Clinical Trials Involving Minors: The Role of the Ethics Consultation in Avoiding Therapeutic Misconception

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 41-41
Author(s):  
Silvia Ceruti ◽  
◽  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ethics Consultation ◽  
Therapeutic Misconception ◽  
Parental Consent ◽  
Research Subjects ◽  
Course Of Action ◽  
Trial Participants ◽  
Central Purpose

"Therapeutic Misconception (TM) occurs when clinical trial participants believe that the central purpose of the trial is therapeutic and that they will personally benefit from participation. If individuals who are entitled to consent to participation in a specific clinical trial do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled may potentially benefit from the intervention under study, this false belief may motivate them to participate, and in extreme cases may disqualify their consent. TM is especially frequent in fields in which the patients are highly vulnerable, such as when they are children and require parental consent. The informed consent is an essential ethical prerequisite before enrolling each and every participant in research that should protect patients through a process of dialog about a planned course of action. We argue that Ethics Consultant’s competencies may be crucial in avoiding TM: The Ethics Consultant should be involved in neonatal and paediatric clinical trials in order to face the unique vulnerability of children as research subjects, and to ensure that parental consent procedures are rigorously managed, enhancing recruitment in research trials in the context of fully understood consent. "

scholarly journals Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

2002 ◽  
Vol 57 (2) ◽  
pp. 83-88 ◽  
Author(s):  
Edson Duarte Moreira ◽  
Ezra Susser
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Usual Method ◽  
Validity Of Results ◽  
Results Of Treatment ◽  
Trial Participants

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

scholarly journals Acceptability of Pulse-Fortified Foods by Two Groups: Participants in a Clinical Trial and Participants in a Consumer Acceptability Panel

Foods ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. 129 ◽  
Author(s):  
Donna Ryland ◽  
Peter Zahradka ◽  
Carla Taylor ◽  
Rhonda Bell ◽  
Michel Aliani
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Question ◽  
Health Benefit ◽  
Influential Factors ◽  
Consumer Acceptability ◽  
Fortified Foods ◽  
Overall Acceptability ◽  
Regular Consumption ◽  
Trial Participants

Pulses are nutrient-rich ingredients used as interventions in clinical trials to determine their effect on lowering blood lipids, which are risk factors for cardiovascular disease. Acceptability of these foods is critical for compliance by participants in clinical trials as well as regular consumption by those eating them for their health benefit. Commercialisation of foods that prove positive for health is required to make them available to the general population. Since the target for commercialisation would be products that will be procured by as many people as possible, the research question becomes whether or not testing is required by the clinical trial participants, by consumer acceptability testing in a sensory unit, or by both to ensure acceptability. The objective of this study was to determine the acceptability of pulse-based soups and casseroles destined for a clinical trial by both the participants in the clinical trial and by consumer participants not in the clinical trial. Neither group received any training regarding sensory analysis. Acceptability of aroma, appearance, flavor, texture, overall acceptability, and the frequency of eating the samples of five formulations fortified with either peas or beans was measured. Groups differed in their acceptability of foods for different attributes with the clinical trial participants providing less discrimination among the sensory attributes for their acceptability. Influential factors could include motivation for healthy eating, age, number of times the product was consumed, amount of the product consumed, and where it was consumed. In conclusion, acceptance measures from both groups are required in order to gain as much information as possible regarding acceptability of attributes for commercialisation of pulse-fortified foods that provide a health benefit.

scholarly journals Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

2018 ◽  
Vol 28 (1) ◽  
pp. 124-133 ◽  
Author(s):  
ARIELLA KELMAN ◽  
ANNA KANG ◽  
BRIAN CRAWFORD
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Research ◽  
Development Program ◽  
Well Being ◽  
Third Party ◽  
Clinical Development Program ◽  
Clinical Trial Evidence ◽  
Access To Medical Care ◽  
Trial Participants

