scholarly journals Clinical investigations for SUS, the Brazilian public health system

2012 ◽  
Vol 130 (3) ◽  
pp. 179-186
Author(s):  
Ana Patrícia de Paula ◽  
Silvana Pereira Giozza ◽  
Michelle Zanon Pereira ◽  
Patrícia Souza Boaventura ◽  
Leonor Maria Pacheco Santos ◽  
...  

CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

2020 ◽  
Vol 5 (2) ◽  
pp. 48
Author(s):  
Florent Mbo ◽  
Wilfried Mutombo ◽  
Digas Ngolo ◽  
Patrice Kabangu ◽  
Olaf Valverde Mordt ◽  
...  

Clinical research on neglected tropical diseases is a challenge in low-resource countries, and the contribution of clinical and operational research to health system strengthening is poorly documented. Developing new, simple, safe, and effective treatments may improve the effectiveness of health systems, and conducting research directly in health structures may have an additional impact. This study describes the process of conducting clinical trials in the Democratic Republic of Congo (DRC) in compliance with international standards, and the role of the trials in strengthening health system functions, including governance, human resources, health information, provision of care, and the equipping of health services with the necessary supplies and infrastructure. We conclude that conducting clinical trials in endemic areas has not only reinforced and supported the aim of conducting high-level clinical research in endemic countries, but has also brought lasting benefits to researchers, staff, and hospitals, as well as to broader health systems, which have positive knock-on effect on patients outside of the clinical trials and their communities. Sustainability, however, remains a challenge in an underfunded health system, especially with respect to specialized equipment. Clinical research in most of sub-Saharan Africa is highly dependent on international input and external technical support; there are areas of weaknesses in trial design and documentation, as well as in data management and analysis. Financing remains a critical issue, as African investigators have difficulties in directly accessing sources of international research funding.


Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Kim S Thomas ◽  
Karin Koller ◽  
Katharine Foster ◽  
Jo Perdue ◽  
Lisa Charlesworth ◽  
...  

2021 ◽  
Author(s):  
Daniel I Rhon ◽  
Robert C Oh ◽  
Deydre S Teyhen

ABSTRACT The DoD has a specific mission that creates unique challenges for the conduct of clinical research. These unique challenges include (1) the fact that medical readiness is the number one priority, (2) understanding the role of military culture, and (3) understanding the highly transient flow of operations. Appropriate engagement with key stakeholders at the point of care, where research activities are executed, can mean the difference between success and failure. These key stakeholders include the beneficiaries of the study intervention (patients), clinicians delivering the care, and the military and clinic leadership of both. Challenges to recruitment into research studies include military training, temporary duty, and deployments that can disrupt availability for participation. Seeking medical care is still stigmatized in some military settings. Uniformed personnel, including clinicians, patients, and leaders, are constantly changing, often relocating every 2-4 years, limiting their ability to support clinical trials in this setting which often take 5-7 years to plan and execute. When relevant stakeholders are constantly changing, keeping them engaged becomes an enduring priority. Military leaders are driven by the ability to meet the demands of the assigned mission (readiness). Command endorsement and support are critical for service members to participate in stakeholder engagement panels or clinical trials offering novel treatments. To translate science into relevant practice within the Military Health System, early engagement with key stakeholders at the point of care and addressing mission-relevant factors is critical for success.


2001 ◽  
Vol 22 (6) ◽  
pp. S126-S134 ◽  
Author(s):  
Vernon M Chinchilli ◽  
Jeffrey M Drazen ◽  
James E Fish ◽  
Robert F Lemanske ◽  
Stephen C Lazarus ◽  
...  

2016 ◽  
Vol 18 (1) ◽  
pp. 36-46 ◽  
Author(s):  
Natalie Pattison ◽  
Nishkantha Arulkumaran ◽  
Sally Humphreys ◽  
Tim Walsh

