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For patients allocated to standard care, information, support and follow-up was offered at the end of the drug trial by their trials doctor and consisted of a consultation that covered details of reasons for trial conclusion and a monthly follow-up appointment back at the cancer centre.
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The study presented in this paper sought to provide an alternative model of trial conclusion management, which responded to the issues identified above and establish if this improved the trial conclusion experience for patients.
Only data from patients admitted following the start of trial will be included, and the data will be censored at trial conclusion for patients remaining on the units after this point.
In particular we examined comments relating to the reporting of trial design (randomisation and blinding), sample size, details of primary and secondary outcomes, requests for additional analyses, and the trial conclusion.
The design optimizes experimental control while building capacity of the participating senior center to screen and deliver BTB; hence, maximizing potential for sustainability and self-sufficiency at trial conclusion if BTB is efficacious and cost-effective.
Demographic and other characteristics for the two study groups at drug trial conclusion are reported in Table 1.
In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.
The findings show that nurse-managed trial conclusion meets patients' information needs at trial conclusion.
The following will recapitulate parts of [ 5], add detail and draw conclusions for trial procedures.
We previously observed in the present cohort that the prognostic value of negative versus positive conclusions was mainly due to high differences among the randomized trials' conclusions: 68±13% for 52 negative conclusions compared with 14±4% (P<0.001) for 118 positive conclusions [3].
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