Dataset Information

Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality.

ABSTRACT: Objectives: To analyze the current situation of cross-border access to clinical trials in the EU with an overview of stakeholders' real-life experience, and to identify the needs, challenges, and potential for facilitation of cross-border access. Methods: We employed a mixed methods design. Semi-structured interviews and an online survey were conducted with a wide range of stakeholders: patient representatives, investigators/physicians, policy and regulatory experts, academic and commercial sponsor representatives, ethics committee members. Interviews underwent a framework analysis. The survey was analyzed descriptively. Results: Three hundred ninety six individuals responded to the survey. The majority were investigators/physicians (46%) and patient representatives (33%). Thirty eight individuals were interviewed. The majority were investigators/physicians (29%) and patient representatives (29%). All European regions were represented in the study. The highest response rate was received from residents of Western European countries (38% of survey respondents, 45% of interviewees), the lowest from Eastern Europe (9% of survey respondents, 5% of interviewees). The study suggested that cross-border participation in clinical trials occurs in practice, however very rarely. Ninety two percentage of survey respondents and the majority of interviewees perceived as needed the possibility to access clinical trials abroad. However, most interviewees also opined that patients ideally should not have to travel in order to access experimental treatment. The lack of access to treatment in the home country of the patient was described as the main motivation to participate in a clinical trial in another country. The logistical and financial burden for patients was perceived as the biggest challenge. Different stakeholders expressed diverging opinions regarding the allocation of financial and organizational responsibility for enabling cross-border access to clinical trials. Participants provided a number of proposals for improving the current system, which were carefully evaluated by the research team and informed future recommendations. Conclusions: Participation in clinical trials abroad is happening rarely but should be facilitated. There was a consensus on the need for reliable and accessible information regarding practical aspects, as well as multi-stakeholder, multi-national recommendations on existing options and best practice on cross-border access to clinical trials. Broader interdisciplinary research is recommended before discussing options in the EU legislative framework to enable clearly defined conditions for cross-border access to clinical trials.

SUBMITTER: Lalova T

PROVIDER: S-EPMC7642582 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality.

Lalova Teodora T Padeanu Cristina C Negrouk Anastassia A Lacombe Denis D Geissler Jan J Klingmann Ingrid I Huys Isabelle I

Frontiers in medicine 20201022

<b>Objectives:</b> To analyze the current situation of cross-border access to clinical trials in the EU with an overview of stakeholders' real-life experience, and to identify the needs, challenges, and potential for facilitation of cross-border access. <b>Methods:</b> We employed a mixed methods design. Semi-structured interviews and an online survey were conducted with a wide range of stakeholders: patient representatives, investigators/physicians, policy and regulatory experts, academic and c ...[more]

PMID: 33195343

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Project description:ObjectiveTo identify the availability of results for trials registered on the European Union Clinical Trials Register (EUCTR) compared with other dissemination routes to understand its value as a results repository.DesignCross sectional audit study.SettingEUCTR protocols and results sections, data extracted 1-3 December 2020.PopulationRandom sample of 500 trials registered on EUCTR with a completion date of more than two years from the beginning of searches (ie, 1 December 2018).Main outcome measuresProportion of trials with results across the examined dissemination routes (EUCTR, ClinicalTrials.gov, ISRCTN registry, and journal publications), and for each dissemination route individually. Prespecified secondary outcomes were number and proportion of unique results, and the timing of results, for each dissemination route.ResultsIn the sample of 500 trials, availability of results on EUCTR (53.2%, 95% confidence interval 48.8% to 57.6%) was similar to the peer reviewed literature (58.6%, 54.3% to 62.9%) and exceeded the proportion of results available on other registries with matched records. Among the 383 trials with any results, 55 (14.4%, 10.9% to 17.9%) were only available on EUCTR. Also, after the launch of the EUCTR results database, median time to results was fastest on EUCTR (1142 days, 95% confidence interval 812 to 1492), comparable with journal publications (1226 days, 1074 to 1551), and exceeding ClinicalTrials.gov (3321 days, 1653 to undefined). For 117 trials (23.4%, 19.7% to 27.1%), however, results were published elsewhere but not submitted to the EUCTR registry, and no results were located in any dissemination route for 117 trials (23.4%, 19.7% to 27.1).ConclusionsEUCTR should be considered in results searches for systematic reviews and can help researchers and the public to access the results of clinical trials, unavailable elsewhere, in a timely way. Reporting requirements, such as the EU's, can help in avoiding research waste by ensuring results are reported. The registry's true value, however, is unrealised because of inadequate compliance with EU guidelines, and problems with data quality that complicate the routine use of the registry. As the EU transitions to a new registry, continuing to emphasise the importance of EUCTR and the provision of timely and complete data is critical. For the future, EUCTR will still hold important information from the past two decades of clinical research in Europe. With increased efforts from sponsors and regulators, the registry can continue to grow as a source of results of clinical trials, many of which might be unavailable from other dissemination routes.