Background Clinical trials in critical care are often resource-intense, with many unique challenges. Barriers to effective recruitment and implementation of study intervention have not been explored in a UK context. Aim To identify facilitating factors and barriers to enrolling patients into critical care clinical trials within the UK from clinician’s perspectives. Methods A qualitative interview study was undertaken on behalf of the National Institute of Health Research critical care specialty group, in which research active clinicians across different Clinical Research Networks were interviewed. A loosely structured interview schedule was used, based on themes generated from the literature associated with accessing critical care trials. Research teams (critical care doctors, research nurses, and trial coordinators) from hospitals from each Clinical Research Network were contacted to try to achieve representation across the UK. Results Interviews were carried out across nine UK Clinical Research Networks with a range of doctors and research nurses. All hospitals were teaching hospitals with varying research nurse numbers and allocated consultant research sessions. There were a range of six to nine ongoing clinical trials in critical care for each centre representative interviewed. Data were analysed using framework analysis, and six final themes were identified related to factors associated with: centre, unit, resources, study, clinician, and patient/family. The most commonly cited barrier to conducting clinical trials was related to resources, namely insufficient human and financial resources, leading to staff and study recruitment difficulties. Clinical uncertainty and equipoise regarding comparative merits of trials were challenging in terms of engaging critical care teams. A number of patient and family factors added complexities in terms of recruitment; however, refusal rates were generally reported as low. Conclusion Flexibility in funding and employment by research teams enables continuity of studies and staff. Innovative measures to incentivise research nurses and clinical teams can help recruit more patients into trials. Research teams are highly committed to providing cover to recruit critical care trials, and a significant effort to anticipate barriers is undertaken; these endeavours are summarised to provide guidance for other teams wishing to address any potential difficulties.


2019 ◽  
Vol 2 (1) ◽  
pp. 21-26
Author(s):  
Fotini Santos Toscas ◽  
Thiago Rodrigues Santos ◽  
Eduardo Jorge Valadares Oliveira

Medical Assistance Equipment (MAE), Orthotics, Prosthetics and Special Materials (OPSM) are strategic subsectors of the Industrial Health Complex (IHC).The dynamism and peculiar characteristics of these technologies characterize the innovation field and the short life cycle of technological developments. The study aims to consolidate the products in a single list by analyzing computerized databases and consulting the technical and other areas in the Ministry of Health. The study strengthens the data obtained and investigates the repeated items in the adopted criteria, crossing this information with previous publications. We established standards about MAE and OPSM in this study that have already been repeated in previous publications. Thus, there is a concentration of skills needs for these technologies in industrial and technological development, as well as in technological services requirement of these products.


Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5600-5600
Author(s):  
Judith Trotman ◽  
Xavier Badoux ◽  
Admir Huseincehajic ◽  
Michele Gambrill ◽  
Anais LeGall ◽  
...  

Abstract Background Readily accessible, smart-phone applications (Apps) have the potential to revolutionise and improve the delivery of patient care. Significant challenges associated with recruiting patients to haematology clinical trials include the rarity of diseases, complexity of trials, limited site locations, and maintaining knowledge of current trials in the context of rapid therapeutic developments. The Haematology Clinical Research Network, of New South Wales and the Australian Capital Territory (NSW/ACT) aimed to develop an App to facilitate clinician and patient access to current information on local clinical trials and improve trial participation by increasing referrals. Methods Key objectives were to develop an App that was free to download, simple to use and effective. Only publically listed data was to be included. Endpoints were rates of App usage, and cross-site and internal clinical trial referrals. Through liaison between the end-users (clinicians, trial managers and patients), and the contracted software developer, App specifications were refined through successive iterations. With the key search filters of Disease, Location, Sponsor and Study Status, the App has an easy to navigate listing of currently recruiting haematology trials. Useful features include: listing of inclusion and exclusion criteria; direct links to ClinTrials.gov; a lay summary; and direct contacts from the mobile device to participating study sites. Real-time data entry into the database app manager ensures currency of trial information. Results ClinTrial Refer went live in May 2013, on both iOS and Android platforms. As at 10th August, ClinTrial Refer has 654 users, over 4358 sessions and 13924 screen views.91% of current users are repeat users. Despite its local application the App has been accessed in 46 countries. Among the target audience in NSW 290 repeat users returned for an average 11 sessions each indicating a high user acceptance. It is being endorsed on the websites of Australian blood cancer consumer groups. A survey has confirmed that since its launch, through having readily accessible data on their smart-phones, ClinTrial Refer has increased clinician awareness of the NSW trial portfolio. In just twelve weeks it has resulted in the cross-referral of an additional 30+ patients for clinical trials, representing a >300% increase over previous referral patterns. This improvement in trials knowledge management has also increased within-site recruitment; however it is harder to quantify the exact short-term impact of ClinTrial Refer within hospitals. The App has already been duplicated for other Australian state-wide haematology networks and the Adolescent & Young Adult Research Network, NSW. Conclusion ClinTrial Refer is an innovative but simple, readily accessible mobile Application. Its widespread adoption across 18 Haematology Clinical Research sites in NSW Australia is facilitating increased patient recruitment to trials. Only recently available on iTunes and Google Play, it has attracted national and international attention as a template for any clinical trial network portfolio. Disclosures: Trotman: Celgene: Grant for App development Other. Huseincehajic:Celgene: Grant for App development Other.


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