Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative

Clinical Trials : Journal of the Society for Clinical Trials
Karim A CalisRoger J Lewis

Abstract

Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring commit...Continue Reading

References

Aug 10, 2006·Clinical Trials : Journal of the Society for Clinical Trials·UNKNOWN SCT Working Group on Data MonitoringCatherine M Tangen
Oct 6, 2016·The New England Journal of Medicine·David L DeMets, Susan S Ellenberg
Nov 26, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Karim A CalisDavid L DeMets

❮ Previous
Next ❯

Citations

Mar 20, 2018·Clinical Trials : Journal of the Society for Clinical Trials·James D NeatonDeborah Wentworth
Dec 14, 2017·Clinical Trials : Journal of the Society for Clinical Trials·David J WeberRoss J Simpson
Nov 19, 2019·Annals of Internal Medicine·Scott R EvansFrank Rockhold
Nov 2, 2019·Clinical Trials : Journal of the Society for Clinical Trials·J Athene LaneMatthew R Sydes
Sep 5, 2018·Therapeutic Innovation & Regulatory Science·Phoebe FriesenArthur Caplan
Jul 23, 2020·Journal of Clinical and Translational Science·Kevin FiscellaJonathan N Tobin
Feb 18, 2018·Clinical Trials : Journal of the Society for Clinical Trials·Amy CorneliAnnemarie Forrest
Sep 9, 2020·Journal of Biopharmaceutical Statistics·Sonia M ThomasStephen M Strakowski
Nov 13, 2020·Pharmacoepidemiology and Drug Safety·Atheline Major-PedersenAnthony N Hollenberg
Jun 3, 2021·Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research·Blair HolbeinTamsin A Knox
Sep 25, 2021·Health Care Management Science·Abhishake KunduTimothy Matis
Oct 2, 2021·JAMA : the Journal of the American Medical Association·William J Meurer, Juliana Tolles
Dec 1, 2021·PloS One·Michael S Bradshaw, Samuel H Payne

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

© 2022 Meta ULC. All rights reserved