Abstract:In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding continued access to investigational medicines in 2013. This article provides insights on the policy, including the parameters that determine when continued access is and is not considered to be appropriate, along with an example from an active clinical development program. It also describes how multiple stakeholders, including those in academia, industry, government, and patient advocacy, have worked together to assess approaches to continued access. Continued access plans should be transparent and agreed to by research participants, investigators, and governments prior to the study and reassessed based on clinical trial evidence of safety and efficacy and availability of adequate treatments, along with relevant international laws and customs. Conducting responsible continued access programs requires close partnerships with investigators, health authorities, and third-party research partners.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

scholarly journals LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

2017 ◽  
Vol 28 (1) ◽  
pp. 67-84
Author(s):  
Katarzyna Syroka-Marczewska
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Reactions ◽  
Legal Aspects ◽  
Science And Society ◽  
Medicinal Products ◽  
Safety And Efficacy ◽  
Pharmacodynamic Effects ◽  
Trial Participants

A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.

scholarly journals Use of a Blockchain-Based Marketplace to Incentivize Participation in Virtual Clinical Trials

2021 ◽  
Vol 1 (1) ◽  
pp. 1-14
Author(s):  
Phillip Olla ◽  
Mustafa Taher Abumeeiz ◽  
Lauren Kay Elliott ◽  
Vijay Rajasekar ◽  
Stephen Bartol
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Participation ◽  
Digital Technologies ◽  
Incentive System ◽  
Detailed Report ◽  
Online Marketplace ◽  
Blockchain Technology ◽  
Physical Interactions ◽  
Trial Participants

There is an emerging need for advancements in how clinical trials are conducted in the current pandemic situation. Healthcare institutions are moving towards using digital technologies to avoid physical interactions between doctors and clinical trial participants. However, difficulties in recruiting and retaining participants are still prevalent. To overcome this issue, an incentive system that can be trusted by doctors as well as trial participants is required. The authors present a detailed report of Cashish, a blockchain-based incentivization system that rewards trial participants in the form of cryptocurrency tokens that they can utilize in an online marketplace that is also backed by the same blockchain. Usage of blockchain technology to provide research participation incentives eliminates the need for trust systems and ensures transparency between doctors and clinical trial participants, while ensuring participant anonymity.

Factors associated with clinical trial participation for patients with prostate cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 96-96
Author(s):  
Brian Shinder ◽  
Sinae Kim ◽  
Hiren V. Patel ◽  
Arnav Srivastava ◽  
Tina M. Mayer ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Stage ◽  
Research Participation ◽  
Sociodemographic Factors ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Factors Associated ◽  
Trial Participants

96 Background: Clinical trials are critical for the development of new treatment paradigms for Prostate Cancer (PCa). The primary aim of this study was to characterize the factors associated with clinical trial participation for patients with PCa. The secondary objective was to examine survival outcomes in the clinical trial and control cohorts. Methods: The National Cancer Database (NCDB) was queried for patients with PCa who were coded as having enrolled in a clinical trial. Trial patients were matched in a 1:8 ratio to controls based on clinical stage. Sociodemographic variables were compared between the two groups and univariate and multivariate logistic regression models evaluated factors associated with clinical trial participation. Kaplan-Meier product limit estimate was used to compare overall survival (OS) between the groups. Results: From 2004-2015, 495 patients enrolled in clinical trials were included for analysis. The mean age of trial patients was 63.2 compared to 66.4 in the matched cohort (p < 0.0001). More patients in the trial group had a Charlson-Deyo comorbidity score of 0 (89.3% vs. 82.1%, p = 0.0002). On multivariate analysis, patients who traveled between 50-250 miles (OR 1.59; 95%CI 1.15-2.19, p = 0.005) or came from a zip code where greater than 93% of the population has a high school degree (OR 4.97; 95%CI 2.89-8.54, p < 0.0001) were more likely to participate in a clinical trial. There was no association between race and insurance status on clinical trial participation. Median OS was not significantly different among clinical trial participants than the control cohort (120.9 months vs. not reached, p = 0.928). Conclusions: In this contemporary analysis of PCa patients from a national hospital registry database, we found that certain patient sociodemographic factors remain associated with clinical trial participation, though clinical trial participants do not seem to experience a difference in OS. Further work, both qualitative and quantitative, is necessary to identify clinical and non-clinical barriers to research participation in order to improve the validity of PCa trials.

