Results for 'All Articles'
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Aaron S. Long, BS; Audrey D. Zhang, MD; Caitlin E. Meyer, MLIS; Alexander C. Egilman, BS; Joseph S. Ross, MD, MHS; Joshua D. Wallach, PhD, MS
Evaluation of Trials Comparing Single-Enantiomer Drugs to Their Racemic Precursors: A Systematic Review
May 6th • 18 mins read
Charles Oo, Barbara Ameer
Revamping the ever-changing landscape of drug development processes in the midst of COVID-19 pandemic
Apr 29th • 2 mins read
Shubham Sharma, J Connor Wells, Wilma M Hopman, Joseph C Del Paggio, Bishal Gyawali, Nazik Hammad, Annette E Hay, Christopher M Booth
Cancer, Clinical Trials, and Canada: Our Contribution to Worldwide Randomized Controlled Trials
Apr 13th • 10 mins read
B. Gyawali, E. G. E. de Vries, U. Dafni, T. Amaral, J. Barriuso, J. Bogaerts, A. Calles, G. Curigliano, C. Gomez-Roca, B. Kiesewetter, S. Oosting, A. Passaro, G. Pentheroudakis, M. Piccart, F. Roitberg, J. Tabernero, N. Tarazona, D. Trapani, R. Wester, G.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring
Apr 20th • 8 mins read
A. Haslam, M.S. Kim, V. Prasad
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
Apr 20th • 7 mins read
Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
Apr 7th • 12 mins read
Kushal T. Kadakia, MSc, Malke Asaad, MD, Erica Adlakha, MS, Michael J. Overman, MD, Cristina M. Checka, MD, and Anaeze C. Offodile II, MD, MPH
Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions
Apr 8th • 4 mins read
Pai, Rekha
Advances in basic research in oncology in 2020: Bridging basic science and clinical care
Mar 24th • 1 min read
Adela Rodriguez, Francis Esposito, Helena Oliveres, Ferran Torres and Joan Maurel
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
Feb 11th • 3 mins read
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
Feb 23rd • 8 mins read
Avi Cherla, MSc; Huseyin Naci, MHS, PhD; Aaron S. Kesselheim, MD, JD, MPH; Bishal Gyawali, MD, PhD; Elias Mossialos, MD, PhD
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
Feb 22nd • 10 mins read
Charles L. Bennett , Sumimasa Nagai , Andrew C. Bennett , Shamia Hoque , Chadi Nabhan , Martin W. Schoen , William J. Hrushesky , Stefano Luminari , Paul Ray , Paul R. Yarnold , Bart Witherspoon , Josh Riente , Laura Bobolts , John Brusk , Rebecca Tombles
The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
Mar 12th • 7 mins read
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
Feb 11th • 4 mins read
Thakur, Sayanta & Lahiry, Sandeep
Accelerated drug approvals in oncology: Pros and cons
Sep 14th • 4 mins read
Karen Geary
Finding the Right Drug at the Right Dose the First Time: Has the Era of Personalized Formularies Finally Arrived?
Sep 27th • 1 min read
Paulo J. Oliveira, Ana M. Urbano
“Oncometabolism: The switchboard of cancer: An editorial”
Feb 1st • 1 min read
Ali Raza Khaki
Loose Regulatory Standards Portend a New Era of Imprecision Oncology
Dec 1st • 4 mins read
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
Nov 20th • 12 mins read
Jorge J. García, Luis E. Raez, Daniel Rosas
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
Aug 3rd • 10 mins read
Ioannis Tsagakis and Maria Papatriantafyllou
Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic
Nov 22nd • 3 mins read
Xuanyi Li, Elizabeth A. Sigworth, Adrianne H. Wu, Jess Behrens, Shervin A. Etemad, Seema Nagpal, Ronald S. Go, Kristin Wuichet, Eddy J. Chen, Samuel M. Rubinstein, Neeta K. Venepalli, Benjamin F. Tillman, Andrew J. Cowan, Martin W. Schoen, Andrew Malty, J
Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
Oct 16th • 12 mins read
Siddharth Agrawal, Nidhi Bansal
Advances and Challenges in Pediatric and Childhood Cancers
Jun 27th • 2 mins read
J. Remon, R. García-Campelo, E. de Álava, R. Vera, J. L. Rodríguez-Peralto, Á. Rodríguez-Lescure, B. Bellosillo, P. Garrido, F. Rojo & R. Álvarez-Alegret
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
Sep 26th • 17 mins read
E.M. Ray, L.A. Carey, K.E. Reeder-Hayes
Leveraging existing data to contextualize phase II clinical trial findings in oncology
