Sentences with phrase «as clinical trial design»

The FDA already has a 6 - year - old program called the Critical Path Initiative that, according to its Web site, funds a number of research projects on topics such as clinical trial design.

Not exact matches

«It essentially gives us a periodic table,» Ron DePinho, President of MD Anderson Cancer Center says, which has provided us with both diagnostic and therapeutic value as well as helped us design clinical trials to accelerate the development of new cancer drugs,».

At The Fertility Center of Las Vegas, each clinical trial is designed as a prospective, randomized study.

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.

It will house 150 researchers and clinician scientists, as well as an additional 100 people working in clinical trial design and administration.

However, as many anti-inflammatory drugs are already available, there may be a relatively short path to designing clinical trials for drugs that modulate the inflammatory response in people with neurodegenerative disease.

«Complex models are needed to effectively evaluate PMed study designs, and this proof - of - concept trial validates the dog with cancer as a model for clinical evaluation of novel PMed approaches,» said Dr. Melissa Paoloni, the study's lead author and former director of the COTC.

People working in biomanufacturing need to be prepared for inspections by the US Food and Drug Administration and the European Medical Evaluation Agency designed to ensure that mass - produced proteins are of the same quality as those used in clinical trials.

The next step, says Salem, will be to try to correlate these findings with patient treatment outcomes, initially as a retrospective, or backward looking study, and then hopefully design a forward looking clinical trial to determine which treatments may be best for patients with SBAs.

«This will require discussions about alternative approaches to the design and conduct of clinical trials as well as to how interventions are approved by the Food and Drug Administration.»

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

His work in designing anticancer compounds had led to millions of dollars in funding and multiple patents, as well as two compounds in clinical trials.

Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new drugs by characterizing key features of efficacy trials, such as trial size, design duration, and end points.

As a member of their scientific advisory boards, he helps the study directors design the pharmacogenomic portion of new clinical drug trials.

But he says their findings may have more immediate implications as well, for the design of clinical trials evaluating the benefits of providing nutrients to patients with sepsis.

When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.

Based on these studies, the authors are designing a clinical trial to test whether DNA repair inhibitors, such as olaparib, are active against IDH1 - and IDH2 - mutant tumors.

Innovative clinical trial approaches that have proven successful in other disease areas such as oncology (e.g., platform trials, umbrella and basket designs) might be employed with stratification of subjects by AT (N) profile, enabling a data - driven approach to identify the biological stage of disease in which an intervention has maximal treatment effects.

In the $ 1.47 million, four - year grant called â $ œBiomarkers of Ischemic Outcomes in Intracranial Stenosisâ $ (BIOSIS), Emory researchers are analyzing blood samples from 451 patients from around the country who were enrolled in a study known as SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis), the first randomized, multicenter clinical trial designed to test whether stenting intracranial arteries would prevent recurrent stroke.

In just the last 6 years the EID outbreaks of MERS, Ebola, Zika, CHIKV as examples have underscored the importance of rapid vaccine development and deployment capabilities to meet EID challenges, as well as growing appreciation for creativity and flexibility in clinical trial design.

Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current Company - Sponsored Clinical Trials of T - Vec Table 8: Clinical Trials of ColoAd1 Table 9: Clinical Trials with JX - 594 Table 10: Clinical Trials with GL - ONC1 Table 11: Clinical Trials of CAVATAK (CVA21) Table 12: Clinical Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus Companies and their Sources of Technology Table 26: Second Generation Oncology Virus Companies and their Sources of Technology Table 27: Third Generation Oncology Virus Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32: Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions

As a Web Applications Engineer he contributes extensive experience with relational database technologies such as MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web applicationAs a Web Applications Engineer he contributes extensive experience with relational database technologies such as MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web applicationas MySQL, MSSQL and Oracle to the development and design of the Clinical Trials Registry and Internet Stroke Center web applications.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

«As a national leader in designing, conducting and analyzing all phases of clinical trials, the University of Chicago is well positioned to play a leadership role in the new network,» said Michelle Le Beau, PhD, Arthur and Marian Edelstein Professor of Medicine and Director of the University of Chicago Medicine Comprehensive Cancer Center.

