Article
Multidisciplinary Sciences
Corey A. Kalbaugh, Julianne M. Kalbaugh, Lisa McManus, Jill A. Fisher
Summary: Participation as a healthy volunteer in US Phase I trials is influenced by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and for longer periods than more privileged groups. Specific groups show more significant performance in terms of the number of trials completed and duration of participation.
Review
Oncology
Igor Radanovic, Naomi Klarenbeek, Robert Rissmann, Geert Jan Groeneveld, Emilie M. J. van Brummelen, Matthijs Moerland, Jacobus J. Bosch
Summary: This study investigated the utilization of immuno-oncology compounds in clinical trials with healthy volunteers and the evaluation of pharmacodynamic endpoints. The study found that while these trials are not widely conducted, they offer advantages such as early dose selection and prevention of non-therapeutic dosing regimens for cancer patients. The focus is on safety and pharmacodynamic endpoints.
FRONTIERS IN ONCOLOGY
(2022)
Article
Pharmacology & Pharmacy
Chen Chaoyang, Dong Xiu, Wei Ran, Ma Lingyun, Zhao Simiao, Li Ruoming, Zhang Enyao, Zhou Ying, Cui Yimin, Liu Zhenming
Summary: The pharmacokinetic characteristics of siponimod in healthy volunteers and patients with MS were explored, and it was found that patients with MS have a slightly lower siponimod clearance. Factors such as dosage regimen, body mass index, CYP2C9 genetic polymorphism, and drug interactions may influence siponimod pharmacokinetics.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Felix Bergmann, Peter Matzneller, Maria Weber, Lusine Yeghiazaryan, Thorsten Fuereder, Thomas Weber, Markus Zeitlinger
Summary: Improving medical care, contributing to scientific research, and trusting treating physicians are the main motives for clinical trial participation among participants. Older patients have higher expectations of receiving optimal treatment during participation. Healthy volunteers with financial motives have participated in more clinical trials. Participants have high trust in medical staff and government research institutions, but low trust in pharmaceutical and health insurance companies.
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Multidisciplinary Sciences
Hengyi Yu, Yinian Fang, Xinxin Qi, Kaifu Wang, Yongfang Lei, Donglin Zhang, Qian Chen, Dong Liu, Xiuhua Ren
Summary: China has become the second largest pharmaceutical market in the world, with over 3000 registered clinical trials in 2021. However, there is a lack of understanding about the characteristics and concerns of Chinese healthy volunteers participating in these trials. A questionnaire survey of 324 healthy volunteers in Wuhan revealed that the majority were young, single and less educated men. Additionally, female volunteers faced more challenges and pressure, and were more cautious and concerned about their health and feelings compared to male volunteers. These findings highlight the need for more support and positive media coverage to protect and promote the participation of healthy volunteers in clinical trials.
SCIENTIFIC REPORTS
(2023)
Article
Neuroimaging
Emma A. Honkanen, Mikael Eklund, Simo Nuuttila, Tommi Noponen, Elina Jaakkola, Elina Makinen, Risto Hirvilammi, Marko Seppanen, Kari Lindholm, Filip Scheperjans, Riitta Parkkola, Juho Joutsa, Andrea Varrone, Valtteri Kaasinen
Summary: This study evaluated differences in brain dopamine transporter (DAT) binding between symptomatic parkinsonism patients and healthy individuals, finding higher DAT binding in the posterior putamen of symptomatic patients compared to controls. DAT binding correlated negatively with age in both groups, but not with motor symptom severity, cognitive function, or depression ratings.
NEUROIMAGE-CLINICAL
(2021)
Review
Immunology
Motoki Amai, Masanori Nojima, Yoshikazu Yuki, Hiroshi Kiyono, Fumitaka Nagamura
Summary: To assess safety in vaccine development, stricter grading scales are required. However, concern exists that their strictness may lead to an overestimation of some adverse events. An analysis of a phase I clinical trial of a preventive vaccine revealed that the occurrence of certain adverse events differed when assessed using FDA grading scale compared to reference intervals. The criteria for hypernatremia and hypokalemia were lower and higher, respectively, than most standards.
Article
Cultural Studies
Jill A. Fisher, Megan M. Wood, Torin Monahan
Summary: This article discusses speculation as a normalized occupational strategy and focuses on contract labor as a domain of financialization. It explores the speculative practices of healthy individuals who participate in pharmaceutical drug trials as their primary income source, utilizing a future-income-over-immediate-pay calculus. Despite providing a sense of control, speculation on contract work for economically precarious individuals ultimately serves as a compensatory function rather than effectively increasing their income.
