Results for 'national clinical trial'
Bridget Rasmusson
Positioning Yourself to Become an MSL in 2022
MSL role, clinical background, academic background, research background, industry, MSL Society, conference, scientific expert, therapeutic expertise, pharma companies
After attending the MSL Society’s 9th annual conference in Vegas Last week, I have taken some time to reflect on inquiries our team received about how to effectively step into the MSL role from a clinical, academic, or research background. Industry is a tough nut to crack, but it is absolutely…
Dec 21st • 10 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
cancer, clinical trials, research funding, Canada, high-income countries
This document reviews Canadian involvement in oncology randomized controlled trials (RCTs) from 2014-2017, comparing them to those from other high-income countries (HICs). Canada contributed to 155 (24%) of 636 HIC-led RCTs. Canadian RCTs focused more on palliative care (72%) compared to 62% in …
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
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
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
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
pediatric oncology, clinical development, trials, success rates
Pediatric Phase 1 trials in oncology aim to assess social value, focusing on rates of approval, transition to further phases, and citation in research. The study analyzed trials from 2004 to 2013, utilizing data from FDA, EMA, ClinicalTrials.gov, EU Clinical Trials Register, and Google Scholar. …
Jun 21st • 28 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
cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology
Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…
Apr 1st • 14 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
NCIS, clinical trials, NCTN, drug indications
Importance: NCTN groups are vital in identifying effective new antineoplastic regimens, but their clinical impact has not been systematically evaluated until now. Objective: To determine the association of NCTN trials with guideline care and new drug indications. Design, Setting, and Participant…
Sep 4th • 17 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
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 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
control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials
The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…
Dec 9th • 20 mins read
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
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
inclusion, woman, global, oncology drug trials, NIH
Women represented 77% of newly diagnosed thyroid cancer cases in 2020 but only comprised 51% of participants in related trials. Women accounted for 48% of global colon cancer cases but only 33% of trial participants for colon cancer therapeutics. Higher enrollment of women in NIH-funded studies …
Aug 26th • 2 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
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
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
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 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
Innovation, Expanded access, Early drug access, Cancer, FDA, EMA
Cancer incidence is increasing globally, and while medical innovation significantly impacts patient survival, the drug development process is lengthy, often exceeding 10 years for marketing authorization (MA). France has implemented the ATU (Temporary Authorization for Use) program to facil…
Apr 7th • 12 mins read
Ioannis Tsagakis and Maria Papatriantafyllou
Safeguarding cancer research funding by European charities amidst the COVID-19 pandemic
cancer charities, cancer research, COVID‐19, funding, pandemic, policy, AECC, AIRC
The COVID-19 outbreak has had a significant impact on cancer research and cancer care. European cancer charities are required to reassess their strategies. There is a need to safeguard income and provide support to cancer researchers. It is crucial to sustain cancer research funding during thes…
Nov 22nd • 3 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
FDA, drug approvals, oncology, cancer drugs
The new, expensive cancer drugs approved by the FDA in 2018 could drastically increase U.S. healthcare spending if widely adopted, but industry forecasts suggest low-level market uptake, maintaining current budget trends. The healthcare system's financial stability partially relies on many eligible …
Aug 31st • 7 mins read