Sentences with phrase «of clinical trial sites»

Coordinate on behalf of clinical trial sites and teams.

First, in 2001, CRI formed a partnership with the Ludwig Institute for Cancer Research to develop the Cancer Vaccine Collaborative (CVC)-- a centralized, academic, global network of clinical trial sites, immune monitoring laboratories, and clinic - grade, GMP cancer vaccine production facilities.

Because clinical trials are a multinational effort in the 21st century, developing a common language for biomarker designations in the Alzheimer's disease spectrum is critical for harmonization across the international roster of clinical trial sites and investigators.

NYU Langone Medical Center last month became the first hospital outside of a clinical trial site to implant a pacemaker - like device in the brain that may be a game - changer for patients with epilepsy.

Not exact matches

He is committed to leveraging the advantages of digital technology and harmonised operational, ethics and governance processes across a group of Australian cancer clinical trial sites so that patients can be linked with potentially life changing treatment trials.

«Many investors expected a more lengthy FDA review process of the JCAR015 trial (and potentially other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all clinical sites of the ROCKET trial, we believe the trial shouldn't be delayed by more than ~ 3 months.»

Globally, the APAC region is an attractive destination for clinical research, with over 50 % of international clinical trials in 2014 having sites in the region, driven by its low cost advantage and patient access.

He designs, leads and contributes to numerous investigator - initiated and industry - sponsored clinical trials involving hundreds of sites and thousands of patients around the world.

The hospital opened in 1913 to treat tuberculosis patients and was the site of the first clinical trials for the hydrazides treatment that eventually led to the cure of the disease, according to the EDC.

In the CSU study, Orme and his team found that BCG strongly inhibited a number of virulent strains of TB obtained from the clinical trial site around Cape Town.

Site personnel (89 %) feel that sponsors of clinical trials should collaborate in the standardization of electronic data collection practices and systems for investigative sites.

In one analysis that included 21 randomized clinical trials, investigators found a risk of 138 surgical site infections per 1000 procedures, and the use of sutures coated with the antimicrobial triclosan reduced this by 39.

He is one of six patients participating in the clinical trial, which is being conducted at the University of Southern California and five other sites across the country.

«These are optimistic results for one of the first targeted therapies for cancer stem cells,» says Antonio Jimeno, MD, PhD, investigator at the CU Cancer Center, director of the university's Cancer Stem Cell - Directed Clinical Trials Program, and principal investigator of the clinical trial at the CU Cancer CentClinical Trials Program, and principal investigator of the clinical trial at the CU Cancer Centclinical trial at the CU Cancer Center site.

Carl E. Clarke, M.D., of the University of Birmingham, England, and coauthors conducted a large clinical trial to evaluate the effectiveness of PT and OT in 762 patients with mild to moderate PD who were recruited from 38 sites across the United Kingdom.

Related sites PhRMA announcement of clinical trials policy National Institutes of Health - funded clinical trials registry Statement from medical journals on clinical trials disclosure

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.

The study included 124 newly diagnosed patients at 25 clinical trial sites in the U.S. Two - thirds of the patients were treated with ICT - 107, an experimental vaccine based on immune system cells called dendritic cells that were exposed to six synthetic proteins, or antigens, known to be involved in GBM development.

According to Jerry Sheehan, assistant director for policy development at the National Library of Medicine, the 2007 law is full of ambiguities about which clinical trials had to register with the site and what kinds of results they had to report.

They cite the example of TransCelerate BioPharma, a group of 10 major pharmaceutical companies that came together to share and direct resources toward selected priorities in order to improve the efficiency of drug development, such as clinical trial site qualification standards.

«Secondary benefits of this trial include the significant improvement in clinical care for children with sickle cell disease at each of the 29 sites because each location had a designated hematologist, neurologist, neuroradiologist and psychologist working as a team to identify and decrease further injury to the brain in this vulnerable population.»

In a particularly dramatic demonstration at the Stanford site of the pilot clinical trial, a woman identified as «T6,» who is diagnosed with amyotrophic lateral sclerosis, was able to use BrainGate for six sessions of a few hours each over the course of 42 days without any interruptions for explicit recalibration after the decoder was initialized on the first day.

In the phase I / II clinical trial of 20 patients, the engineered cells were deemed safe, trafficked to the site of the tumor (bone marrow), and persisted in 90 percent of the patients who reached two years follow up after infusion, the research team found.

But the most promising candidates — compounds called vaginal microbicides that thwart the virus at the site of infection — have failed repeatedly in clinical trials.

Several human clinical trials began last fall at test sites including BIDMC, WRAIR, and National Institute of Allergy and Infectious Diseases affiliated clinical trial sites.