Sep 21st • 3 mins read
Yuan Zhang, Xu Liu, Ying-Qin Li, Ling-Long Tang, Lei Chen, Jun Ma
A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma-To Know, Then to Measure
Aug 12th • 10 mins read
Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
Sep 6th • 20 mins read
Daan Geert Knapen, Nathan I. Cherny, Panagiota Zygoura, Nicola Jane Latino, Jean-Yves Douillard, Urania Dafni, Elisabeth G.E. de Vries, Derk Jan de Groot
Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1
Sep 6th • 17 mins read
Ramez Kouzy , Joseph Abi Jaoude , Walker Mainwaring , Timothy A. Lin , Austin B. Miller , Amit Jethanandani , Andres F. Espinoza , Vivek Verma , Clifton D. Fuller , Bruce D. Minsky , Claus Rödel , Cullen M. Taniguchi , Ethan B. Ludmir
Professional Medical Writer Assistance in Oncology Clinical Trials
Sep 17th • 7 mins read
Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities
Nov 18th • 15 mins read
Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Aug 31st • 16 mins read
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
Aug 16th • 8 mins read
Jaques van Heerden, MD, Mohamed Zaghloul, MD, Anouk Neven, MSc, Teresa de Rojas, MD, PhD, Jennifer Geel, MD, Catherine Patte, MD, Joyce Balagadde-Kambugu, MD, Peter Hesseling, MD, Francine Tchintseme, MD, Eric Bouffet, MD, and Laila Hessissen, MD
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
Aug 7th • 10 mins read
Consolación Molto MD, Thomas J. Hwang AB, Maria Borrell MD, Marta Andres MD, Ignasi Gich MD, PhD, Agustí Barnadas MD, PhD, Eitan Amir MD, PhD, Aaron S. Kesselheim MD, JD, MPH, Ariadna Tibau MD, PhD
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
Jul 22nd • 12 mins read
Vishwanath Sathyanarayanan, MD, DM, Christopher R. Flowers, MD, MSc, and Swaminathan P. Iyer, MD, MBBS
Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States
Jul 21st • 12 mins read
Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development
Jul 9th • 3 mins read
Cornelius F Waller & Adriano Friganovi´c
Biosimilars in oncology: key role of nurses in patient education
Jun 15th • 10 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
Jun 26th • 18 mins read
Mateusz T. Wasylewski, Karolina Strzebonska, Magdalena Koperny, Maciej Polak, Jonathan Kimmelman, Marcin Waligora
Clinical development success rates and social value of pediatric Phase 1 trials in oncology
Jun 21st • 28 mins read
Haiqing Isaac Dai, Yulia Vugmeyster, Naveen Mangal
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects
Jun 18th • 30 mins read
Melissa H. Roberts & Gary T. Ferguson
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Jun 18th • 6 mins read
Muneera Al Hussain
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
Jun 24th • 3 mins read
Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
May 22nd • 8 mins read
Dylan V Neel, David S Shulman, Clement Ma, Florence Bourgeois, Steven G DuBois
Sponsorship of oncology clinical trials in the United States according to age of eligibility
Apr 29th • 8 mins read
Ashley Woolmore , Dirk Arnold , Jean‐Yves Blay , Christian Buske , Alfredo Carrato , Winald Gerritsen , Marc Peeters , Jesus Garcia‐Foncillas , David Kerr
The Oncology Data Network (ODN): Methodology, Challenges, and Achievements
May 21st • 8 mins read
Audrey D. Zhang, Jeremy Puthumana, Nicholas S. Downing, MD
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
Apr 21st • 20 mins read
Sean X Zhang, MSc , Dean Fergusson, PhD , Jonathan Kimmelman, PhD
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
Apr 1st • 14 mins read
Tanja Cufer, Tudor E. Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopovic, Jacek Jassem, Dragana Jovanovic, Zhasmina Mihaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Nov 24th • 10 mins read
Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Feb 23rd • 12 mins read
Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
Feb 17th • 7 mins read
Jingjing Yu, Isabelle Ragueneau-Majlessi
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
Jan 25th • 12 mins read
Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
Jan 20th • 20 mins read
Carrie Printz
Precision medicine for pediatric cancers lags behind that for adult cancers: Citing hurdles in clinical trial recruitment and drug development, researchers are exploring ways to close gaps
Jan 9th • 2 mins read
Kelvin Chan, Seungree Nam, Bill Evans, Claire de Oliveira Alexandra Chambers, Scott Gavura, Jeffrey Hoch, Rebecca E Mercer, Wei Fang Dai, Jaclyn Beca, Mina Tadrous, Wanrudee Isaranuwatchai
Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
Jan 7th • 8 mins read
Mythili Shastry, PhD, Avantika Gupta, PhD, Sarat Chandarlapaty, MD, PhD, Matthew Young, MD, Thomas Powles, MD, and Erika Hamilton, MD
Rise of Antibody-Drug Conjugates: The Present and Future
May 25th • 20 mins read
Ruben Van Paemel, Roos Vlug, Katleen De Preter, Nadine Van Roy, Frank Speleman, Leen Willems, Tim Lammens, Geneviève Laureys, Gudrun Schleiermacher, Godelieve A. M. Tytgat, Kathy Astrahantseff, Hedwig Deubzer, Bram De Wilde
The pitfalls and promise of liquid biopsies for diagnosing and treating solid tumors in children: a review
Jan 3rd • 10 mins read
Massimo Di Maio, Francesco Perrone, Pierfranco Conte
Real-World Evidence in Oncology: Opportunities and Limitations
Dec 24th • 8 mins read
Jakub P. Hlávka, PhD, Pei-Jung Lin, PhD, Peter J. Neumann, ScD
Outcome measures for oncology alternative payment models: practical considerations and recommendations
Dec 1st • 10 mins read
Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach
Dec 20th • 15 mins read
Jonathan H. Cheng, Justin W. Tiulim, Sheng Zhou, Anthony El-Khoueiry and Jorge Nieva
Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials
Oct 18th • 10 mins read
Mariam A. Ahmed, Chirag Patel, Nicole Drezner, Whitney Helms, Weiwei Tan, Daria Stypinski
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development
Oct 31st • 20 mins read
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A Furukawa
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Oct 24th • 18 mins read
Carrie Printz
First person profile: Supriya G. Mohile, MD, MS: A respected geriatric oncologist, Dr. Mohile has conducted innovative research on improving care for older patients with cancer
Oct 11th • 2 mins read
S.E. Abdullah, E. Oflazoglu, J.C. Soria, M.M. Dar
New Realities of Phase I Clinical Trials in the Era of
Oct 7th • 5 mins read
J. Remon, R. García-Campelo, E. de Álava, R. Vera, J. L. Rodríguez-Peralto, Á. Rodríguez-Lescure, B. Bellosillo, P. Garrido, F. Rojo & R. Álvarez-Alegret
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
Sep 26th • 16 mins read
Guillaume Beinse, MD, Virgile Tellier, Valentin Charvet, MSc, Eric Deutsch, MD, PhD, Isabelle Borget, PharmD, PhD, Christophe Massard, MD, PhD., Antoine Hollebecque, MD, PhD, and Loic Verlingue, MD
Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2
Sep 20th • 12 mins read
Joseph M. Unger, PhD, MS, Van T. Nghiem, PhD, Dawn L. Hershman, MD, MS
Association of National Cancer Institute-Sponsored Clinical Trial Network Group Studies With Guideline Care and New Drug Indications
Sep 4th • 17 mins read
Mark Verrill, Paul Declerck, Sibylle Loibl, Jake Lee & Javier Cortes
The rise of oncology biosimilars: from process to promise
Aug 23rd • 18 mins read
M. Ochoa de Olza, M. Oliva, C. Hierro I. Matos, J. Martin-Liberal, E. Garralda
Early-drug development in the era of immuno-oncology: are we ready to face the challenges?
Jun 26th • 26 mins read
Leslie Bernstein, PhD
First person profile: Leslie Bernstein, PhD: An epidemiologist known for her groundbreaking discoveries about breast cancer, Dr. Bernstein continues to push the field forward
Aug 12th • 4 mins read
R. Kurzrock, L.A. Gurski, R.W. Carlson, D.S. Ettinger, S.M. Horwitz, S.K. Kumar, L. Million, M. von Mehren, A.B. Benson III
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
Aug 2nd • 8 mins read
Omer Ben‐Aharon, Racheli Magnezi, Moshe Leshno, and Daniel A. Goldstein
Median Survival or Mean Survival: Which Measure Is the Most Appropriate for Patients, Physicians, and Policymakers?
