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Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-03-15 Nicholette Conway, Orin Chisholm
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Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-03-08 Gaia Geraci, Robert Smith, Alison Hansford, Eric Johnsson, Helen Critchley, Lama Abi Khaled, Laura King, Michelle Cheng, Tanja Colin, Tse Siang Kang
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New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-03-04 Kenneth Getz, Zachary Smith, Emily Botto, Elisabeth Murphy, Arnaud Dauchy
The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a follow-up study in 2022 to assess trends in protocol amendment experiences and the impact amendments have had on clinical trial performance, particularly during the COVID-19 pandemic. Sixteen pharmaceutical companies and contract research organizations provided data on 950 protocols and 2188 amendments. The results show that
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A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-03-04 Fernanda Lacerda da Silva Machado, Martín Cañás, Martín A. Urtasun, Gustavo H. Marín, Flavia Caixeta Albuquerque, Lisa Pont, Irma Convertino, Marco Bonaso, Marco Tuccori, Ursula Kirchmayer, Luciane Cruz Lopes
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Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-20 Wan Lee Chow, Nur Afiqah Mohd Salleh, Tse Siang Kang
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Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-18 Anders Vinther, Emma Ramnarine, Thierry Gastineau, Laura O’Brien, Oliver Brehm, David Fryrear
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Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-16 Abigail Dirks, Maria Florez, Francois Torche, Steve Young, Brian Slizgi, Kenneth Getz
Background Risk-based monitoring (RBM) and risk-based quality management (RBQM) offer a compelling approach to increase efficiency, speed and quality in clinical trials by prioritizing and mitigating risks related to essential safety and efficacy data. Since 2013, the FDA and EMA have encouraged the use of RBM/RBQM, however adoption has been slow with limited understanding of the barriers to adoption
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Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-10 Colleen Davenport, Patricia Gravel, Yamei Wang, Setareh A. Williams, Alethea Wieland, Bruce Mitlak
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Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-09 Sylviane de Viron, Laura Trotta, William Steijn, Steve Young, Marc Buyse
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Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-07 Michael Torok, Leslie Sam, Jennifer Hebert
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Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-06
Abstract The past years have sharpened the industry’s understanding of a Quality by Design (QbD) approach toward clinical trials. Using QbD encourages designing quality into a trial during the planning phase. The identification of Critical to Quality (CtQs) factors and specifically Critical Data and Processes (CD&Ps) is key to such a risk-based monitoring approach. A variable that allows monitoring
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A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-06 Bernadette Johnson-Williams, Kellie Reynolds, Joga Gobburu, Albert Rundio
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Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-05 Rima Izem, Emmanuel Zuber, Nadia Daizadeh, Frank Bretz, Oleksandr Sverdlov, Pascal Edrich, Janice Branson, Evgeny Degtyarev, Nikolaos Sfikas, Robert Hemmings
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The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-05 Rong Tang, Wei-Chen Chen, Heng Li, Nelson Lu, Yu Zhao
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Decentralized Clinical Trials in the Development of Drugs and Biological Products Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-02-02 Ryan Robinson, Leonard Sacks
Decentralized clinical trials (DCTs) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. FDA supports decentralization to improve participation in clinical trials. While there are benefits of DCTs, including convenience for participants, sponsors and investigators should be aware of potential challenges such as coordination of
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Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-29
Abstract A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during
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Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-24 Sai Dharmarajan, Zhong Yuan, Yeh-Fong Chen, Leila Lackey, Saurabh Mukhopadhyay, Pritibha Singh, Ram Tiwari
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Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-09 Jayanthi Boobalan, Kyu-Been Sohn, Ornamphai Shinawatra
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Quantifying Site Burden to Optimize Protocol Performance Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-08 Maria Florez, Zachary Smith, Zachary Olah, Mike Martin, Kenneth Getz
Background The increase in protocol complexity and the resulting rise in the effort required by investigative sites to implement protocols have been well documented, but existing measures of site burden only offer an incomplete view of the burden experienced by site personnel. The introduction of Decentralized Clinical Trials—trials supported by remote and virtual technologies and services—is expected
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Aggregate IND Safety Reporting for Smaller Companies and Programs Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-08 Greg Ball, Mengchun Li, Jim Buchanan, Barbara Hendrickson, Richard C. Zink, Steve Snapinn, Jay Herson
The United States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) Final Rule (US FDA, Final rule: Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans, 2010) applies to all human drugs and biological products being studied under an IND. The Final
