Identifying and Addressing Safety Signals in Clinical Trials: Some Issues and Challenges

2012 ◽  
pp. 137-156 ◽  
Author(s):  
Thomas R. Fleming
Keyword(s):  
Clinical Trials ◽  
Safety Signals

scholarly journals A hierarchical testing approach for detecting safety signals in clinical trials

2020 ◽  
Vol 39 (10) ◽  
pp. 1541-1557 ◽  
Author(s):  
Xianming Tan ◽  
Bingshu E. Chen ◽  
Jianping Sun ◽  
Tejendra Patel ◽  
Joseph G. Ibrahim
Keyword(s):  
Clinical Trials ◽  
Hierarchical Testing ◽  
Testing Approach ◽  
Safety Signals

scholarly journals Worsening of Lymphopenia during Apremilast Treatment

2016 ◽  
Vol 8 (3) ◽  
pp. 319-322 ◽  
Author(s):  
Antonios G.A. Kolios ◽  
Lars E. French ◽  
Alexander A. Navarini
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Private Practice ◽  
Laboratory Tests ◽  
Oral Route ◽  
Surrogate Markers ◽  
Regular Monitoring ◽  
Term Basis ◽  
Safety Signals

Apremilast is an oral phosphodiesterase IV inhibitor recently registered for the treatment of psoriasis and psoriatic arthritis in Switzerland and other countries. Even though it offers only moderate efficacy compared to biologics, many patients prefer drugs given by the oral route. Apremilast is frequently used in private practice, as it showed no relevant safety signals in clinical trials and often, laboratory tests are omitted completely. Here we report a patient who developed acute lymphopenia and worsening of psoriasis during apremilast treatment, which resolved with discontinuation of apremilast. We suggest that at least in prospective registries, that regular monitoring of laboratory surrogate markers should be performed on a long-term basis to detect rare but potentially important safety signals.

THE PATIENT IN YOUR ALZHEIMER’S DISEASE STUDY MAY BE IN ANOTHER: DUPLICATION AND DECEPTION IN CLINICAL TRIALS OF ALZHEIMER’S DISEASE

2020 ◽  
pp. 1-4
Author(s):  
T. Shiovitz ◽  
B. Steinmiller ◽  
C. Steinmetz ◽  
S. Perez ◽  
R. Oseas
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Active Treatment ◽  
Memory Loss ◽  
Mechanisms Of Action ◽  
Efficacy And Safety ◽  
Significant Issue ◽  
Disease Study ◽  
Safety Signals

Duplicate and deceptive subjects, a significant issue in CNS studies, are not often considered in Alzheimer’s Disease (AD) clinical trials. However, AD patients and their study partners may be motivated to take advantage of different mechanisms of action, increase odds of receiving active treatment, and/or obtain financial compensation, which may lead them to participate in multiple studies. CTSdatabase reviewed memory loss subjects (n=1087) from January 2017 through May 2019 to determine how many attempted to screen at multiple sites. 117 subjects (10.8%) visited more than one site within two years. When these potential AD subjects went to additional sites, it was predominantly for non-memory indications (often MDD or schizophrenia). For those that participated in studies, the rate of duplication approached 4% of screened AD subjects. This data indicates that significant numbers of AD subjects attempt to enroll at multiple sites, which confounds efficacy and safety signals in clinical trials.

Detection of drug safety signals from clinical trials data: Role of SUSARs

2018 ◽  
Vol 131 ◽  
pp. 218-223 ◽  
Author(s):  
Christelle Perez ◽  
Pascale Olivier ◽  
Barbara Lortal ◽  
Sophie Duranton ◽  
Jean-Louis Montastruc ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Safety ◽  
Safety Signals

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

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.

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