Jul 18th • 15 mins read
Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022
Jun 10th • 30 mins read
Louis Everest, BSc; Monica Shah, BSc; Kelvin K.W. Chan, MD, MSc, PhD
Comparison of Long-term Survival Benefits in Trials of Immune Checkpoint Inhibitor vs Non-Immune Checkpoint Inhibitor Anticancer Agents Using ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale
Jul 10th • 12 mins read
Roman Adam, Ariadna Tibau, Consolación Molto Valiente, Boštjan Šeruga, Alberto Ocaña, Eitan Amir, Arnoud J. Templeton
Clinical benefit of cancer drugs approved in Switzerland 2010–2019
Jun 10th • 35 mins read
Christopher A. Busch, MSC; Johannes Krisam, PhD; Meinhard Kieser, PhD
A Comprehensive Comparison of Additional Benefit Assessment Methods Applied by Institute for Quality and Efficiency in Health Care and European Society for Medical Oncology for Time-to-Event Endpoints After Significant Phase III Trials—A Simulation Study
Jun 28th • 30 mins read
YuQian Liu, PharmD
Uptake of Oncology Biosimilars: Managed Care Strategies to Improve Value-Based Care Systems
Jul 7th • 25 mins read
Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
Jul 28th • 20 mins read
Yichen Zhang, MSc; Huseyin Naci, PhD; Anita K. Wagner, PharmD, DrPH
Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
Aug 10th • 30 mins read
Rachel E. Sachs, JD, MPH, Kyle A. Gavulic, BA, Julie M. Donohue, PhD
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
Oct 8th • 25 mins read
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
Aug 1st • 45 mins read
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
Dec 1st • 20 mins read
Rinda Devi Bachu, Mariam Abou-Dahech, Swapnaa Balaji, Sai H. S. Boddu, Samson Amos, Vishal Singh, R. Jayachandra Babu, Amit K. Tiwari
Oncology biosimilars: New developments and future directions
Nov 25th • 30 mins read
Miloš D. Miljković, MD, MSc, Jordan E. Tuia, BA, Timothée Olivier, MD
Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020
Oct 31st • 10 mins read
John Hair, Thomas Maryon, and Cristian Lieneck
Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption
Oct 27th • 30 mins read
Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs
Dec 9th • 20 mins read
S.F. Oosting, J. Barriuso, A. Bottomley, M. Galotti, B. Gyawali, B. Kiesewetter, N.J. Latino, F. Martinelli, M. Pe, G. Pentheroudakis, F. Roitberg, H. Vachon, E.G.E. de Vries, M. Piccart, N.I. Cherny
Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
Apr 1st • 30 mins read
Deeksha Joshi, Rubiya Khursheed, Saurabh Gupta, Diksha Wadhwa, Thakur Gurjeet Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, Gaurav Gupta, Rajaraman D. Eri, Kylie A. Williams, Kamal Dua, Sachin Kumar Singh
Biosimilars in Oncology: Latest Trends and Regulatory Status
Dec 5th • 20 mins read
K. Ribi, N. Kalbermatten, M. Eicher, F. Strasser
Towards a novel approach guiding the decision-making process for anticancer treatment in patients with advanced cancer: framework for systemic anticancer treatment with palliative intent
Jun 1st • 25 mins read
Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
May 9th • 5 mins read
Envision Pharma Group
Medical affairs: The power behind redefining commercialization
Aug 2nd • 3 mins read
Envision Pharma Group
Empowering people to drive medical affairs performance with AI
Aug 14th • 5 mins read
Ravi B. Parikh, MD, MPP Rebecca A. Hubbard, PhD Erkuan Wang, MA Trevor J. Royce, MD, MPH Aaron B. Cohen, MD, MSCE Amy S. Clark, MD, MSCE Ronac Mamtani, MD, MSCE
Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval
