Review
Oncology
Simona Secondino, Costanza Canino, Domiziana Alaimo, Marta Muzzana, Giulia Galli, Sabrina Borgetto, Sabrina Basso, Jessica Bagnarino, Chiara Pulvirenti, Patrizia Comoli, Paolo Pedrazzoli
Summary: Cell therapy approaches in solid tumors are currently challenging due to lack of significant therapeutic response and on-target off-tumor toxicity. Novel cell therapy programs are exploring advanced therapy medicinal products and combination therapy for improved outcomes. This review focuses on current clinical research in this setting, which will likely contribute to future advancements in cancer treatment.
Letter
Multidisciplinary Sciences
Eduardo F. Motti
Summary: This is a letter to the editor.
Article
Immunology
W. Watson Buchanan, Colin A. Kean, K. D. Rainsford, Walter F. Kean
Summary: A clinical trial is a research method that investigates the therapeutic intervention's efficacy, both short-term and long-lasting, as well as its potential toxicity. The history of clinical trials can be traced back to Babylonian King Nebuchadnezzar's court around 600 BC, as described in the Book of Daniel. However, it is in the past 500 years that significant written documentation and interpretation of therapeutic benefits have been made. Examples such as Lind's demonstration on the effectiveness of oranges and lemons for scurvy treatment in 1747, and Edward Jenner's unethical experiment on inoculation in 1796, showcase the importance of clinical trials. Ethical considerations, rigorous clinical observations, statistics, scientific purity of therapeutic agents, and safety testing have contributed to the foundation of modern clinical trials.
INFLAMMOPHARMACOLOGY
(2023)
Review
Pharmacology & Pharmacy
Tessa van Rijssel, Amos J. de Jong, Yared Santa-Ana-Tellez, Martin Boeckhout, Mira G. P. Zuidgeest, Ghislaine J. M. W. van Thiel
Summary: This study provides insight into the ethics review of decentralized clinical trials (DCTs), with European ethics committees and national competent authorities expressing hesitancy towards DCTs and focusing on potential risks and burdens. The authors recommend addressing these aspects explicitly when submitting a DCT protocol, and propose careful monitoring of both the benefits and risks to advance the review and practice of this innovative approach to ethically optimize drug development.
DRUG DISCOVERY TODAY
(2022)
Article
Multidisciplinary Sciences
Jaishree Mendiratta, Ravi N. Vaswani, Gayatri Saberwal
Summary: In multinational trials conducted in India, there are some trials with planned or actual over-recruitment of participants from India, leading to potential unfairness to Indian participants and the population. Additionally, there are delays in updating completed study records in the Clinical Trials Registry-India (CTRI).
Review
Cardiac & Cardiovascular Systems
Perrine Janiaud, Lars G. Hemkens, John P. A. Ioannidis
Summary: The COVID-19 crisis has resulted in a large number of clinical trials activities, with most trials being small in scale and experiencing delays in publishing results. Small trials and observational analyses may generate misleading conclusions, while larger trials are more likely to produce consistent evidence. The pandemic has disrupted trial conduct, leading to the development and wider adoption of new methods to facilitate recruitment and overall trial implementation.
CANADIAN JOURNAL OF CARDIOLOGY
(2021)
Review
Public, Environmental & Occupational Health
Carlo Petrini, Chiara Mannelli, Luciana Riva, Sabina Gainotti, Gualberto Gussoni
Summary: Decentralized clinical trials (DCTs) reduce or eliminate the need for patients to physically access hospital-based trial sites through the use of digital tools and moving trial activities. DCTs adapt to patients' routines, offer better access and inclusion, and depend on infrastructure, regulatory framework, and partnerships for feasibility and quality.
FRONTIERS IN PUBLIC HEALTH
(2022)
Article
Multidisciplinary Sciences
Corey A. Kalbaugh, Julianne M. Kalbaugh, Lisa McManus, Jill A. Fisher
Summary: Participation as a healthy volunteer in US Phase I trials is influenced by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and for longer periods than more privileged groups. Specific groups show more significant performance in terms of the number of trials completed and duration of participation.
