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

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

<strong>Background</strong> The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database pro...

Полное описание

Библиографические подробности
Главные авторы:	Ladanie, A, Speich, B, Naudet, F, Agarwal, A, Pereira, T, Sclafani, F, Martin-Liberal, J, Schmid, T, Ewald, H, Ioannidis, J, Bucher, H, Kasenda, B, Hemkens, L
Формат:	Journal article
Опубликовано:	BioMed Central 2018

Схожие документы

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
по: Aviv Ladanie, и др.
Опубликовано: (2018-09-01)

Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project
по: Matthias Briel, и др.
Опубликовано: (2019-11-01)

Marginal structural models and other analyses allow multiple estimates of treatment effects in randomized clinical trials: meta-epidemiological analysis
по: Ewald, H, и др.
Опубликовано: (2018)

Current use and costs of electronic health records for clinical trial research: a descriptive study
по: Mc Cord, K, и др.
Опубликовано: (2019)

A scoping review shows that several nonvalidated budget planning tools for randomized trials are available
по: Speich, B, и др.
Опубликовано: (2019)

The Perception of Educational Software Development Self-Efficacy among Undergraduate CEIT Teacher Candidates
по: Adem Uzun, и др.
Опубликовано: (2013-08-01)

What proportion of ethically approved randomised clinical trials can be found in a trial registry?
по: Speich, B, и др.
Опубликовано: (2019)

Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)-rationale and design for an international collaborative study.
по: Kasenda, B, и др.
Опубликовано: (2020)

Treatments for subacute cough in primary care: systematic review and meta-analyses of randomised clinical trials
по: Speich, B, и др.
Опубликовано: (2018)

Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study
по: Benjamin Kasenda, и др.
Опубликовано: (2020-08-01)

Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data
по: Speich, B, и др.
Опубликовано: (2017)

Lung cancer screening in the gulf: Rationale and recommendations
по: Sami M Bennji, и др.
Опубликовано: (2022-01-01)

Lissi Rasmussen: Livshistorier og Kriminalitet. En empirisk undersøgelse af etnisk minoritetsunge i Københavns Fængsler, deres baggrund, status og fremtid. Hvilke kommunikationsmuligheder er der? Center for Europæisk Tænkning (CEIT), Det Teologiske Fakultet, Københavns Universitet, 2010, 236 sider. Bogen kan downloades gratis fra http://www.teol.ku.dk/afd/ceit//lissi_rasmussen _rapport
по: Stine Fehmerling
Опубликовано: (2010-09-01)

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)
по: Speich, B, и др.
Опубликовано: (2019)

Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies
по: Aviv, L, и др.
Опубликовано: (2019)

Meta-research on pragmatism of randomized trials: rationale and design of the PragMeta database
по: Julian Hirt, и др.
Опубликовано: (2023-06-01)

Characteristics and survival of patients with cancer with intended off-label use—a cohort study
по: Amanda Katherina Herbrand, и др.
Опубликовано: (2022-05-01)

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
по: Speich, B, и др.
Опубликовано: (2019)

Antioxidant Therapy in Cancer: Rationale and Progress
по: Maochao Luo, и др.
Опубликовано: (2022-06-01)

Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list
по: Speich, B, и др.
Опубликовано: (2017)

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days [version 1; peer review: 2 approved]
по: Perrine Janiaud, и др.
Опубликовано: (2020-10-01)

The worldwide clinical trial research response to the COVID-19 pandemic - the first 100 days [version 2; peer review: 2 approved]
по: Perrine Janiaud, и др.
Опубликовано: (2020-10-01)

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
по: Gryaznov, D, и др.
Опубликовано: (2020)

Development of a Publicly Available, Comprehensive Database of Fiber and Health Outcomes: Rationale and Methods.
по: Kara A Livingston, и др.
Опубликовано: (2016-01-01)

Rationale for extent of operation choice in rectal cancer
по: R. Nikitenko, и др.
Опубликовано: (2021-11-01)

Rationale for MYC imaging and targeting in pancreatic cancer
по: Günter Schneider, и др.
Опубликовано: (2021-10-01)

Immunotherapy in endometrial cancer: rationale, practice and perspectives
по: Wenyu Cao, и др.
Опубликовано: (2021-06-01)

An open science pathway for drug marketing authorization-Registered drug approval.
по: Florian Naudet, и др.
Опубликовано: (2021-08-01)

An open science pathway for drug marketing authorization—Registered drug approval
по: Florian Naudet, и др.
Опубликовано: (2021-08-01)

Targeting MDMX for Cancer Therapy: Rationale, Strategies, and Challenges
по: De-Hua Yu, и др.
Опубликовано: (2020-08-01)

Shift work and cancer – considerations on rationale, mechanisms, and epidemiology
по: Giovanni Costa, и др.
Опубликовано: (2010-03-01)

Current Challenges in Prostate Cancer Management and the Rationale behind Targeted Focal Therapy
по: Al B. Barqawi, и др.
Опубликовано: (2012-01-01)

ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening
по: Bullard Emily, и др.
Опубликовано: (2009-12-01)

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)
по: Benjamin Speich, и др.
Опубликовано: (2019-02-01)

Availability of patient-centered cancer support services: A statewide survey of cancer centers.
по: Kathleen B Cartmell, и др.
Опубликовано: (2018-01-01)

Rationale for repeat breast-conserving surgery after in-breast recurrence of breast cancer
по: V. A. Uimanov, и др.
Опубликовано: (2014-07-01)

Application of Autofluorescence Endoscopy for Colorectal Cancer Screening: Rationale and an Update
по: Hiroyuki Aihara, и др.
Опубликовано: (2012-01-01)

Virtual reality for management of cancer pain: Study rationale and design
по: Hunter Groninger, и др.
Опубликовано: (2022-04-01)

Toward Maximizing Immunotherapy in Metastatic Castration Resistant Prostate Cancer – Rationale for Combinatorial Approaches Using Chemotherapy
по: Susan F Slovin
Опубликовано: (2012-05-01)

Biological rationale for patient-specific treatment of breast cancer. Analysis of new data for breast cancer
по: R. M. Paltuev
Опубликовано: (2020-03-01)