Academic health centers: integration of clinical research with healthcare and education. Comments on a workshop

Arai, Roberto Jun; Noronha, Irene de Lourdes; Nicolau, José Carlos; Schmidt, C. D.; Albuquerque, Gustavo M. de; Mahaffey, Kenneth W.; Krieger, Eduardo Moacyr; Júnior, José Ota ́vio Costa Auler

doi:10.6061/clinics/2017/e515s

Cited by 3 publications

(4 citation statements)

References 17 publications

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“…In 2023, six new sites in North and Northwest regions received support, and three of them have ongoing studies. The next efforts will be applied to maintain the qualification programs as new sites need careful attention on the staff capacitation and infrastructure once the learning curve may be long [ 43 , 44 ]. Notably, the partnering may engage sponsors to prioritize actions such as capacitation programs for new research sites in regions where no clinical trials are found.…”

Section: New Opportunities To Improve Cancer Research Scenario In Brazilmentioning

confidence: 99%

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Resende,

Arai,

Barrios

et al. 2024

ecancer Journal

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Clinical research is the cornerstone of improvements in cancer care. However, it has been conducted predominantly in high-income countries with few clinical trials available in Brazil and other low-and-middle-income countries (LMIC). Of note, less than one-third of registered clinical trials addressing some of the most commonly diagnosed cancers (breast, lung and cervical) recruited patients from LMIC in the last years. The Institute Project CURA promoted the fourth CURA meeting, discussing barriers to cancer clinical research and proposing potential solutions. A meeting was held in São Paulo, Brazil, in June 2023 with representatives from different sectors: Brazilian Health Regulatory Agency (Anvisa), National Commission of Ethics in Research (CONEP), non-governmental organisations, such as the Latin American Cooperative Oncology Group, the Brazilian Society of Clinical Oncology (SBOC), Contract Research Organisations, pharmaceutical companies and investigators. A total of 16 experts pointed out achievements as shortening the time of regulatory processes involving Anvisa and CONEP, development of staff training programs, maintenance of the National Program of Oncological Attention (PRONON), and the foundation of qualified centres in North and Northeast Brazilian regions. Participants also highlighted the need to be more competitive in the field, which requires optimising ongoing policies and implementing new strategies as decentralisation of clinical research centres, public awareness campaigns, community-centered approaches, collaborations and partnerships, expansion of physicians-directed policies, exploring the role of the steering committee. Active and consistent reporting of the initiatives might help to propagate ongoing advances, increasing Brazilian participation in clinical cancer research. Engagement of all players is crucial to maintain continuous progress with further improvements in critical points including regulatory timelines and increments in qualified human resources which aligned with new educational initiatives focused on physicians and the general population will expand access to cancer clinical trials in Brazil.

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Section: New Opportunities To Improve Cancer Research Scenario In Brazilmentioning

confidence: 99%

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Resende,

Arai,

Barrios

et al. 2024

ecancer Journal

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“…All personnel involved in clinical trials, mainly investigators, must receive formal and continuous high‐quality training with special focus on POTs ; this could be provided by institutions participating in clinical trials with or without industry financial support.…”

Section: Latin America Clinical Research Environmentmentioning

confidence: 99%

“…Training All personnel involved in clinical trials, mainly investigators, must receive formal and continuous highquality training with special focus on POTs[59]; this could be provided by institutions participating in clinical trials with or without industry financial support. A comprehensive work of updated education on POTs has to be guaranteed for the different members of local institutional review boards, including recent international updates of legislations; this could be provided by institutions (investigators included) participating in clinical trials.…”

mentioning

confidence: 99%

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

et al. 2019

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The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high‐tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower‐middle‐ and low‐income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. Implications for Practice Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer.

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“…On the other hand, hospitals possess extensive patient data and registries, and they bear the responsibility of delivering optimal care based on evidence-based research (Sackett et al, 1996). However, clinicians and physicians often require comprehensive technical, epidemiological, ethical, and scientific support to effectively translate their research interests into publications (Arai et al, 2018). Availability and easy access to research services like that encourage them to initiate and conduct research besides their clinical duties.…”

Section: Introductionmentioning

confidence: 99%

Enhancing research support services in health organizations by implementing a “Research Concierge Desk”, a case study

AlFattani,

AlFirm,

AlBedah

et al. 2024

Front. Res. Metr. Anal.

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Health organizations with teaching and research responsibilities face the need to establish a comprehensive system that addresses the processes and challenges associated with research activities; a system that assists local institutes in becoming research-active by identifying gaps and providing actionable recommendations. The involvement of epidemiologists, biostatisticians, and data scientists is paramount in offering technical and scientific support to health researchers. In our organization, research support services, such as technical, statistical, logistical, and scientific assistance, have been provided to researchers for the past 20 years under the name of “Data Clinic Service”. This article discusses the establishment of a physical booth called the “Research Concierge Desk” within a medical center to offer on-site, free-of-charge, and direct consultations to researchers, thereby improving accessibility to data clinic services. The underlying concept of the “Research Concierge Desk” is to align the research workflow for busy clinicians, who require vital assistance in the technical aspects of their research. As well, the desk and its digital platform enabled us to assess research process workflow, such as research submission, data clinic requests, research progress tracking, and researcher satisfaction assessment. We present the initiation of the “Research Concierge Desk” as an innovative solution in hospital settings, outline the available resources, benefits, challenges, and propose areas for improvement. The experience gained from implementing the “Research Concierge Desk” model can greatly benefit other health centers in adopting a similar approach to develop enhanced services for clinical researchers.

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Academic health centers: integration of clinical research with healthcare and education. Comments on a workshop

Cited by 3 publications

References 17 publications

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Improving access to cancer clinical research in Brazil: recent advances and new opportunities. Expert opinions from the 4th CURA meeting, São Paulo, 2023

Personalizing Precision Oncology Clinical Trials in Latin America: An Expert Panel on Challenges and Opportunities

Enhancing research support services in health organizations by implementing a “Research Concierge Desk”, a case study

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