The positive safety profile to date, the evidence supporting engraftment of the cells post-implantation, and the improvements we are seeing in upper extremity motor function highlight the promising findings coming from this Phase 1 / 2a clinical trial, which will guide us as we work to design future studies.

But, he notes that it will be necessary to perform well - designed clinical trials that test the safety and efficacy of high - grade NMN in humans before making the leap to using NMN (or perhaps its analogs) as pharmacotherapeutic agents.

\ n \ nI've blogged about Geron's work here http://speakingofresearch.com/2009/01/23/a-new-era-for-embryonic-stem-cells/ and I'll confess that I'm quite optimistic about this one, as Geron seem to have been pretty thorough in their pre-clinical work and conservative in their clinical trial design.

Before joining IDRI, Tracey worked as a Protocol Development Manager with the HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center where she led multi-disciplinary teams in the design and implementation of clinical trials evaluating candidate HIV and tuberculosis vacTrials Network at the Fred Hutchinson Cancer Research Center where she led multi-disciplinary teams in the design and implementation of clinical trials evaluating candidate HIV and tuberculosis vactrials evaluating candidate HIV and tuberculosis vaccines.

In the next several years, when the laboratory process for recreating micro tumors is fast and reliable, Dr. Simeone expects to offer a Phase 1 clinical trial to design tailored single and combination therapies, as well as experimental agents targeting specific mutations.

Known as adaptive trial design, the PrecISE asthma trial platform represents a novel approach in asthma clinical research.

As one of the of the center's research projects, Dr. Kent P. Hymel, a child abuse pediatrician at Penn State Children's Hospital, will lead eight pediatric intensive care units from across the country in a randomized clinical trial designed to assess the impact of a novel screening tool for pediatric abusive head trauma.

Study designs, both large scale clinical trials as well as smaller mechanistic studies, will take into consideration and take advantage of the heterogeneity of clinical phenotypes in the study design.

Immune Design entered into clinical collaboration agreements with Merck, known as MSD outside the U.S. and Canada, to evaluate the safety and efficacy of two Immune Design immuno - oncology investigative agents, G100 and LV305, separately combined with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in Phase 1 trials in patients with non-Hodgkin's lymphoma (NHL) and melanoma, respectively.

As a graduate student from China, specializing in highly technical design of clinical drug trials, she had little connection to America's long - running debate...

With a strong background in clinical research (immunoassay development, protein extraction and purification, molecular and cell biology and pharmacology), in combination with medical and scientific writing as well as working experience with regulatory affairs and clinical trial planning and designing, my education and experience can bring a solid foundation to the ar...

Data were collected as part of a clinical trial (the SAFE Home Project) designed to test the effect of anticipatory guidance on parents» injury prevention practices.

Dr Kolko directed the trial, conceived of the design, designed and interpreted most of the analyses, and was responsible for most of the writing; Dr Campo contributed to the design of the trial, provided consultation during the trial, and helped to write and edit the manuscript; Dr Kilbourne offered recommendations on the organization of the manuscript, and helped to write and edit the manuscript; Mr Hart contributed to the design and conduct of all data analyses; Dr Sakolsky served as the consulting psychiatrist on the trial, offered recommendations on study measures, and helped to edit the manuscript; Dr Wisniewski served as the primary statistician on the project and contributed to the original clinical trial design / randomization scheme and made recommendations for the analytic plan; and all authors approved the final manuscript as submitted.

The program was designed as a multicentre trial, and includes referrals from both clinical and community samples (JIGSAW Youth Mental Health Services in Geelong, Deakin University, and Drummond Street Services in Carlton).

The IHDP began in 1985 and was designed as a eight - site, randomized clinical trial evaluating early childhood development, center - based education, and home - based family support services, as well as pediatric surveillance in an attempt to reduce the risk for developmental delay, behavioral issues and health problems LBW, PT (≤ 37 weeks gestational age) infants.