Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials

2019 ◽  
Vol 16 (4) ◽  
pp. 440-442
Author(s):  
Nicolas Molinari ◽  
Carey Suehs ◽  
Isabelle Vachier ◽  
Laurie Pahus ◽  
Laurence Halimi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Healthy Volunteers ◽  
Willingness To Participate ◽  
Limited Effect

scholarly journals Phase 1 healthy volunteer willingness to participate and enrollment preferences

2017 ◽  
Vol 14 (5) ◽  
pp. 537-546 ◽  
Author(s):  
Stephanie C Chen ◽  
Ninet Sinaii ◽  
Gabriella Bedarida ◽  
Mark A Gregorio ◽  
Ezekiel Emanuel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Healthy Volunteers ◽  
Financial Incentives ◽  
Phase 1 ◽  
The United States ◽  
Willingness To Participate ◽  
Invasive Procedures ◽  
Wide Range ◽  
Human Vaccine

Background/aims: Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and other biologics and accept risks and burdens without anticipated health benefits from participation. Although emerging data have shown that healthy volunteers are influenced by risk, some still worry that financial incentives lead them to take on unreasonable risk. Yet little is known about healthy volunteers’ preferences and how they make choices about enrolling in research studies. Methods: We surveyed 654 healthy volunteers at the end of their participation in a phase 1 Pfizer trial in the United States, Belgium, and Singapore to examine their reported willingness to enroll in studies of different types, with various procedures, and with possible side-effects. Results: The majority of respondents were willing to join many kinds of studies, but fewer were willing to participate in first-in-human vaccine studies or studies of psychiatric drugs than in other study types. With regard to procedures, a substantial proportion were unwilling to participate in studies that involved invasive procedures, such as a lumbar puncture (45.4%) and bone marrow biopsy (42.3%), but willing to participate in studies with less invasive procedures such as a computed tomography scan of the heart (86.8%), magnetic resonance imaging (87.4%), and skin allergy testing (86.8%). Although there was some variation by gender and region, the majority were willing to participate in studies with side-effects like pain (80%) or nausea and vomiting (64%), but only a minority were willing to join if the research drug would result in their having a one in a million chance of death (34.4%), a small chance of kidney damage (16.7%), or influence how their mind works (23.2%; Figure 4). Conclusion: Our results suggest that healthy volunteers are willing to participate in a wide range of types of phase 1 clinical trials, and express preferences for low risk and familiar studies and study procedures, preferences which are partially affected by offers of payment.

The Use of Methotrexate in Rheumatoid Arthritis

1985 ◽  
Vol 19 (5) ◽  
pp. 349-358 ◽  
Author(s):  
Peter W. Letendre ◽  
Douglas J. DeJong ◽  
Donald R. Miller
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Folic Acid ◽  
Side Effects ◽  
Adverse Effects ◽  
Systemic Administration ◽  
Refractory Disease ◽  
Controlled Clinical Trials ◽  
Folic Acid Antagonist ◽  
Acid Antagonist

The use of methotrexate in rheumatoid arthritis is reviewed. Methotrexate, a folic acid antagonist, is sometimes employed in an attempt to symptomatically control patients whose disease does not respond adequately to conventional therapies. Systemic administration of 7.5–15 mg/wk in a “pulse” fashion appears to be effective without precipitating severe adverse effects. However, concern over potentially serious side effects and a lack of well-controlled clinical trials have limited its use to severe, refractory disease. Further studies are needed before its role in rheumatoid arthritis can justifiably be expanded.

scholarly journals Readiness to Participate in Psychiatric Research

2003 ◽  
Vol 48 (7) ◽  
pp. 480-484 ◽  
Author(s):  
Daniele Zullino ◽  
Philippe Conus ◽  
François Borgeat ◽  
Charles Bonsack
Keyword(s):  
Clinical Trials ◽  
Financial Incentive ◽  
University Hospital ◽  
Psychiatric Research ◽  
Willingness To Participate ◽  
Research Projects ◽  
Hospital Physician ◽  
Recruitment Process ◽  
Consent Rate ◽  
Retention Strategies

Background: The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Seeking patients' views about their experience in research projects may allow investigators to develop more effective recruitment and retention strategies. Methods: A total of 100 patients consecutively admitted to a psychiatric university hospital were interviewed with respect to their willingness to participate in a study. For a different study scenario, patients were asked whether they would be ready to participate if such a study were organized in the service and to indicate their reasons for refusing or for participating. Results: The general readiness to participate in a study ranged between 70% and 96%. The prospect of remuneration did not notably augment the potential consent rate. The most common and spontaneous motivation for agreeing to take part in a study was to help science progress and to allow future patients to benefit from improved diagnosis and treatment (87%). The presence or lack of a financial incentive was rarely chosen as an argument to agree (23%) or to refuse (7%) to participate. Patients relied mainly on their treating physicians when contemplating possible participation in a study (family physician [65%] and hospital physician [54%]). Conclusions: Clinicians and, in particular, treating doctors can play an important role in facilitating the recruitment process.

