Laboratory data in healthy volunteers: reference values, reference changes, screening and laboratory adverse event limits in Phase I clinical trials

1999 ◽  
Vol 55 (1) ◽  
pp. 13-19 ◽  
Author(s):  
M. Sibille ◽  
N. Deigat ◽  
I. Durieu ◽  
M. Guillaumont ◽  
D. Morel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Phase I ◽  
Healthy Volunteers ◽  
Reference Values ◽  
Laboratory Data ◽  
Phase I Clinical Trials ◽  
Laboratory Adverse Event

scholarly journals Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

2018 ◽  
Vol 13 (5) ◽  
pp. 494-510 ◽  
Author(s):  
Jill A. Fisher ◽  
Lisa McManus ◽  
Megan M. Wood ◽  
Marci D. Cottingham ◽  
Julianne M. Kalbaugh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Employment Status ◽  
Qualitative Interviews ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Financial Compensation ◽  
Trial History

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea

2021 ◽  
pp. 155626462110342
Author(s):  
Ji-Hye Seo ◽  
Ock-Joo Kim ◽  
Sang-Ho Yoo ◽  
Eun Kyung Choi ◽  
Ji-Eun Park
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Health Science ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Financial Reward ◽  
Therapeutic Purpose ◽  
The Republic

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered “university graduation” and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers’ participation in research was “financial reward.” Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

scholarly journals Healthy volunteers' perceptions of risk in US Phase I clinical trials: A mixed-methods study

PLoS Medicine ◽  
2018 ◽  
Vol 15 (11) ◽  
pp. e1002698 ◽  
Author(s):  
Jill A. Fisher ◽  
Lisa McManus ◽  
Marci D. Cottingham ◽  
Julianne M. Kalbaugh ◽  
Megan M. Wood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mixed Methods ◽  
Phase I ◽  
Healthy Volunteers ◽  
Mixed Methods Study ◽  
Phase I Clinical Trials ◽  
Perceptions Of Risk

Personality of healthy volunteers participating in phase I clinical trials

1989 ◽  
Vol 10 (11) ◽  
pp. 1199-1200 ◽  
Author(s):  
Jordi Camí ◽  
Manuel Llorente ◽  
Magí Farré ◽  
JoséMaría Badenas ◽  
Balbina Ugena
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Phase I Clinical Trials

scholarly journals Clinical trials on healthy volunteers in Mumbai and Ahmedabad: expanding the framework of expropriation

2021 ◽  
Vol 8 (6) ◽  
pp. 2839
Author(s):  
Navneet A. Wadkar
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Perceived Risk ◽  
Financial Incentives ◽  
Exploratory Research ◽  
Gender Based Violence ◽  
Phase I Clinical Trials ◽  
Contributing Factors ◽  
Financial Compensation

Background: Healthy volunteers (HVs) in phase I clinical trials in India are often motivated by financial compensation. Historical expropriation and every day struggle for life of HVs which contributes to normalization of the risk are often ignored as contributing factors to normalization of risk. Therefore this research was aimed to study expropriation experiences of the HVs.Methods: This research has employed qualitative and exploratory research design. The purposive sampling method was used to recruit nine HVs from two cities Mumbai and Ahmedabad.Results: All of the HVs and their family members were alienated from land and livelihood in their villages through different social, economic, political and cultural processes. The financial compensation was a primary motivation and not altruism. The compensation amount was spent to pay debts, medical and other emergencies, consumer goods and alcohol. To maximize their earnings, HVs have participated in consecutive and/or more than one trial simultaneously.Conclusions: The serial participation of the HVs in phase I trials has exposed them to serious risks which they are unable to recognize unless severe adverse events (SAE) occurred. The existing scholarship suggests that the perceived risk by healthy volunteers normalized through attractive financial incentives and serial participation. But findings of this research indicate that state induced violence, caste, class, gender based violence and everyday struggle of survival are also major contributing factors. 

scholarly journals Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0256994
Author(s):  
Corey A. Kalbaugh ◽  
Julianne M. Kalbaugh ◽  
Lisa McManus ◽  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
New Drugs ◽  
Trial Participation ◽  
Sociodemographic Characteristics ◽  
Phase I Trials ◽  
Full Time ◽  
Phase I Clinical Trials ◽  
Over Time

Background Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. Objective This study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. Methods The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project’s end three years later (December 2016). Trial experiences are presented as medians and quartiles. Results The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. Implications Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups.

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