Sentences with phrase «trial design for»

Rethinking the traditional drug development process for rare diseases will be critical, including trial design for small populations, real - world evidence collection, stronger patient engagement for data collection and definition of clinical end - points.

An expert panel that the Italian government asked to come up with a trial design for a controversial Italian stem cell therapy has thrown in the towel.

«FDA's approach to evaluation of recent hepatitis C drugs underscores the Agency's flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development,» said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products / Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper.

The guideline presents possible streamlined development programs and clinical trial designs for antibacterial drugs to treat se...

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.

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.

Mr. Siegal's other client successes include securing a 2016 trial victory in federal court defending Marvel Entertainment against a claim that it stole a patent - holder's design for a Spiderman role play web - shooting toy, and numerous federal and state appellate arguments in criminal and civil matters.

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.

The trial uses complex and innovative design features, testing for different dosing, different durations of treatment, and different age groups.

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.

Dr. Chawla designed and led the ATHOS 3 Phase 3 trial for La Jolla Pharmaceutical's FDA - approved drug for shock, Giapreza ™.

All of these items were designed by people through trial and error, and available to anyone to download, for free.

After Abbott, he co-founded DCVC company BlueTalon, which was initially focused on enterprise data security for data - driven clinical trial design and population health management.

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.

The Freedom From Religion Foundation chose just a few locations for the board: Madison, Wisconsin, (where the organization is based), Dayton, Tennessee, (where the Scopes Monkey Trial of 1925 was held, of course), and Dover, Pennsylvania, (where a local school board sought to integrate the concept of intelligent design into science classes in 2005).

Catholic News Agency: NASA worker's lawsuit charges discrimination over intelligent design A NASA mission specialist allegedly demoted for his beliefs about intelligent design is suing Jet Propulsion Laboratories in a civil trial to begin in Los Angeles March 7.

The sample size was small, and the researchers stated that the research findings indicate the need for a randomised control trial (RCT) as RCT's are widely recognised as the best study design.

Last month, Coke launched a $ 2, 250 ml, «entry» - price can designed to appeal to cash - strapped teens and trials have begun for similar new «single - coin» products.

Symposium, Exhibition, & Concept Bar at Breakthrough Napa Valley Conference November 13, 2014: Rootstock presents a full day of high - level, provocative seminars and industry experts, wine trials and tastings, and exhibits when this revolutionary conference designed for top quality grape growers, vineyard and winery owners, and winemakers worldwide...

The company designs its clinical trials to guarantee that its studies are structure / function compliant and follow strict guidelines issued by FTC, FDA, and EFSA for subject population and endpoint selection.

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.

Last week the Soviet unveiled a brand - new racing car, the Kharkov Six, in an arrestingly streamlined version designed for straightaway speed trials.

In 1984 Avent introduced a baby bottle that set the standard for feeding bottles worldwide and since then Avent has designed and manufactured products that are inspired by nature and developed through extensive research and clinical trials.

Fun for the whole family, the trails at Mount Snow range from the longest beginner trial in New England, to expert terrain designed to thrill even the most experienced riders.

Trials are needed that examine interventions designed specifically for women with multiples and delivered by people with training about how to overcome the particular challenges of breastfeeding more than one infant.

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.

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.

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.

Cluster trial with no apparent adjustment for design effect.

Declan Devane is a co-author in one of the included trials in this review (Begley 2011) Jane Sandall was and is principal investigator for two studies evaluating models of midwife - led continuity of care (Sandall 2001), and co-investigator on the «Birthplace in England Research Programme», an integrated programme of research designed to compare outcomes of births for women planned at home, in different types of midwifery units, and in hospital units with obstetric services.

Pellecchia said the road to a therapeutic for human trials is still long and includes the iterative design and synthesis of more potent and selective agents.

They may have done a thesis with a translational focus, but few will have received training in the requirements for doing modern patient - oriented research, which includes large doses of epidemiology, statistics, and human - subject trial design.

Two other multi-national trials randomized 27,438 patients to either bococizumab or placebo and were designed to evaluate the impact of the drug on cardiovascular outcomes, including nonfatal heart attack and stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death.

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.

However, as many anti-inflammatory drugs are already available, there may be a relatively short path to designing clinical trials for drugs that modulate the inflammatory response in people with neurodegenerative disease.

«This study's results can have practice changing implications on how future prostate cancer trials are designed in terms of identifying the men for these studies who are at high risk for early death due to ineffective initial treatment for their prostate cancer,» stated Anthony Victor D'Amico, MD, PhD, chief, Genitourinary Radiation Oncology, Brigham and Women's Hospital and senior author of the study.

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.

«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.

In this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis pain.

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

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

«The trial was designed to have equal late toxicity, so although there were some differences in shorter - term side effects, the results for long - term toxicity were precisely what we hoped to find,» said Dr. Widmark.

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.

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.

Promising results from the new trial would be a major step forward for a field that has long been criticized for studies that are poorly designed, incomplete or lack control - group comparisons, as well as for the peddling of unproved therapies in many clinics worldwide.

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

The next step, says Salem, will be to try to correlate these findings with patient treatment outcomes, initially as a retrospective, or backward looking study, and then hopefully design a forward looking clinical trial to determine which treatments may be best for patients with SBAs.