Constructing Risk Knowledge

2020 ◽  
pp. 206-229
Author(s):  
Jill A. Fisher
Keyword(s):  
Phase I ◽  
Healthy Volunteers ◽  
Phase I Study ◽  
Model Organism ◽  
Clinical Procedures ◽  
Collective Risk ◽  
Investigational Drugs ◽  
Personal Experiences ◽  
Collective Experience ◽  
Risk Knowledge

Healthy volunteers’ construction of trials as safe is enabled by their categorization of some studies as riskier than others. Chapter 8 describes this process as a type of model organism epistemology and illustrates how this knowledge comes from personal experiences as well as stories and rumors healthy volunteers hear from other participants. This information accretes into what could be thought of as collective “risk filters” when the same types of investigational drugs or clinical procedures continuously emerge at the center of healthy volunteers’ stories. A risk filter acts as a preliminary basis for evaluating the risk of a specific Phase I study by comparing it to the collective experience of participants in similar clinical trials. Regardless of their claims about inherent risk, healthy volunteers mobilize this information in their decision-making about which Phase I trials to join and which to avoid.

Speculating on Health

2020 ◽  
pp. 230-252
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Health Behaviors ◽  
Phase I ◽  
Healthy Volunteers ◽  
Illicit Drugs ◽  
Model Organism ◽  
Healthy Weight ◽  
Economic Risk ◽  
Screening Process ◽  
Investigational Drugs

While healthy volunteers are concerned about the risks of studies, they are often much more vocal about the economic risk of not qualifying for studies. This chapter examines how being disqualified from studies through screen failures heightens their sense of risk as they attempt to earn income through clinical trials. It also considers how the screening process itself profoundly influences their health behaviors even outside of their study participation, including maintaining a healthy weight, eating nutritious food, consuming vitamins and supplements, and abstaining from deleterious substances, such as alcohol, tobacco, and illicit drugs. These actions on the part of healthy volunteers, which contribute to their model organism status, indicate that Phase I participation could counterintuitively improve their general health even as they expose themselves to the unknown risks of investigational drugs.

scholarly journals A randomized, placebo-controlled phase I study assessing the safety and immunogenicity of aPseudomonas aeruginosahybrid outer membrane protein OprF/I vaccine (IC43) in healthy volunteers

2013 ◽  
Vol 10 (1) ◽  
pp. 170-183 ◽  
Author(s):  
Kerstin Westritschnig ◽  
Romana Hochreiter ◽  
Gerhard Wallner ◽  
Christa Firbas ◽  
Michael Schwameis ◽  
...  
Keyword(s):  
Membrane Protein ◽  
Phase I ◽  
Healthy Volunteers ◽  
Outer Membrane ◽  
Outer Membrane Protein ◽  
Phase I Study

NXY-059 Does Not Affect Bleeding Time in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Phase I Study

2007 ◽  
Vol 47 (2) ◽  
pp. 264-272 ◽  
Author(s):  
Dag Nilsson ◽  
Johan Wemer ◽  
Yi-Fang Cheng ◽  
Ingalill Reinholdsson ◽  
Gunnar Englund ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Volunteers ◽  
Phase I Study ◽  
Bleeding Time ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Crossover Phase

Safety evaluation of BacoMind™ in healthy volunteers: A phase I study

Phytomedicine ◽  
2007 ◽  
Vol 14 (5) ◽  
pp. 301-308 ◽  
Author(s):  
K. Pravina ◽  
K.R. Ravindra ◽  
K.S. Goudar ◽  
D.R. Vinod ◽  
A.J. Joshua ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Volunteers ◽  
Phase I Study ◽  
Safety Evaluation

A large multicenter, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with European and United States reference pegfilgrastim.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23118-e23118
Author(s):  
Gordon P. Otto ◽  
Roumen Nakov ◽  
Steven Schussler ◽  
Stefanie Schier-Mumzhiu ◽  
Celine Schelcher ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Phase I Study ◽  
Geometric Mean ◽  
Primary Objective ◽  
Local Tolerability ◽  
Pivotal Phase ◽  
Double Blind

e23118 Background: Similarity of the pharmacokinetic (PK)/pharmacodynamic (PD) profiles of Sandoz proposed biosimilar pegfilgrastim and EU-reference biologic was confirmed in a pivotal Phase I study. In order to confirm PK/PD similarity to the US reference biologic, and to bridge between the two references, a 3-way study was conducted. Methods: A randomized, double-blind, single-dose, 3-treatment, 6-sequence crossover Phase I study was performed in healthy volunteers (HVs) to demonstrate similarity in PK, PD, safety and immunogenicity between Sandoz proposed biosimilar, US reference, and EU reference pegfilgrastim administered subcutaneously (6 mg/0.6 mL) in each treatment period. The primary objective was to demonstrate PK (AUC0-inf, AUC0-last, Cmax) and PD similarity (ANC AUEC0-last, ANC Emax). The study was powered (90%) to achieve confidence intervals (CIs) within biosimilarity margins 0.8─1.25 in pairwise comparisons. Secondary objectives were additional PK/PD parameters, safety and immunogenicity. Results: The study included 577 male and female HVs. PK and PD similarity were demonstrated between Sandoz proposed biosimilar and US reference (Table), as well as EU reference and between both reference biologics since the 90% CIs of the geometric mean ratios were contained within the pre-defined margins of 0.80‒1.25. Safety, immunogenicity and secondary PK/PD parameters were also similar across treatment groups. Conclusions: This large randomized, double-blind, single-dose, 3-treatment, 6-sequence crossover study demonstrated PK and PD similarity between Sandoz proposed biosimilar, US reference and EU reference pegfilgrastim with similar safety, local tolerability and immunogenicity. Clinical trial information: 2016-003549-27. [Table: see text]

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