Sentences with phrase «trials designed a»

Accountable for overall management of the company cardiac clinical trials designed to bring unique annuloplasty rings to market.

It should say that the food meets nutrient profiles established by the Association of American Feed Control Officials (AAFCO) or that it has passed feeding trials designed to AAFCO standards.

These are subscription services that come with limited trials designed to get you hooked.

All were hugely expensive trials designed to apply the gold standard (randomized double blind controlled trials) to the question of whether lowering blood sugars would reduce cardiovascular disease.

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.

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.

RESCUE and REVERSE are two separate randomized, double - masked, sham - controlled pivotal Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

To address this growing problem, NIAID is funding and conducting research on many aspects of antimicrobial (drug) resistance, including basic research on how microbes develop resistance, development of new and faster diagnostics, and clinical trials designed to find new vaccines and treatments effective against drug - resistant microbes.

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.

Identifying the molecular causes of disease represented a major breakthrough in the history of medicine, moving the discipline from pattern recognition and therapeutic strategies based on syndromic pathophysiology to molecular mechanism and evidence ‐ based therapies derived from clinical trials designed on the basis of molecular mechanism.

All previous clinical trials designed to reduce the levels of amyloid - beta using one therapy at a time have had limited success.

Dr. Timmerman, who holds the Effie Marie Cain Distinguished Chair in Cancer Therapy Research, has championed the use of SABR globally and has served as the lead investigator in several national trials designed to evaluate the efficacy and safety of SABR to treat cancer in the lung, liver, spine, and prostate.

To definitively prove there is a problem, Bjursten says scientists would have to find a plausible biological mechanism to explain these differences — and then run two randomized controlled trials designed to look at whether the donor's sex and pregnancy history affect the recipient.

The researchers caution that the reliable detection of small to moderate risks and benefits of drug therapies requires cogent data from large - scale randomized trials designed a priori to test the hypothesis.

Nor does it stop them from destroying field trials designed to address questions around environmental impact, performance, and effectiveness as a human food.

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

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.

The fifth day of the study involved a 109 - minute cycling trial designed to replicate a road race.

After five days, all participants took part in a 109 - minute, high - intensity cycling trial designed to replicate a road race.

«The STAMPEDE trial is changing the face of prostate cancer because the flexibility of the trial design means that we can investigate a number of different treatment options rapidly and in parallel, enabling scientists to get results much more quickly than they usually would.

It will house 150 researchers and clinician scientists, as well as an additional 100 people working in clinical trial design and administration.

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.

«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.»

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.

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

A larger clinical trial designed to do just that will begin recruiting subjects later this year.

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..

Thanks to the crossover intervention trial design, the researchers could control most of the potential confounders, such as population characteristics or past medical history.

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 months.

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.

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

This study was a randomized, double - blind, placebo - controlled trial designed to characterize the safety, tolerability and pharmacokinetics of AVI - 7288 after daily repeat dosing.

The benefits of psychiatric drugs have been exaggerated and the harms underplayed due to poor trial designs, argues one expert in The BMJ.

With CROs now often involved in every step of the process — from planning, trial design, volunteer recruitment and trial implementation to data analysis and dealing with regulatory authorities — it is the strategic account leader's job to ensure the process is integrated and runs efficiently.

The Maternal Vitamin D Osteoporosis Study (MAVIDOS) is the first randomised, placebo - controlled trial designed to measure the impact of pregnancy vitamin D supplementation on the bone health of babies using bone density scanning.

«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.

«Trial designs should be methodologically rigorous and capable of generating results that are clearly interpretable, acceptable to the host communities and, to the extent possible, minimize delays to completing the research,» the report says.

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.

Everybody has to agree what is a reasonable clinical trial design.

Although some patients in PD - 1 inhibitor trials have had such prior treatments, without a trial designed to address the question, «it's hard to draw conclusions,» Diaz says.

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.

Dr Gambhir said the team looked at whether a randomized control trial (RCT)-- where all people in the population have the same chance of being selected; or a stepped - wedge cluster trial design — which would give vaccine to healthcare workers and eventually treat all of them — is most safe and effective in evaluating a vaccine.

After enrolling in the study — a phase 1 trial designed to investigate the safety and antitumor activity of JCAR017 — she was found to have new lesion in the right temporal lobe of her brain.

Phase I trial - an early clinical trial designed to study an experimental vaccine in humans.

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.