Article
Pharmacology & Pharmacy
Ivett Jakab, Melanie D. Whittington, Elizabeth Franklin, Susan Raiola, Jonathan D. Campbell, Zoltan Kalo, R. Brett McQueen
Summary: This study aimed to engage patients and payers to discuss and rank the importance of additional value criteria. Payers viewed value as criteria providing tangible benefits, while patients saw value as options potentially benefiting them in the future. However, payers found these criteria difficult to measure and incorporate into objective decision making.
FRONTIERS IN PHARMACOLOGY
(2021)
Review
Pharmacology & Pharmacy
Ting Wang, Neil McAuslane, Helga Gardarsdottir, Wim G. Goettsch, Hubert G. M. Leufkens
Summary: There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies and support positive HTA recommendations. This study evaluates pharmaceutical companies' strategies and practices for seeking HTA-related scientific advice based on information collected directly from companies.
DRUG DISCOVERY TODAY
(2022)
Review
Public, Environmental & Occupational Health
Na Zhou, Hong Ji, Zheng Li, Jun Hu, Jia-Hua Xie, Yu-Heng Feng, Ni Yuan
Summary: This study summarizes the criteria for the recommendation of orphan drugs in different countries and identifies the variability in decision-making. The findings provide insights for the establishment of criteria in the process of health insurance access for orphan drugs in different countries.
FRONTIERS IN PUBLIC HEALTH
(2022)
Review
Food Science & Technology
Muralikrishna Gangadharan Komala, Ser Gin Ong, Muhammad Uzair Qadri, Lamees M. Elshafie, Carol A. Pollock, Sonia Saad
Summary: The regulatory processes for nutraceuticals lack global consensus, leading to issues of quality and safety. This review examines the regulations in the USA, Europe, and Australia, and highlights concerns regarding efficacy and safety, product development, gaps in regulation, and challenges in ensuring authenticity. The need for an effective and transparent system, collaboration, and international risk assessment criteria is emphasized to enhance trust and ensure efficacy and safety.
Article
Medicine, General & Internal
Ashley Jaksa, Patrick J. Arena, Kelvin K. W. Chan, Rami H. Ben-Joseph, Pall Jonsson, Ulka B. Campbell
Summary: In recent years, there has been a growing emphasis on the importance of real-world data and evidence in regulatory and health technology assessment decision-making processes. However, there is limited consensus on defining transferred data and there is insufficient focus on the transferability of such data.
FRONTIERS IN MEDICINE
(2022)
Article
Environmental Studies
Peter D. Blair
Summary: Effective science and technology (S&T) assessment capabilities providing advice for Congress require credibility and relevance. Those who provide advice must be authoritative, objective, and independent, while the advice itself must be relevant, useful, and timely. Congress often draws on traditional options like the National Research Council, Congressional Research Service, Office of Technology Assessment, and Government Accountability Office when seeking S&T advice.
SCIENCE AND PUBLIC POLICY
(2021)
Article
Oncology
Louise Binder, Majd Ghadban, Christina Sit, Kathleen Barnard
Summary: Public reimbursement systems in Canada face the challenge of balancing limited resources with the provision of necessary treatments. Health technology assessment (HTA) plays a crucial role in analyzing the value of drugs and making recommendations for public reimbursement. CADTH provides recommendations to all provinces in Canada, except Quebec. Recent changes have resulted in reduced cost per quality-adjusted life year (QALY) threshold, leading to greater price reductions in drug recommendations to provinces.
Article
Economics
Ashley Jaksa, Anthony Louder, Christina Maksymiuk, Gerard T. Vondeling, Laura Martin, Nicolle Gatto, Eric Richards, Antoine Yver, Mats Rosenlund
Summary: This review compared 7 case studies of regulatory and HTA agencies' evaluations of oncology ECAs. Common critiques include selection bias and confounding, but there is low agreement among agencies. The influence of ECAs on decision-making also varies.