Changes in morphine analgesia and side effects during daily subcutaneous administration in healthy volunteers

Pain ◽  
2008 ◽  
Vol 137 (2) ◽  
pp. 395-404 ◽  
Author(s):  
Karin Lottrup Petersen ◽  
Thomas Meadoff ◽  
Scott Press ◽  
Michelle M. Peters ◽  
Matthew D. LeComte ◽  
...  
Keyword(s):  
Side Effects ◽  
Healthy Volunteers ◽  
Subcutaneous Administration ◽  
Morphine Analgesia

Knowledge and attitudes regarding clinical trials and willingness to participate among prostate cancer patients

2015 ◽  
Vol 45 ◽  
pp. 443-448 ◽  
Author(s):  
Celia P. Kaplan ◽  
Anna Maria Nápoles ◽  
Steven Narine ◽  
Steven Gregorich ◽  
Jennifer Livaudais-Toman ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Willingness To Participate ◽  
Knowledge And Attitudes

scholarly journals Molecular and Therapeutic Potential and Toxicity of Valproic Acid

2010 ◽  
Vol 2010 ◽  
pp. 1-18 ◽  
Author(s):  
Sébastien Chateauvieux ◽  
Franck Morceau ◽  
Mario Dicato ◽  
Marc Diederich
Keyword(s):  
Valproic Acid ◽  
Clinical Trials ◽  
Side Effects ◽  
Histone Deacetylase Inhibitors ◽  
Short Chain Fatty Acid ◽  
Therapeutic Potential ◽  
Mood Stabilizer ◽  
Chain Fatty Acid ◽  
Histone Deacetylation ◽  
Transcription Sites

Valproic acid (VPA), a branched short-chain fatty acid, is widely used as an antiepileptic drug and a mood stabilizer. Antiepileptic properties have been attributed to inhibition of Gamma Amino Butyrate (GABA) transaminobutyrate and of ion channels. VPA was recently classified among the Histone Deacetylase Inhibitors, acting directly at the level of gene transcription by inhibiting histone deacetylation and making transcription sites more accessible. VPA is a widely used drug, particularly for children suffering from epilepsy. Due to the increasing number of clinical trials involving VPA, and interesting results obtained, this molecule will be implicated in an increasing number of therapies. However side effects of VPA are substantially described in the literature whereas they are poorly discussed in articles focusing on its therapeutic use. This paper aims to give an overview of the different clinical-trials involving VPA and its side effects encountered during treatment as well as its molecular properties.

scholarly journals Willingness to Participate in Vaccine-Related Clinical Trials among Older Adults

2018 ◽  
Vol 15 (8) ◽  
pp. 1743 ◽  
Author(s):  
Divyanshu Raheja ◽  
Evelyn Davila ◽  
Eric Johnson ◽  
Rijalda Deović ◽  
Michele Paine ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trials ◽  
Clinical Research ◽  
Elderly Person ◽  
The Elderly ◽  
Cross Sectional Study ◽  
Willingness To Participate ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Research Findings

The purpose of this study is to understand among a convenience sample of 400 adults aged 60 years of age or older (1) reasons for being willing or unwilling to participate in a vaccine clinical research study and (2) overall perceptions about vaccine clinical research. A cross-sectional study using a sample of older adults residing in the metro-Atlanta area and surrounding neighborhoods was conducted. The study questionnaire contained 37 questions, including questions about socio-demographics and perceptions about clinical trial processes. Statistical analysis was conducted using logistic regression. The adjusted modeling results indicated that sex, distance to research clinic, and being informed about the research findings played a role in the likelihood of an elderly person participating in a vaccine study. Males were more likely to participate in clinical trials as compared to females (OR: 2.486; CI: 1.042–5.934). Most participants were willing to travel up to 25 miles from the research clinic. Of the respondents, 45% were unlikely to participate if the results of the current trial are not shared. Improving access to clinical trials in terms of distance traveled and ensuring streamlined processes to inform participants about the results of the trial in the future would increase willingness to participate in vaccine clinical trials. The survey could serve as a useful tool for conducting vaccine studies and other clinical trials by understanding the barriers specific to the elderly.

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