Medicines and translational research: steps, actors, and health policies in the Brazilian context

Lupatini, Evandro de Oliveira; Barreto, Jorge Otávio Maia; Zimmermann, Ivan Ricardo; Silva, Everton Nunes da

doi:10.1590/0103-11042019S214

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REVIEW • Saúde debate 43 (spe2) • Nov 2019 • https://doi.org/10.1590/0103-11042019S214 copy

Medicines and translational research: steps, actors, and health policies in the Brazilian context

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ABSTRACT

Translational research has come up with the purpose of reducing the time gap between basic research and its clinical application. As for what concerns medicines, this time can reach decades, demanding the evaluation of barriers through translational research. Our aim was to review the literature in order to identify the steps of translational research, as well as normative acts, public health policies, and the key agents in the Brazilian context. For the identification of translational research framework, a systematic search was carried out on PubMed, Embase, and Lilacs databases, with 23 publications selected. Official websites were consulted to gather information on policies and actors. As a result, the literature initially pointed to one step (from bench to bedside), recently incorporating the additional steps of research synthesis and the public health impact assessment. Several actors are transversally involved in translational research, such as universities, research institutions, and funding agencies. It is observed that Brazil has implemented important policies in the fields of pharmaceutical services, research, science, technology, and innovation in health, which may potentially integrate resources, actors, and efforts aimed to the practical application of research results in clinical practice, improving the health and life condition of the population.

KEYWORDS
Translational medical research; Health systems; Health policy; Pharmaceutical services; Pharmaceutical preparations

