The CRA - a key element in obtaining clinical proof
4 December 2012, Philine van den Tol
As a Director of Clinical Operations in a specialized early phase oncology CRO, I would like to rethink the role and the necessary skills and attitude of CRAs. It starts with the observation that SMS-oncology attracts the attention of many experienced CRAs wanting to join us. These are vivid and experienced professionals with the ambition to become CRA at SMS-oncology. But what does it take to become an excellent CRA and to support sponsors who are trying to achieve proof of concept in their clinical studies with innovative anti-cancer treatments?
At SMS-oncology CRAs develop their career along the lines of understanding scientific and logistic complex trials, in collaboration with key opinion leaders, key sites and the oncology professionals at SMS-oncology. The key responsibility of the CRA is to ensure the data collected according to the protocol and to the highest integrity standards is complete, accurate and traceable. But does it automatically make you an excellent CRA by simply fulfilling these tasks?
Insights for the CRA with the aspiration to become excellent and to deliver more added value in early phase trials.
Scientific knowledge and medical specialization
A CRA should be scientifically sound to be a partner for the investigator and sponsor staff. A CRA at SMS-oncology has to respond to the continuing specialization by understanding the mechanisms of different oncology drugs and indications and is able to deliver substantial added value.
Different intellect at different stages.
In early phase oncology trials one faces different intellectual challenges compared to late phase trials. It is essential for an early phase oncology CRA to understand the different stages of drug development and their specific needs.
It requires organizational talent to assist the site so that it can optimally recruit and treat patients according to the study protocol. This can only be done by empathetic and emotionally intelligent professionals that can manage all the different personalities and stakeholders in the trial.
In order to achieve all of the above, a CRA at SMS-oncology needs to be a team player and excellent at time management, problem solving, selling ideas, developing working methods and making informed decisions. It is important that a CRA has an open eye for the unexpected in explorative early phase oncology trials. Furthermore, a CRA must have clear understanding of its own capabilities and have an open mind on how to develop those further.
A CRA that wants to become excellent is not able to do this on his / her own and needs to be part of a team with fellow CRAs and a project manager who are also interested in the content. This team should have the same aspiration of scientific curiosity and the motivation to work on complex, explorative trials. The CRA needs to be supported by a company that wants their employees to be happy and secure in their jobs and gives them the opportunity to grow.
By performing early phase proof of concept trials we attract the CRAs that aspire a career of exploration and development. By employing these kind of professionals we are able to secure new explorative trials.