Results for 'Mean survival'
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?
Immunotherapies, Median survival, Mean survival, Weibull
The average Restricted Mean Survival Time (RMST) for modern oncology agents approved by the FDA from 2013 to 2017 is 3.6 months, which is lower than the average median Overall Survival (OS) or Progression-Free Survival (PFS) of 4.6 months. When assuming a Weibull distribution post-trial, t…
Jul 18th • 15 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
cancer drug therapy, overall survival, FDA approvals, surrogate endpoints, EMA approvals, quality of life
The study evaluates the overall survival (OS) benefit of cancer drugs approved in China between 2005 and 2020. Out of 141 cancer drug indications approved, 68 showed a documented overall survival benefit, while 34 did not prolong life. Recent regulatory reforms in China aim to improve the availa…
Aug 10th • 30 mins read
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
FDA drug approval, surrogate endpoints, oncology drugs, overall survival correlation, clinical trials analysis, drug approval guidelines
ere are summary bullets based on the provided text: The FDA has increasingly approved oncologic drugs based on surrogate endpoints, which often lack a demonstrated correlation with clinically meaningful outcomes like overall survival. A review of FDA analyses from 2005 to 2022 examined the valid…
Dec 1st • 20 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
cancer clinical trials, benefit of clinical trials, clinically meaningful, ASCO
In value-based medicine, clinical trials must show both statistically significant and clinically meaningful improvements, such as ASCO's recommendation of a 20% relative improvement in overall survival for metastatic solid tumors. Lawrence et al. found that while many phase III trials met statistica…
Jun 27th • 2 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
ESMO, MCBS, FDA, ASCO-VF, EMA, QOL
Recent oncology therapies approved by the FDA and EMA often lack evidence of clinically meaningful improvements in quality of life (QOL). Only 40% of FDA-approved and 58% of EMA-approved oncology therapies had published QOL evidence. Clinically meaningful QOL improvements beyond minimal dif…
Feb 11th • 4 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
bevacizumab, metastatic breast cancer, RR, PFS, FDA, oncology clinical trials
The use of Response Rate (RR), Progression-Free Survival (PFS), and Overall Survival (OS) in clinical trials leading to FDA approval is associated with different study durations: RR: Median study duration of 25 months (range, 11-54 months). PFS: Median study duration of 31 months (range, 10-…
Apr 1st • 10 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
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
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
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
clinical trials, RESOLVED2, FDA
Challenge in Oncology Drug Development: The field is currently facing an increase in the number of antineoplastic agents (ANAs) entering phase I clinical trials (P1CTs) and a high attrition rate for final FDA approval. Objective: Development of a machine learning algorithm, RESOLVED2, to …
Sep 20th • 12 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
Benefit Scale, MCBS, Quality of Life, Health Assessment, Oncology Scale, Cancer Guidelines, Treatment Evaluation, Medicine Scoring
The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was introduced in 2015 to standardize the assessment of clinical benefits from cancer treatments. ESMO-MCBS helps in health-technology assessment, especially given the increasing number of treatment options and rising cancer care costs. Ne…
Apr 1st • 30 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
ASCO, TNT, Gastrointestinal Cancer Symposium
Six out of 18 cancer drugs with accelerated approval still have indications on labeling and are recommended in guidelines despite not showing improvement in primary endpoints in post-approval trials. This issue highlights the imbalance between speed and evidence in the accelerated approval pathwa…
Aug 4th • 13 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
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
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
pharmaceutical regulation, US Food and Drug Administration, European Medicines Agency, cancer.
Regulatory agencies often have limited evidence on the clinical benefits and harms of new drugs at the time of market approval. There is frequent discordance between the FDA and EMA in regulatory outcomes and the use of special regulatory pathways for cancer drugs of uncertain therapeutic value. …
Oct 6th • 48 mins read
Alison Betts, Piet H. van der Graaf
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology
bispecific antibodies, mechanistic quantitative, pharmacology, strategies, bsAbs, immune cells, MABEL aproach
Bi-specific antibodies (bsAbs) are crucial in cancer therapy research. BsAbs offer advantages such as enhanced efficacy and reduced systemic toxicity. Early clinical trials face challenges with dose selection and predicting effective doses. Clinical variability is influenced by factors like fun…
Jun 24th • 18 mins read