Sentences with phrase «concerns about clinical trials»

It also found that a «climate of fear» existed in the Department of Psychiatry, where concerns about clinical trials first surfaced.

Not exact matches

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

«Industry - financed clinical trials on the rise, as number of NIH - funded trials falls: Researchers concerned about trends in research funding as commercial ventures run six times more trials than academic investigators.»

Duke opened clinical trials that relied on Potti's work even as others were expressing concerns about their accuracy.

Similarly, patients who chose not to enroll in a clinical trial cited concerns about insurance not covering costs, and fear that their out - of - pocket costs would increase.

While there is a lot of excitement about the drug, which improved seniors» response to the flu vaccine in a clinical trial last year, there are concerns about its side effects, especially with long - term use.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

An investigation into how patient outcomes are assessed in clinical trials has revealed a worrying lack of consistency, raising concerns about funding being wasted on the acquisition of poor quality data.

He is less concerned about the system's black - box nature, so long as the models it generates can be shown to be safe during clinical trials.

Nonetheless, the result has renewed concern about the oversight of clinical trials for gene therapy.

Amy Comstock Rick, CEO of the Parkinson's Action Network, says her group isn't too concerned about language in the spending bill that states that NCATS can not fund clinical trials that go beyond a certain stage.

In response to similar concerns about human studies, the U.S Food and Drug Administration (FDA) in 2007 mandated that researchers conducting human clinical trials preregister the details in an online database like ClinicalTrials.gov.

Concerns about immunological consequences of rAAV - mediated gene transfer were substantiated by the outcome of a clinical trial in which human hemophilia B patients were infused into the liver with rAAV -2-F.

«We have been very concerned about reports of patients using unproven medical therapies whose safety and efficacy have not been tested in systematic clinical trials,» he said.

«The lack of association between response rates and hard clinical outcomes raises concerns about fast track approval of new drugs, based on results from trials utilizing solely these surrogate markers,» the researchers wrote.

NIH studies on the issue cite a number of different reasons that patients elect not to participate in clinical trials, including fear of a reduced quality of life, concern about receiving a placebo, potential side effects, and concern that the experimental drug might not be the best option.

Lysogene's MPS IIIA gene therapy clinical trial strategy includes a partnership with the MPS patient networks to ensure families are well informed about our development program and are able to make informed choices concerning the best treatment strategy for their children.

All things considered, if you are concerned about your LDL levels (and what it means for your lipoprotein a levels and overall risk for heart disease), the Daily Reset Shake (4) does have the full dose of resistant starch as found in clinical trials.

Unless otherwise specified, participation in most clinical trial requires that you come back to the UC Davis Veterinary Medical Teaching Hospital for your visits and for any concerns about adverse events.

Indeed, the US National Institutes of Health recently suspended its clinical trials in the country, citing concerns about an unstable regulatory environment.

The block randomised design was chosen because it is a more practical design to use for trials of health promoting interventions delivered in groups.26 Only parents of children whose behaviour fell in the worst half of the distribution were invited to take part because of concerns about documenting change in population samples using instruments designed to identify and measure change in clinical populations.