Practical Recommendations for Regional Consistency Evaluation in Multi-Regional Clinical Trials with Different Endpoints

AbstractThe present paper discusses drawbacks and limitations of likelihood-based inference in sequential clinical trials for treatment comparisons managed via Response-Adaptive Randomization. Taking into account the most common statistical models for the primary outcome—namely binary, Poisson, exponential and normal data—we derive the conditions under which (i) the classical confidence intervals degenerate and (ii) the Wald test becomes inconsistent and strongly affected by the nuisance parameters, also displaying a non monotonic power. To overcome these drawbacks, we provide a very simple solution that could preserve the fundamental properties of likelihood-based inference. Several illustrative examples and simulation studies are presented in order to confirm the relevance of our results and provide some practical recommendations.

Download Full-text

Challenges and practical recommendations for successfully recruiting inactive, statin-free older adults to clinical trials

BMC Research Notes ◽

10.1186/s13104-020-05017-1 ◽

2020 ◽

Vol 13 (1) ◽

Author(s):

Colleen S. Deane ◽

Bethan E. Phillips ◽

Kenneth Smith ◽

Anna M. Steele ◽

Tina Libretto ◽

...

Keyword(s):

Older Adults ◽

Clinical Trials ◽

Practical Recommendations

Download Full-text

Statistical Considerations in Design, Execution, and Analysis of Multiregional Clinical Trials: Consistency Evaluation and Adaptive Trials

10.1201/9781003109785-16 ◽

2021 ◽

pp. 229-252

Author(s):

Lanju Zhang ◽

Weining Z. Robieson

Keyword(s):

Clinical Trials ◽

Adaptive Trials ◽

Consistency Evaluation

Download Full-text

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100072460 ◽

1973 ◽

Vol 31 ◽

pp. 404-405

Author(s):

D. C. Swartzendruber ◽

Norma L. Idoyaga-Vargas

Keyword(s):

Clinical Trials ◽

Soft Tissue ◽

Tumor Tissue ◽

Soft Tissue Tumors ◽

Clinical Usefulness ◽

Electron Microscopic ◽

Normal Cells ◽

Electron Microscopic Autoradiography ◽

Peritoneal Cells ◽

Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

Download Full-text