Sentences with phrase «efficacy trial involving»

Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.

Antibody action Only an efficacy trial involving people at risk of infection can reveal whether a vaccine prevents infection.

Not exact matches

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).

Although professional lactation support can improve the duration of overall breast feeding, its effect in improving exclusive breast feeding is unclear.11 18 22 Thus far, studies that report improvement of rates of exclusive breastfeeding have involved mainly community based peer counselling strategies.23 24 25 Even then, a randomised trial in the UK recently cast doubt on the efficacy of this approach.26 There are current recommendations from NICE for the UK - wide implementation of the baby friendly initiative.4 5 6 The 2006 NICE costing report on routine postnatal care of women and their babies estimates that efforts to improve rates of breast feeding will result in substantial cost savings for the NHS.6

The trial needs to involve at least 50 people with OCD and a credible control treatment to really test the efficacy of this idea, says Jon Abramowitz, a clinical psychologist at the University of North Carolina at Chapel Hill.

Previous clinical trials of creatine in symptomatic HD patients have been limited in scale, involved daily doses of 10 grams or less, and did not provide evidence of potential efficacy.

And scientists who conduct human challenge studies, which typically involve a few dozen participants, say they have critical benefits: In addition to saving time and money, they can reveal harm caused by a potential drug or vaccine before it enters large - scale human efficacy trials.

The rule provides a framework for potential licensure of medical products when definitive efficacy studies that would involve exposing healthy human volunteers are unethical and field trials after accidental human exposure are not feasible.

After the trial there will be a review of the efficacy of the approach, the underpinning science and a review of the ethical issues involved.

The GP practices were involved in ensuring the study not only had access to specific COPD patients but also that the usual clinical care provided by the practices was built into the trials — the study was therefore rooted in a real clinical environment unlike tradition efficacy trial model.

But efficacy trials often involve only several hundred to a few thousand patients.

[44] Two other phase II clinical trials evaluated the efficacy of imatinib in patients with melanoma — including mucosal melanomas — harboring KIT mutations and / or amplifications, with a subset of cases involving mucosal primaries, and both found a disease control rate of approximately 50 %.

«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»

These mutant kinases are attractive therapeutic targets, as demonstrated by the efficacy of imatinib in BCR - ABL — positive chronic myelogenous leukemia (CML), 5 as well as in MPD associated with activating alleles involving PDGFRA or PDGFRB.2, 6,7 In addition, activating mutations in the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknown.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the application.

Finally, the bulk of evaluations have involved well - controlled efficacy trials that utilize clear inclusion / exclusion criteria and well - trained and supervised clinicians, and also monitor the fidelity of the intervention being provided.

The study involves data collection with a subsample of 9 — 13 year - old children who participated in a randomized efficacy trial of Treatment Foster Care of Oregon for Preschoolers (TFCO - P).