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1.
Brain Spine ; 4: 102816, 2024.
Article in English | MEDLINE | ID: mdl-38666069

ABSTRACT

Introduction: Imposter syndrome (IS), characterized by persistent doubts about one's abilities and fear of exposure as a fraud, is a prevalent psychological condition, particularly impacting physicians. In neurosurgery, known for its competitiveness and demands, the prevalence of IS remains high. Research question: Recognizing the limited literature on IS within the neurosurgical community, this European survey aimed to determine its prevalence among young neurosurgeons and identify associated factors. Material and methods: The survey, conducted by the Young Neurosurgeon Committee of the European Association of Neurosurgical Societies, gathered responses from 232 participants. The survey included demographics, the Clance Imposter Phenomenon Survey (CIPS), and an analysis of potential compensatory mechanisms. Results: Nearly 94% of respondents exhibited signs of IS, with the majority experiencing moderate (36.21%) or frequent (40.52%) symptoms. Analyses revealed associations between IS and factors such as level of experience, sex, and board-certification. Discussion and conclusion: The findings suggest a significant prevalence of IS among young neurosurgeons, with notable associations with sex and level of experience. Compensatory mechanisms, such as working hours, article reading, and participation in events, did not show significant correlations with IS. Notably, male sex emerged as an independent protective factor against frequent/intense IS, while reading more than five articles per week was identified as a risk factor. The identification of protective and risk factors, particularly the influence of gender and reading habits, contributes valuable insights for developing targeted interventions to mitigate IS and improve the well-being of neurosurgeons.

2.
Brain Spine ; 4: 102765, 2024.
Article in English | MEDLINE | ID: mdl-38510593

ABSTRACT

Introduction: Artificial intelligence (AI) based large language models (LLM) contain enormous potential in education and training. Recent publications demonstrated that they are able to outperform participants in written medical exams. Research question: We aimed to explore the accuracy of AI in the written part of the EANS board exam. Material and methods: Eighty-six representative single best answer (SBA) questions, included at least ten times in prior EANS board exams, were selected by the current EANS board exam committee. The questions' content was classified as 75 text-based (TB) and 11 image-based (IB) and their structure as 50 interpretation-weighted, 30 theory-based and 6 true-or-false. Questions were tested with Chat GPT 3.5, Bing and Bard. The AI and participant results were statistically analyzed through ANOVA tests with Stata SE 15 (StataCorp, College Station, TX). P-values of <0.05 were considered as statistically significant. Results: The Bard LLM achieved the highest accuracy with 62% correct questions overall and 69% excluding IB, outperforming human exam participants 59% (p = 0.67) and 59% (p = 0.42), respectively. All LLMs scored highest in theory-based questions, excluding IB questions (Chat-GPT: 79%; Bing: 83%; Bard: 86%) and significantly better than the human exam participants (60%; p = 0.03). AI could not answer any IB question correctly. Discussion and conclusion: AI passed the written EANS board exam based on representative SBA questions and achieved results close to or even better than the human exam participants. Our results raise several ethical and practical implications, which may impact the current concept for the written EANS board exam.

