The world of clinical trials has its own pack of myths. However, it is a highly regulated environment, where technology and coordinators closely monitor patients, ensure compliance with ethical standards and the proper conduct of research protocols. Meeting with Marie Devaux, nurse and research coordinator, who practises at the Institut de recherches cliniques de Montréal (IRCM).
Before beginning a clinical trial, that is, the assessment of a diagnostic method or a treatment on humans, the recruitment stage has to be gone through. “I advertise in newspapers or on Facebook, then I call participants to whom I submit questionnaires and finally give them an appointment at the clinic,” explains Marie Devaux.
Currently, the 23-year-old nurse is working on a main protocol that spans 18 weeks. Participants are asked to take Omega-3 supplements to assess risk factors for type 2 diabetes.
“We monitor their sensitivity to the supplements, such as insulin secretion and intravenous position,” she explains. “Blood tests have to be taken regularly and the slightest change has to be watched for.”
When an adverse event occurs, Marie Devaux has to submit it to the ethics committee. “Sometimes there my be a risk of infiltration with the intravenous if the catheter is not installed properly, which can cause swelling and pain,” she points out. “This situation must be declared to determine if the consent form needs to be reassessed, for example.” Annual reports also have to be produced and sent to this committee.
Relationship with the patients
Participants in the current study come and spend four full days per week at the IRCM. “We spend a lot of time with them, so we end up getting to know each other well,” says Marie Devaux. “There are people with whom we create real connections.”
The flexibility allowed by working in the laboratory rather than in the hospital also makes it possible to be more attentive to patient needs. “We can focus on someone, because we feel a lot less overloaded,” she says.
The research coordinator has less of a sense of helping the patient directly, however, as was the case in her hospital internships. “I was doing more of the helping relationship, because people were often in worse shape and more grateful,” she indicates.
Conversely, in the clinical trial laboratory, most of the participants are “healthy” and it is rare to cross paths with them again when the studies are completed. They are often people motivated to advance science or who want more information on their state of health.
Marie Devaux is therefore close to many patients, but she also works alongside several other nurses, research assistants and nutritional students, among others.
As a team, these people make sure that they achieve their goal: improving treatments or creating new ones. “We realize how much clinical lab work can influence technical practice,” she exclaims. Communication between the lab and the clinic is indeed essential to keep doctors informed of the various advances.