Sentences with phrase «not on clinical trials»

Not exact matches

Not surprisingly, the spread of diseases (not to mention unhealthy lifestyles that lead to diseases) on a global level is much easier than coordinating care, managing supply chains and clinical trials and rolling out treatmenNot surprisingly, the spread of diseases (not to mention unhealthy lifestyles that lead to diseases) on a global level is much easier than coordinating care, managing supply chains and clinical trials and rolling out treatmennot to mention unhealthy lifestyles that lead to diseases) on a global level is much easier than coordinating care, managing supply chains and clinical trials and rolling out treatments.

«Watson is able to give us faster, better matching of patients to potential clinical trials that our oncologists wouldn't have otherwise be able to see — and I sit with our oncologists who work on this kind of thing,» Christopher Ross, CIO at the Mayo Clinic, told MobiHealthNews in an interview.

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.

Some retrospective studies and preclinical work have indicated that it might also lower a person's risk of cancer, though at least one clinical trial wasn't able to show that it had any protective effect on esophageal cancer.

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 asserted that the clinical hold on the ROCKET trial did not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company has launched two clinical trials now recruiting patients.

We may be subject to different or contradictory regulatory requirements in different countries, and different regulatory authorities may not be aligned on the clinical trials necessary to support approval of our product candidates.

However, a recent clinical trial (39) did not find any beneficial effects of short - term (6 wk) dark chocolate and cocoa consumption on cardiovascular outcomes or on neuropsychological tests.

While this is not really a surprise, since similar research and trials with wounds on people has shown the healing benefits of using medical grade manuka honey, this is the first time a clinical trial has been done on horses.

In addition, there was no effect on breastfeeding duration when the pacifier was introduced at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.

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.

Refusal by the drug's manufacturer to release full details of their clinical trials, has forced the government to make a decision on stockpiling that is not based on the evidence.

She is currently planning a clinical trial to see if a pretzel snack containing linoleic acid and fiber can help obese girls on DMPA maintain or lose weight versus overweight girls on DMPA who don't eat the snack.

Another clinical trial, which Kaplitt is not involved in, is testing the effect on depression of a deep brain stimulator implanted into the same brain area.

«If you don't use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.

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.»

Sean Morrison, Professor and Director of the Children's Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added: «Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials.

High - dose vitamin D supplementation in postmenopausal women was not associated with beneficial effects on bone mineral density, muscle function, muscle mass or falls, according to the results of a randomized clinical trial published online by JAMA Internal Medicine.

In focus groups, he found that many patients still weren't entirely clear on the implications of certain financial arrangements after hours of discussion, and he worries that even simple statements might not be understood or taken into account properly when patients are deciding whether or not to participate in a clinical trial.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

But the Harvard stem cell and regenerative biologist Amy Wagers, a co-author on three of the mouse papers, said in an email to STAT that she does not agree that her teams» studies provide a scientific basis for Maharaj's clinical trial.

Clinical trials on larger animals, like dogs and cats, are currently not being funded.

«The recent niacin clinical trials offer important new evidence that raising «good» cholesterol (HDL) levels on top of statin therapy does not have the positive outcome that had been hoped for,» said Neil Stone, M.D., the Robert Bonow MD Professor in Cardiology at Feinberg and a cardiologist at Northwestern Memorial Hospital.

Just a few weeks ago, WHO said that using any of the experimental drugs or vaccines in the pipeline simply wasn't in the cards, because none of them have been through a phase I clinical study, the type of trial in which medical products are tested on healthy volunteers to study their toxicity.

Some experts say any treatments should not be given on a compassionate use basis, but should be part of a carefully conducted clinical trial, so as to learn as much about a compound's efficacy as possible.

A neuregulin - 1 treatment is not available on the market, though it is being explored in clinical trials as a potential treatment for chronic heart failure and Parkinson's disease.

And it called for a nationwide moratorium on new clinical trials for stem - cell therapies, adding that patients in existing clinical trials should not be charged.

Being able to hold your own in a conversation on Wayne Rooney's or David Beckham's latest career move may not seem an obvious prerequisite for a career in clinical research, but it is a skill that Emma Harding - Esch found invaluable in her work as project coordinator for a trial in Gambia, west Africa.