Article
Fisheries
Ernesto Jardim, Manuela Azevedo, Jon Brodziak, Elizabeth N. Brooks, Kelli F. Johnson, Nikolai Klibansky, Colin P. Millar, Coilin Minto, Iago Mosqueira, Richard D. M. Nash, Paraskevas Vasilakopoulos, Brian K. Wells
Summary: This paper examines the potential of using ensemble modelling to capture assessment uncertainties and enhance the robustness of advice provision, discussing both the advantages and challenges of this approach. It emphasizes the uncertainties in stock assessment processes and the need for simpler models due to the complexity of fish population dynamics. Recommendations are made for revisions to the current assessment modelling methods and further research to evaluate the benefits in modelling and advice performance.
ICES JOURNAL OF MARINE SCIENCE
(2021)
Article
Public, Environmental & Occupational Health
Jack Wallace, Yinzong Xiao, Jess Howell, Alex Thompson, Nicole Allard, Emily Adamson, Jacqui Richmond, Behzad Hajarizadeh, Melanie Eagle, Joseph Doyle, Margaret Hellard
Summary: The study emphasizes the conflict between biomedical and public health explanations and the lived experience of hepatitis B among people of Chinese ethnicity in Australia. Beliefs about hepatitis B are embedded within cultural understandings of health that can conflict with biomedical explanations of the infection. Acknowledging these perspectives provides for insightful communication between health services and their clients, and the development of nuanced models of care informed by the experience of people with hepatitis B.
Article
Green & Sustainable Science & Technology
Armin Grunwald
Summary: The paper discusses Technology Assessment (TA), Responsible Research and Innovation (RRI), and Sustainability Research (SR) as manifestations of reflexive modernization in problem-oriented and transformative research. It aims to unfold the hypothesis regarding these approaches within reflexive modernization, clarify the meaning of 'reflexive' in each approach, identify commonalities and differences between them, and draw conclusions for their relation and further development.
Article
Health Care Sciences & Services
Boris Schmitz
Summary: The role of scientific research is crucial in modern society for driving innovation, informing policies, and shaping public opinion. However, communicating scientific findings to the general public can be challenging due to its technicality and complexity. Lay abstracts, generated by artificial intelligence language models, can provide easily understandable summaries of key findings and implications, increasing the visibility and impact of scientific research.
Article
Nursing
Amynah S. Mevawala, Faith A. Strunk, Roya Haghiri-Vijeh, Inge B. Corless, Padmavathy Ramaswamy, Kendra J. Kamp, Sheryl Scott, Sarah Gray
Summary: This article discusses the experience with a scientific hackathon at an international nursing research congress in Canada. The hackathon united international nursing scholars and focused on developing technology-based solutions for healthcare issues, showcasing the potential for collaboration and innovation in the field.
Article
Medicine, General & Internal
Francisco D. Rodriguez-Gomez, Oriol Penon, Dominique Monferrer, Pilar Rivera-Gil
Summary: The lack of specific regulatory guidelines for nanotechnology-enabled health products (NHPs) is hindering their development and patient access. A novel classification system is proposed in this study to establish a standardized framework for regulatory assessment. This system combines scientific and regulatory principles and allows sorting nano-based innovations and regulatory guidelines based on the type of NHPs they address. It serves as a useful tool for monitoring the state of the art of NHPs and supports the development of regulatory guidelines for regulators, as well as helps manufacturers align their development plans with applicable guidelines and standards to meet regulatory expectations.
FRONTIERS IN MEDICINE
(2023)
Review
Economics
Cassandra Nemzoff, Hiral A. Shah, Lieke Fleur Heupink, Lydia Regan, Srobana Ghosh, Morgan Pincombe, Javier Guzman, Sedona Sweeney, Francis Ruiz, Anna Vassall
Summary: Adaptive Health Technology Assessment (aHTA) is a method used in situations where time constraints, certainty, and low budget impact are factors. It can support decision-making more quickly and efficiently, reduce duplication, but currently lacks standardization, transparency, and measurement of uncertainty.