Sentences with phrase «trial designed not»

Not exact matches

But the short answer for anyone who doesn't want to buy a book is that the standard old - fashioned clinical trial is designed to answer a specific question about a population with lots of different specific characteristics.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Amgen Executive Vice President of Research and Development Sean Harper said the study was designed to explore Kyprolis dosing regimens, noting that the the trial did not meet its goal in improving progression - free survival versus Velcade in patients who had not yet been treated for the disease.

However, let's not miss that God designed marriage not only to stretch us beyond our selfishness to become more like Jesus through trials, but also to bring great joy to our lives with the myriad of gifts marriage provides.

We aren't designed to understand why we're going through this trial.

Primarily because we do not find the same benefits in better - designed studies — sibling comparison studies and the PROBIT randomized controlled trial.

Even if necessity is the mother of breast - pump invention, getting new designs of a medical device through FDA trials isn't easy.

Our study illustrates that a randomized intervention trial with good socioeconomic information can help assess interventions designed to improve population health not only by examining the intervention effects on primary outcomes but also by evaluating the intervention's impact on socioeconomic inequalities.

However, the trials showed that women living in areas where they are not well - informed about home birth may welcome ethically well - designed trials that would ensure an informed choice.

I was really excited to find a music and gym class designed for siblings, but after a 2 week trial I knew it was not for us.

The other PC trials (6, 27) were not designed to promote exclusive breastfeeding and did not observe improvements in exclusive breastfeeding rates.

They did not allow conclusions to be drawn except that women living in areas where they are not well informed about home birth may welcome ethically well - designed trials that would ensure an informed choice.

However, the trials show that women living in areas where they are not well informed about home birth may welcome ethically well - designed trials that would ensure an informed choice.

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.

We excluded a further 13 trials as the intervention was not designed to support continued breastfeeding; these studies examined more general interventions in the postnatal period (Ball 2011; Barlow 2006; Barnet 2002; Black 2001; Gagnon 1997; MacArthur 2002; Peterson 2002; Pollard 2011; Ratner 1999; Rush 1991; Serrano 2010; Thomson 2009; Wiggins 2005); a further trial by Baqui 2008 focused on breastfeeding initiation only, rather than on postnatal support to encourage continuation.

Throughout the trial Mr Griffin maintained his comments were attacking religion and not race, and were designed motivate political activity.

«Many of these individuals would still like to help find treatments, and this trial design allows them to participate while respecting their autonomy, their right not to know their personal genetic information.»

«Getting this information, while it's disappointing, is really what this trial is designed to do, because [it] will move the field forward when we understand more about why [the vaccine] was not protective.»

«The work will have direct implications for designing clinical trials using oncolytic viruses, not only for brain tumors, but for other solid tumors.»

Since randomized clinical trials — the gold - standard in research — don't accommodate patients» preferences, Zoellner and her research team used a study design called a «doubly randomized preference trial» to investigate whether giving patients a choice affects their treatment outcomes.

Others did recruit enough patients but didn't use a randomized controlled trial design, which weakened results.

A statin drug commonly used to lower cholesterol is not effective in reducing the number and severity of flare ups from chronic obstructive pulmonary disease (COPD), according to the results of a large multicenter clinical trial designed and directed by Gerard J. Criner, MD, Director of Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia, PA..

Phase 1 trials are typically only designed to determine if a new drug is safe, and can't answer whether a new drug works.

In the recently concluded Scopes - like trial of Kitzmiller v. Dover School District, one of the defendants claimed not to know the source of the funds for 60 copies of an intelligent - design book, which he admitted to only having glanced through, for the school library.

Nonetheless, events like the famous Scopes trial in Tennessee in 1925 did not put an end to the furor in evangelical religious circles, which continues unabated and debated today regarding «intelligent design» in school teaching.

«While the present report suggests that optimal outcome measures for FXS are not yet fully developed, the recent failures of clinical trials in the FXS treatment field represent an opportunity to implement novel study designs and methodologies,» concludes Budimirovic.

The point is that the traditional model of designing a few - month - long placebo controlled trial of a pain score outcome is not sufficient.

Well - designed, placebo - controlled trials of the drug in men who do not meet the standard criteria for treatment have been scant in number, and their results have been inconsistent.