3.
Int J Mol Sci ; 25(4)2024 Feb 16.
Article in English | MEDLINE | ID: mdl-38397015

ABSTRACT

Diabetes mellitus (DM) is a highly prevalent disease worldwide, estimated to affect 1 in every 11 adults; among them, 90-95% of cases are type 2 diabetes mellitus. This is partly attributed to the surge in the prevalence of obesity, which has reached epidemic proportions since 2008. In these patients, cardiovascular (CV) risk stands as the primary cause of morbidity and mortality, placing a substantial burden on healthcare systems due to the potential for macrovascular and microvascular complications. In this context, leptin, an adipocyte-derived hormone, plays a fundamental role. This hormone is essential for regulating the cellular metabolism and energy balance, controlling inflammatory responses, and maintaining CV system homeostasis. Thus, leptin resistance not only contributes to weight gain but may also lead to increased cardiac inflammation, greater fibrosis, hypertension, and impairment of the cardiac metabolism. Understanding the relationship between leptin resistance and CV risk in obese individuals with type 2 DM (T2DM) could improve the management and prevention of this complication. Therefore, in this narrative review, we will discuss the evidence linking leptin with the presence, severity, and/or prognosis of obesity and T2DM regarding CV disease, aiming to shed light on the potential implications for better management and preventive strategies.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Leptin , Obesity , Adult , Humans , Cardiovascular Diseases/metabolism , Diabetes Mellitus, Type 2/metabolism , Leptin/metabolism , Obesity/metabolism
4.
Blood Coagul Fibrinolysis ; 34(8): 545-548, 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37942747

ABSTRACT

Glanzmann's Thrombasthenia (GT) is a rare hemorrhagic condition caused by a platelet surface receptor disorder of the glycoprotein (GP) IIb/IIIa. Symptoms of GT are various forms of hemorrhages, such as purpura, epistaxis and menorrhagia. Gastrointestinal bleeding (GIB) is a rare expression of the condition and may occur due to traumas in the GI tract or as a consequence of gastrointestinal angiodysplasia (GIADs). In this case report, we present a middle-aged woman with recurrent GIB consequent to GIADs with persistent melena and iron deficiency anemia. After several unsuccessful therapeutic interventions, the patient was studied by the hereditary hemorrhagic telangiectasia's (HHT - Osler-Weber-Rendu disease) unit, where she received bevacizumab, showing a complete improvement in symptoms as well as a reduction in her GIADs. This case shows that bevacizumab could be a possible line of treatment for patients with coagulation disorders with GIADs.


Subject(s)
Angiodysplasia , Blood Platelet Disorders , Menorrhagia , Thrombasthenia , Humans , Middle Aged , Female , Thrombasthenia/complications , Thrombasthenia/drug therapy , Bevacizumab/therapeutic use , Platelet Glycoprotein GPIIb-IIIa Complex , Menorrhagia/etiology , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/complications , Rare Diseases/complications , Angiodysplasia/complications , Angiodysplasia/drug therapy
5.
Brain Spine ; 3: 102665, 2023.
Article in English | MEDLINE | ID: mdl-38021023

ABSTRACT

Introduction: Technological advancements provided several preoperative tools allowing for precise preoperative planning in cranial neurosurgery, aiming to increase the efficacy and safety of surgery. However, little data are available regarding if and how young neurosurgeons are trained in using such technologies, how often they use them in clinical practice, and how valuable they consider these technologies. Research question: How frequently these technologies are used during training and clinical practice as well as to how their perceived value can be qualitatively assessed. Materials and methods: The Young Neurosurgeons' Committee (YNC) of the European Association of Neurosurgical Societies (EANS) distributed a 14-items survey among young neurosurgeons between June 1st and August 31st, 2022. Results: A total of 441 responses were collected. Most responders (42.34%) received "formal" training during their residency. Planning techniques were used mainly in neuro-oncology (90.86%), and 3D visualization of patients' DICOM dataset using open-source software was the most frequently used (>20 times/month, 20.34% of responders). Software for 3D visualization of patients' DICOM dataset was the most valuable technology, especially for planning surgical approach (42.03%). Conversely, simulation based on augmented/mixed/virtual reality was considered the less valuable tool, being rated below sufficiency by 39.7% of responders. Discussion and conclusion: Training for using preoperative planning technologies in cranial neurosurgery is provided by neurosurgical residency programs. Software for 3D visualization of DICOM datasets is the most valuable and used tool, especially in neuro-oncology. Interestingly, simulation tools based on augmented/virtual/mixed reality are considered less valuable and, therefore, less used than other technologies.

