Sentence examples for applicable trials from inspiring English sources

Overall, a median, per drug, of 71% (IQR 0 100%) of applicable trials complied with FDAAA (see table 2).

We reviewed whether FDAAA applicable trials (for both the 'controlled' and 'interventional' samples) had timely registration and reporting as defined by FDAAA.

Overall, per drug, a median of 67% (IQR 0 100%) of applicable trials fully complied with the law (see table 2), with considerable variation.

As a result of the US FDA Amendments Act, Section 801, passed in 2007, ClinicalTrials.gov has required (since September 2008) the posting of results of aggregate data from applicable trials by researchers within 12 months of completion.

The PRECIS Review PRR) tool was developed by Koppenaal et al. [ 21] to evaluate systematic reviews and the randomized controlled trials used in the review to help policy makers decide on applicable trials to inform their work.

Item 1: Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym "A multi-center, investigator-blinded, randomized, 12-month, parallel-group, non-inferiority study to compare the efficacy of 1.6 to 2.4 g Asacol® Therapy QD [once daily] versus divided dose (BID [twice daily]) in the maintenance of remission of ulcerative colitis".

8 Applicable clinical trials include phase II to IV interventional controlled trials registered after the enactment of the FDAAA 801 (or ongoing at this date) involving drugs, biologic agents, or devices (only after FDA approval for any use) regardless of sponsorship and involving at least one US site, whatever the primary country of origin of the trials.

Therefore, these STEs may not be applicable to trials that require subjects in all arms to be randomised to an anti-hypertensive drug, or to trials of homogeneous populations, for example, trials of only heart or renal failure patients.

The legal requirements enshrined in FDAAA (table 2) offer at least two potential interpretations for what constitutes an applicable clinical trial: controlled and interventional trials.

This article will review the technical aspects of cardiovascular gene therapy; its application for promoting a functional endothelium, smooth muscle cell growth inhibition, therapeutic angiogenesis, tissue engineered vascular conduits, and discuss the current status of various applicable clinical trials.

160 Among applicable drug trials published in 1997-99, 47% reported monitoring the level of adherence.