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Dr. Lucas Moreno
Dr. Lucas Moreno is the first author of the international work that presents a series of considerations for early phase studies with the aim of accelerating the arrival of new therapies to patients.
Dr. Lucas Moreno, head of the Pediatric Oncology and Hematology Service at Vall d'Hebron University Hospital and of the Childhood Cancer and Hematologic Diseases group at Vall d'Hebron Research Institute (VHIR), has participated in a global consensus document on recommendations for conducting early phase clinical trials with drug combinations for the treatment of pediatric cancer. This is a joint work between clinicians, statisticians, regulatory experts and patient experts from Europe and North America and is published in Journal of Clinical Oncology.
The development of new therapies for children with cancer is essential to improve patient outcomes and reduce short- and long-term side effects. Previous experience suggests that the use of several agents simultaneously may be more effective than treatment with a single drug, and may help to avoid resistance. To evaluate potential drug combinations, an international paper presents a consensus document to maximize the efficiency of early-stage clinical trials being conducted. "The goal is to make a rapid and efficient assessment to evaluate drug combinations without compromising safety or increasing toxicity. In this way, we hope to accelerate the arrival of new therapies to patients", says Dr. Moreno. Currently, 287 early clinical trials of drug combinations for pediatric cancer are underway.
The authors argue that there is interest in platform clinical trials, in which different drug combinations can be studied at the same time and the differences compared to monotherapy with standard treatment can be analyzed. It is also recommended that phase I and phase II be carried out at the same time in order to achieve faster results and, at the same time, reduce the resources required. It is also encouraged that a few patients be included initially in order to determine safe doses and to know early on whether it is appropriate to continue with the treatment.
Although the aim of trials is to answer a scientific question about the efficacy and safety of treatments, it is necessary to consider that patients participate in this type of study in the hope that it may also benefit them directly. This is why it is essential to make a good selection of patients and to use doses that are expected to have good results. In relation to the dose, it is recommended that it be adjusted according to that used in adults and patient body surface.
Finally, the work emphasizes the inclusion of the voice of patients and their families, as well as taking into account regulatory experts from the beginning of the cynical development of pediatric cancer treatments.
"The goal is to make a rapid and efficient assessment to evaluate drug combinations without compromising safety or increasing toxicity", says Dr. Lucas Moreno.
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