JOURNAL OF CULTURAL ECONOMY
(2021)
Article
Psychiatry
Juliana Mendes Rocha, Giordano Novak Rossi, Flavia L. Osorio, Jose Carlos Bouso Saiz, Gabriela De Oliveira Silveira, Mauricio Yonamine, Eduardo Jose Crevelin, Maria Eugenia Queiroz, Jaime E. Cecilio Hallak, Rafael Guimaraes Dos Santos
Summary: The study examined the effects of ayahuasca on personality in healthy volunteers and found inconsistent results, with a significant increase in Openness scores observed only in one of the trials 21 days post-drug intake. No similar effects were observed in the other trials.
FRONTIERS IN PSYCHIATRY
(2021)
Article
Respiratory System
Alison Mackie, Juliane Rascher, Marion Schmid, Verena Endriss, Tobias Brand, Wolfgang Seibold
Summary: BI 1265162 was well tolerated in single and multiple doses up to 6.5 days. Systemic exposure primarily represents drug absorbed through the lungs rather than renal excretion. Absolute bioavailability ranged from 0.50% to 40%.
Article
Gastroenterology & Hepatology
Edward Gane, Man-Fung Yuen, Dong Joon Kim, Henry Lik-Yuen Chan, Bernadette Surujbally, Vedran Pavlovic, Sudip Das, Miriam Triyatni, Remi Kazma, Joseph F. Grippo, Simon Buatois, Annabelle Lemenuel-Diot, Ben-Fillippo Krippendorff, Henrik Mueller, Yuchen Zhang, Hyung Joon Kim, Apinya Leerapun, Tien Huey Lim, Young-Suk Lim, Tawesak Tanwandee, Won Kim, Wendy Cheng, Tsung-Hui Hu, Cynthia Wat
Summary: The study evaluated the safety and efficacy of RO7062931 in healthy volunteers and patients with chronic hepatitis B. Supradose-proportional increases in plasma exposure and urinary excretion of RO7062931 were observed at the same dosage. Patients exhibited dose-dependent reductions in HBsAg levels when treated with RO7062931.
Article
Plant Sciences
Siva Rama Raju Kanumuri, Jessica Mamallapalli, Robyn Nelson, Christopher R. McCurdy, Carol A. Mathews, Chengguo Xing, Abhisheak Sharma
Summary: This study examined the clinical pharmacokinetics of kava in healthy volunteers, finding higher exposure after single-dosing and longer duration of exposure after multiple doses.
JOURNAL OF ETHNOPHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Tobias Litzenburger, Juergen Steffgen, Ewald Benediktus, Fabian Mueller, Armin Schultz, Elliott Klein, Meera Ramanujam, Christian Harcken, Alpana Gupta, Jing Wu, Sabrina Wiebe, Xiujiang Li, Mary Flack, Steven J. Padula, Sudha Visvanathan, Andreas Huennemeyer, Jianan Hui
Summary: BI 705564 demonstrated good safety, pharmacokinetics, and pharmacodynamics in clinical trials, with efficient target engagement and proof of mechanism shown through effects on allergic skin responses. Mild bleeding-related adverse events were observed, likely due to inhibition of platelet aggregation by BTK inhibition.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2021)
Review
Nutrition & Dietetics
Bahareh Barkhidarian, Lucas Roldos, Michele M. Iskandar, Ahmad Saedisomeolia, Stan Kubow
Summary: Probiotics have the potential to improve micronutrient status in healthy subjects, but studies show varying degrees of efficacy. Further clinical trials are needed to determine the most effective strains of probiotics, doses, and durations of interventions.
Article
Health Care Sciences & Services
Hongmin Li, Ying Liu, Yuanyuan He, Ran Chen, Peng Guo, Na Wang, Boxin Liu, Xinxin Cheng, Liyuan Tang, Xinya Dai, Xiaoyang Sun, Weihong Li, Ying Wang, Lijuan Zhang, Yanrong Wang, Xibo Bai
Summary: This study retrospectively analyzed the reasons for screening failure in phase I clinical trials and proposed measures such as strengthening informed consent, improving test sample quality, correcting the definition of no clinical significance, and arranging low-cost and non-invasive examinations to reduce screening costs and protect volunteers.
ANNALS OF PALLIATIVE MEDICINE
(2022)