They argue that «universal conclusions about its benefits can not be drawn» and say further studies and better designed trials are needed.

Moreover, trials are often designed as best - case scenarios to show a drug's potential; in patients» hands, the drug may not work as well.

Innovative clinical trial approaches that have proven successful in other disease areas such as oncology (e.g., platform trials, umbrella and basket designs) might be employed with stratification of subjects by AT (N) profile, enabling a data - driven approach to identify the biological stage of disease in which an intervention has maximal treatment effects.

The study, designed to enroll 90 patients, was terminated prematurely due to three neurological events that prolonged trial enrollment, but were not cell related.

The authors write that this trial was not designed to determine the effects of testosterone on CVD events, and that a substantially larger trial would be needed to determine this.

A test - of - concept trial is not designed to establish the efficacy of a particular candidate but rather to help researchers decide if a candidate is worth testing in larger Phase III trials.

The trial was not designed to shed light on the question of whether the drug also can help to create new brown fat cells.

His team identified a factor that may be important for clinical trial design: progesterone was not toxic to all glioblastoma cell lines, and its toxicity may depend on whether the tumor suppressor gene p53 is mutated.

The clinical trial on Vivitrol ® was designed to see if Vivitrol ® was effective for treating opiate addiction, but did not compare it to either of the other approved medications for opiate addiction (methadone or buprenorphine).

Trials of drugs designed to reduce blood pressure in people with dementia have not been successful.

In addition to the small sample size and the fact that the trial was not designed or intended as an efficacy study, one important caveat is that because the trial was not investigator - blinded, it is likely that at least some bias was introduced into the assessments, particularly on the more subjective ones such as the IGA and some components of the MDS - UPDRS II and III subscales.

\ n \ nI've blogged about Geron's work here http://speakingofresearch.com/2009/01/23/a-new-era-for-embryonic-stem-cells/ and I'll confess that I'm quite optimistic about this one, as Geron seem to have been pretty thorough in their pre-clinical work and conservative in their clinical trial design.

Remember — this trial was not designed to prove that IONIS - HTTRx helps with HD symptoms or progression.

The trial was designed to test the safety of the drug and whether or not the drug could do what it was designed to do - reduce the production of the huntingtin protein.

We also performed subgroup meta - analyses by type of prevention (primary v secondary: in this study, trials involving healthy populations or patients with any specific disease except for cardiovascular disease were classified as primary prevention trials, and trials involving patients with cardiovascular disease were classified as secondary prevention trials), type of supplement by quality and dose (each supplement, vitamins only, antioxidants only, or antioxidants excluding vitamins), type of outcome (cardiovascular death, angina, fatal or non-fatal myocardial infarction, stroke, or transient ischaemic attack), type of outcome in each supplement, type of study design (randomised, double blind, placebo controlled trial v open label, randomised controlled trial), methodological quality (high v low), duration of treatment (< 5 years v ≥ 5 years), funding source (pharmaceutical industry v independent organisation), provider of supplements (pharmaceutical industry v not pharmaceutical industry), type of control (placebo v no placebo), number of participants (≥ 10000 v < 10000), and supplements given singly or in combination with other vitamin or antioxidant supplements by quality.

«Given that the majority of studies included in our review weren't well - designed trials, better - quality research on this topic is needed to better inform consumers and clinicians as to whether foot [orthotics] or shock - absorbing insoles can be used to decrease injury risk,» he said.

- The serum's trial bottle isn't well designed for the thin product.

Human trials are few and have not been able to provide strong evidence, due to shortfalls in their design (6, 7, 8, 9, 10).

I did buy a base design for my blog, which helped tons in terms of not having to learn how to code, but a lot of it I customized myself through lots of trial and error.

Remember, free trial accounts are usually designed to let you get an insight into the inner workings of the site to make a decision about whether or not you want to upgrade to a paid membership.

This part of the free trial is designed to help you make a decision on whether or not an upgraded paid membership is for you or not.

There is no doubt that there are many websites for meeting black singles and many of those offer free trials which means that you are going to get a chance to use the free period in order to see whether or not you are going to like the websites and if you are satisfied with the number of the members, design and all the things that matter when it comes to black dating.