6.
Microsc Microanal ; 29(3): 900-912, 2023 Jun 09.
Article in English | MEDLINE | ID: mdl-37749688

ABSTRACT

The oxygen stoichiometry of hollandite, KxMnO2-δ, nanorods has been accurately determined from a quantitative analysis of scanning-transmission electron microscopy (STEM) X-Ray Energy Dispersive Spectroscopy (XEDS) experiments carried out in chrono-spectroscopy mode. A methodology combining 3D reconstructions of high-angle annular dark field electron tomography experiments, using compressed-sensing algorithms, and quantification through the so-called ζ-factors method of XEDS spectra recorded on a high-sensitivity detector has been devised to determine the time evolution of the oxygen content of nanostructures of electron-beam sensitive oxides. Kinetic modeling of O-stoichiometry data provided K0.13MnO1.98 as overall composition for nanorods of the hollandite. The quantitative agreement, within a 1% mol error, observed with results obtained by macroscopic techniques (temperature-programmed reduction and neutron diffraction) validate the proposed methodology for the quantitative analysis, at the nanoscale, of light elements, as it is the case of oxygen, in the presence of heavy ones (K, Mn) in the highly compromised case of nanostructured materials which are prone to electron-beam reduction. Moreover, quantitative comparison of oxygen evolution data measured at macroscopic and nanoscopic levels allowed us to rationalize beam damage effects in structural terms and clarify the exact nature of the different steps involved in the reduction of these oxides with hydrogen.

7.
World Neurosurg ; 176: e190-e199, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37187347

ABSTRACT

BACKGROUND: Barriers to neurosurgery training and practice in Latin American and Caribbean countries (LACs) have been scarcely documented. The World Federation of Neurosurgical Societies Young Neurosurgeons Forum survey sought to identify young neurosurgeons' needs, roles, and challenges. We present the results focused on Latin America and the Caribbean. METHODS: In this cross-sectional study, we analyzed the Young Neurosurgeons Forum survey responses from LACs, following online survey dissemination through personal contacts, social media, and neurosurgical societies' e-mailing lists between April and November 2018. Data analysis was performed using Jamovi version 2.0 and STATA version 16. RESULTS: There were 91 respondents from LACs. Three (3.3%) respondents practiced in high-income countries, 77 (84.6%) in upper middle-income countries, 10 (11%) in lower middle-income countries, and 1 (1.1%) in an unclassified country. The majority (77, or 84.6%) of respondents were male, and 71 (90.2%) were younger than 40. Access to basic imaging modalities was high, with access to computed tomography scan universal among the survey respondents. However, only 25 (27.5%) of respondents reported having access to imaging guidance systems (navigation), and 73 (80.2%) reported having access to high-speed drills. A high GDP per capita was associated with increased availability of high-speed drills and more time dedicated to educational endeavors in neurosurgery, such as didactic teaching and topic presentation (P < 0.05). CONCLUSIONS: This survey found that neurosurgery trainees and practitioners of Latin America and the Caribbean face many barriers to practice. These include inadequate state-of-the-art neurosurgical equipment, a lack of standardized training curricula, few research opportunities, and long working hours.


Subject(s)
Neurosurgeons , Neurosurgery , Male , Humans , Female , Latin America , Cross-Sectional Studies , Neurosurgery/education , Caribbean Region
11.
Brain Spine ; 2: 100929, 2022.
Article in English | MEDLINE | ID: mdl-36248173

