Traditional methodology of phase II trials has been questioned, both for the choice of the endpoint and for the study design itself.
This study proposes a comprehensive and systematic methodology of Phase Change Materials assessment for Latent Heat Thermal Energy Storage design, which comprises prescreening, ranking and performance objective examination based on Multi-Criteria Decision Making tools.
Although new drug development in oncology is founded on principles outlined in the organised methodology of phase I, II, and III trials, based on rigorous study design using standardised criteria, this approach has been applied very slowly in the field of neuro-oncology.
[ 14] This may be a viable direction to follow if we are to revise the methodology of phase IV NI trials.
In rare cancers, where large trials may be unfeasible, the methodology of phase II uncontrolled studies has often been applied to trials whose aim was indeed to explore efficacy, not simply antitumor activity.
More details about the methodology of this phase have been published elsewhere [ 32].
Usual methodology of cancer phase II trials consists in testing the null hypothesis Π≤ Π0versus Π≥ Π1 = Π0 + δ, where Π0 is the highest probability of response which would indicate that the agent is of no further interest, and Π1the smallest probability of response indicating that the agent may be promising.
This paper details the design and methodology of a phase IIb/III trial (CASSIOPEIR: CRF Asian Study w ith Oral PGI2 derivative for Evaluating Improvement of Renal function) conceived on the basis of the evidence and findings mentioned above in order to investigate whether TRK-100STP isuperioror to placebo in treating patients with primary glomerular disease or nephrosclerosis.
The web-based application of the proposed methodology for phase diagram visualization with interactive zooming capabilities is also discussed.
To optimize the distribution network a methodology of three phases was proposed: location, allocation, routing and routing-inventory.
