scholarly journals How health literacy can enhance the design and conduct of clinical trials from consent to conclusion

2020 ◽  
Vol 40 (1-2) ◽  
pp. 41-49
Author(s):  
Catina O’Leary ◽  
Chris Casey ◽  
Diane Webb ◽  
Deborah Collyar ◽  
Andrew Pleasant
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Health Literacy ◽  
Medical Care ◽  
Standard Medical Care ◽  
Literacy Activities ◽  
Trial Process ◽  
Primary Focus ◽  
Trial Participants ◽  
Literacy Research

Health literacy research and interventions have provided multiple tools to improve communication between professionals and patients in clinical contexts for many years. Despite the reality that many patients participate in clinical trials in conjunction with standard medical care, only recently have efforts extended to address and improve the health literacy of both clinical trial researchers and participants. To date, the primary focus of health literacy activities in clinical trials has centered on communicating trial results to trial participants. This report describes the opportunities and strategies necessary to layer health literacy activities across the clinical trial process from consent to conclusion.

scholarly journals Defining the Threshold of Permissible Risk for Non-therapeutic Clinical Trials with Children in Europe

2017 ◽  
Vol 24 (4) ◽  
pp. 414-431
Author(s):  
Katherine Wade*
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Medicinal Products ◽  
Council Of Europe ◽  
Therapeutic Trials ◽  
Research With Children ◽  
Individual Trial ◽  
The One ◽  
Definition Of ◽  
Trial Participants

Abstract It is important that clinical research with children is encouraged so that they are not exposed to the dangers of extrapolation from adult treatments. Clinical trials with investigational medicinal products (imps) are an important part of improving medical care for children. Both the 2001 Clinical Trials Directive and the 2014 Regulation recognise the need for such research, including the need for non-therapeutic trials with imps. However, it is also recognised that a balance must be struck between permitting tailored medical care for children as a group on the one hand, and protecting individual trial participants from harm on the other. A central issue in striking this balance relates to defining the threshold of risk which should be permitted in such research. This article provides a critical analysis of the current European law in relation to the definition of acceptable risk for non-therapeutic clinical trials with imps and makes recommendations for reform, drawing on law from the Council of Europe, as well as law from the us.

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.

Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project

2000 ◽  
Vol 18 (15) ◽  
pp. 2805-2810 ◽  
Author(s):  
Charles L. Bennett ◽  
Tammy J. Stinson ◽  
Victor Vogel ◽  
Lyn Robertson ◽  
Donald Leedy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Medical Care ◽  
Phase Ii ◽  
Third Party ◽  
Disease Stage ◽  
Cancer Center ◽  
Policy Debate ◽  
Economic Analyses

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

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.

Transforming the clinical trial process: The I-SPY 2 trial as a model for improving the efficiency of clinical trials and accelerating the drug-screening process.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. TPS2633-TPS2633 ◽  
Author(s):  
Meredith B. Buxton ◽  
Kelsey Natsuhara ◽  
Angela DeMichele ◽  
Jane Perlmutter ◽  
Nola M Hylton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Screening ◽  
Screening Process ◽  
Trial Process

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.

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