Dec 8th • 2 mins read
E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
Jun 7th • 8 mins read
Shun-Long Ou, Jing Luo, Hua Wei, Xiao-Li, Qian Jiang
Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers
Apr 21st • 13 mins read
J. Mulder, S. Teerenstra, P. B. van Hennik, A. M. G. Pasmooij, V. Stoyanova-Beninska, E. E. Voest & A. de Boer
Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit
Apr 11th • 14 mins read
Robbe Saesen, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, André Freitas, Alessandro Gronchi, Miguel A. Hernán, Frank Hulstaert, Piet Ost, Petr Szturz, Helena M. Verkooijen, Michael W
Defining the role of real-world data in cancer clinical research: The position of the
Mar 20th • 10 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
Apr 6th • 2 mins read
Min Jeong Kim, Hyo Jung Kim, Danbee Kang, Hee Kyung Ahn, Soo-Yong Shin, Juhee Cho, Yeon Hee Park,
Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
Oct 9th • 4 mins read
Shen Lin, Yaping Huang, Liangliang Dong, Meiyue Li, Yahong Wang, Dian Gu, Wei Wu, Dongni Nian, Shaohong Luo, Xiaoting Huang, Xiongwei Xu and Xiuhua Weng
The correlation between the costs and clinical benefits of PD-1/PD-L1 inhibitors in malignant tumors: An evaluation based on ASCO and ESMO frameworks
Feb 23rd • 9 mins read
Jing Luo, Shunlong Ou, Hua Wei, Xiaoli Qin, Rui Peng, Song Wang and Qian Jiang
Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020
Feb 24th • 8 mins read
Yafang Huanga, Weiyi Xiongb, Jingwei Zhaoa, Wentao Lia, Li Mac, Hao Wua
Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021
Mar 9th • 10 mins read
G. Zarkavelis A.L. Amylidi C. Verbaanderd N.I. Cherny Y. Metaxas E.G.E. de Vries P. Zygoura T. Amaral K. Jordan M. Strijbos U. Dafni N. Latino M. Galotti F. Lordick R. Giuliani F. Pignatti G. Pentheroudakis
Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines
Nov 14th • 21 mins read
Garth W. Strohbehn, MD, MPhil, Allen S. Lichter, MD and Mark J. Ratain, MD
US Government Payer-Funded Trials to Address Oncology's Drug-Dosing Conundrum: A Congressional Call to Action?
Feb 13th • 5 mins read
Cinzia Dello Russo, Pierluigi Navarra
What is the weight of expectation bias in oncology trials?
Feb 11th • 3 mins read
Qiyou Wu, Zhiwei Lian, Xin Wang, Hanchao Cheng, Jing Sun, Hui Yu, Gong Zhang, Fan Wu, Jian Liu and Chuanben Chen
Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China
Jan 12th • 13 mins read
H. K. van Halteren, J. Bennouna, B.Brasiuniene, A.J. Cunquero Tomas, A.M. Garcia Trinidad, A. Indini, G. Liposits, B. Pellegrino, L. Popovic, A.Tan, R.Vidra & M.Strijbos
Twelve ESMO Congress 2022 breakthroughs: practicing oncologists' perceptions and potential application on presented data
Jan 10th • 12 mins read
John Devin Peipert, PhD, Karen Kaiser, PhD, Sheetal Kircher, MD, George J. Greene, PhD, Sara Shaunfield, PhD, Katherina Hauner, PhD, David Cella, PhD, and Daniel K. Mroczek, PhD
Medical Oncologists’ Knowledge and Perspectives on the Use of Biosimilars in the United States
Jan 9th • 9 mins read
Rajat Thawani, Neha Agrawal, Nicholas F Taflin, Adel Kardosh, Emerson Y Chen
Application of Value Framework to Phase III Trials of Immune Checkpoint Inhibitors in Esophageal and Gastric Cancer
Jan 13th • 8 mins read
Timothy Qi, Tyler Dunlap, Yanguang Cao1
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
Sep 2nd • 10 mins read
Neil Carleton and Priscilla F. McAuliffe
Are the chronological age cutoffs used in clinical oncology guidelines biologically meaningful?