However, the authors stress that «further clinical investigations will be essential to establish the optimal dose, duration and safety, and whether vitamin D2 or D3 have different effects on mortality risk, since the available trials are based on elderly populations in general (an age group with high competing risk of death often due to multiple co-existing disease conditions) and they do not typically include cause - specific deaths as the primary outcomes.»

While the finding does not directly lead to a test for immunotherapy response yet, Choueiri said, «We intend to look at these specific genomic alterations in larger, randomized controlled trials, and we hope that one day these findings will be the impetus for prospective clinical trials based on these alterations.»

But even if clinical trials go on to prove that young human blood has rejuvenating effects, we don't yet know if these will be enough to counteract the ageing effects an older person's own blood may have on their body.

Clinical trials of weight loss have been shown to improve participants» mood, but this could be a result of the supportive environment rather than the weight loss itself, as the effects are seen very early on in treatment and are not related to the extent of weight loss.

Although the molecule used in this study isn't one of the molecules under clinical trial, Zlotnick said the mechanism sheds light on the behavior of the experimental drugs.

Selecting participants for Alzheimer's disease dementia or MCI trials based on the AT (N) scheme would enrich the trial with persons with the greatest likelihood of decline in the time frame of a clinical trial.

I'm beginning to think there's need for some kind of citizen's watch group that channels public outrage when patients are lured into clinical trials for treating serious diseases based on models / methods that haven't been properly vetted.

However, clinical trials based on promising results from these models have not identified disease - modifying therapies (2, 3).

In addition to Davis and Clark, other coauthors on the study, entitled «CRLX101 nanoparticles localize in human tumors and not in adjacent, nonneoplastic tissue after intravenous dosing,» include Devin Wiley (MS» 11, PhD» 13) and Jonathan Zuckerman (PhD» 12); Paul Webster of the Oak Crest Institute of Science; Joseph Chao and James Lin at City of Hope; and Yun Yen of Taipei Medical University, who was at City of Hope and a visitor in the Davis lab at the initiation of the clinical trial.

High - Level Consultation Event 2016: «Towards Ethics & Principles of Science Policy - Making» EuroScience Open Forum Manchester 2016: «Evidence Newcomers: Revolutionising Regional & Global Initiatives» «Waging War On Drugs Doesn't Work — Applying Harm Reduction Science Does» «The Right To Be Forgotten vs The Right To Know» «Toxicant Detectives: The Chemical Innovation Race, Lifestyle Risks & the Role of Animal Experiments» «Clinical Trial & Error: Why Narrowing The Resources Gap Matters» AAAS Boston 2016: «Neuroscience Clues To The Chemistry Of Addictions & Mood Disorders» «Statecraft & Scalpel: Regional & Global Health Diplomacy in 2016 And Beyond» Science Forum South Africa 2015: «Harm Reduction: Scientists Tackling Our Lifestyle Killers»

I found my trial on ClinicalTrials.gov, but that site doesn't always update their clinical trials and so they may list some trials as available when they've already closed and not accepting anybody else.

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.

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).

The GDC will support clinical trials that focus on single patients, known as «n of 1» clinical trials, and will become an important component in how precision medicine is used to treat individual patients.

When a patient participates in a clinical trial, other available FDA - approved therapies are still available later on, in case a trial medication doesn't work.

We do not portray the drug ground - breaking in terms of the mechanism of action, we recognise that this is a drug that is known to reduce labido, however conducting a clinical trial on men with paedophilia to test how well they respond to the intervention is an important step that has currently been ignored.

And because the researchers can run computer simulations based on their model, they aren't subject to the restrictions associated with clinical trials.

It is Tocagen's policy to focus on these required clinical trials, which does not allow us to support an Expanded Access Program at this time.

NIH studies on the issue cite a number of different reasons that patients elect not to participate in clinical trials, including fear of a reduced quality of life, concern about receiving a placebo, potential side effects, and concern that the experimental drug might not be the best option.

«This clinical trial simply would not have been possible without the CDP initiative and it demonstrates how Cancer Research UK and Cancer Research Technology can work with industry to develop anti-cancer drugs that would otherwise remain on companies» shelves.

While women who are pregnant, breastfeeding or may become pregnant are often excluded from clinical trials for type 2 diabetes drugs, the exclusion is not based on the risk of fetal harm, according to Penn State College of Medicine researchers.