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US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-05 Joseph M. Gendy, Naomi Nomura, Jeffrey N. Stuart, Gideon Blumenthal
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Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-04
Abstract Background Accelerated approval (AA) program expedites access to promising drugs for life-threatening conditions, particularly in oncology. However, challenges arise from the trade-off between faster access and the certainty of clinical benefits. We examined the differences between the indications for successful conversion of AA to regular approval (RA) and those withdrawn from the perspective
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Pediatric Market Access: A Qualitative Study Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-03 Lieke Maas, Angelika Joos, Mickael Hiligsmann
Objectives This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate current challenges. Methods Twenty-two semi-structured interviews were conducted with experts from pharmaceutical industry, regulatory authorities, national health technology assessment (HTA) bodies, pediatricians, and academia from the Netherlands (NL)
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Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2024-01-01 Marina Ghadanian, Ellen Schafheutle
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An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-26 Rakhi Kilaru, Sonia Amodio, Yasha Li, Christine Wells, Sharon Love, Yuling Zeng, Jingjing Ye, Monika Jelizarow, Abhinav Balakumar, Maciej Fronc, Anne Sofie Osterdal, Tim Rolfe, Susan Talbot
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Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-22 Takashi Watanabe, Kaori Ambe, Masahiro Tohkin
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Detection, Monitoring, and Mitigation of Drug-Induced Nephrotoxicity: A Pragmatic Approach Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-18 Nicola Antognini, Ronald Portman, Victor Dong, Nicholas J. Webb, Deepa H. Chand
The kidneys play a pivotal role in elimination of most drugs; therefore, a comprehensive understanding of renal physiology and pathology is important for those involved in drug development. High filtration capacity and metabolic activity make the kidneys vulnerable to drug-induced nephrotoxicity (DIN). Acute DIN may manifest on a background of renal impairment that has resulted from underlying disease
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Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-17 Amalia Alexe, Anju Garg, Birgit Kovacs, Nadezda Abramova, Olatayo Apara, Osa Eisele, Maria Fernanda Scantamburlo Fernandes, Leesha Balramsingh-Harry, Keele Wurst, David Lewis
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Delivering Digital Health Solutions that Patients Need: A Call to Action Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-11 Veronica Popa, Jan Geissler, Rebecca Vermeulen, Elizabeth Priest, Katherine Capperella, Gözde Susuzlu, Sharon F. Terry, Nicholas Brooke
Digital health solutions have the potential to complement traditional healthcare approaches and deliver improved health outcomes, but there are system-wide challenges that need to be addressed. These include fragmentation of the digital health landscape, regulatory processes that lack the agility to accommodate the fast pace of digital health advances, and inadequate transparency around data sharing
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Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-06 Jumpei Saito, Hidefumi Nakamura, Miki Akabane, Akimasa Yamatani
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Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-06 Ashwin Mali, Vijaykumar Kuvar, Saily Bharadwaj
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A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-01 Zachary Smith, Kenneth Getz
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The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8 Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-12-01 Madeleine Whitehead, Melissa Suprin, Tashan Mistree, Margaret Mary Kearns, Gerard Marini, Christine Goffe, Marion Pillwein, Vimi Abdul-Shukkoor
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Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-23 Pei Li, Su Wang, Yuwen Chen
Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical practice, which can be analyzed to generate real-world evidence (RWE). The Chinese government has been actively promoting regulatory reform that is in line with the characteristics of TCM, optimizing the clinical evidence system for TCM, and exploring the important role of RWE in
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Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-22 Peter Baker, Tamika Cathey, Jared R. Auclair
The COVID-19 pandemic forced industry and national regulatory authorities (NRAs) to think about innovative ways to ensure business continuity, including Good Manufacturing Practices (GMP) inspections. Even prior to COVID-19, it was understood that GMP site inspections, especially redundant inspections, are a time and resource-intensive process for both industry and regulators in high-income countries
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An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-10 Sheena Dupuy, Laura Opincar, Kirtida Pandya, Susan Wnorowski, Marianne Cuellar, Jennifer Riggins, Evelyn R. Hermes-DeSantis
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Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial? Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-07 Terry Katz,Maryrose Petrizzo,Kamila Novak,Munish Mehra
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Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019 Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-05 Atasi Poddar, Miranda Raggio, John Concato
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Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-11-01 Dawn Edwards, N. Best, J. Crawford, L. Zi, C. Shelton, A. Fowler
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Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in Japan Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-29 Tomoaki Hasegawa, Sono Sawada, Tomoyuki Saito, Mei Kohama, Kazuhiro Kajiyama, Chieko Ishiguro, Takahiro Nonaka, Toshiyuki Okamura, Yukari Iwasaki, Takahiro Ueda, Toyotaka Iguchi, Naoya Horiuchi, Yoshiaki Uyama