ABSTRACT

Introduction: Modern technologies are increasingly applied in neurosurgical resident training. To date, no data are available regarding how frequently these are used in the training of neurosurgeons, and what the perceived value of this technology is. Research question: The aim was to benchmark the objective as well as subjective experience with modern- and conventional training technologies. Material and methods: The EANS Young Neurosurgeons Committee designed a 12-item survey. It was distributed to neurosurgical residents and board-certified neurosurgeons between 6th of February and April 13, 2022. Results: We considered 543 survey responses for analysis. Most participants (67%) indicated not having gained any training experience with modern technology. Most (40.7%) indicated lack of any modern or conventional training technology. Cadaver training was available to 27.6% while all modern training technology to <10%. Participants from countries with high gross domestic product per capita had more access to modern training technologies (p â€‹< â€‹0.001). The perceived value of the different technologies was highest for hands-on OR training, followed by cadaver lab. The value of these was rated higher, compared to all modern technologies (p â€‹< â€‹0.001). Discussion and conclusion: Our survey reveals that cadaver labs are used more frequently than modern technologies for today's neurosurgical training. Hands-on training in the operating room (OR) was rated significantly more valuable than any conventional and modern training technology. Our data hence suggest that while modern technologies are well perceived and can surely add to the training of neurosurgeons, it remains critical to ensure sufficient OR exposure.

12.
Front Pharmacol ; 13: 1007790, 2022.
Article in English | MEDLINE | ID: mdl-36313304

ABSTRACT

Background: Tumor angiogenesis is considered as a crucial pathologic feature of cancer with a key role in multidrug resistance (MDR). Adverse effects of the currently available drugs and the development of resistance to these remain as the hardest obstacles to defeat. Objetive: This work explores flora from Argentina as a source of new chemical entities with antiangiogenic activity. Methods: Tube formation assay using bovine aortic endothelial cells (BAECs) was the experiment of choice to assess antiangiogenic activity. The effect of the pure compound in cell invasiveness was investigated through the trans-well migration assay. The inhibitory effect of the pure compound on VEGFR-2 and PKC isozymes α and ß2 activation was studied by molecular and massive dynamic simulations. Cytotoxicity on peripheral blood mononuclear cells and erythrocyte cells was evaluated by means of MTT and hemolysis assay, respectively. In silico prediction of pharmacological properties (ADME) and evaluation of drug-likeness features were performed using the SwissADME online tool. Results: Among the plants screened, T. minuta, showed an outstanding effect with an IC50 of 33.6 ± 3.4 µg/ml. Bio-guided isolation yielded the terthiophene α-terthienylmethanol as its active metabolite. This compound inhibited VEGF-induced tube formation with an IC50 of 2.7 ± 0.4 µM and significantly impaired the invasiveness of bovine aortic endothelial cells (BAECs) as well as of the highly aggressive breast cancer cells, MDA-MB-231, when tested at 10 µM. Direct VEGFR-2 and PKC inhibition were both explored by means of massive molecular dynamics simulations. The results obtained validated the inhibitory effect on protein kinase C (PKC) isozymes α and ß2 as the main mechanism underlying its antiangiogenic activity. α-terthienylmethanol showed no evidence of toxicity against peripheral blood mononuclear and erythrocyte cells. Conclusion: These findings support this thiophene as a promising antiangiogenic phytochemical to fight against several types of cancer mainly those with MDR phenotype.

13.
Stem Cell Res Ther ; 13(1): 345, 2022 07 26.
Article in English | MEDLINE | ID: mdl-35883198

ABSTRACT

Peripheral arterial disease is atherosclerotic occlusive disease of the lower extremity arteries and afflicts hundreds of millions of individuals worldwide. Its most severe manifestation is chronic limb-threatening ischemia (Petersen et al. (Science 300(5622):1140-2, 2003)), which is associated with severe pain at rest in the limbs, which progresses to necrosis, limb amputation, and/or death of the patient. Consequently, the care of these patients is considered a financial burden for both patients and health systems. Multidisciplinary endeavors are required to address this refractory disease and to find definitive solutions that lead to improved living conditions. Revascularization is the cornerstone of therapy for preventing limb amputation, and both open vascular surgery and endovascular therapy play a key role in the treatment of patients with CLI. Around one-third of these patients are not candidates for conventional surgical treatment, however, leading to higher amputation rates (approaching 20-25% at one year) with high morbidity and lower quality of life. Advances in regenerative medicine have enabled the development of cell-based therapies that promote the formation of new blood vessels. Particularly, mesenchymal stem cells (MSCs) have emerged as an attractive therapeutic agent in various diseases, including CLI, due to their role in tissue regeneration and immunomodulation. This review discusses the characteristics of MSCs, as well as their regenerative properties and their action mechanisms on CLI.


