Sentences with phrase «data on trial»

2 reviewers independently extracted data on trial location and methods, patient characteristics, type and duration of the intervention, and outcomes.

provide data on trial site «projects» and the ability to analyse and monitor these projects using a cross-government approach;

The Lex Machina Copyright Litigation Report breaks down the thousands of copyright cases filed in the last 5 years to showcase how this data can be used to inform litigation strategy: from detailed analysis of different judicial districts useful to forum planning, to timing data on trial and injunctions that can drastically improve budgeting, as well as top parties and firms for firm marketing and outside counsel selection.

Those media reports relied on preliminary data on a trial of a new drug in Guinea that were leaked by a nongovernmental organization that was helping conduct the study, the researchers say.

When he went to other contract research firms and asked for data on a trial, they generally produced an overwhelming amount of paper: records of failed tests, meticulous explanations of how the chemists had made adjustments, and more.

Not exact matches

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.

And Marathon barely did any actual clinical legwork to get the drug cleared for Duchenne — it relied on 1990 - era clinical trial data before tacking on just enough study material to win an approval that doesn't even address the root cause of the disease.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

The Finnish drug maker on Sunday presented results from phase I trial of a prostate cancer treatment, saying according the data it «has been well tolerated, with no significant treatment - related adverse events.»

While the asthma trial data is just one point, the study's results could go a long way in assuring scientists that information generated through the platform (at least for certain kinds of studies) is on point.

To access BI Intelligence's full reports on Location - Based Mobile Marketing, as well as full - access to our archive of in - depth reports, charts and data, sign up for a free trial subscription.

«Our expectation based on all our trial data heavy research is that we know that when somebody tries it, they'll buy it again, they'll tell their friends, they'll tell their colleagues,» Sebastiani says.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

Juno's setbacks contrast with the biologics license application planned this year by Novartis, and the rolling BLA in progress by Kite Pharma — which on Tuesday reported positive 6 - month trial data for its CAR T - cell lead candidate.

Panoply's machine learning based data warehouse management saves a lot of time spent on maintenance and trial - and - error tuning, allowing data engineers to focus on helping deliver business insights.

Additional clinical trial data later this year on Tesaro's key drug, Niraparib, which targets advanced solid tumors in ovarian and breast cancers, could help narrow the valuation gap, the people said.

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.

The pressure on Mr. Cohen, 56, escalated in November, when prosecutors charged Mathew Martoma, a former SAC portfolio manager, with trading in the drug stocks Elan and Wyeth based on confidential drug trial data that a doctor had leaked to him.

Zelia Rosenzweig shares how she has focused on improving the pre-sales cycle by removing data silos and one - off reports to give the entire trial team better insight and access into new customer opportunities.

Pharmaceuticals: Reflects Canada's existing regimes, systems and laws on: patent linkage; protection for clinical trial data; and early working exceptions.

We chose to model the effects on body weight because good evidence (from both trials and epidemiological studies) links regular consumption of sugar sweetened drinks to weight gain.8 10 12 Moreover, data from longitudinal studies support the idea that changes in the price of sugar sweetened drinks are linked to changes in body weight.20 Other groups have used this form of modelling to estimate the effects of a sugar sweetened drink tax on obesity.18 21 22

Improved postharvest practices: A recent research study undertaken by WFLO with funding by the Bill & Melinda Gates Foundation provides an great assortment of data on the results of 12 past projects, postharvest losses % for 26 crops, a description of the value chain for 30 crops in 4 countries (Rwanda, Benin, Ghana and India) and 21 field trials of postharvest technologies suitable for helping small farmers reduce losses and improve their incomes.

In a public dialogue on Golden Rice held by the National Anti-Poverty Commission or NAPC last August, medical doctors has warned that there are not enough data presented to establish safety of Golden Rice to human health thus warranting the discontinuation of human feed trials.

A technical briefing focused on event selection, nutritional impact, safety assessment and agronomic data from the GR2E Golden Rice confined field trials in Bangladesh.

It certainly is ironic that, while the gold standard of medical research is the randomized controlled trial, which generally looks at the risks and benefits of an intervention on a population level, it is individual women who have to make the decisions — and individual women may not always find these kind of data helpful.

In reality, EFSA had told the Commission in a letter: «The evidence, however, does not establish that starting DHA supplementation at 4 - 6 months in infants who had received a control (DHA - free) formula in the first months of life would have an effect on the visual development of those children...... There are no data from specific randomised control trials supporting a benefit of DHA supplementation starting at 6 months of life in infants fed a DHA - free formula in the first 6 months of life......» (3)

«We have analysed all the data and feedback and reviewed a number of incidents including the George Smith one and we have made a few changes,» said Kemp, speaking at Twickenham on the eve of the new Premiership season where the trial will continue.

Our use of observational data reflects the existing literature on lactation and maternal health; apart from a single randomized trial examining the effect of exclusive lactation duration on maternal weight loss, 48 there are no published studies of maternal health outcomes in randomized trials of breastfeeding.

