinical Research Associates (CRAs) and Project Managers (PMs). However, we will underscore that actual competence manifests in the effective execution of specific tasks and advocate for a rigorous training process tailored to the distinct functions of these roles.

Competence Beyond Titles:

In clinical studies, as in other industries, it is expected to encounter the persistent fallacy that possessing an academic title guarantees a professional’s competence to fulfill the various functions assigned to them. In this scenario, it is crucial to recognize that competence goes beyond obtaining a title that complies with established rules and regulations. As Pallas (2019) notes, there is increasing pressure across various domains to transition from decision-making processes based on tradition, authority, or the opinions of considered expert professionals to ones validating the proper competencies of the individual. This shift towards a competence-centered model allows for validating the knowledge and skills necessary to carry out specific activities (Lopez, 2016).

Presently, several companies dedicated to clinical research have chosen to hire professionals with medical degrees for roles such as Clinical Research Associate (CRA) and Project Manager (PM), aiming to enhance the quality of services provided. While this initiative may contribute to industry development, it is crucial to understand that real competence manifests in effectively executing specific tasks. Therefore, hiring Clinical Oversight Management with medical degrees without subjecting them to a rigorous training process in the particular functions of a CRA or a PM could lead to contradictory and detrimental effects on the overall team’s effectiveness.

In this context, it is essential to recognize that competence involves the ability to identify, interpret, argue, and solve problems and consistently update and apply acquired knowledge to achieve set objectives. This comprehensive view of competence aligns with Lopez’s (2016) notion, emphasizing that competence goes beyond the mere accumulation of knowledge and skills, encompassing the ability to adapt to individual and societal demands.

It is essential to underscore that this reflection is not intended to criticize medical professionals choosing to venture into clinical research from the abovementioned roles. On the contrary, it seeks to highlight companies’ responsibility in creating training plans that enable professionals to understand the diverse challenges they will face. Additionally, the need for guidance from more experienced professionals during the training process is emphasized, ensuring comprehensive and practical development in clinical research.

Experience vs. Competence:

Accumulated work experience over the years is essential but does not always guarantee competence. We have often observed professionals with extensive years of experience who cannot efficiently apply what they have learned. Resistance to change and a lack of adaptability are common obstacles among those who rely solely on their experience. The ability to learn, adapt to new methodologies, and stay updated with the latest software for clinical trialstrends in clinical research is essential to ensure the quality of studies. For example, adaptive designs like Sequential Multiple Assignment Randomized Trials (SMART) present individualized treatments supported by sequential statistical analyses controlling the type I error rate, posing significant challenges for study coordinators in recruitment, obtaining informed consent, data management, and patient education and follow-up (Hornung et al., 2018).
These trials require continuous adjustments in the type or intensity of treatment based on patient outcomes, adding complexity to the tasks of monitors and data managers. The dynamic nature of SMARTs demands a careful approach to maintain the integrity and validity of collected data. The interplay between these variables underscores the importance of precise and coordinated execution for the success of adaptive trials (Hornung et al., 2018).


In conclusion, competence in clinical studies transcends academic appearances and the accumulation of experience. It involves the ability to identify, interpret, and effectively solve problems and adapt to the changing demands of clinical research. While work experience remains valuable, it does not guarantee automatic competence. Resistance to change and a lack of adaptability can undermine even those with years of experience. We emphasize the importance of continuous training and a practical approach to staying updated with innovations in clinical trial design. Additionally, we reiterate the responsibility of companies to provide comprehensive training plans and support from experienced professionals to ensure the compelling and harmonious development of teams dedicated to clinical research.