Since structural damage outcomes require lengthy clinical trials, the availability of biomarkers associated with these long-term endpoints would be an attractive therapeutic development strategy, especially in early phase trials when decisions are being made whether and how to proceed with pivotal clinical trials.
Since drugs targeting these latter molecular alterations are in clinical trials, the availability of this information might significantly improve the possibility of these patients to receive a personalized therapy [ 5].
As targeted-therapies directed to different pathogenic mechanisms of sepsis begin to reach the phase of human clinical trials, the availability of biomarkers capable of identifying discrete patient subgroups among the highly heterogeneous population of patients with sepsis, could well be the difference between failure and success of new therapies for sepsis [ 4].
To help place the trial in the context of other settings authors should explain key features that make the intervention feasible in their trial setting and elsewhere (such as, the widespread availability of the trial drug, the availability of trained staff to deliver the intervention, electronic databases that can identify eligible patients).
Participants were attracted to the trial by the availability of regular health monitoring and personalised information, particularly those who were aware of a family history of diabetes.
Researchers initiating randomized controlled trials should register trials to ensure the availability of trial results, independently of their full publication.
For these two trials, given the availability of target lesion/vessel failure endpoints in the diabetic cohort, we substituted this for the target vessel revascularisation outcome.
Effectiveness trials standardize the availability of the intervention in the study sample but do not go to extremes to reinforce implementation by providers or participation by patients.
In a pragmatic prospective multi centre two-armed randomized controlled trial in the Netherlands the availability and involvement for the general practitioners of a nurse specialist will be compared with usual care.
To design such a trial however, necessitates the availability of both a standard rehabilitation programme and appropriate education material.
