Marta Lalinde: “Childhood cancer research is a great challenge that needs time and resources”

Marta Lalinde is the clinical trials coordinator of the Pediatric Oncohematology Unit of the Miguel Servet Children's Hospital in Zaragoza. She has been in this newly created position for two and a half years, which is funded equally by Aspanoa and the IIS Aragón

He has been coordinating open trials in Oncopediatrics at the Miguel Servet for more than two years.

Yes, I take care of coordinate, manage and supervise various tasks related to the patients participating in the trials, the tests that are carried out in the hospital and the clinical data that is generated.

Does it act as a link?

That's right, between the promoter (those who propose the project and implement it) and the center or hospital. Do follow-up of patients included in trials So that we do not miss any evaluation or test required by the protocol, I send samples, biopsies and images for centralized review to other centers, record the information generated on the test platforms or Data Collection Notebook and if there is any problem I try to solve it and respond.

Does a project of this type require a lot of bureaucracy?

Yes, so that when it is launched or when the monitors come to review that the trial is following everything specified in the protocol, there have been no deviations or unreported adverse events and that everything is perfectly recorded. Furthermore it implies manage local documentation and maintain the Researcher File (ISF) of each trial updated for review by monitors or possible audits.

How does the Pediatric Oncohematology Unit at the Miguel Servet Hospital work?

As coordinator I am part of the research team of the unit and work closely with doctors and other members of the team. The doctors or researchers are in charge of the entire healthcare and clinical part. If a new patient arrives, the first thing that is done is to diagnose them and once the name and surname of their disease is known, the clinical trial that adapts to the situation and disease is offered.

And what would be the next step?

It is requested sign informed consents and they are explained what the protocol and all the tests and possible adverse effects consist of, and all doubts are clarified for the parents and also for the patient. This is when the 'screening' phase begins, where the first tests or evaluations required by the protocol are performed to evaluate whether the patient meets the inclusion criteria and does not meet the exclusion criteria so that the trial treatment can begin.

And once your participation is confirmed?

Then you start with the treatment scheme and the relevant evaluations are carried out during its evolution. Sometimes you have to send samples to be analyzed or images to be reviewed, request audiometry, and fill out quality of life questionnaires.

It is a long process…

Once the scheme is completed, the visit takes place end of treatment and, if the disease is in remission, the patient is followed up. These visits are usually in consultation and more spaced out. Close follow-up is carried out and their evolution continues to be evaluated up to 5 years post-treatment.

How many clinical trials does Oncopediatrics work on?

right now we have 11 open for recruitment, six closed to participant recruitments, but of which information continues to be sent and doubts resolved, and eight records.

What are some of them?

There are tests for various types of cancer, such as leukemias, ependymoma, lymphomas, medulloblastoma, kidney tumors, liver tumors, sarcoma... We also have some trials pending to open, others have already completed recruitment and some are even being closed in order to generate final results.

What are the records for?

The most voluminous are the Spanish Registry of Childhood Tumors (RETI) and the leukemia registry, because it is the most common childhood cancer. In general, it can be said that records serve to collect useful information that allows us to generate knowledge to guide future studies and thus advance this fight.

Who finances clinical trials?

The vast majority of tests and projects are academics, that is, they are promoted by research foundations of the hospitals and universities themselves, both national and international. The scarce funding and lack of interest of the pharmaceutical industry in pediatric cancer research comes from the low prevalence of this disease. It's hard to say it like that, based on a simple matter of numbers, but the industry is that cold. Research into childhood cancer is a great challenge that requires time and resources.

How many children are treated each year in Oncopediatrics?

In the unit they are treated one year after 40 to 45 new patients. At 18 years of age, when they come of age, they are usually referred to adults. Currently, around 200 patients will be included, including clinical trials and registries.

How is this clinical research coordinator position funded?

It is financed by Aspanoa (the Association of Parents of Children with Cancer of Aragon) and the Health Research Institute (IIS) Aragón.

Source: Heraldo de Aragón

Image: Asier Alkorta/Aspanoa