Evolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes
Published 2020 View Full Article
- Home
- Publications
- Publication Search
- Publication Details
Title
Evolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes
Authors
Keywords
-
Journal
Future Oncology
Volume -, Issue -, Pages -
Publisher
Future Medicine Ltd
Online
2020-10-19
DOI
10.2217/fon-2020-0591
References
Ask authors/readers for more resources
Related references
Note: Only part of the references are listed.- FDA Approval and Regulation of Pharmaceuticals, 1983-2018
- (2020) Jonathan J. Darrow et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Efficacy and safety of anti-PD-1 immunotherapy in patients with advanced Non Small Cell Lung Cancer with BRAF, HER2 or MET mutation or RET-translocation. GFPC 01-2018.
- (2020) Florian Guisier et al. Journal of Thoracic Oncology
- Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
- (2020) Mehmet Burcu et al. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
- Estimating the clinical cost of drug development for orphan versus non-orphan drugs
- (2019) Kavisha Jayasundara et al. Orphanet Journal of Rare Diseases
- Clinical Outcomes of Patients with Advanced Cancer and Pre‐Existing Autoimmune Diseases Treated with Anti‐Programmed Death‐1 Immunotherapy: A Real‐World Transverse Study
- (2019) Alessio Cortellini et al. ONCOLOGIST
- Comprehensive analysis of the characteristics and treatment outcomes of patients with non-small cell lung cancer treated with anti-PD-1 therapy in real-world practice
- (2019) Beung-Chul Ahn et al. JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
- The US Food and Drug Administration's Real‐World Evidence Framework: A Commitment for Engagement and Transparency on Real‐World Evidence
- (2019) M. Khair ElZarrad et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Effect estimates in randomized trials and observational studies: comparing apples with apples
- (2019) Sara Lodi et al. AMERICAN JOURNAL OF EPIDEMIOLOGY
- Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
- (2019) Alison Cave et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Small But Mighty: The Use of Real‐World Evidence to Inform Precision Medicine
- (2019) Rebecca A. Miksad et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Real-world data on PD-1 inhibitor therapy in metastatic melanoma
- (2019) Anna Arheden et al. ACTA ONCOLOGICA
- Real‐world progression, treatment, and survival outcomes during rapid adoption of immunotherapy for advanced non–small cell lung cancer
- (2019) Sean Khozin et al. CANCER
- Examining the Use of Real‐World Evidence in the Regulatory Process
- (2019) Brett K. Beaulieu‐Jones et al. CLINICAL PHARMACOLOGY & THERAPEUTICS
- Developing real-world comparators for clinical trials in chemotherapy-refractory patients with gastric cancer or gastroesophageal junction cancer
- (2019) Ian Chau et al. Gastric Cancer
- Immuno-oncology drug development goes global
- (2019) Jia Xin Yu et al. NATURE REVIEWS DRUG DISCOVERY
- Current Perspectives in Cancer Immunotherapy
- (2019) Theodoulakis Christofi et al. Cancers
- FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer
- (2019) Suparna Wedam et al. CLINICAL CANCER RESEARCH
- Trends in clinical development for PD-1/PD-L1 inhibitors
- (2019) Jia Xin Yu et al. NATURE REVIEWS DRUG DISCOVERY
- Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative
- (2018) Grant D. Huang et al. Contemporary Clinical Trials
- Development and Validation of a High-Quality Composite Real-World Mortality Endpoint
- (2018) Melissa D. Curtis et al. HEALTH SERVICES RESEARCH
- Real world experience in low-dose ipilimumab in combination with PD-1 blockade in advanced melanoma patients
- (2018) Michael Constantin Kirchberger et al. Oncotarget
- Do immune checkpoint inhibitors need new studies methodology?
- (2018) Roberto Ferrara et al. Journal of Thoracic Disease
- Immuno-Oncology: Emerging Targets and Combination Therapies
- (2018) Henry T. Marshall et al. Frontiers in Oncology
- LBA5Efficacy and safety of nivolumab (nivo) monotherapy versus chemotherapy (chemo) in recurrent small cell lung cancer (SCLC): Results from CheckMate 331
- (2018) M Reck et al. ANNALS OF ONCOLOGY
- The Next Generation of Immunotherapy for Cancer: Small Molecules Could Make Big Waves
- (2018) William G. Kerr et al. JOURNAL OF IMMUNOLOGY
- Outcomes and Toxicities of Programmed Death‐1 (PD‐1) Inhibitors in Hodgkin Lymphoma Patients in the United States: A Real‐World, Multicenter Retrospective Analysis
- (2018) Steven M. Bair et al. ONCOLOGIST
- Real‐World Outcomes of Patients with Metastatic Non‐Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval
- (2018) Sean Khozin et al. ONCOLOGIST
- PCN21 - COMPARATIVE EFFICACY OF NIVOLUMAB±IPILIMUMAB VERSUS STANDARD OF CARE (SOC) FOR THIRD-LINE (3L) PATIENTS WITH RECURRENT SMALL CELL LUNG CANCER (SCLC) USING POPULATION-ADJUSTED INDIRECT COMPARISON
- (2018) S. Cope et al. VALUE IN HEALTH
- End points and statistical considerations in immuno-oncology trials: impact on multiple myeloma
- (2017) Antje Hoering et al. Future Oncology
- The use of immunotherapy in the treatment of melanoma
- (2017) Tala Achkar et al. Journal of Hematology & Oncology
- Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial
- (2017) Yoon-Koo Kang et al. LANCET
- How much do clinical trials cost?
- (2017) Linda Martin et al. NATURE REVIEWS DRUG DISCOVERY
- Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma
- (2017) Jeffrey Weber et al. NEW ENGLAND JOURNAL OF MEDICINE
- Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available: Table 1.
- (2016) Miguel A. Hernán et al. AMERICAN JOURNAL OF EPIDEMIOLOGY
- Key cost drivers of pharmaceutical clinical trials in the United States
- (2016) Aylin Sertkaya et al. Clinical Trials
- Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial
- (2016) Howard L Kaufman et al. LANCET ONCOLOGY
- Blinatumomab vs historical standard therapy of adult relapsed/refractory acute lymphoblastic leukemia
- (2016) N Gökbuget et al. Blood Cancer Journal
- Response rates and durability of chemotherapy among 62 patients with metastatic Merkel cell carcinoma
- (2016) Jayasri G. Iyer et al. Cancer Medicine
- FDA Approval: Blinatumomab
- (2015) D. Przepiorka et al. CLINICAL CANCER RESEARCH
- Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial
- (2015) Alexander M M Eggermont et al. LANCET ONCOLOGY
- Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: a European consensus position paper
- (2014) P. G. Casali et al. ANNALS OF ONCOLOGY
Add your recorded webinar
Do you already have a recorded webinar? Grow your audience and get more views by easily listing your recording on Peeref.
Upload NowAsk a Question. Answer a Question.
Quickly pose questions to the entire community. Debate answers and get clarity on the most important issues facing researchers.
Get Started