Dataset Information

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

ABSTRACT: Background: Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, careful supervision of research activities has to be ensured. Objective: To describe and analyze the features of the clinical trials involving vulnerable populations in various countries classified by development status and geographic region. Methods: Retrospective study that involved analysis of data obtained from the International Clinical Trials Registry Platform (ICTRP) database between 01/2014 and 12/2014 from countries with (i) highest trial densities during 2005 to 2012, (ii) highest average growth rate in clinical trials, and (iii) greatest trial capabilities. Results: Statistical analysis of this study showed that patients incapable of giving consent personally are 11.4 times more likely to be vulnerable patients than patients who are capable, and that patients in upper-middle-income countries are 1.7 times more likely to be vulnerable patients than patients from high-income countries when participating in global clinical trials. Malaysia (21%), Egypt (20%), Turkey (19%), Israel (18%), and Brazil (17%) had the highest percentages of vulnerable populations involving children. Conclusions: Although the inability to provide consent personally was a factor associated with vulnerability, arbitrary criteria may have been considered when classifying the populations of clinical trials as vulnerable. The EU Clinical Trials Register should provide guidance regarding exactly what aspects or factors should be taken into account to frame given populations as vulnerable, because vulnerability is not applicable to all risk situations.

SUBMITTER: da Silva RE

PROVIDER: S-EPMC5776907 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

da Silva Ricardo E RE Amato Angélica A AA Guilhem Dirce B DB de Carvalho Marta R MR Lima Elisangela da C EDC Novaes Maria Rita C G MRCG

Frontiers in pharmacology 20180117

<b>Background:</b> Although policies and guidelines make use of the concept of vulnerability, few define it. The European Union's directive for clinical trials does not include explanations for or the reasoning behind the designation of certain groups as vulnerable. Emerging economies from lower middle-income countries have, in recent years, had the largest average annual growth rate, as well as increase, in number of clinical trials registered in the US government's database. Nevertheless, care ...[more]

PMID: 29403381

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Project description:BackgroundA novel remote method for external dosimetric TPS-planned auditing of intensity modulated radiotherapy (IMRT) and volumetric modulated arc therapy (VMAT) for clinical trials using electronic portal imaging device (EPID) has been developed. The audit has been applied to multiple centers across Australia and New Zealand. This work aims to assess the audit outcomes and explores the variables that contributed to the audit results.MethodsThirty audits were performed of 21 radiotherapy facilities, 17 facilities underwent IMRT audits and 13 underwent VMAT audits. The assessment was based on comparisons between the delivered doses derived from images acquired with EPIDs and planned doses from the local treatment planning systems (TPS). Gamma pass-rate (GPR) and gamma mean value (GMV) were calculated for each IMRT field and VMAT arc (total 268 comparisons). A multiple variable linear model was applied to the GMV results (3%/3 mm criteria) to assess the influence and significance of explanatory variables. The explanatory variables were Linac-TPS combination, TPS grid resolution, IMRT/VMAT delivery, age of EPID, treatment site, record and verification system (R&V) type and dose-rate. Finally, the audit results were compared with other recent audits by calculating the incidence ratio (IR) as a ratio of the observed mean/median GPRs for the remote audit to the other audits.ResultsThe average (± 1 SD) of the centers' GPRs were: 99.3?±?1.9%, 98.6?±?2.7% & 96.2?±?5.5% at 3%, 3 mm, 3%, 2 mm and 2%, 2 mm criteria respectively. The most determinative variables on the GMVs were Linac-TPS combination, TPS grid resolution and IMRT/VMAT delivery type. The IR values were 1 for seven comparisons, indicating similar GPRs of the remote audit with the reference audits and?>?1 for four comparisons, indicating higher GPRs of the remote audit than the reference audits.ConclusionThe remote dosimetry audit method for clinical trials demonstrated high GPRs and provided results comparable to established more resource-intensive audit methods. Several factors were found to influence the results including some effect of Linac-TPS combination.

Project description:ImportanceEffective, continuous improvement in patient engagement depends on an intimate understanding of public and patient perceptions and experiences in clinical research.ObjectivesTo identify the views of clinical trial participants and nonparticipants and characterize trends in these views over time.Design, setting, and participantsIn this survey study, a questionnaire was administered online from May 8 to July 24, 2017, by the Center for Information and Study on Clinical Research Participation (CISCRP), and findings were compared with previous studies conducted in 2013 and 2015. The 2017 sample included responses from 12 427 individuals from 68 countries and represents a 10% participation rate. Similar to international assessments conducted by the CISCRP and other organizations, this study drew responses from a convenience sample; any adult older than 18 years who received an email or had online access was eligible to participate.Main outcomes and measuresSignificant changes were observed in the perceptions and clinical trial experiences of the public and study volunteers compared with past CISCRP studies.ResultsA total of 12 427 individuals (mean [SD] age, 55 [15] years; 7355 [59.2%] female; 10 085 [81.2%] white), 2194 (17.7%) of whom had participated in previous clinical research studies, responded to the survey in 2017. Findings indicated a belief in the importance of clinical research, but limited understanding of the research process persists. In 2017, a total of 10 506 individuals (84.5%) perceived clinical research to be very important to the discovery and development of new medicines; however, 4079 of 6919 respondents (59.0%) were unable to name a place where studies were conducted. A total of 11 182 respondents (90.0%) believed that clinical research is generally safe; however, 5578 of 12 427 individuals (44.9%) reported that clinical trials are rarely considered as an option when discussing treatments or medications with their physician. Clinical trial participation was perceived as inconvenient and burdensome; in the latest survey, 1075 respondents (49.0%) expressed that their clinical trial participation disrupted their daily routine.Conclusions and relevanceThe results of this study may provide a foundation from which to build meaningful and effective engagement with the public and patients and revealed roadblocks, including knowledge gaps among the public, limited physician involvement in discussing clinical trials as treatment options, and the inconveniences that patients encounter after they volunteer to participate. These findings may inform patient engagement strategies and tactics and ultimately help accelerate the drug-development process.

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Dataset Information

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

Publications

Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.

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