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Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-27 Sampada Gandhi, Benjamin Taylor, Lexie Rubens, Nileesa Gautam, Nancy Sherman, Kanti Chittuluru, Kevin Wolter
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Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-27 Ensei Miura
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An Evaluation of the Swissmedic Regulatory Framework for New Active Substances Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-26 Magda Bujar, Simon Andreas Dalla Torre di Sanguinetto, Adem Kermad, Claus Bolte, Neil McAuslane
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Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-23 Muhammed Y. Idris, William E. Fitzsimmons, Priscilla Pemu
Background Health care inequity includes the lack of adequate representation of various populations in clinical trials. Government, academic and industry organizations have highlighted these issues and committed to actions to improve. In order to assess the current status and future success of these initiatives a quantitative objective measure to assess the state of clinical trial diversity is needed
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The Term 'Deselect' is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches. Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-18 Eric P Brass
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Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-10 Flávia Nathiely Silveira Fachel, Roselena Silvestri Schuh, Patrícia Bencke Grudzinski, Helder Ferreira Teixeira, Guilherme Baldo, Ursula Matte
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Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-07 Shuai Wang, Robert Frederich, James P. Mancuso
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Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-10-03 Akira Ito, Mamoru Narukawa
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New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-29 Zachary Smith, Emily Botto, Otis Johnson, Todd Rudo, Kenneth Getz
Background A lack of diversity and representation in clinical trials is an established issue in drug development, and the COVID-19 pandemic increased awareness of the problem among the general public. This awareness has led to increased pressure on drug development sponsors, as well as additional attention and regulation from federal bodies, to improve the diversity of clinical trials. This study updates
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Training New DMC Members: A Call to Action Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-25 Frank Rockhold, Kenneth Mahaffey, David DeMets
Historically, clinical trialists developed DMC expertise and experience with “on the job training”. Clinical trialists have recognized a large and growing gap between the demand and supply of trained DMC members due in part to the huge increase in ongoing clinical trials. A critical need exists to increase the supply of DMC trained clinicians and biostatisticians. Despite a rich collection of published
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Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-26 Ran Duan, Kaiyi Chen, Yu Du, Pandurang M. Kulkarni, Yongming Qu
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Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-24 Neil Bertelsen, Lode Dewulf, Silvia Ferrè, Rebecca Vermeulen, Karlin Schroeder, Laureline Gatellier, Ify Sargeant, Daniela Luzuriaga, Hayley Chapman, Nicholas Brooke
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Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-18 Ziling Xiang, Hui Jiang, Wengao Jiang, Yali Wang, Hang Zheng
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Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-15 Mengjia Yu, Sheng Zhong, Yunzhao Xing, Li Wang
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Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-08 Urimara Argotti, Lada Leyens, Carlos Lisbona, Pilar López, Sergio Alonso-Orgaz, Angel Nevado, Virginia Cozzi
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Planning Benefit-Risk Assessments Using Visualizations Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-08 Michael W. Colopy, Lovemore Gakava, Chen Chen
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Prioritizing Early Disease Intervention Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-09-05 H. Hugo Caicedo, Jonathan J. Darrow, Julio C. Caicedo, Alex Pentland
Scholars and practitioners have described how investing in health care earlier rather than later can be beneficial, from how “biomarkers” offer promise for early disease detection to healthcare system “incentives” that can promote early preventive medicine. Work by health economists has also made clear that the “health capital” of an individual depreciates over time in the absence of investments in
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Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-08-31 Feifei Peng, Hang Zheng
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Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-08-25 Pei Li, Su Wang, Yuwen Chen
Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical researchers and regulators in recent years. The application and development of RWD/E in drug regulatory decision-making have been vigorously promoted in China. This study seeks to provide a broad overview of how RWE has been contributing to drug regulatory decisions
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Aiding the Adoption of Master Protocols by Optimizing Patient Engagement Ther. Innov. Regul. Sci. (IF 1.5) Pub Date : 2023-08-24 Raymond A. Huml, Deborah Collyar, Zoran Antonijevic, Robert A. Beckman, Ruben G. W. Quek, Jingjing Ye
Master protocols (MPs) are an important addition to the clinical trial repertoire. As defined by the U.S. Food and Drug Administration (FDA), this term means “a protocol designed with multiple sub-studies, which may have different objectives (goals) and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure.” This