Article
Multidisciplinary Sciences
Akl C. Fahed, Anthony A. Philippakis, Amit Khera
Summary: Polygenic scores can be used to identify individuals with high disease risk based on inherited DNA variations. This has the potential to enhance clinical trials by targeting individuals with higher risk for disease or increased likelihood of benefiting from treatment.
NATURE COMMUNICATIONS
(2022)
Article
Oncology
J. L. Perez-Gracia, N. Penel, E. Calvo, A. Awada, H. T. Arkenau, T. Amaral, V. Gruenwald, M. F. Sanmamed, L. Castelo-Branco, G. Bodoky, M. P. Lolkema, M. Di Nicola, P. Casali, R. Giuliani, G. Pentheroudakis
Summary: In recent years, the burden of bureaucracy in clinical research has significantly increased, negatively impacting investigators and clinical research teams. While compliance with regulations and guidelines is important, the overinterpretation and substitution by sponsors and CROs have increased administrative burden. A survey among 940 investigators confirmed excessive administrative burden and bureaucracy as obstacles to clinical research.
ANNALS OF ONCOLOGY
(2023)
Article
Oncology
Justine M. Kahn, Darrell M. Gray, Jill M. Oliveri, Chasity M. Washington, Cecilia R. DeGraffinreid, Electra D. Paskett
Summary: This commentary addresses the growing need for diversity, equity, and inclusion (DEI) in cancer care, particularly in relation to equal access and accrual to clinical trials. The authors describe steps taken in their own clinical practice and propose actions at various levels to improve DEI in clinical trials.
Article
Health Care Sciences & Services
Katie Gillies, Paula R. Williamson, Vikki A. Entwistle, Heidi Gardner, Shaun Treweek, Marion K. Campbell
Summary: The ELICIT Study developed a core outcome set for interventions aimed at improving decision-making about participation in randomized controlled trials, through a mixed-method study involving literature review, interviews, Delphi survey, and consensus meeting. Consensus was reached on 12 core outcomes essential for evaluating interventions to improve decision-making about participating in randomized controlled trials.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Immunology
Amy C. Sherman, Nadine Rouphael, Lindsey R. Baden
Summary: This article reviews the importance of vaccine clinical trials in developing effective COVID-19 vaccines. It highlights the challenges of supply chain disruptions, infection control, study designs, and participant factors, as well as specific solutions to streamline the clinical trial process.
CLINICAL INFECTIOUS DISEASES
(2022)
Article
Computer Science, Interdisciplinary Applications
Esther Nanzayi Ngayua, Jianjia He, Kwabena Agyei-Boahene
Summary: The increasing demand for new therapies and clinical interventions has led researchers to conduct numerous clinical trials. Advanced technologies such as artificial intelligence and machine learning are being utilized to improve efficiency and productivity in clinical trials. Research shows a growing interest in the field, with a focus on recruitment, eligibility, and validation studies. Further empirical studies are expected to implement AI, ML, DL, and IoT in clinical trials.
Review
Nutrition & Dietetics
Sindusha Mysore Saiprasad, Olivia Grace Moreno, Dennis A. Savaiano
Summary: Supplementing with Bifidobacterium and galacto-oligosaccharides (GOS) can improve gut health and benefit lactose intolerant individuals. Most studies have reported positive effects of Bifidobacterium and GOS in managing lactose intolerance.
Article
Chemistry, Multidisciplinary
Dries Matthys, Jochen Vleugels, Kathleen Denis, Tim Dieryckx, Stijn Verwulgen
Summary: An optical intervention using prism glasses to redirect the cyclist's sight was found to reduce neck strain and aerodynamic drag, improving cycling efficiency. The experiment showed a consistent reduction in drag ranging from 3.5% to 4.7%, resulting in energy savings of 9.7 watts to 13.0 watts when cycling at 45 km/h.
APPLIED SCIENCES-BASEL
(2023)
Article
Business
Juan Du, Bo Bernhard Nielsen, Catherine Welch
Summary: This article provides a contextualized understanding of the potential for blockchain technology to become a general-purpose technology (GPT) by analyzing international business use cases. It discusses how the extensiveness, evolvability, and enabling aspects of blockchain influence the value, vision, and viability required for successful real-world applications.