Dec 1st • 4 mins read
Gracy Crane, John C. W. Lim, Churn-Shiouh Gau, Jipan Xie & Laura Chu
The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations
Jun 28th • 13 mins read
Laurent Azoulay
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
Apr 26th • 9 mins read
Francesco Cerisoli, PhD, Farzad Ali, MSc, Tamás Bereczky, MA, PhD, Natacha Bolaños, BS, Lars Bullinger, MD, Sujith Dhanasiri, MPhil, MSc, James Gallagher, PhD, Sonia García Pérez, MSc, Jan Geissler, MiBA, Yann Guillevic, DEA, Kathryn Harrison, PhD, Anasta
Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools
May 17th • 12 mins read
P.S. Mishra-Kalyani, L. Amiri Kordestani, D.R. Rivera, H. Singh, A. Ibrahim, R.A. DeClaro, Y. Shen, S. Tang, R. Sridhara, P.G. Kluetz, J. Concato, R. Pazdur, J.A. Beaver
External control arms in oncology: current use and future directions
Jan 9th • 9 mins read
Sarah A. Weiss, MD, and Harriet Kluger, MD
CheckMate-067: Raising the Bar for the Next Decade in Oncology
Dec 2nd • 2 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Report from American Society of Clinical Oncology Symposium 2020 and American Society of Clinical Oncology Gastrointestinal Cancer Symposium 2021
Aug 4th • 13 mins read
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
Jan 1st • 12 mins read
Mahnum Shahzad, BA, Huseyin Naci, MHS, PhD, Anita K. Wagner, PharmD, MPH, DrPH
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
Oct 18th • 5 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
Aug 4th • 12 mins read
Kristina Jenei, BSN, MS, Daniel E. Meyers, MD, MS, Vinay Prasad, MD, MPH
The Inclusion of Women in Global Oncology Drug Trials Over the Past 20 Years
Aug 26th • 2 mins read
Sarah M. Dermody, Andrew G. Shuman
Implications of Research Biopsies in Clinical Trials
Aug 31st • 2 mins read
Cheryl Ho, MD, Howard J. Lim, MD, Dean A. Regier, PhD
Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program
Jun 5th • 6 mins read
Diana Brixner, PhD, RPh [email protected], Joseph Biskupiak, PhD, MBA, Gary Oderda, PharmD, MPH, Douglas Burgoyne, PharmD, FAMCP, Daniel C Malone, RPh, PhD, FAMCP, Bhakti Arondekar, PhD, MBA, and Alexander Niyazov, PharmD, RPh, MPH
Payer perceptions of the use of real-world evidence in oncology-based decision making
Aug 1st • 12 mins read
Kyle A. Dymanus BS, Mohit Butaney MBBS, Diana E. Magee MD, MPH, MSc, Amanda E. Hird MD, MSc, Amy N. Luckenbaugh MD, Merry W. Ma MD, PhD, Mary E. Hall MD, Heather L. Huelster MD, Aaron A. Laviana MD, MBA, Nancy B. Davis MD, Martha K. Terris MD, Zachary Kla
Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
Jun 23rd • 8 mins read
Fernando Petracci, Chirag Ghai, Andrew Pangilinan, Luis Alberto Suarez, Roberto Uehara, Marwan Ghosn
Use of real-world evidence for oncology clinical decision making in emerging economies
May 5th • 12 mins read
Nora Hutchinson, MD, CM, MPhil, Benjamin Carlisle, PhD, Adelaide Doussau, MD, PhD
Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
May 18th • 5 mins read
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
Apr 30th • 12 mins read
Michael Z. Liao, Dan Lu, Matts Kågedal, Dale Miles, Divya Samineni, Stephanie N. Liu, Chunze Li
Model-Informed Therapeutic Dose Optimization Strategies for Antibody-Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration-Approved Antibody-Drug Conjugates?