Project description:IntroductionEast African cross-border areas are visited by mobile and vulnerable populations, such as men, female sex workers, men who have sex with men, truck drivers, fisher folks and young women. These groups may not benefit from traditional HIV prevention interventions available at the health facilities where they live, but may benefit from services offered at public venues identified as places where people meet new sexual partners (e.g. bars, nightclubs, transportation hubs and guest houses). The goal of this analysis was to estimate availability, access and uptake of prevention services by populations who visit these venues.MethodsWe collected cross-sectional data using the Priorities for Local AIDS Control Efforts sampling method at cross-border locations near or along the land and lake borders of Kenya, Rwanda, Tanzania and Uganda from June 2016-February 2017. This bio-behavioural survey captured information from a probability sample of 11,428 individuals at 833 venues across all areas. Data were weighted using survey sampling weights and analysed using methods to account for the complex sampling design.ResultsAmong the 85.6% of persons who had access to condoms, 60.5% did not use a condom at their last anal or vaginal sexual encounter. Venues visited by high percentages of persons living with HIV were not more likely than other venues to offer condoms. In 12 of the 22 cross-border areas, male or female condoms were available at less than 33% of the venues visited by persons having difficulty accessing condoms. In 17 of the 22 cross-border areas, education outreach visits in the preceding six months occurred at less than 50% of the venues where participants had low effective use of condoms.ConclusionsIndividuals visiting venues in cross-border areas report poor access to and low effective use of condoms and other prevention services. Availability of HIV prevention services differed by venue and population type and cross-border area, suggesting opportunities for more granular targeting of HIV prevention interventions and transnational coordination of HIV programming.

Project description:BackgroundStroke patients are often affected by long-term disabilities with needs concerning social issues. There is relatively little consideration of social recovery of patients and the support required to return to work, receive social benefits, participate in daily life activities, maintain contact with family and friends and to organize financial affairs. In our study we aimed to investigate if existing tools record social needs adequately. We analyzed the current provision of social support provided in long-term care after stroke and whether unmet social needs were associated with quality of life, caregiver burden, overall function and degree of disability.MethodsOur analysis is part of the Managing Aftercare of Stroke study (MAS-I), a cross-sectional exploratory study of patient needs 2-3 years after initial stroke. Assessment tools included the Nikolaus-score (social situation), the EuroQoL (quality of life), the German Burden Scale for Family Caregivers (caregiver burden), the modified Rankin Scale (disability / dependence), Stroke Impact Scale (function and degree of disability) and the Stroke Survivor Needs Questionnaire (unmet needs).ResultsOverall 57 patients were included in MAS-I, with ten patients classified in urgent need of socio-economic support according to the Nikolaus-score. Patients with lower than normal Nikolaus-score had a higher degree of disability. Thirty percent of all patients had never received professional social support. Social worker contact happened mostly during the stay in acute hospital or rehabilitation institution. Only four patients (11%) reported long-term support after discharge. Apart from social worker contact during acute care, 43% of patients had unmet needs in the long-term aftercare. Forty percent of all patients included in MAS-I were recommended for social work intervention after an in-depth analysis of their situation. Finally, we saw that unmet social needs were associated with lower quality of life and higher caregiver burden.ConclusionsOur data suggest significant unmet needs in social care in long-term stroke patients. Screening tools for unmet social needs such as the Nikolaus-score do not holistically report patients' needs.Trial registrationClinicaltrials.Gov NCT02320994 . Registered 19 December 2014 (retrospectively registered).

Project description:BackgroundThe emergence and spread of multidrug resistant microorganisms is a serious threat to transnational public health. Therefore, it is vital that cross-border outbreak response systems are constantly prepared for fast, rigorous, and efficient response. This research aims to improve transnational collaboration by identifying, visualizing, and exploring two cross-border response networks that are likely to unfold during outbreaks involving the Netherlands and Germany.MethodsQuantitative methods were used to explore response networks during a cross-border outbreak of carbapenem resistant Enterobacteriaceae in healthcare settings. Eighty-six Dutch and German health professionals reflected on a fictive but realistic outbreak scenario (response rate ≈ 70%). Data were collected regarding collaborative relationships between stakeholders during outbreak response, prior working relationships, and trust in the networks. Network analysis techniques were used to analyze the networks on the network level (density, centralization, clique structures, and similarity of tie constellations between two networks) and node level (brokerage measures and degree centrality).ResultsAlthough stakeholders mainly collaborate with stakeholders belonging to the same country, transnational collaboration is present in a centralized manner. Integration of the network is reached, since several actors are beneficially positioned to coordinate transnational collaboration. However, levels of trust are moderately low and prior-existing cross-border working relationships are sparse.ConclusionGiven the explored network characteristics, we conclude that the system has a promising basis to achieve effective coordination. However, future research has to determine what kind of network governance form might be most effective and efficient in coordinating the necessary cross-border response activity. Furthermore, networks identified in this study are not only crucial in times of outbreak containment, but should also be fostered in times of non-crisis.

Dataset Information

Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality.

Publications

Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality.

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