Author	Year	Type of study	Origin	Context	Main conclusions
Sung et al.¹⁴14 Sung NS, Crowley WF, Genel M, et al. Central challenges facing the national clinical research enterprise. JAMA. 2003; 289(10):1278-87.	2003	Narrative Review	Unites States	Research and Innovation	The core challenges facing clinical research can be listed in public participation, information systems, workforce training and funding.
Davis D¹⁵15 Davis D, Evans M, Jadad A, et al. The case for knowledge translation: shortening the journey from evidence to effect. BMJ. 2003; 327(7405):33-5.	2003	Narrative Review	Canada	General practitioner	Further research is needed to discuss and test knowledge translation models, determining which domains and clinical contexts are most appropriate and which interventions produce results from medical care.
Hörig et al.¹⁶16 Hörig H, Marincola E, Marincola FM. Obstacles and opportunities in translational research. Nat Med. 2005; 11(7):705-8.	2005	Opinion Article	Unites States	General practitioner	A new model of healthcare practices is paramount and should seek better communication between basic scientists, general practitioners, health professionals and patients.
Graham et al.¹⁷17 Graham ID, Logan J, Harrison MB, et al. Lost in knowledge translation: Time for a map? J Contin Educ Health Prof. 2006; 26(1):13-24.	2006	Narrative Review	Canada	Health education	The implications of translating knowledge for continuing education in health professions include the need to be based on the best available knowledge, the use of proven and effective educational strategies, and the value of learning about planning theories for change in practice.
Khoury et al.¹⁸18 Khoury MJ, Gwinn M, Yoon PW, et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genet Med. 2007; (9):665-74.	2007	Narrative Review	Unites States	Genomics	The complete continuum of translational research needs adequate support in genetics, since a maximum of 3% of research published in this field so far focuses on T2 onwards and evidence-based guidelines and research on T3 and T4 are very rare.
Westfall et al.¹⁹19 Westfall JM, Mold J, Fagnan L. Practice-Based Research - "Blue Highways" on the NIH Roadmap. JAMA. 2007; 297(4):403.	2007	Opinion Article	Unites States	General practitioner	Practice-based research is a crucial scientific step for the major medical advances of the next 25 years.
Woolf SH²2 Woolf SH. The Meaning of Translational Research and Why It Matters. JAMA. 2008; 299:211-3.	2008	Opinion Article	Unites States	Research and Innovation	The appropriate investment in T2 research is vital to recover the investments in T1 research, because bringing a medicine to the market without knowing how to bring it to the patients impairs its major objective.
Contopoulos-Ioannidis et al.²⁰20 Contopoulos-Ioannidis DG, Alexiou GA, Gouvias TC, et al. Life cycle of translational research. Science. 2008; 321:1298-9.	2008	Systematic review	Greece	Medicines	Successful translation takes a lot of effort and time, even under the best of circumstances. However, making unrealistic promises for breakthroughs and quick cures can undermine the credibility of science in the public eye.
Dougherty et al.²¹21 Dougherty D, Conway PH. The "3T's" Road Map to Transform US Health Care. JAMA. 2008; 299(19):2319.	2008	Opinion Article	Unites States	Collective Health	Starting a national discussion involving all participants in the translational research phases is a first step in improving health outcomes and transforming the health system of the USA.
Rubio et al.⁸8 Rubio DM, Schoenbaum EE, Lee LS, et al. Defining translational research: implications for training. Acad Med. 2010; 85(3):470-5.	2010	Narrative Review	Unites States	Health education	Translational research moves in a bidirectional manner from one type of research to another, from basic research to population-based research and vice versa, involving collaboration between scientists from various disciplines.
McClain DA²²22 McClain DA. Bridging the gap between basic and clinical investigation. Trends Biochem Sci. 2010; 35:187-8.	2010	Opinion Article	Unites States	General practitioner	As mechanisms for promoting translational research, it stands out, among others, the training of individuals across the whole spectrum of translations, the simplification of the process of knowledge translation, the application of advances in computer science, image generation and data analysis to translational research and career development of translational researchers.
Morris et al.¹⁰10 Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011; 104:510-20.	2011	Narrative Review	England	General practitioner	Although little is yet known about the timing of delays and how they should be managed, translating scientific findings to benefit patients faster is a political priority of many health research systems.
Trochim et al.¹¹11 Trochim W, Kane C, Graham MJ, et al. Evaluating translational research: A process marker model. Clin Transl Sci. 2011; 4:153-62.	2011	Narrative Review	Unites States	General practitioner	Although there is still no consensus on translational phase models, there is little doubt that evaluation will be essential to manage translational research effectively.
Cabieses et al.²³23 Cabieses B, Espinoza MA. La investigación traslacional y su aporte para la toma de decisiones en políticas de salud. Rev peru med exp salud publica. 2011; 28(2):288-297.	2011	Systematic review	Chile	Collective Health	The incorporation of a translational perspective can become a priority for any country seeking to define what should be investigated, who should finance and how much resources should be invested in each stage of the research, in favor of the health of the population.
Guimarães R⁴4 Guimarães R. Pesquisa Translacional: uma interpretação. Ciênc. Saúde Colet. 2013; 18:1731-44.	2013	Opinion Article	Brazil	Research and Innovation	The universal health system as a fundamental part of the ecosystem of the demands of innovation by society.
Fishburn CS⁵5 Fishburn CS. Translational research: The changing landscape of drug discovery. Drug Discov Today. 2013; 18(9-10):487-94.	2013	Opinion Article	Unites States	Medicines	Translational research represents a dominant strategy in the field of medicine discovery and will be paramount in defining the relationships between its actors in the coming decades.
Montoya HAC²⁴24 Montoya HAC. Reflexiones sobre la integración de las ciencias básicas biomédicas con la práctica clínica en programas de pregrado. Rev colomb rehabil. 2013; 12:22-30.	2013	Narrative Review	Colombia	Health education	The integration of basic sciences with clinical areas will provide an educational context of greater applicability to future professionals.
Silva et al.³3 Silva AB, Morel CM, Moraes IHS. Proposta conceitual de telessaúde no modelo da pesquisa translacional Proposal for a telehealth concept in the translational research model. Rev Saude Publica. 2014; 48:347-56.	2014	Narrative Review	Brazil	Telehealth	Telehealth is close to translational research by allowing people to connect science and benefit those in health services.
Hanney et al.¹1 Hanney SR, Castle-Clarke S, Grant J, et al. How long does biomedical research take? Studying the time taken between biomedical and health research and its translation into products, policy, and practice. Heal Res Policy Syst. 2015; 13:1-18.	2015	Narrative Review	England	General practitioner	It is necessary to distinguish between time elapsed and undesirable delays, as certain periods of time in the translation of research are necessary to ensure the safety, efficacy and cost-benefit of treatments.
Cohrs et al.⁹9 Cohrs RJ, Martin T, Ghahramani P, et al. Translational medicine definition by the European society for translational medicine. New Horizons Transl Med. 2015; (2):86-8.	2015	Consensus	Europe	General practitioner	Translational Medicine is defined as "an interdisciplinary branch of the biomedical field, supported by three main pillars: bench, bedside and community". Its objective is to "combine disciplines, resources, knowledge and techniques within these pillars to promote improvements in prevention, diagnosis and therapies".
NIH²⁵25 National Center for Advancing Translational Sciences. Translational Science Spectrum [internet]. 2015 [acesso em 2019 mar 24]. Disponível em: https://ncats.nih.gov/files/translation-factsheet.pdf. https://ncats.nih.gov/files/translation-...	2015	Fact Sheet	Unites States	General practitioner	The spectrum of translational science is not linear or unidirectional and each stage is based on and informs the others.
Vivas et al.²⁶26 Vivas LM, Lippi MC, Silva GV, et al. Pesquisa Translacional como abordagem para acelerar a inovação tecnológica em saúde. Espac. 2017; 38(14):25.	2016	Systematic review	Brazil	Research and Innovation	The translational approach presents the interaction between the translation phases in a dynamic and non-linear way, with activities occurring in parallel and requiring constant feedback.
Luz PL²⁷27 Luz PL. Medicina translacional - nova fronteira. Rev Soc Cardiol Estado São Paulo. 2018; 28(1):14-19.	2018	Narrative Review	Brazil	General practitioner	Among other points, it is essential to change culture within universities seeking the integration of basic and clinical research and multidisciplinarity.

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