Results for 'Clinical trials'
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
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
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
FDA, NHS, accelerated approval, NICE, clinical trial findings
The study evaluates the acceptance and coverage of FDA-accelerated approved cancer drugs by the National Health Service (NHS) in England, focusing on decisions made by the National Institute for Health and Care Excellence (NICE). A total of 93 cancer drug indications received accelerated approval…
Feb 22nd • 10 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
E.M. Ray, L.A. Carey, K.E. Reeder-Hayes
Leveraging existing data to contextualize phase II clinical trial findings in oncology
HER2, phase II trials, oncology, iDFS, EBC, early stage breast cancer
In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30% having HER2 amplification. The standard care for HER2-positive EBC involves chemotherapy plus HER2-directed therapy for one year. The phase II Adjuvant Paclitaxel and Trastuzumab (APT) tr…
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
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
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
PMW usage, phase III oncology trials, professional medical writer assistance
The use of professional medical writers (PMWs) in oncologic phase III randomized controlled trials (RCTs) has been historically low, but recent data on their usage is limited. This study aimed to quantify the usage of PMWs in cancer-specific phase III RCTs by analyzing trial manuscripts on Clinic…
Sep 17th • 7 mins read
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
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
European organisation for Research and Treatment of Cancer, EORTC, clinical research
Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase. The role of multi-stakeholder partnerships in the clinical development of anticancer medicines requires further clarification…
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
pediatric oncology, clinical trials, research, Africa, collaborative research
Current childhood cancer survival rates in African countries range from 8.1% to 30.3%. The review focuses on pediatric oncology trials in Africa, highlighting challenges and suggesting research collaboration opportunities. Data were collected from the SIOP global mapping survey, ClinicalT…
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
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
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
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
clinical trials, industry, oncology, pediatric, sponsorship
The sponsorship mix of trials relevant to young people with cancer has not been well-documented, which may impact policies and regulations in pediatric cancer drug development. An analysis of interventional trials in the U.S. from 2007 to 2018 was conducted using the ClinicalTrials.gov registry, …
Apr 29th • 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
clinical trials, FDA, Novel therapeutic agents, biologics
The number of special regulatory programs for drug and biologic approvals by the FDA has increased since the introduction of the Fast Track designation in 1988. This study analyzed 273 new drugs and biologics approved by the FDA for 339 indications across three periods: 1995-1997, 2005-2007,…
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
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
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
Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes
The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life (HRQoL) information. Data was collected for cancer indications approved between January 2009 and October 2015, using sources like the EMA website, clinical…
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
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
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
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
Precision Medicine, pediatrics, clinical trials
Pediatric precision oncology faces challenges due to the rarity of pediatric cancers, which limits research and funding compared to adult cancers. Dr. Katherine Janeway highlights the need for more validated pre-clinical models and pharmaceutical interest in pediatric cancers. The RACE Act, effe…
Jan 9th • 2 mins read