Cargando…

Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016

IMPORTANCE: Clinical trial evidence used to support drug approval is typically the only information on benefits and harms that patients and clinicians can use for decision-making when novel cancer therapies become available. Various evaluations have raised concern about the uncertainty surrounding t...

Descripción completa

Detalles Bibliográficos
Autores principales:	Ladanie, Aviv, Schmitt, Andreas M., Speich, Benjamin, Naudet, Florian, Agarwal, Arnav, Pereira, Tiago V., Sclafani, Francesco, Herbrand, Amanda K., Briel, Matthias, Martin-Liberal, Juan, Schmid, Thomas, Ewald, Hannah, Ioannidis, John P. A., Bucher, Heiner C., Kasenda, Benjamin, Hemkens, Lars G.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Medical Association 2020
Materias:	Original Investigation
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656288/ https://www.ncbi.nlm.nih.gov/pubmed/33170262 http://dx.doi.org/10.1001/jamanetworkopen.2020.24406

Ejemplares similares

The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs
por: Ladanie, Aviv, et al.
Publicado: (2018)

Characteristics and interpretation of subgroup analyses based on tumour characteristics in randomised trials testing target-specific anticancer drugs: design of a systematic survey
por: Schandelmaier, Stefan, et al.
Publicado: (2020)

Association of Supporting Trial Evidence and Reimbursement for Off-Label Use of Cancer Drugs
por: Herbrand, Amanda Katherina, et al.
Publicado: (2021)

Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project
por: Herbrand, Amanda Katherina, et al.
Publicado: (2019)

Characteristics and survival of patients with cancer with intended off-label use—a cohort study
por: Schmitt, Andreas Michael, et al.
Publicado: (2022)

Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation
por: Speich, Benjamin, et al.
Publicado: (2019)

Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies
por: Blümle, Anette, et al.
Publicado: (2016)

Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study
por: Kasenda, Benjamin, et al.
Publicado: (2020)

Reporting Quality of Journal Abstracts for Surgical Randomized Controlled Trials Before and After the Implementation of the CONSORT Extension for Abstracts
por: Speich, Benjamin, et al.
Publicado: (2019)

Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study
por: Mc Cord, Kimberly A, et al.
Publicado: (2021)

The reporting of studies using routinely collected health data was often insufficient
por: Hemkens, Lars G., et al.
Publicado: (2016)

Developing and testing a Corona VaccinE tRiAL pLatform (COVERALL) to study Covid-19 vaccine response in immunocompromised patients
por: Kusejko, Katharina, et al.
Publicado: (2022)

Investigation of continuous effect modifiers in a meta-analysis on higher versus lower PEEP in patients requiring mechanical ventilation - protocol of the ICEM study
por: Kasenda, Benjamin, et al.
Publicado: (2014)

A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna®
por: Speich, Benjamin, et al.
Publicado: (2021)

A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
por: Speich, Benjamin, et al.
Publicado: (2022)

Comparison of randomized controlled trials discontinued or revised for poor recruitment and completed trials with the same research question: a matched qualitative study
por: Briel, Matthias, et al.
Publicado: (2019)

Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials
por: Taji Heravi, Ala, et al.
Publicado: (2021)

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days
por: Janiaud, Perrine, et al.
Publicado: (2020)

Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial)
por: Speich, Benjamin, et al.
Publicado: (2019)

Adjunctive corticosteroids for Pneumocystis jiroveci pneumonia in patients with HIV infection: a meta-analysis of randomised controlled trials
por: Briel, Matthias, et al.
Publicado: (2005)

An open science pathway for drug marketing authorization—Registered drug approval
por: Naudet, Florian, et al.
Publicado: (2021)

The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports
por: Erhel, Florian, et al.
Publicado: (2020)

Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020)
por: Kim, Jeeyun A., et al.
Publicado: (2021)

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects
por: Gryaznov, Dmitry, et al.
Publicado: (2020)

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)
por: Gryaznov, Dmitry, et al.
Publicado: (2022)

Barriers and Facilitating Factors for Conducting Systematic Evidence Assessments in Academic Clinical Trials
por: McLennan, Stuart, et al.
Publicado: (2021)

Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial)
por: Merlo, Christoph, et al.
Publicado: (2020)

Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021
por: Benjamin, David J., et al.
Publicado: (2022)

Serum lactate dehydrogenase as an early marker for outcome in patients treated with anti-PD-1 therapy in metastatic melanoma
por: Diem, S, et al.
Publicado: (2016)

Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey
por: Hemkens, Lars G, et al.
Publicado: (2016)

Reminding Peer Reviewers of Reporting Guideline Items to Improve Completeness in Published Articles: Primary Results of 2 Randomized Trials
por: Speich, Benjamin, et al.
Publicado: (2023)

Preserving equipoise and performing randomised trials for COVID-19 social distancing interventions
por: Cristea, Ioana Alina, et al.
Publicado: (2020)

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis
por: Razavi, Marianne, et al.
Publicado: (2019)

Infection biomarkers in primary care patients with acute respiratory tract infections–comparison of Procalcitonin and C-reactive protein
por: Meili, Marc, et al.
Publicado: (2016)

Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial
por: Speich, Benjamin, et al.
Publicado: (2020)

Challenges and Lessons Learned From COVID-19 Trials: Should We Be Doing Clinical Trials Differently?
por: Janiaud, Perrine, et al.
Publicado: (2021)

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis
por: Speich, Benjamin, et al.
Publicado: (2022)

Scoping review and characteristics of publicly available checklists for assessing clinical trial feasibility
por: Gloy, Viktoria, et al.
Publicado: (2022)

Association between Ambient Air Pollution and Diabetes Mellitus in Europe and North America: Systematic Review and Meta-Analysis
por: Eze, Ikenna C., et al.
Publicado: (2015)

Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care: study protocol for a randomised controlled trial and baseline characteristics of participating general practitioners [ISRCTN73182671]
por: Briel, Matthias, et al.
Publicado: (2005)

Cannot write session to /tmp/vufind_sessions/sess_fndmj4g1o905e3tgtfcm9jtr3f