Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=33053601&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests
in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215
Early phase dose-finding trials in virology #MMPMID33053601
Dehbi HM; Lowe DM; O'Quigley J
Stat Med 2021[Jan]; 40 (2): 240-253 PMID33053601show ga
Little has been published in terms of dose-finding methodology in virology. Aside from a few papers focusing on HIV, the considerable progress in dose-finding methodology of the last 25 years has focused almost entirely on oncology. While adverse reactions to cytotoxic drugs may be life threatening, for anti-viral agents we anticipate something different: side effects that provoke the cessation of treatment. This would correspond to treatment failure. On the other hand, success would not be yes/no but would correspond to a range of responses, from small, no more than say 20% reduction in viral load to the complete elimination of the virus. Less than total success matters since this may allow the patient to achieve immune-mediated clearance. The motivation for this article is an upcoming dose-finding trial in chronic norovirus infection. We propose a novel methodology whose goal is twofold: first, to identify the dose that provides the most favorable distribution of treatment outcomes, and, second, to do this in a way that maximizes the treatment benefit for the patients included in the study.
|Antiviral Agents/*administration & dosage[MESH]
|Clinical Trials as Topic/*statistics & numerical data[MESH]
|Dose-Response Relationship, Drug[MESH]
|Drug-Related Side Effects and Adverse Reactions[MESH]
Stat+Med 2021 ; 40 (2): 240-253