The Tuberculosis Network Clinical Trials Group (TBNET), an international consortium of clinicians and scientists, documented the management of 380 patients with Multidrug - Resistant Tuberculosis (MDR - TB) at 23 different sites across Europe over five years.

The white paper recommends that practitioners follow relevant guidance documents and that deviation from consensus recommendations should be supported by clinical studies or pursued in the setting of a clinical trial approved by an institutional review board; that practitioners receive training in a new procedure before beginning its practice, that the training should include a practical, «hands - on» component and that all team members directly involved with the radiation therapy decisions should participate in at least five proctored cases before performing similar procedures independently; and that professional societies should accelerate the generation of new or updated guidance documents for the following disease sites and techniques: skin, central nervous system, gastrointestinal, lung or endobronchial and esophagus, and, while outside the charge of this panel, assess the need for updated guidance documents for accelerated partial breast irradiation using electronic brachytherapy.

Described this week in the New England Journal of Medicine (July 4, 2013 print issue), the clinical trial was conducted at multiple sites in China and designed in partnership with a physician at UC San Francisco.

China has many times more people who have strokes every year than the United States because of the size of the population and higher stroke rates, which allowed investigators to screen 41,561 patients in just three years at the 114 clinical sites, and enroll 5,170 patients in the trial.

Olliaro returned from Guinea on 22 October, where he had been scouting for sites to do clinical trials of candidate Ebola drugs.

St. Michael's was the only site outside of the United States involved in the Phase 2 clinical trial for the drug and had the largest number of patients enrolled in the Phase 3 trial.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

Several changes were made for researchers engaged in clinical trials: TCPS 2 (2014) suggested that data from these trials be made available and provided modified methods of data access in multi-site clinical trials for both Principal and Site Investigators [2].

Michael Frankel, MD, Emory professor of neurology, will serve as site principal investigator of the clinical trial at Grady Memorial Hospital.

The EHDN supports HD research and clinical development at all stages, from basic and applied science through to the development of new treatment strategies, clinical assessment tools, and best clinical practice guidelines, to site feasibility assessment, site selection and patient recruitment for clinical trials.

The authors of the current study conducted a randomized, multicenter, clinical trial that included 1,000 Chinese women with PCOS at 21 sites in China.

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

To achieve this, CIRM approved $ 70 million «to create a new statewide network of sites that will act as a hub for stem cell clinical trials.»

Collateral benefits to clinical trial sites include equipment and facilities, skills development, high - quality jobs for local researchers, healthcare workers and other staff, and generally a higher standard of healthcare for trial participants.

The new network is also taking steps to standardize the prioritization of new studies and to put in place a unified system — including a central institutional review board that will cover studies conducted by the entire system — to protect research subjects at more than 3,000 clinical trial sites.

Lead Academic Participating Site grants, created specifically for the NCTN, will provide scientific leadership in development and conduct of clinical trials in association with the adult clinical trial groups.

A team from the University of Chicago Medicine Comprehensive Cancer Center has received a five - year, $ 3.9 - million award from the National Cancer Institute to serve as a Lead Academic Participating Site for the newly created National Clinical Trials Network (NCTN).

San Diego, January 8, 2015 — ViaCyte, Inc., a privately - held regenerative medicine company with the first stem cell - derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company's Phase 1/2 clinical trial of its VC - 01TM product candidate.

In 2005, Dan co-founded and served as President and CEO of Inviragen Inc., which he transformed from a virtual start - up to a global clinical stage company with sites in Colorado, Wisconsin and Singapore and translated two vaccines from the research bench to human clinical trials, including one for dengue fever.

The PEC - Direct trial is now underway in the U.S. and Canada, with clinical sites established at University of Alberta, UC San Diego, and the University of Minnesota.

«Nature gave us this second copy [of SMN] that can make a little bit of full - length protein,» says Basil Darras, director of clinical neurology at Boston Children's Hospital and a site coordinator in the Isis trial.

The location and enrollment start date of the first Canadian clinical trial site have not yet been disclosed.

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The Johns Hopkins Kimmel Cancer Center is one of 11 Lead Academic Organization sites of the National Cancer Institute's Experimental Therapeutics Clinical Trials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental thClinical Trials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental therTrials Network (ETCTN), which supports the evaluation of early phase clinical trials on experimental thclinical trials on experimental thertrials on experimental therapies.

Researchers from the Broad Institute of MIT and Harvard analyzed blood samples from almost 5,000 of about 15,000 infants and children who participated in the phase 3 clinical trial at 11 study sites in six countries in Africa between 2009 and 2013.