CALIFORNIA MANAGEMENT REVIEW
(2023)
Article
Pharmacology & Pharmacy
Rita Nogueiras-Alvarez
Summary: With the trend towards promoting personalised medicine, the application of pharmacogenetics and pharmacogenomics is becoming increasingly important. Clinical trials that include pharmacogenetic and pharmacogenomic information can improve knowledge about the effectiveness and safety of new drugs, with a focus on areas such as oncology and mental health. Training in pharmacogenetics and pharmacogenomics is necessary for researchers and clinicians to properly interpret the data and contribute to better prescribing decisions and patient care, ultimately leading to the implementation of personalised medicine.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Geriatrics & Gerontology
Jennifer Gabbard, Tina R. Sadarangani, Rupak Datta, Chanee D. Fabius, Cameron J. Gettel, Natalie F. Douglas, Lisa A. Juckett, Andrew M. Kiselica, Komal Patel Murali, Ellen P. McCarthy, Alexia M. Torke, Christopher M. Callahan
Summary: The lack of infrastructure to support a coordinated clinical response for people living with dementia (PLWD) and the shortage of researchers conducting rigorous embedded pragmatic clinical trials (ePCTs) are hindering the delivery of high quality dementia care. The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's disease and Related Dementias Clinical Trials (IMPACT) Collaboratory aims to address these challenges by funding career development awards and providing training opportunities and support networks. This report discusses the career development challenges faced by early-career researchers involved in ePCTs for dementia care and offers concrete suggestions to address these challenges.
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
(2023)
Review
Biochemistry & Molecular Biology
Janisha Patel, Xueliang Gao, Haizhen Wang
Summary: Current therapies for T-cell acute leukemia have improved survival rates, but high mortality rates remain due to relapsed disease, resistance, and toxicities/infection. Newer agents are being investigated to optimize upfront therapies and decrease relapse rates. This review summarizes the progress of chemo/targeted therapies and novel strategies for T-cell acute leukemia, as well as immunotherapy clinical trials using antibodies and CAR-T therapy. The combination of targeted therapy and immunotherapy may be a promising approach.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2023)
Article
Medicine, General & Internal
Jennifer Le-Rademacher, Heather Gunn, Xiaoxi Yao, Daniel J. Schaid
Summary: Clinical trials are important for evaluating the safety and efficacy of new interventions. Traditional explanatory trials focus on exploring the biological causes and effects, while pragmatic trials consider real-world conditions and aim to optimize interventions in diverse clinical practices. It is essential to maintain scientific rigor, increase trial efficiency, ensure generalizability of results, and address health disparities through technology and decentralized approaches.
MAYO CLINIC PROCEEDINGS
(2023)
Review
Biochemistry & Molecular Biology
Muhammad Faraz Raghib, Evanthia Bernitsas, Masaru Tanaka
Summary: This systematic review examines the effect of antimicrobials on multiple sclerosis (MS). While animal models have shown promising results, studies in humans have been limited, with only some antibiotics and antiparasitic drugs showing improvement. Further large, multicenter, well-designed studies are needed to evaluate the effect of antimicrobials in MS.
Article
Medicine, Research & Experimental
Mark J. Kupersmith, Nathalie Jette
Summary: There are multiple reasons for the failure or limited applicability of clinical trials, including restrictive entry criteria, short duration studies, unrecognized adverse drug effects, and reporting bias. To improve the conduct and applicability of clinical trials, two approaches are suggested: utilizing animal models that more accurately simulate human disease to determine dosing and outcomes, and using big data to identify and manage known and potential risk factors and confounding issues.
Review
Health Care Sciences & Services
Michael Anderson, Huseyin Naci, Deborah Morrison, Leeza Osipenko, Elias Mossialos
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2019)
Review
Oncology
Denis Lacombe, Jan Bogaerts, Bertrand Tombal, Francois Maignen, Leeza Osipienko, Richard Sullivan, Vassilis Golfinopoulos
MOLECULAR ONCOLOGY
(2019)
Review
Economics
Francisca Crispi, Huseyin Naci, Eva Barkauskaite, Leeza Osipenko, Elias Mossialos
APPLIED HEALTH ECONOMICS AND HEALTH POLICY
(2019)
Article
Health Care Sciences & Services
Pilar Pinilla-Dominguez, Huseyin Naci, Leeza Osipenko, Elias Mossialos
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE
(2020)
Article
Health Care Sciences & Services
Demi Radeva, Gareth Hopkin, Elias Mossialos, John Borrill, Leeza Osipenko, Huseyin Naci
INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE
(2020)
Article
Medicine, General & Internal
Behdin Nowrouzi-Kia, Leeza Osipenko, Parvin Eftekhar, Nasih Othman, Sultan Alotaibi, Alexandra M. Schuster, Hae Sun Suh, Andrea Duncan
Summary: This study provides a preliminary understanding of the impact of the first lockdown on post-secondary students, faculty, and staff worldwide. The survey results indicate that the lockdown had both positive and negative effects on social life, access to services, health experiences, and mental well-being.
SAGE OPEN MEDICINE
(2022)
Article
Medicine, General & Internal
Leeza Osipenko
Summary: The study assessed the extent and type of data redaction in all active technology appraisals and highly specialised technology evaluations issued by NICE, finding that a significant amount of data, including clinical and economic data, were redacted. Policy recommendations are proposed to ensure transparency of these important data.