Review
Gastroenterology & Hepatology
Elliot B. Tapper, Marina Serper, David S. Goldberg
Summary: Patients with chronic liver disease can benefit from pragmatic trial designs, which aim to provide evidence for the adoption of interventions in real-world clinical practice. The efficiency of identifying, recruiting, and following patients, the resemblance of interventions and design to usual clinical care, and the importance of outcomes to patients are key factors in determining the pragmatism of a trial. This review focuses on the promise, trade-offs, and purpose of pragmatic trials in hepatology.
Article
Biology
Nora Hutchinson, Hannah Moyer, Deborah A. Zarin, Jonathan Kimmelman
Summary: This article describes the importance of informativeness in guiding clinical, policy, or research decisions. The study found that the majority of randomized interventional trials designed to guide clinical practice possess features that may compromise their ability to do so.
Review
Multidisciplinary Sciences
Melina von Wernsdorff, Martin Loef, Brunna Tuschen-Caffier, Stefan Schmidt
Summary: Open-label placebos do not require deception, and studies have found a significant overall effect in different conditions, indicating promise as a treatment. However, further research is needed to explore this potential further.
SCIENTIFIC REPORTS
(2021)
Article
Cell & Tissue Engineering
Catherine Lindgren, Ashley Leinbach, Julie Annis, Jay Tanna, Nan Zhang, Jonathan H. Esensten, Patrick J. Hanley
Summary: Cellular therapies are increasingly conducted through multi-center trials to ensure broader access, but remote sites face challenges in shipping and preparing products. By sharing academic consortium experiences, best practices have been developed to overcome these challenges and ensure successful participation in trials.
Article
Pediatrics
Pirkko Lepola, Maxine Kindred, Viviana Giannuzzi, Heidi Glosli, Martine Dehlinger-Kremer, Harris Dalrymple, David Neubauer, Geraldine B. Boylan, Jean Conway, Jo Dewhurst, Diane Hoffman
Summary: This study compiled and analyzed current legal, ethical, and regulatory guidance for pediatric clinical trials in Europe, creating a comprehensive guide divided into 30 subject elements. The guide, available on Enpr-EMA website, aims to improve ethical standards in pediatric clinical trials.
ARCHIVES OF DISEASE IN CHILDHOOD
(2022)
Review
Medicine, General & Internal
Karolina Strzebonska, Mateusz Blukacz, Mateusz T. Wasylewski, Maciej Polak, Bishal Gyawali, Marcin Waligora
Summary: This systematic review with meta-analysis evaluated the efficacy and safety profiles of cancer umbrella trials testing targeted drugs or a combination of targeted therapy with chemotherapy. The study found that, on average, one in five cancer patients responded to a given therapy, while one in 125 died due to drug toxicity. The results do not support the expectation of increased patient benefit in cancer umbrella trials, and further studies should be conducted.
Review
Health Care Sciences & Services
Mark Fedyk, Brian Dewar, Lucas Jurkovic, Stephanie Chevrier, Simon Kitto, Rosendo Rodriguez, Raphael Saginur, Dar Dowlatshahi, Robert Fahed, Michel Shamy
Summary: The study aims to identify and count the types of reasons used in academic papers about the ethical permissibility of randomized trials and proposes a more detailed classification of these reasons. The findings show that 10 themes effectively cover all the analyzed text excerpts, and these themes cannot be reduced to the occurrence of relevant keywords. Different individuals and organizations use different reasons to consider randomized trials justified, and even when they use similar language, the concepts they reference may not be consistent.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Review
Pharmacology & Pharmacy
Ana Zugic, Vanja Tadic, Snezana Savic
Article
Multidisciplinary Sciences
Ana Gledovic, Aleksandra Janosevic Lezaic, Veljko Krstonosic, Jelena Djokovic, Ines Nikolic, Danica Bajuk-Bogdanovic, Jelena Antic Stankovic, Danijela Randjelovic, Sanela M. Savic, Mila Filipovic, Slobodanka Tamburic, Snezana D. Savic
Article
Dermatology
Milica Lukic, Ivana Pantelic, Snezana Savic
DERMATOLOGIC THERAPY
(2020)
Article
Chemistry, Multidisciplinary
Ana Gledovic, Aleksandra Janosevic Lezaic, Ines Nikolic, Marija Tasic-Kostov, Jelena Antic-Stankovic, Veljko Krstonosic, Danijela Randjelovic, Dragana Bozic, Dusan Ilic, Slobodanka Tamburic, Snezana Savic
Summary: This study successfully developed biocompatible oil-in-water nanoemulsions based on polyglycerol esters as carriers for natural active ingredients such as red raspberry seed oil and fruit extracts. The nanoemulsions showed promising antioxidant activity, selective cytotoxicity towards malignant melanoma cells, and significant improvement in skin hydration in human volunteers.