Subject(s)
Limb Salvage , Mesenchymal Stem Cells , Chronic Limb-Threatening Ischemia , Humans , Ischemia/therapy , Lower Extremity/blood supply , Lower Extremity/surgery , Quality of Life , Risk Factors , Treatment Outcome
14.
Eur Spine J ; 31(10): 2629-2638, 2022 10.
Article in English | MEDLINE | ID: mdl-35188587

ABSTRACT

BACKGROUND: Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures. METHODS: Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity. RESULTS: Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities. CONCLUSIONS: Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.


Subject(s)
Spinal Fusion , Back Pain/diagnosis , Back Pain/etiology , Back Pain/surgery , Female , Humans , Lumbar Vertebrae/surgery , Male , Middle Aged , Models, Statistical , Prognosis , Spinal Fusion/methods , Treatment Outcome
15.
J Neurosurg Sci ; 2022 02 11.
Article in English | MEDLINE | ID: mdl-35147400

ABSTRACT

BACKGROUND: The expanding field of global neurosurgery calls for a committed neurosurgical community to advocate for universal access to timely, safe, and affordable neurosurgical care for everyone, everywhere. This study aims to (i) assess the current state of global neurosurgery activity amongst European neurosurgeons and (ii) identify barriers to involvement in global neurosurgery initiatives. METHODS: Cross-sectional study through dissemination of a web-based survey, from September 2019 to January 2020, to collect data from European neurosurgeons at various career stages. Descriptive analysis was conducted on respondent data. RESULTS: Three hundred and ten neurosurgeons from 40 European countries responded. 53.5% regularly follow global neurosurgery developments. 29.4% had travelled abroad with a global neurosurgery collaborative, with 23.2% planning a future trip. Respondents from high income European countries predominantly travelled to Africa (41.6%) or Asia (34.4%), whereas, respondents from middle income European countries frequently traversed Europe (63.2%) and North America (47.4). Cost implications (66.5%) were the most common barrier to global neurosurgery activity, followed by interference with current practice (45.8%), family duties (35.2%), difficulties obtaining humanitarian leave (27.7%) and lack of international partners (27.4%). 86.8% would incorporate a global neurosurgery period within training programmes. CONCLUSIONS: European neurosurgeons are interested in engaging in global neurosurgery partnerships, and several sustainable programmes focused on local capacity building, education and research have been established over the last decade. However, individual and system barriers to engagement persist. We provide insight into these to allow development of tailored mechanisms to overcome such barriers, enabling European neurosurgeons to advocate for the Global Surgery 2030 goals.

16.
Eur J Trauma Emerg Surg ; 48(3): 2189-2198, 2022 Jun.
Article in English | MEDLINE | ID: mdl-34401937

ABSTRACT

BACKGROUND: COVID-19 has overloaded health care systems, testing the capacity and response in every European region. Concerns were raised regarding the impact of resources' reorganization on certain emergency pathology management. The aim of the present study was to assess the impact of the outbreak (in terms of reduction of neurosurgical emergencies) during lockdown in different regions of Spain. METHODS: We analyzed the impact of the outbreak in four different affected regions by descriptive statistics and univariate comparison with same period of two previous years. These regions differed in their incidence level (high/low) and in the time of excess mortality with respect to lockdown declaration. That allowed us to analyze their influence on the characteristics of neurosurgical emergencies registered for every region. RESULTS: 1185 patients from 18 neurosurgical centers were included. Neurosurgical emergencies that underwent surgery dropped 24.41% and 28.15% in 2020 when compared with 2019 and 2018, respectively. A higher reduction was reported for the most affected regions by COVID-19. Non-traumatic spine experienced the most significant decrease in number of cases. Life-threatening conditions did not suffer a reduction in any health care region. CONCLUSIONS: COVID-19 affected dramatically the neurosurgical emergency management. The most significant reduction in neurosurgical emergencies occurred on those regions that were hit unexpectedly by the pandemic, as resources were focused on fighting the virus. As a consequence, life-threating and non-life-threatening conditions' mortality raised. Results in regions who had time to prepare for the hit were congruent with an organized and sensible neurosurgical decision-making.