We used data from a large cluster - randomized trial to assess the impact of a breastfeeding promotion intervention on socioeconomic inequalities in breastfeeding (exclusivity and duration) and in child cognitive ability at early school age.

Although not directly comparable, our findings are in broad agreement with those from routine data in Scotland that have indicated a positive association between Baby Friendly accreditation, but not certification, and breastfeeding at 1 week of age.17 Our findings reinforce those of Coutinho and colleagues who reported that high exclusive breastfeeding rates achieved in Brazilian hospitals implementing staff training with the course content of the Baby Friendly Hospital Initiative were short - lived and not sustained at home unless implemented in combination with post-natal home visits.35 Similarly in Italy, training of staff with an adapted version of the Baby Friendly course content resulted in high breastfeeding rates at discharge, with a rapid decrease in the days after leaving hospital.36 In contrast, a cluster randomized trial in Belarus (PROBIT) found an association between an intervention modelled on the Baby Friendly Initiative with an increased duration of breastfeeding37 an association also reported from an observational study in Germany.38 Mothers in Belarus stay in hospital post-partum for 6 — 7 days, and in Germany for 5 days, with post-natal support likely to be particularly important in countries where mothers stay in the hospital for a shorter time, with early discharge likely to limit the influence of a hospital - based intervention.

Despite the fact that there are a lack of randomized trials and data on outcomes is limited, we have enough experience with pre-implantation genetic diagnosis to feel confident that this is a safe and highly accurate procedure.

The «unexpected deaths» were based on data from an industry - funded, academic - researcher - run clinical trial described in two papers published in 1999 and 2000.

DF and K - TT advised on the study design, coordinated the study, liaised with participants, entered data, and monitored the trial.

The trial data were collected on printed case record forms, and the unit performed data entry.

Data derived from two randomized trials with primiparous women from Honduras, one based on low birth weight and the other on normal birth weight infants, show that infants who were exclusively breastfed for six months (vs. four months) began to crawl earlier.5 In addition, the normal birth weight trial showed that babies who were exclusively breastfed for six months were significantly more likely to be walking by one year compared with those who were exclusively breastfed for four months (60 % vs. 39 %).

Although this study was not powered to assess the impact of mother — infant sleep proximity on long - term breastfeeding outcomes, these indicative data suggested that such a trial was warranted; this trial is now underway and due to report in 2010.

The trial of Tommy Sheridan cast new light on the News of the World's use of private detectives who have been convicted of illegal phone hacking and «blagging» confidential data.

Thomas Smith, who studies the epidemiology of malaria at the Swiss Tropical Institute in Basel, says it may be premature to say exactly what the efficacy is based on this early data from the trial, which is still ongoing.

The FDA reviews more liver health data and approves duloxetine for depression and diabetic neuropathy (pain), based on another set of clinical trials.

The study looks at data on 26 side effects from a trial of approximately 10,000 patients and suggests that cases of muscle pain and weakness are unlikely to be directly caused by statins, but may instead be due to the so - called nocebo effect, where the expectation of side effects can make patients more likely to report them.

Based on the analysis of data from eight of the included trials, 47 % of patients in the control groups were given a prescription, compared with 29 % in the groups where the GPs or patients had received training or information.

The result will be corresponding data representations for clinical and trial data, both based on the RIM.

«My concern is that independent trials are on the decline and that means we have less high - quality data to inform public health that are not influenced by commercial interests,» says study leader Stephan Ehrhardt, MD, MPH, an associate professor in the Bloomberg School's Department of Epidemiology.

Rather than create drastic salt policies based on conflicting data, Alderman and his colleague Hillel Cohen propose that the government sponsor a large, controlled clinical trial to see what happens to people who follow low - salt diets over time.

Respondents in this year's survey pointed to five main causes of the field's less than favorable reputation: drug and product recalls such as the withdrawal of Avandia; safety issues such as the discovery of problems with raw material from China used in medical products; scandals, including evidence that pharmaceutical companies have failed to release data from trials whose results cast doubts on their drugs» safety and efficacy; lawsuits brought against companies that failed to warn patients of problems with their products; and ethical issues such as kickbacks for physicians promoting specific medications.

We were the first to put up a clinical trial registry with all our data on a website.

The logical substitution was a medication called abraxane, but there were insufficient safety data on combining that with other drugs used in the trial.

The authors do note that this large study can not definitively prove cause and effect; nonetheless, the findings are strongly consistent with «a wealth of existing observational and clinical trial data to support health benefits of nut consumption on many chronic diseases.»

Following additional scrutiny after Vioxx's withdrawal, and the addition of cardiovascular experts to the trial's data safety monitoring board, the DSMB concluded that patients taking a high dose of Celebrex had a 3.4-fold increase in the risk of heart attacks or strokes compared to those on placebo; those on a moderate dose had a 2.5-fold increase in risk.

In work showing the potential to use a brain - computer interface and virtual avatar to treat people with gait disabilities, researchers collected data from eight healthy subjects, all of whom participated in three trials involving walking on a treadmill while watching an avatar.