Article
Chemistry, Applied
Milica Lukic, Mila Filipovic, Nevena Pajic, Dominique Lunter, Dragana Bozic, Snezana Savic
Summary: The research investigated the formulation of acidic topical products with glycolic acid and found that they can induce skin acidification without causing barrier impairment or irritation after short- and long-term use. Higher concentrations of glycolic acid contribute to the lamellar structure of the emulsion.
INTERNATIONAL JOURNAL OF COSMETIC SCIENCE
(2021)
Article
Pharmacology & Pharmacy
Mirjana D. Timotijevic, Tanja Ilic, Snezana Savic, Ivana Pantelic
Summary: This paper explores the changes in topical film-forming systems (FFS) after solvent displacement, emphasizing their skin transformation as an area of special interest. The lack of appropriate characterization techniques is addressed and a comprehensive set of methods to evaluate FFS skin performance is proposed. The study investigates the physico-chemical, mechanical, and sensory properties of FFS and resulting films, and includes in vivo assessments of skin irritation, friction, and substantivity. The findings suggest that the type of film former affects transepidermal water loss, and that a hydrophobic methacrylate copolymer-based film reduces water loss by 40-50%, indicating a semi-occlusive effect. The analysis of tribological parameters and friction curves provides valuable insights, demonstrating the importance of reaching the plateau as the onset of the secondary formulation. The in vivo study confirms the high substantivity of all samples and supports the optimal ratio of hydrophobic cationic and hydrophilic polymers found during early screening.
Article
Biochemistry & Molecular Biology
Mirjana D. Timotijevic, Tanja Ilic, Bojan Markovic, Danijela Randjelovic, Nebojsa Cekic, Ines Nikolic, Snezana Savic, Ivana Pantelic
Summary: Polymeric film-forming systems have been studied for their properties and a combination of hydrophobic polymers has been found to achieve sustained and immediate drug delivery through the skin.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Pharmacology & Pharmacy
Ines Nikolic, Mitar Simic, Ivana Pantelic, Goran Stojanovic, Jelena Antic Stankovic, Bojan Markovic, Snezana Savic
Summary: Various approaches have been proposed for improving dermal drug delivery, such as chemical penetration enhancers and electrical current methods like iontophoresis. In this study, curcumin-loaded nanoemulsions with and without monoterpenes as penetration enhancers, as well as an adhesive dermal delivery system based on iontophoresis, were designed and evaluated. The results showed that iontophoresis was equally efficient as other methods in terms of curcumin penetration through superficial skin layers. Further improvement of iontophoresis as a mobile adhesive system would be a practical contribution in the field of dermal drug application.
Article
Green & Sustainable Science & Technology
Tamara Nikolic Turnic, Sara Mijailovic, Maja Nikolic, Jelena Dimitrijevic, Olivera Milovanovic, Katarina Djordjevic, Marko Folic, Ljiljana Tasic, Vladimir Reshetnikov, Maria Mikerova, Dragan Milovanovic, Vladimir Jakovljevic
Summary: This study aimed to analyze the current methods of online teaching at the Faculty of Medical Sciences, University of Kragujevac, Republic of Serbia, and assess the attitudes of biomedical students towards education during the COVID-19 pandemic. The researchers developed and validated a new tool, eMedQ, for evaluating students' perceptions of digital education.
