Sentences with phrase «larger efficacy trials»

Human safety trials for a vaccine to jump - start immunity could begin later this year; larger efficacy trials may be a year and a half away.

[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger efficacy trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline] vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data from ongoing safety trials).»

«The next steps are to move ahead with a larger efficacy trial in West Africa.»

All foster care children were part of a larger efficacy trial to evaluate Multidimensional Treatment Foster Care for Preschoolers (MTFC - P)[now called Treatment Foster Care Oregon for Preschoolers (TFCO - P)-RSB- and were assigned to intervention or comparison groups at study entry.

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).

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

If large - scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

It is worth noting at this point that this is not yet another case of a drug entering the market only to be withdrawn later because of lack of efficacy or even adverse reactions which could have been noticed with longer or larger trials.

Stitziel and his colleagues pointed out that this question will be addressed later this month with the reporting of results from a large clinical trial called IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE -trial called IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE -Trial (IMPROVE - IT).

«Randomized trials have confirmed the value of radiation dose escalation for prostate tumors, and the potential benefits of larger radiation doses in fewer fractions, are expected to increase the therapeutic efficacy for men with prostate cancer,» said Anders Widmark, MD, a professor of radiation sciences at Umeå University in Umeå, Sweden and lead author of the study.

The company plans in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III efficacy trials across a larger set of demographics are scheduled to begin early next year.

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.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

This led to two large clinical trials carried out by the Mayo Clinic in the late 1970s and mid-1980s (2, 3), which demonstrated that oral administration of a high dose of vitamin C had no efficacy as a cancer therapeutic.

This finding helps explain why two large clinical trials testing HIV pre-exposure prophylaxis, or PrEP, in women failed to show efficacy.

Yale enrolled the largest number of participants at any one site (84 of 790) for these double - blind, placebo - controlled trials that investigated the efficacy of testosterone gel for multiple outcomes, including sexual function, physical function, and vitality.

Westin launched his campaign last spring, and by the fall he had handed over management of his clinical trials — most recently testing the efficacy of a combination of three drugs used to treat large B - cell lymphoma — to colleagues.

It also provides valuable information that may assist researchers in the development of genetic tests based on next generation sequencing, and in the initiation of large intervention trials to assess the efficacy of orphan drugs.

Arnold hopes to run a larger trial that can better evaluate metformin's efficacy, but funding has been an issue.

Promising outcomes of preliminary studies in patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but safety and efficacy have not yet been proven in large - scale clinical trials.

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

As the next step for this line of research, the investigators plan to expand to a larger prospective multicenter trial to further investigate the efficacy of the treatment in a larger sample of patients with dry AMD.

A test - of - concept trial is not designed to establish the efficacy of a particular candidate but rather to help researchers decide if a candidate is worth testing in larger Phase III trials.

The development track will begin with a Phase I trial to test the vaccine regimen's safety and immunogenicity and depending on those study results, a larger efficacy study will follow.

The next step is a longer, larger trial to test the drug's «efficacy» - does it slow the progression of HD?

The authors concluded that these meta - analyses support the need for further controlled, larger trials to assess the clinical efficacy of rTMS on negative and positive symptoms of schizophrenia, while suggesting the need for exploration for alternative stimulation protocols.

MHRP is proud to have led a large group that executed the landmark RV144 vaccine trial, the first study to show efficacy in preventing HIV infection.

Dr. O'Haire says the valuable data from the pilot study helped secure the NIH R21 grant to conduct the large - scale, clinical trial to further investigate the efficacy and role of service dogs for military veterans with PTSD and their spouses.

While large - scale randomised clinical trials have demonstrated the efficacy of schema therapy (ST) for borderline personality disorder (BPD) and other PDs, current studies are expanding to assess its usefulness for other disorders and particular treatment settings.

Larger trials that can investigate the role of baseline relationship functioning on PTSD, and relationship satisfaction outcomes are needed to facilitate treatment - matching efforts and to determine the boundaries of CBCT's efficacy.

More funding is needed for large - scale effectiveness trials that examine ways of disseminating evidence - based interventions in real - world settings and for large - scale trials that compare the efficacy of different evidence - based programs for different populations.

As this study shows, when the «dose» is large enough, parent training seems more effective than when data from all participants are used in an intent to treat analysis; (c) the present study provided a more rigorous test than most prior studies by only admitting children to treatment who met DSM - IV criteria for ODD; and, perhaps most importantly, (d) this study was designed as an effectiveness trial, while most prior studies were efficacy - oriented.

For the National Center for Special Education Research and in partnership with ICI, SRI is conducting a longitudinal randomized controlled trial to evaluate the efficacy of C&C as implemented in five large urban high schools.

In addition, she is co-principal investigator on the ED - funded efficacy trial of Foundations, a positive and proactive approach to schoolwide discipline, and of the National Institute of Justice - funded implementation and evaluation study of positive discipline and trauma - informed services in a large urban school district.

The small open trial presented here precludes conducting any significant cost - effective analyses, but it will be important for future work to continue to explore how brief PT programs can be administered to a larger number of parents while maintaining their efficacy.