Subject(s)
COVID-19 , COVID-19/epidemiology , Communicable Disease Control , Delivery of Health Care , Emergencies , Humans , Neurosurgical Procedures , Spain/epidemiology
18.
J Neurosurg Spine ; : 1-10, 2020 May 29.
Article in English | MEDLINE | ID: mdl-32470938

ABSTRACT

OBJECTIVE: The 6-minute walking test (6WT) is used to determine restrictions in a subject's 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements. METHODS: The maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16-91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3-40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs. RESULTS: The ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87-0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7-597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001). CONCLUSIONS: This study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.

20.
Ciencia Reguladora ; (5): 19-25, Oct2019. tab, graf
Article in Spanish | BINACIS | ID: biblio-1025040

ABSTRACT

El avance de la ciencia y tecnología en los últimos años dio lugar a la necesidad de dar respuesta a una mayor cantidad de preguntas en investigación de forma más eficiente. Esto ha provocado la generación de nuevos diseños en investigación, dando origen a los "protocolos maestros". A diferencia de los diseños tradicionales en los que en cada ensayo clínico se prueba habitualmente un solo fármaco, en una única población, con una patología determinada, los protocolos maestros utilizan una estructura con un diseño de ensayo clínico y un protocolo para evaluar simultáneamente múltiples fármacos y/o enfermedades, en múltiples sub-estudios. Entre estos novedosos diseños se pueden mencionar tres tipos: canasta (basket), paraguas (umbrella) y plataforma (platform) los cuales serán analizados en este artículo. Debido a su complejidad, el abordaje de estos nuevos modelos de ensayo clínico requiere la revisión y actualización permanente de los estándares vigentes y una constante discusión por parte de las diferentes agencias regulatorias a nivel mundial. Estos diseños no deben considerarse a priori como medios para reducir la rigurosidad de la planificación de los ensayos clínicos ni disminuir los estándares regulatorios, sino como herramientas para gestionar situaciones experimentales complejas. Desde el punto de vista regulatorio, para poder analizar y dar respuesta a estos desafíos, ANMAT cuenta, actualmente, con espacios de intercambio que permiten crear el ámbito apropiado de discusión científica-regulatoria que aliente el desarrollo de nuevos medicamentos, pero manteniendo estrictos estándares de calidad éticos y científicos. En esta revisión se plantea la necesidad de conocer en detalle estos nuevos diseños analizando sus potenciales beneficios y limitaciones


The need to answer a greater number of questions more efficiently has led to the generation of new designs in research, giving rise to the "master protocols". This term refers to a clinical trial design created to evaluate multiple hypotheses through substudies that are developed simultaneously and that may contain an adaptive design. Among these novel designs, three types can be mentioned: basket, umbrella and platform which will be analyzed in this article. Due to their complexity, the approach of these new clinical trial designs requires the continuing revision and updating of the current standards and a constant discussion by the different regulatory agencies worldwide. From the regulatory point of view, in order to analyze and satisfy these challenges, ANMAT currently has exchange spaces that allow the creation of the appropriate field of scientific-regulatory discussions that encourage the development of new medicines, while maintaining strict standards of ethical and scientific quality. This revision raises the need to know in detail these new designs analyzing their potential benefits and limitations.


Subject(s)
Social Change , Clinical Protocols , Clinical Trial
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