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Results for 'Clinical study'

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
OVN Avatar 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

ESMO-MCBS, bias, clinical trial design, clinical trial implementation, clinical trial reporting, clinical trial analysis

The ESMO-MCBS is a tool used for scoring the clinical benefit of cancer medicines as reported in clinical trials, assuming valid research methodologies and quality implementation. The tool's effectiveness is compromised by studies with flawed design, implementation, or data analysis, w…

Apr 20th • 8 mins read

Virtual Clinical Trials in Oncology-Overview, Challenges, Policy Considerations, and Future Directions
OVN Avatar 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

Virtual, Clinical trials, policy, analytics, telemedicine

The COVID-19 pandemic has significantly impacted clinical research, particularly in oncology, by accelerating the adoption of virtual clinical trials. These trials can address challenges such as high costs and participant burdens associated with traditional trials. Virtual Clinical Trials: Utiliz…

Apr 8th • 4 mins read

Accelerated drug approvals in oncology: Pros and cons
OVN Avatar Thakur, Sayanta & Lahiry, Sandeep
Accelerated drug approvals in oncology: Pros and cons

Clinical study, drug approval, medical oncology

The summary of the content highlights the success of the accelerated approval process, especially for oncology drugs. Key points include: The rise of accelerated approval processes is significant, particularly in oncology. The use of surrogate endpoints and their validation has been debated. Th…

Sep 14th • 4 mins read

Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
OVN Avatar 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

Cancer Medical research, Randomized controlled trials, Clinical trial design

Clinical trials are crucial in establishing cancer care standards, but the social dynamics among researchers in this field have not been extensively studied. A social network analysis of authors involved in chemotherapy-based prospective trials from 1946 to 2018 reveals significant insights. The …

Oct 16th • 12 mins read

A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma-To Know, Then to Measure
OVN Avatar 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

value framework, European Society for Medical Oncology, Magnitude of Clinical Benefit Scale, American Society of Clinical Oncology, drug therapy, nasopharyngeal neoplasms

The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have developed frameworks to evaluate cancer treatments, particularly for nasopharyngeal carcinoma. A study compared these frameworks using data from 15 randomized controlled trials of systemic c…

Aug 12th • 10 mins read

Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
OVN Avatar Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration

Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency

The study evaluates the clinical benefits of immune checkpoint inhibitors using the ESMO-MCBS and ASCO VF scales. 18 indications for these inhibitors were approved based on RCTs conducted between 2011 and 2018. All indications meet the ESMO-MCBS 1.1 threshold for meaningful bene…

Aug 31st • 16 mins read

Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
OVN Avatar 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

USFDA, ESMO-MCBS, NCCN, ASCO-CRC, clinical, drug aroval

The study evaluates the clinical benefit and pricing of breakthrough-designated versus non-breakthrough-designated cancer drugs. The analysis covers approvals from July 2012 to December 2017, using frameworks like ASCO-VF, ASCO-CRC, ESMO-MCBS, and NCCN Evidence Blocks. High clinical benef…

Jul 22nd • 12 mins read

Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study
OVN Avatar Benjamin Gregory Carlisle, Adélaïde Doussau, Jonathan Kimmelman
Patient burden and clinical advances associated with post approval monotherapy cancer drug trials: a retrospective cohort study

clinical advances, monotherapy cancer drug trials, FDA

Objective: The study investigates the efforts to extend the uses of new drugs by testing them for new, non-approved indications and examines the patient burden and clinical impact. Design and Setting: A retrospective cohort study focused on post-approval trials of anticancer drugs approved betwee…

Feb 17th • 7 mins read

EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
OVN Avatar 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

ESMO, hematological malignancies, Clinical benefit scale, EHA

The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…

Jan 20th • 20 mins read

Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials
OVN Avatar Jonathan H. Cheng, Justin W. Tiulim, Sheng Zhou, Anthony El-Khoueiry and Jorge Nieva
Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials

biomarker, clinical trial, targeted therapy, immunotherapy, mandatory research biopsy, oncology, lung cancer, head and neck cancer