Article
Pharmacology & Pharmacy
Jelena B. Dokovic, Sotiria Demisli, Sanela M. Savic, Bojan D. Markovic, Nebojsa D. Cekic, Danijela V. Randjelovic, Jelena R. Mitrovic, Dominique Jasmin Lunter, Vassiliki Papadimitriou, Aristotelis Xenakis, Snezana D. Savic
Summary: A nanotechnology-based approach to drug delivery is an important trend in biomedical science, offering advantages such as increased active concentration, bioavailability, and safety compared to conventional drug delivery systems. Nanoemulsions, as biodegradable, biocompatible and relatively easy to manufacture nanocarriers, have gained attention in the field. This study assessed the impact of oil phase selection on the physicochemical characteristics and injectability of curcumin-loaded PEGylated nanoemulsions. The results showed that the oil phase had a structural impact on the stabilizing layer of the nanoemulsions, and different oil phase selections significantly influenced the critical quality attributes of the PEGylated nanoemulsions.
Article
Biochemistry & Molecular Biology
Ana Gledovic, Aleksandra Janosevic-Lezaic, Slobodanka Tamburic, Snezana Savic
Summary: This study assessed and improved the oxidative stability of red raspberry seed oil and identified potential natural antioxidants for protection. Additionally, it explored the use of biodegradable polyglycerol esters-based surfactants for preparing stable nanoemulsions.
Review
Pharmacology & Pharmacy
Tanja Ilic, Jelena B. B. Dokovic, Ines Nikolic, Jelena R. R. Mitrovic, Ivana Pantelic, Snezana D. Savic, Miroslav M. M. Savic
Summary: Contemporary trends in combinatorial chemistry and drug design focus on developing lipophilic drugs with poor water solubility to improve delivery across the blood-brain barrier. Lipid nanocarriers, with innovative excipients/ligands, offer a promising solution to overcome the challenges of drug delivery through the blood-brain barrier. However, the lack of standardized methods and experimental conditions in the literature hinders systematic comparison and slows down the advancement in brain-targeting using lipid-based nanoparticles. This review provides an overview of commonly used methods in preclinical testing of lipid nanoparticles, such as liposomes, nanoemulsions, solid lipid nanoparticles, and nanostructured lipid carriers for CNS disorder treatment via parenteral route.
Article
Pharmacology & Pharmacy
Mila Vukasinovic, Sanela Savic, Nebojsa Cekic, Tanja Ilic, Ivana Pantelic, Snezana D. Savic
Summary: This study proposes a combination of in silico, instrumental tools and simplified sensory studies to efficiently characterize emulsions. By using experimental design method, the optimal formulation content was determined and the physical properties and sensory characteristics of each formulation were analyzed, providing guidance for early-stage development applications.
Article
Engineering, Chemical
Ana Gledovic, Danica Bajuk-Bogdanovic, Snezana Uskokovic-Markovic, Leposava Pavun, Snezana Savic, Aleksandra Janosevic Lezaic
Summary: In this study, several essential oils (EOs) were incorporated into nanoemulsions (NEs) as potential carriers for natural bioactives. The type of EO, surfactant, and oil mix concentration were found to be crucial factors for NE properties and stability. Raman spectra of the EOs confirmed the active ingredients and their interaction with the nanocarrier. Overall, oregano-loaded NEs were the most effective and stable system, preserving its high antioxidant activity during storage.
HEMIJSKA INDUSTRIJA
(2022)
Review
Biochemistry & Molecular Biology
Milica Lukic, Ivana Pantelic, Snezana D. Savic
Summary: Skin surface acidity plays a crucial role in maintaining skin health and barrier function, affecting keratinocyte differentiation, epidermal lipid formation, skin microbiome, and diseases. Therefore, controlling skin pH value can promote skin health, and formulating acidic products can effectively maintain skin health.
