Clinical trial nurses: a hidden job, but essential for the success of studies

Marisa de la Rica and Laura Díez, nurses from the Clinical Research Unit of the IIS Aragón, highlight their work, essential but unknown within the profession, as part of the multidisciplinary teams that form clinical trials.

A clinical trial is a research project that allows us to find out how the body reacts to certain treatments for different diseases. In short, it involves testing a new drug or combination of several drugs to see how a disease progresses and the possible side effects that may appear. During the time stipulated for the trial, ethical and legal standards must be followed both nationally and internationally, in addition to having a protocol that must be strictly followed.

A multidisciplinary team works tirelessly on each study in all the hospitals or centres where it is carried out to obtain the most reliable data and to ensure that the trial is successful. This is not always the case and, on many occasions, trials end up being halted because the expected results are not being obtained or because, simply, the drugs used do not work as expected. But, to reach this conclusion, a huge amount of work must first be carried out by the entire team, in which nurses are essential.

Questions

Laura Díez and Marisa de la Rica are the two nurses who work in the Clinical Trials Unit of the Aragon Health Research Institute, located at the Lozano Blesa Clinical Hospital (Zaragoza). Although it is a very unknown job within the profession, the nurses who work in these units are essential for the study to be carried out in an optimal manner. They are the ones who are with the patient, resolve doubts, help throughout the process and prepare the samples to send them to those responsible for the study in the country where necessary. The chain cannot fail because an error in the protocol can mean the loss of a lot of information and the nurses are in charge of making sure that everything goes well.

70 trials

"Right now we have between 60 and 70 trials in different specialties. The most common is oncology, but we also have urology, dermatology, ophthalmology, neurology, infectious diseases... Each patient has certain scheduled appointments and we have a kit for each of their visits. We have to follow the protocol strictly because it is the way to obtain the data that is needed," explains Díez.

She herself He stresses that entering a trial is not easy, as certain specific requirements must be met., which are sent by the principal investigator. “First, a recognition visit is made and we carry out some specific tests so that the doctor can assess the possibility of including the patient. If all the requirements are met, everything would be prepared so that the person could enter the study,” he says.

Protocol

As has been said, following the protocol from start to finish is essential. “We have to comply with the times set out in the document. In some cases, we are asked for a pharmacokinetic test ten minutes after finishing the treatment or during the first hour. We have to comply strictly because otherwise there could be a deviation from the protocol,” Díez.

Both work in their office, where the trial documentation is kept and safeguarded. In fact, they must keep it while the studio is open and then store it for another 25 years in fireproof boxes in case there is a fire.Our work is relatively unknown because we are not limited to nursing techniques such as extracting or handling these samples, but we also have an essential role in data collection. We collect the data in an electronic notebook, so that, at the same time as we enter it, it reaches the centres that manage this data, which are often not here in Spain but are in other countries such as India or the United States. It is almost immediate information," says Marisa de la Rica.

Accompany

In addition to those specific tasks, as nurses they also have a essential function in the accompaniment“The patients we have, especially those with cancer, live with great uncertainty. Firstly, the uncertainty of a recent diagnosis, which is often combined with the fact that they have been offered to enter a clinical trial as soon as they are diagnosed. We also have the uncertainty of the prognosis because we see their progression during treatment. Other times they get worse and have to stop the study or they have been admitted and we have to go up to the Oncology ward to see them there,” says De la Rica.

Along these lines, talking to the patient is essential for them to understand everything.We are a bit like translators of all the papers that you have signed and read. and that, perhaps, they have not had time to process in five minutes. We explain everything in a way that is understandable and then we begin with the consultations," he says.

Family

And together with these patients are relatives who also feel great uncertainty about the situation. “We always try to ensure that the relative and the patient go together while we care for them in the unit, which is very important. And sometimes we have very deteriorated patients who need palliative care. Palliative care and clinical trials do not have to be at odds, but rather they should go hand in hand,” says De la Rica.

As the professionals closest to the patient, they must also work on their own emotional well-being. “We see patients for many months and we have an almost personal relationship. Sometimes we stop seeing them because they get worse or we find out that they have died. For us, working together is essential because we share this situation and we support each other.", He emphasizes.

Samples

Once the samples have been collected, they must be processed in the laboratory and sent to their destination. “Almost all of them go abroad, so we have to know very well what procedures each country requires because if we do it incorrectly, the sample may end up in customs and the data may not arrive,” explains De la Rica.

Also The sample conservation model is very important. The unit has freezers at minus 80º and they must be stored in special plastic containers that can withstand these temperatures. The shipment is then prepared, paying close attention to all the documentation, papers, invoices or delivery notes that are needed. “We cannot allow the sample to remain in customs because, logically, it would be damaged,” he concludes.

In short, a chain that cannot be broken and that is essential to improve the lives of patients, with research and scientific advances.

Source: nurse diary