Sentences with phrase «efficacy trials»

"Efficacy trials" refers to the scientific research conducted to determine the effectiveness or success of a particular treatment or intervention. These trials are designed to understand whether a treatment can do what it claims to do and achieve the desired outcome. Full definition
The critical next step is to initiate safety and efficacy trials in humans.
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.
But efficacy trials often involve only several hundred to a few thousand patients.
The Kids in Transition to School (KITS) foster care program began with a 5 - year randomized efficacy trial of a preventive intervention to enhance psychosocial and academic school readiness in foster children as they enter school.
OSLC conducted a randomized efficacy trial of KITS 2005 - 2010 and a follow - up study 2010 - 2015.
Dr. Caskey and her team are planning clinical efficacy trials of this approach.
Another collaborative vaccine efficacy trial began last month in South Africa.
Her work, which is moving from efficacy trials into community settings, is at the cutting edge of Type II translational research.
She has created toxin - smothering antibodies that have been shown to be safe in humans by Caprion Pharmaceuticals, paving the way for efficacy trials.
«Information from this new study will inform vaccination schedules in future efficacy trials
Levy is trying to find a new biotech company to begin efficacy trials on humans as soon as possible.
«New research method questions traditional efficacy trial model.»
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.
Fruits and vegetables are associated with lower lung cancer risk only in the placebo arm of the beta - carotene and retinol efficacy trial (CARET).
The effects of the FTI might be even stronger in real - world than in highly controlled efficacy trials.
A recent efficacy trial found that those randomized to MBRP, as compared with those in a control group, demonstrated significantly lower rates of substance use and greater decreases in craving following treatment.
Strollo led a large study of the new treatment, a yearlong safety and efficacy trial involving 126 people with moderate to severe obstructive apnea.
In 2015, she completed the second randomized clinical efficacy trial testing the efficacy of Mothering from the Inside Out, a mentalization based psychotherapy that aims to promote maternal reflective functioning - the capacity to make sense of and manage emotional distress in difficult parenting situations and to make sense of young children's emotional needs in order to promote secure attachments.
The vaccine is undergoing efficacy trials in Thailand and the company thinks it will prompt similar types of responses to all four subtypes.
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.
The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.
At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might scale up production in parallel with the safety and efficacy trials now under way so that the product could be ready for wider distribution by April if warranted.
Col. Nelson Michael, director of WRAIR's Military HIV Research Program (MHRP) and Zika program co-lead noted that, «The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials.
We are in the midst of an unprecedented time in HIV vaccine research; we have four concurrent efficacy trials underway, which will collectively enroll 12,200 volunteers in the search for an HIV vaccine over the next few years.
«Everything about this approval was highly unusual,» says internist Joseph Ross of Yale University, who analyzes efficacy trials that the FDA uses to decide whether to approve a new drug.
A non-randomized efficacy trial was conducted with 141 post-9 / 11 military members and veterans with PTSD to compare usual care alone (n = 66) versus usual care plus a trained service dog (n = 75).
In early 2011, Trifexis was released after a safety and efficacy trial using only 352 dogs in the field study, only 176 of which received Trifexis.
This two - arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive - behavioural therapy (CBT)- based intervention for fatigue among in - centre haemodialysis patients.
Second, in a field that is moving rapidly from developer - led efficacy trials, to implementation trials in complex real - world services, we need to be sure that effect sizes are not declining over time, as developer control over trials is relaxed.
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 project will extend the evidence on the efficacy of the intervention from two previous randomized efficacy trials of the KITS Program with special needs populations to examine the impacts of the intervention on the broader population of children from disadvantaged backgrounds in general education.
Randomized, Double - Blind Evaluation of Late Boost Strategies for HIV - Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial.
[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.»
The authors of the current study hypothesize that these previous trials may have inadvertently selected subjects who would be nonresponsive to the medication and conclude that future efficacy trials may require the identification of subgroups of patient populations.
Traditional efficacy trials have limited relevance to everyday clinical practice and should be changed, according the authors of a new study into chronic obstructive pulmonary disease (COPD) treatments.
β - Carotene serves as a prototypical example of this approach which led to negative results in two phase III randomized cancer prevention trials, the Alpha - Tocopherol, Beta - Carotene Cancer Prevention Study (8) and the Carotene and Retinol Efficacy Trial (9).
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 purposes of this study were to assess whether effects in student behavior and academics at posttest shown in a recent efficacy trial (Walker et al., 2009) were maintained at follow - up and to examine the relationship of implementation fidelity to outcomes.
This information was critical in the design and implementation of the current Phase 1 trial and will be of significant benefit in planning the Phase 2/3 clinical efficacy trial
«The results of our efficacy trial posed many questions,» she said.
The study is the first head - to - head safety and efficacy trial of buprenorphine implants and daily sublingual buprenorphine on long - term remission of opioid use disorder in patients who were previously stabilized on 8 mg or less of sublingual buprenorphine.
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