The study investigates the impact of requiring fresh tumor tissue biopsies for enrollment in clinical trials. Key findings include: Requiring biopsies significantly increases screening duration, with a median of 30 days compared to 14 days for trials without biopsy requirements (p < 0.0001). …

Oct 18th • 10 mins read

New Realities of Phase I Clinical Trials in the Era of
OVN Avatar S.E. Abdullah, E. Oflazoglu, J.C. Soria, M.M. Dar
New Realities of Phase I Clinical Trials in the Era of

durvalumab, durvalumab experience, clinical trials, immunotherapy

The development of cancer immunotherapy, particularly durvalumab, has progressed rapidly due to innovative strategies, such as novel study designs. Durvalumab, an anti-PD-L1 monoclonal antibody, was developed by AstraZeneca starting in 2012, with initial trials leading to its accelerated appr…

Oct 7th • 5 mins read

Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
OVN Avatar 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

IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry

The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…

Jul 28th • 20 mins read

Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
Partner Avatar Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?

patient engagement in pharma, patient-centric drug development, life sciences industry innovation, patient insights in medicine, regulatory compliance in patient engagement, patient involvement in clinical trials, benefits of patient advocacy, patient-cen

The life sciences industry is in a constant state of advancement, bringing more and more groundbreaking medicines, cutting-edge technologies, and innovative solutions to market. Amidst these rapid changes, patients remain at the heart of these scientific developments. In recent decades, the l…

May 9th • 5 mins read

The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
OVN Avatar 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

registry, oncology, observational study, prospective cohort study, real-world evidence

Oncology patient registries are valuable for generating Real-World Evidence (RWE) due to: Prospective, primary data collection Characterizing smaller patient populations not typically included in clinical trials Providing insights into the rapidly changing disease course Allowing for longitudi…

Jun 7th • 8 mins read

Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
OVN Avatar 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

real-world data, preliminary attainability assessment, observational study, clinical data warehouse, PAR framework, brain metastasis, breast cancer

The study proposes the PAR framework for data attainability screening in clinical research, particularly useful for addressing unmet clinical needs in BCBM. A survey showed clinical questions had a mean score of 4.37, indicating the significance of these questions. RWE generation is crucial…

Oct 9th • 4 mins read

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
OVN Avatar 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

Early phase clinical trial, Dose-expansion cohort, Single-arm trial, Pivotal trial, FDA approved indications, Targeted anticancer drugs

Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021. 59.6% of indications were approved based on Early Phase Clinical Trials (EPCTs). There was a notable annual increase of 22.2% in approvals based on EPCTs, compared to a 5.0% increase for ph…

Mar 9th • 10 mins read

Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
OVN Avatar Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

clinical guidelines, FDA, accelerated approval cancer drugs, surrogate measures, NCCN, EMA

Six of 18 cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines despite no improvement in the primary endpoint in post-approval trials. These findings reflect the lack of fulfillment of the compromise between…

Aug 4th • 12 mins read

Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
OVN Avatar 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

clinical trials, drug approval, health care disparities, medical oncology, sexism

Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence. Despite FDA guidelines from June 2015 requiring consideration of biological variables like sex in research designs, disparities persist. Women continu…

Jun 23rd • 8 mins read

Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
OVN Avatar 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

clinical trials, biologics, FDA approval, drug development

The study provides a crucial understanding of the role and impact of patient contributions in oncology drug development, focusing on their association with clinically impactful drug outcomes. Successful oncology drugs required an average of 12,217 patients in pre-license trials, with higher numbers …

May 18th • 5 mins read

The Evidence REVEAL Study: Exploring the Use of Real-World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry
OVN Avatar 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

real world evidence, CCT, complex clinical trial

The European Medicines Agency (EMA) should develop an RWE framework for premarketing authorization in Europe. EMA and the European Medicines Regulatory Network (EMRN) could lead the development of RWE standards in the EU and beyond. Joint demonstration projects by the European Commission and ind…

Nov 20th • 10 mins read

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