Apr 26th • 15 mins read
Laleh Amiri-Kordestani & Richard Pazdur
Oncology approvals in 2020: a year of firsts in the midst of a pandemic
Jan 29th • 4 mins read
Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
Feb 15th • 13 mins read
Jason J. Yang, BS Naomi So, MD Nolan J. Maloney, MD Julia Arzeno, MD Katherine K. Clifton, MD Daniel Q. Bach, MD, MPH
Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation
Oct 23rd • 4 mins read
Marc Clausen MA, Chloe Mighton MS, Ruhi Kiflen MPH, Agnes Sebastian MSc, Wei Fang Dai MPH, Rebecca E. Mercer PhD, Jaclyn M. Beca MSc, Wanrudee Isaranuwatchai PhD, Kelvin K.W. Chan MD PhD, Yvonne Bombard PhD
Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders’ perspectives
Nov 4th • 12 mins read
Peter Varnai, Anoushka Davé, Kristine Farla, Anke Nooijen, Liana Petrosova
The Evidence REVEAL Study: Exploring the Use of Real-World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
Nov 20th • 10 mins read
Aviv Ladanie, PhD, Andreas M. Schmitt, MD, Benjamin Speich, PhD, Florian Naudet, PhD, Arnav Agarwal, MD, Tiago V. Pereira, PhD, Francesco Sclafani, PhD, Amanda K. Herbrand, MD, Matthias Briel, MD, MSc, Juan Martin-Liberal, PhD, Thomas Schmid, MD, Hannah E
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016
Nov 10th • 6 mins read
Patrick C. DeMartino, MD, Miloš D. Miljković, MD, MS, Vinay Prasad, MD
Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
Aug 31st • 7 mins read
Bruce A. Feinberg, DO Ajeet Gajra, MBBS, MD Marjorie E. Zettler, PhD, MPH Todd D. Phillips, PharmD Eli G. Phillips Jr., PharmD, JD Jonathan K. Kish, PhD, MPH
Use of Real-World Evidence to Support FDA Approval of Oncology Drugs
Sep 14th • 16 mins read
MAXIMILIAN SALCHER-KONRAD, HUSEYIN NACI, COURTNEY DAVIS
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
Oct 6th • 48 mins read
Mohamed Elmeliegy PhD, Derek Z. Yang BS, Engie Salama PharmD, Kourosh Parivar MPharm, Diane D. Wang PhD
Discordance Between Child-Pugh and National Cancer Institute Classifications for Hepatic Dysfunction: Implications on Dosing Recommendations for Oncology Compounds
Jul 20th • 18 mins read
Alison Betts, Piet H. van der Graaf
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
Jun 24th • 18 mins read
Dylan V. Neel, David S. Shulman, Clement Ma, Florence Bourgeois, Steven G. DuBois
Sponsorship of oncology clinical trials in the United States according to age of eligibility
Apr 29th • 6 mins read
Emerson Y. Chen, MD, Alyson Haslam, PhD, Vinay Prasad, MD
FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019
Mar 9th • 4 mins read
Massimo Di Maio, MD, Marco Audisio, MD, Claudia Cardone, MD
The Use of Not-Negative Conclusions to Describe Results of Formally Negative Trials Presented at Oncology Meetings
Feb 13th • 2 mins read
Pan Pantziarka, Ciska Verbaanderd & Lydie Meheus
Biased by design? Clinical trials and patient benefit in oncology
Nov 27th • 3 mins read
Thomas J. Hwang, Liat Orenstein, Steven G. DuBois, Katherine A. Janeway, Florence T. Bourgeois
Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers
Oct 29th • 10 mins read
Dominic H. Moon, Ronald C. Chen
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
Jun 27th • 2 mins read
Yassine Kamal Lyauk, Daniël Martijn Jonker, Trine Meldgaard Lund
Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations
Jun 29th • 15 mins read
Chad Williamson, MBA, MS Leanne Berger, BS, Thomas P. Sullivan, BS SHOW
Addressing oncologists' gaps in the use of biosimilar products
Jun 19th • 5 mins read
Sean P Martin, Xin Wei Wang
The evolving landscape of precision medicine in primary liver cancer
Mar 29th • 3 mins read
Jonathan H Seltzer MD, MBA, MA, Gary Gintant PhD, Laleh Amiri-Kordestani MD, Jack Singer MD, Luana Pesco Koplowitz MD, PhD, Javid J Moslehi MD, Ana Barac MD, PhD, Anthony F. Yu MD
Assessing cardiac safety in oncology drug development
Jun 12th • 12 mins read
G. Pentheroudakis
Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer
Jun 6th • 2 mins read
Emerson Y. Chen, MD, Vikram Raghunathan, MD, Vinay Prasad, MD, MPH
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
May 28th • 5 mins read
Kirill Peskov, Ivan Azarov, Lulu Chu, Veronika Voronova, Yuri Kosinsky, Gabriel Helmlinger
