Introduction to Trials Submitted

These characteristics were already observed in a meta-analysis of the initial trials submitted to the European Medicine Agency.

HCV trials submitted to the Food and Drug Administration (2013–2017) to support approval or to expand an indication of 12-week interferon-free DAA regimens with or without ribavirin to treat HCV genotype 1 (GT1) infection were pooled to explore efficacy comparisons by ethnicity.

The objective of this review was to summarise the characteristics of non-randomised trials submitted to the European Medicines Agency (EMA) or Food and Drug Administration (FDA) for indications in haematological cancers, haematological non-malignant conditions, stem cell transplants or rare metabolic diseases.

In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive.

We assessed breast cancer, non–small cell lung cancer, type 2 diabetes mellitus, and pain clinical trials submitted to ClinicalTrials.

In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval.

With the recent publication of clinical trials submitted to the FDA in efforts to gain approval of the cannabidiol based therapeutic Epidiolex, a rare opportunity exists to examine high-quality data for a drug which has in recent years been marketed as a greatly unregulated dietary supplement.

With the advent of patient-focused drug development, the US Food and Drug Administration (FDA) has redoubled its efforts to review patient-reported outcome (PRO) data in cancer trials submitted as part of a drug's marketing application.

Methods We restricted our extraction to interventional clinical trials submitted between 2007 and 2018, and included MeSH terms that are part of the nervous system (n=19 344) or cardiovascular disease (n=19 234) categories and included a list of neurointerventional terms.

Methods We reviewed MD Anderson Cancer Center clinical trials submitted to the institutional protocol office for scientific and ethical review between January 2009 and December 2013, the same length time period as the previous article.

They focus specifically on the 28 registration trials submitted to the Agency for anti-PD-1/ PD-L1 inhibitor therapies through the end of 2017.