Diversifying Clinical Research Participants

2016 ◽  
pp. 234-258
Author(s):  
Saliha Akhtar ◽  
Cynthia Israel ◽  
Michelle Lee D'Abundo
Keyword(s):  
Clinical Trial ◽  
Information Technology ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Information Technology ◽  
Health Information ◽  
Research Process ◽  
Use Of Technology ◽  
Online Strategies ◽  
Trial Participants

The diversification of clinical trial participants to include women and minorities is one of the biggest challenges for the clinical research industry. The lack of diversity in clinical trials prevents the tailoring of healthcare interventions specifically for women and minorities. The purpose of this chapter is to explore how health information technology and online strategies can be applied in the clinical trial research process to increase the recruitment and retention of women and minorities in clinical trials. By examining this issue from both the individual (participant) and clinical stakeholder perspective, appropriate strategies utilizing available technology are proposed. In the health care environment, strategies to diversify clinical trial participants include the secondary use of Electronic Health Records, and disease registries, as well as e-learning to raise awareness and train health professionals and clinical trial staff. In order to recruit diverse participant populations, the use of online advertising, social media, e-newsletters, tablets, smartphones, and apps are detailed. Lessons from previous use of technology in recruitment are outlined as well as future trends. In summary, while there are recognized challenges to implementation, the current health information technology and online strategies available seem promising as methods of increasing the participation of women and minorities in clinical trials.

Racial distribution of clinical trial participants in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18516-e18516
Author(s):  
Monaliben Patel ◽  
Lisa M. Hess ◽  
Eric Wen Su ◽  
Xiaohong Li ◽  
Debora S. Bruno
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase 2 ◽  
Phase 3 ◽  
Black Patients ◽  
The Us ◽  
Oncology Clinical Trials ◽  
Seer Data ◽  
Trial Participants

e18516 Background: Lack of diverse representation in clinical trials negatively impacts the cancer survival of patients and populations unaccounted for in clinical research. Efforts such as the 1993 NIH Revitalization Act have focused on improving the diversity of trial participants in the US. This retrospective study evaluated the racial distribution of oncology clinical trial participants using data published in clinicaltrials.gov from Jan 2010 through Dec 2020. Methods: I2E of Linguamatics (IQVIA, Inc), a natural language processing software, was used to identify participant race in oncology trials. Data extracted included trial identifier, year of completion, sponsor, cancer type, and race. Studies were limited to academic, cooperative group and government studies headquartered in the US. Clinical trial results were compared to the racial distribution of SEER 2010 data using z-test. Results: Data from 35,686 patients (14,220 enrolled to 236 phase 2 and 21,471 enrolled to 47 phase 3 trials) were available for analysis. A summary by race is provided in the Table, excluding unknown, which represented 8.5% of phase 2 and 3.5% of phase 3 trials. The proportions of white/black patients enrolled to phase 2 and phase 3 trials beginning in 2010-12 were 84.4%/11% and 83.1%/9.9%, respectively (total enrollment 84.9%/9.6%). For trials beginning in 2015-17, white/black enrollment represented 88.5%/8.1% of patients enrolled to phase 2 and 86.4%/10.1% of patients in phase 3 trials. Black patients represented 9.6% of all trial participants, in contrast with the SEER data where 12% of all patients were black (p < 0.001). For lung cancer trials, black participants represented only 7.9% of all trial participants whereas in breast cancer trials, 10.2% of participants were black, versus the SEER data specific to these tumor types (black patients represent 10.9%/11.5% of lung/breast cancer diagnoses between 2013 to 2017, both p < 0.01). Conclusions: This study suggests that over the past decade most races (other than white) have been significantly underrepresented in US oncology clinical trials, and is even more pronounced for black patients with lung cancer. Based on this analysis, there is no evidence that trial enrollment distribution, particularly of white versus black participants, has changed since 2010. Data are limited to the relative lack of studies reporting results that began enrollment after 2017. These findings suggest that the development of new strategies to improve the recruitment of racial minorities to oncology clinical trials are warranted.[Table: see text]

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