Public Health

Data Monitoring Committees in Clinical Trials: A Practical by Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets

By Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets

There was colossal progress within the use of information tracking committees in recent times, via either executive enterprises and the pharmaceutical undefined. This development has been caused via expanding attractiveness of the worth of such committees in safeguarding trial members in addition to maintaining trial integrity and the validity of conclusions. This very well timed e-book describes the operation of information tracking committees, and offers an authoritative consultant to their institution, objective and tasks. offers a realistic evaluation of knowledge tracking in scientific trials. Describes the aim, obligations and operation of information tracking committees. offers at once acceptable recommendation for these dealing with and engaging in medical trials, and people serving on info tracking committees. supplies perception into scientific info tracking to these sitting on regulatory and moral committees. Discusses concerns pertinent to these operating in medical trials in either the U.S. and Europe. the sensible tips supplied through this e-book might be of use to execs operating in and/or dealing with scientific trials, in educational, govt and settings, really clinical statisticians, clinicians, trial co-ordinators, and people operating in regulatory affairs and bioethics.

Show description

Read Online or Download Data Monitoring Committees in Clinical Trials: A Practical Perspective PDF

Best public health books

Environmental and Health Risk Assessment and Management: Principles and Practices

"This e-book is ready the felony, least expensive, and functional evaluate and administration of dicy actions bobbing up from regimen, catastrophic environmental and occupational exposures to damaging brokers. It starts off the place emission and publicity research ends by means of supplying estimates or predictions of deleterious exposures.

Dompaminergic Neuron Transplantation in the Weaver Mouse Model of Parkinson's Disease (Neuroscience Intelligence Unit)

This publication is the fruits of fifteen years of study at the transplantation of dopaminergic neurons within the striatum of the weaver mouse (wv/wv), a neurological mutant characterised by way of genetically-determined degeneration of midbrain dopamine neurons. This mutant constitutes the single on hand laboratory version with a prolonged disease that mimics Parkinson's illness.

The New Profile of Drug-Resistant Tuberculosis in Russia: A Global and Local Perspective (Summary of a Joint Workshop)

An expected 2 billion humans, one 3rd of the worldwide inhabitants, are contaminated with Mycobacterium tuberculosis, the bacterium that reasons tuberculosis. unfold during the air, this infectious disorder killed 1. 7 million in 2009, and is the prime killer of individuals with HIV. Tuberculosis (TB) can also be a sickness of poverty--the overwhelming majority of tuberculosis deaths happen within the constructing international.

Creating a Healthy School Using the Healthy School Report Card

Winning scholars aren't basically an expert but in addition emotionally and bodily fit, inspired, civically engaged, ready for paintings and financial self-sufficiency, and prepared for the realm past their very own borders. to aid scholars meet this general, a college needs to use a coordinated, evidence-based strategy that helps studying, instructing and scholar progress in brief, the college needs to create a fit institution group.

Additional resources for Data Monitoring Committees in Clinical Trials: A Practical Perspective

Example text

At those meetings at which the study protocol and DMC charter have defined the main objective to be safety monitoring, the committee should give careful consideration to a comprehensive summary of evolving safety data. It also is important, although less uniformly recognized, that efficacy data should also be available for DMC review at such times. An intervention that introduces safety risks could still provide a favorable benefit-to-risk profile if it also provides important beneficial effects on efficacy.

Put it: The commitment and cooperation of patients currently on study are wasted if a study becomes equivocal or misleading. Thousands of future patients are at risk for receiving an ineffective or costly or toxic treatment (if a treatment is erroneously reported as superior) or are at risk for not receiving an effective treatment (if a new treatment is erroneously reported as being not better than a standard). Even patients yet to be entered on study, the very patients we most seek to protect by early termination, are not necessarily helped by such action, since they are likely to receive the regimen that appeared preferable in early data, even though more data or longer follow-up might have shown it to be inferior.

Illustrations are provided for trials in which recommendations for termination were made due to favorable benefit-to-risk, unfavorable benefit-to-risk, or inability to answer the primary questions. 1 Termination due to favorable benefit-to-risk A large majority of trials monitored by DMCs do not terminate early, but continue to their protocol-specified time of completion. However, interim efficacy results for some trials can be so compelling for clinically relevant outcome measures that early termination is recommended by an independent DMC.

Download PDF sample

Rated 4.98 of 5 – based on 18 votes