Quantitative Mechanistic Modeling in Support of Pharmacological Therapeutics Development in Immuno-Oncology
Apr 30th • 12 mins read
Ronak Saluja, BS, Louis Everest, Sierra Cheng, Matthew Cheung, MD; Kelvin K. W. Chan, MD, MSc, PhD
Assessment of Whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit
May 16th • 15 mins read
Alfredo Addeo, MD; Glen J. Weiss, MD, MBA; Bishal Gyawali, MD, PhD
Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis
May 10th • 8 mins read
Alyson Haslam, PhD; Vinay Prasad, MD, MPH
Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs
May 3rd • 10 mins read
Talal Hilal, MD; Mohamad Bassam Sonbol, MD; Vinay Prasad, MD, MPH
Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration
May 2nd • 15 mins read
Ajaikumar B Kunnumakkara [email protected], Devivasha Bordoloi, Bethsebie Lalduhsaki Sailo, Nand Kishor Roy, Krishan Kumar Thakur, Kishore Banik, Mehdi Shakibaei, Subash C Gupta, and Bharat B Aggarwal
Cancer drug development: The missing links
Apr 18th • 20 mins read
Carrie Printz
Cancer experts point to new advances in research and treatment: A recent report by the American Association for Cancer Research highlights unprecedented successes as well as ongoing challenges in the cancer field
Apr 1st • 2 mins read
Marc Thill, Nicholas Thatcher, Vladimir Hanes & Gary H. Lyman
Biosimilars: what the oncologist should know
Dec 18th • 25 mins read
Dylan V. Neel, MPhil, David S. Shulman, MD, and Steven G. DuBois, MD
Timing of first-in-child trials of FDA-approved oncology drugs
Mar 18th • 10 mins read
Emerson Y. Chen, MD, Sunil K. Joshi, BA, Audrey Tran, BA
Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials
Apr 1st • 10 mins read
Janice Bonsu, MPH, Lawrence Charles, MD, Avirup Guha, MD, Farrukh Awan, MD, MS, Jennifer Woyach, MD, Vedat Yildiz, MS, Lai Wei, PhD, Hani Jneid, MD, and Daniel Addison, MD
Representation of Patients With Cardiovascular Disease in Pivotal Cancer Clinical Trials
Mar 18th • 3 mins read
Di Maria Jiang, Kelvin K. W. Chan, Raymond W. Jang, Christopher Booth, Geoffrey Liu, Eitan Amir, Robert Mason, Louis Everest, Elena Elimova
Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
Mar 7th • 8 mins read
M. Bertagnolli and J. Tabernero
Value assessment frameworks in oncology: championing concordance through shared standards
Feb 18th • 1 min read
Jonathon Webster, MD and B. Douglas Smith, MD
The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia
Jan 29th • 10 mins read
Jiaxi Zhou, Jonathon Vallejo, Paul Kluetz, Richard Pazdur, Tamy Kim, Patricia Keegan, Ann Farrell, Julia A Beaver, Rajeshwari Sridhara
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016
Aug 4th • 15 mins read
Carina Dolan, PharmD, BCOP
Opportunities and challenges in biosimilar uptake in oncology
Jun 26th • 7 mins read
Hagop M. Kantarjian MD, Ferran Prat PhD, JD, David P. Steensma MD, Razelle Kurzrock MD, David J. Stewart MD, Mikkael A. Sekeres MD, Joseph Leveque MD
Cancer research in the United States: A critical review of current status and proposal for alternative models
May 14th • 10 mins read
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
Mar 11th • 15 mins read
Yan Ji, Jin Y. Jin, David M. Hyman, Geoffrey Kim and Ajit Suri
Challenges and Opportunities in Dose Finding in Oncology and Immuno-oncology
Jul 11th • 10 mins read
Nicole M. Kuderer and Gary H. Lyman
Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety
Jun 20th • 3 mins read
Kirsten B Goldberg, Gideon M Blumenthal, Amy E McKee and Richard Pazdur
The FDA Oncology Center of Excellence and Precision Medicine
Nov 6th • 3 mins read
Laura A. Levit, Raymond P. Perez, David C. Smith, Richard L. Schilsky, Daniel F. Hayes, and Julie M. Vose
Streamlining Adverse Events Reporting in Oncology: An American Society of Clinical Oncology Research Statement
Feb 20th • 3 mins read
Ariadna Tibau, Consolación Molto, Alberto Ocana, Arnoud J Templeton, Luis P Del Carpio, Joseph C Del Paggio, Agustí Barnadas, Christopher M Booth, Eitan Amir
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
Dec 13th • 7 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Aug 22nd • 5 mins read
