This chapter details the basic characteristics of such trials and shows the opportunities elicited by smart designs of exploratory trials, exploratory investigational new drug (eIND) filing, microdosing studies, early decision making, adaptive trial design, and the combination of regulatory and exploratory trials.
In the first 4 trials (exploratory trials), the rat was allowed to dig in both cups, and an error was recorded if the first dug occurred in the unbaited cup.
This is a pilot trial whose exploratory nature does not necessarily require a formal sample size calculation.
33 Within this trial, an exploratory analysis using volumetric assessment rather than RECIST for CNS lesions suggested longer TTP in patients with >10% volumetric reductions.
MRC proposed a new procedure for introducing and evaluating complex clinical interventions including five phases: theory, modeling, exploratory trial, definitive randomised trial and long-term implementation.
The MRC has identified five essential steps in the evaluation of such an intervention – theory, modelling, exploratory trial, definitive randomised trial and long-term implementation [ 48].
The high levels of recruitment, retention and collection of outcome measurements in the exploratory trial suggest that a definitive trial is deliverable.
We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here.
This would require a major investment of resources and therefore we will first conduct an exploratory trial to understand the feasibility of a full trial.
An OHA exploratory trial in the same population as the proposed trial demonstrated that at baseline 35% of gingival sites were bleeding on probing with sd = 25% [ 27].
