Sentences with phrase «of clinical trial design»

This type of trial is considered the pinnacle of clinical trial design.

The data from extensive laboratory studies on correlates of risk of HIV infection will be used in one aspect of the clinical trial design.

In an interview in the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approved.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

A new analysis of clinical data from the TRACK - HD and COHORT studies proposes a way to design of clinical trials designed to delay the onset of HD, rather than treating symptoms after they occur.

We are a very active member of the Children's Oncology Group Phase I and Phase II - III consortiums, offering families access to a wide range of clinical trials designed to find new treatments for childhood cancers.

Not exact matches

In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.

In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test at least four of its drug candidates on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive clinical trials.

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.

«It essentially gives us a periodic table,» Ron DePinho, President of MD Anderson Cancer Center says, which has provided us with both diagnostic and therapeutic value as well as helped us design clinical trials to accelerate the development of new cancer drugs,».

We have numerous ongoing clinical trials designed to evaluate our drugs in a variety of health conditions.

In those areas that we have mapped, it typically takes us a few hours to go from a mechanism - inspired idea for treating a disease to knowing the companies that might have relevant clinical and preclinical assets to license, the companies from whom a candidate could be commissioned, trial designs and endpoints, competing and complementary agents, current and future standard of care, market size, comparable pricing, financing strategy, and potential acquirers, all meant to enable a thoughtful first - pass assessment of whether an idea could be worth a much deeper assessment.

We need to design clinical trials and outcomes in a way that captures the downsides of aging in a quantitative way» that allows targets for drug approvals by the FDA.

He designs, leads and contributes to numerous investigator - initiated and industry - sponsored clinical trials involving hundreds of sites and thousands of patients around the world.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

His primary research interests since 1996 have been in the design and conduct of a number of randomized trials in clinical obstetrics and perinatology.

At The Fertility Center of Las Vegas, each clinical trial is designed as a prospective, randomized study.

In addition, structured training in study design, epidemiology, clinical investigation and health policy research is available for fellows interested in systematic pursuit of a career in clinical research or clinical trials.

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.

Amyloid buildup is a key pathological feature of Alzheimer's, and determining the degree to which someone's brain is riddled with the molecule is essential for designing effective clinical trials.

The clinical trial is designed to assess safety and activity of escalating doses of the special cells (AST - OPC1) for individuals with a complete cervical spinal cord injury.

So Szmulewitz and colleague Mark Ratain, MD, the Leon O. Jacobson professor of medicine and director of the Center for Personalized Therapeutics at the University of Chicago Medicine, designed a randomized clinical trial to see if the drug could be used more efficiently and at less expense.

The researchers add that this information will be relevant to the design of clinical trials of lipid - modifying agents, which should carefully monitor participants for dysglycemia and the incidence of diabetes.

«Given the enormous societal toll of chronic pain, being able to predict placebo responders in a chronic pain population could both help the design of personalized medicine and enhance the success of clinical trials,» said Marwan Baliki, research scientist at RIC and an assistant professor of physical medicine and rehabilitation at Northwestern University Feinberg School of Medicine.

«Complex models are needed to effectively evaluate PMed study designs, and this proof - of - concept trial validates the dog with cancer as a model for clinical evaluation of novel PMed approaches,» said Dr. Melissa Paoloni, the study's lead author and former director of the COTC.

He, along with his colleague Mark Rubinstein, Ph.D. also of the Hollings Cancer Center, designed a clinical trial that started in 2016.

The trial design proposed here would also ease the burden of clinical documentation for the practicing physician.

Published in the journal Molecular Cancer Therapeutics, the study also found that use of a second inhibitor might improve the effectiveness of these drugs by possibly preventing resistance, and it recommends that clinical trials should be designed to include a second inhibitor.

She says a number of experimental drugs now in clinical trials are designed to target serotonin in other ways in the brain, and may have better success than the SSRIs.

People working in biomanufacturing need to be prepared for inspections by the US Food and Drug Administration and the European Medical Evaluation Agency designed to ensure that mass - produced proteins are of the same quality as those used in clinical trials.

In it, critical care specialist Charles Natanson of the Clinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma pClinical Center at the U.S. National Institutes of Health in Bethesda, Maryland, argued that blood substitutes, no matter how they're designed, raise the risk of death by almost 30 % and nearly triple the rate of heart attacks in the people who receive them in clinical trials, mainly surgery and trauma pclinical trials, mainly surgery and trauma patients.

«We're doing a lot of work to improve clinical trial design and to improve the way drugs are discovered and developed,» Perlmutter says.

Researchers are designing the first clinical trials of stem cell treatments for fetuses afflicted with rare bone and blood diseases.

Designed to test the safety and effectiveness of this new approach, the clinical trial was led by principal investigator Richard Andersen, the James G. Boswell Professor of Neuroscience at Caltech, neurosurgeon Charles Y. Liu, professor of neurological surgery, neurology, and biomedical engineering at USC, and neurologist Mindy Aisen, chief medical officer at Rancho Los Amigos.

A U.K. team is designing a clinical trial even more radical than prenatal stem cell therapy: the first ever test of gene therapy in pregnancy.

«The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell - based interventions with respect to the design, initiation and conduct of U.S. clinical trials,» the authors wrote.

«This will require discussions about alternative approaches to the design and conduct of clinical trials as well as to how interventions are approved by the Food and Drug Administration.»

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

Toxicologist Thomas Hartung of the Johns Hopkins Bloomberg School of Public Health in Baltimore agrees: «Clinical drug trials in general are very well designed.

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..

According to Dr. Sumowski, «The significant effect of warmer weather on cognition should be considered when designing and conducting clinical trials.

The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.

His work in designing anticancer compounds had led to millions of dollars in funding and multiple patents, as well as two compounds in clinical trials.

Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new drugs by characterizing key features of efficacy trials, such as trial size, design duration, and end points.

Of the 10 patients enrolled in the study — a clinical trial designed to evaluate safety and feasibility — none of the participants experienced any dangerous side effects and one patient's disease remained stable after 18 monthOf the 10 patients enrolled in the study — a clinical trial designed to evaluate safety and feasibility — none of the participants experienced any dangerous side effects and one patient's disease remained stable after 18 monthof the participants experienced any dangerous side effects and one patient's disease remained stable after 18 months.

Professor Melanie Calvert, from the University of Birmingham, explained, «Researchers face a difficult task in designing effective clinical trials that include PROs.

The FDA already has a 6 - year - old program called the Critical Path Initiative that, according to its Web site, funds a number of research projects on topics such as clinical trial design.

«Part of what was exciting about the design of this clinical trial is that we decided early on to accept women from a younger and generally sicker population than is typically enrolled in clinical trials,» says Dr. Cristofanilli, who is also a researcher at the Sidney Kimmel Cancer Center at Thomas Jefferson University.

Some of my duties include the design, testing, and manufacturing of the product; working with the contractors and clinical - trials teams; and exploring different distribution systems.