Sentence examples for trials for registration from inspiring English sources

Clinical trials can be categorised into phase III trials for registration and phase IV trials after market approval.

First, the mere fact of a statutory requirement for the registration of trials, for registration to be on time and for results to be posted, does not appear to have had much impact on the behaviours of researchers and sponsors conducting trials in the USA.

With the recently legislated "breakthrough product" definition in the U.S., it may be possible to plan a single trial for registration purposes to confirm a major clinical effect observed in phase I.

However, clinical trials used for registration purposes usually employ placebo as a comparator.

Finally, it should be noted that clinical trials used for registration purposes may employ surrogate outcome measures.

Real-world data on the benefit/risk profile of medicines is needed, particularly in patients who are ineligible for randomised controlled trials conducted for registration purposes.

The results of this meta-analysis provide a preliminary assessment of the CV risk associated with exenatide treatment across trials used for registration.

The initial clinical trials developed for registration did not require or measure in any pre-planned design eGFR or GFR as inclusion/exclusion criteria but only serum creatinine concentration.

Although the saxagliptin trials intended for registration completed their primary analysis point before the 2008 FDA guidance, an assessment of investigator-identified CV events was completed in a meta-analysis of pooled data from 8 phase II and phase III clinical trials [ 23].

It was agreed that M&S was important in helping understand a new disease area and how regulatory requirements (e.g., the suitability of endpoints, populations in early- and late-stage trials, requirements for registration, and label claims) determine the feasibility for clinical development of a new compound.

A schema involving three sequential trials for agent registration is described.