Sentences with phrase «clinical trial design for»

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.

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.

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 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.

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.

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.

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.

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.»

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.

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.

«With knowledge like this, we can design clinical trials using JAK inhibitors for SS patients based on their JAK mutations,» said Elenitoba - Johnson.

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.

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.

«What most pharma look to me for is my 10 years of experience in pharmacogenomic clinical drug trial design and result interpretation,» he explains.

It was conducted under a special protocol assessment with the US Food and Drug Administration, which considers an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses acceptable for FDA approval.

But he says their findings may have more immediate implications as well, for the design of clinical trials evaluating the benefits of providing nutrients to patients with sepsis.

When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.

One project involves probing Foundation Medicine's growing database of tumor profiles for specific mutations and using that information to either design drugs or to parse patients into clinical trials of the company's drugs, says Pao.

«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.

If doctors had known that TNF - blocking drugs mimic the effects of a major risk factor for the disease, they might have designed their clinical trials differently, he says.

«They will be the new standard of care and will replace the 2010 ELN recommendations for managing AML patients and designing clinical trials.»

«The mouse work is promising enough to adapt these technologies for real time analysis of patient materials so that clinical trials can be designed to test this new diagnostic and drug selection approach,» he said.

The original algorithm is now freely available upon request, but Origent hopes to market programs that can be tailored to specific clinical trial designs or even used to help doctors make more personalized predictions for their patients.

Using a randomized, placebo - controlled clinical trial (RCT) design, they randomized 48 participants into four equal groups of 12 people: low - to - moderate intensity, high - volume aerobic exercise (LO: HI); high - intensity, low - volume aerobic exercise (HI: LO); low - to - moderate intensity, low - volume aerobic exercise (LO: LO); and placebo (PLA) for an eight - week period.

Finding genetic markers for the placebo effect could raise ethical questions about how companies design their clinical trials, Furmark says.

However, in this Phase II clinical trial, designed to prospectively evaluate the safety and effectiveness of ACHT for patients with HIV - related lymphoma, researchers discovered that this population had no greater likelihood of developing these complications compared to those without the virus.

«This is the first human trial of this novel stem cell - based implant, which is designed to replace a single - cell layer that degenerates in patients with dry age - related macular degeneration,» says lead author and surgeon for the study Dr. Amir H. Kashani, assistant professor of clinical ophthalmology at the Keck School of Medicine of USC.

In the $ 1.47 million, four - year grant called â $ œBiomarkers of Ischemic Outcomes in Intracranial Stenosisâ $ (BIOSIS), Emory researchers are analyzing blood samples from 451 patients from around the country who were enrolled in a study known as SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis), the first randomized, multicenter clinical trial designed to test whether stenting intracranial arteries would prevent recurrent stroke.

In just the last 6 years the EID outbreaks of MERS, Ebola, Zika, CHIKV as examples have underscored the importance of rapid vaccine development and deployment capabilities to meet EID challenges, as well as growing appreciation for creativity and flexibility in clinical trial design.

While biostatisticians help ensure a clinical trial is designed for success, bioinformaticians translate massive databases of cancer - related information that was virtually unknowable just two decades ago when the ambitious Human Genome Project.

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.

Biostatisticians and bioinformaticians must have a high level of understanding of the research question being asked, and design the trial accordingly with the information available, setting reasonable expectations for a new treatment based on input from the clinical investigator.

«In time, these findings should help us assign patients to the appropriate clinical trial and to improve the design of clinical trials — particularly for precision medicines that target the newly identified genetic alterations,» said Brent Orr, MD, PhD, of St. Jude Pathology.

«Once we understand how these drugs impact specific cells and tissues we'll be in a position to design clinical trials for humans,» said Kennedy.

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).