Sentence examples for justification of trial from inspiring English sources

In general, the probability of beta error is traditionally and, again, arbitrarily set at 0.10 to 0.20 (for example, power 0.80 to 0.90) and used in the statistical design and justification of trial sample size.

The basic designs (in the statistical sense) vary from the informal with no justification of trial size given (see for example, Giralt et al, 1997), to the popular two stage Gehan (1961) design (see for example, Scheithauer et al, 1999) and the more recent designs as, for example, proposed by Simon (1989).

Although we are aware that participants can benefit from first-in-human trials, [ 16] this is irrelevant, since the evaluation and justification of a trial needs to precede the initiation of the trial, and phase I trials are designed for safety and feasibility, not to provide direct benefits.

An important condition in the justification of a trial is the existence of genuine uncertainty in regard to the answer to a research question.

Apart from these scientific and regulatory issues with post-authorization NI trials without added benefit claims, or those with added benefit claims but without (or with questionable) scientific evidence, there is also an issue with the ethical justification of these trials.

The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings.

JOGS = Justification of Green Scripts trial [6] Intra-practice correlation coefficients in this survey of adults receiving care for diabetes varied widely.

We have proposed that three scientific criteria are important for the ethical justification of randomized clinical trials (RCTs): (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review.

The data extraction form was developed based on Jones et al. [ 8] to include data on whether systematic reviews were referenced and used in the design of trials for justification of treatment comparison, choice of frequency or dose, selection of an outcome, withdrawals or adverse events etc (refer to Jones et al. for a full listing).

Information leaflets will be made available to local centres, in appropriate languages, which explain the justification for the trial, the process of trial entry and follow up.

The concepts of 'equipoise' defined in this literature are all attempts to give more precise expression to what is meant by 'uncertainty' here, and to give a sound basis to the ethical justification of randomisation in controlled trials.