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24 páginas. Este trabajo aborda las características más importantes de la investigación clínica en Colombia en pacientes Diabéticos tipo 2 y su relación con la economía de la salud. La realización de los ensayos clínicos ofrece ventajas a los pacientes y a los centros de investigación, en primer lugar proporciona acceso a tratamientos experimentales a pacientes que no tendrían otra forma de obtenerlo, en segundo lugar favorece a la comunidad científica el contacto con la investigación médica mundial estando a la vanguardia en los últimos avances terapéuticos y por último constituye una fuente de ingresos para los centros e investigadores, que permite a su vez la financiación de nuevas actividades investigadoras, formativas o de compra de equipamiento destinado a la investigación. El Observatorio de Diabetes de Colombia reconoce que la DM representa una carga económica importante, y es por esto que la investigación clínica puede aliviar en parte ésta situación y se sustenta también en la falta de antidiabéticos que se ve agravada por los problemas inherentes a los fármacos existentes en cuanto a eficacia, seguridad y tolerancia, es evidente, por tanto, la necesidad de nuevos fármacos que controlen la diabetes tipo 2. Aunque los protocolos en DM no son diseñados para cubrir las necesidades del sistema de salud en Colombia, influyen positivamente en los pacientes que participan en ellos al tener controlada la enfermedad y por ende podría haber una relación en la economía de la salud, pues al tener controlado metabólicamente un grupo de pacientes, se podrían evitar costos indirectos (mortalidad prematura y discapacidad debidas a la DM) o costos directos (medicación, hospitalizaciones, consultas y complicaciones de la DM) que no tendría que asumir el sistema de salud de Colombia. Al demostrar con métodos económicos la relación que tiene el desarrollo de ensayos clínicos en el país con la economía de la salud, se podrían involucrar varios actores (sistema de salud, EPS, IPS, profesionales de salud) lo que fomentaría la inversión por parte de la industria farmacéutica; por lo que es importante efectuar una evaluación económica aplicada, describiendo la minimización de costos, costo-beneficio, costo-efectividad, costo-utilidad de los ensayos clínicos. This paper addresses the most important features of clinical research in Colombia in Diabetic patients type 2 and their relation with health economics. Conducting clinical trials offers advantages to patients and research centers, firstly, provides access to experimental treatments to patients who would otherwise have no way of obtaining it, secondly, it favors the scientific community's contact with global medical research being at the forefront of the latest therapeutic advances and finally, providing a source of income for the centers and researchers, which in turn allows the financing of new research, training or purchasing of equipment to support research. Colombian Diabetes Observatory recognizes that DM represents an important economic burden and this is why clinical research can partially alleviate this situation and is also supported by the lack of anti-diabetics that is aggravated by the inherent problems of drugs existing in terms of efficacy, safety and tolerance, it is clear, therefore, the need for new drugs that control type 2 diabetes. Although the protocols in DM are not designed to meet the needs of the health system in Colombia, they positively influence the patients that participate in them by having controlled the disease and therefore could have a relation in the health economy, since having a group of patients metabolically controlled, indirect costs (premature mortality and disability due to DM) or direct costs (medication, hospitalizations, consultations and complications of DM) would not have to be assumed by the Colombian health system. By demonstrating with economic methods the relationship that has the development of clinical trials in the country with health economics, several actors could be involved (health system, EPS, IPS, health professionals) which would encourage investment from the pharmaceutical industry; so it is important to carry out an economic evaluation applied to health technologies: cost minimization, cost-benefit, cost-effectiveness, cost-utility.

In Nederland verrichten de geneesmiddelenindustrie en (academische) ziekenhuizen veel geneesmiddelenonderzoek met mensen; ze dienen jaarlijks zo'n 600 onderzoeksdossiers voor beoordeling in bij erkende medischethische toetsingscommissies. Bij de organisatie en uitvoering van klinisch onderzoek worden vaak Contract Research Organisaties (CRO's) betrokken. Deze organisaties kunnen worden ingehuurd door de opdrachtgever van klinisch onderzoek om functies en verplichtingen voor het onderzoek van hen over te nemen. Er blijken minstens 114 CRO's betrokken te zijn bij klinisch geneesmiddelenonderzoek in Nederland. De kwaliteitsborging van CRO's draagt bij aan de veiligheid en de kwaliteit van het klinisch onderzoek. Veel van de veldpartijen en overheidsinstanties die betrokken zijn bij klinisch onderzoek blijken tevreden over het kwaliteitsniveau van de CRO's in Nederland. Dit blijkt uit een onderzoek van het RIVM dat in opdracht van de Inspectie voor de Gezondheidszorg (IGZ) is uitgevoerd. De IGZ is verantwoordelijk voor het toezicht op het klinisch geneesmiddelenonderzoek. Een register van CRO's kan eraan bijdragen om meer overzicht van de CRO's in Nederland te krijgen. Er bestaat in Nederland wel een koepelvereniging voor CRO's, maar niet alle CRO's zijn daarbij aangesloten. Daarnaast zouden CRO's zelf en de bedrijven die CRO's inhuren, normen voor de eigen beroepsgroep (veldnormen) kunnen ontwikkelen die de kwaliteit van CRO's waarborgen.

Mestrado em Engenharia Geológica Ao longo da história, o Homem tem procurado benefícios para a saúde através do uso das águas termais. Apesar de se reconhecer atualmente a sua eficácia terapêutica, maior parte dos mecanismos de ação continuam desconhecidos. Os estudos científicos que documentam a eficácia terapêutica das águas termais são escassos, sendo necessário correlacionar a composição das águas termais com o tratamento das patologias existentes para credibilizar o tratamento termal como alternativa sustentada aos tratamentos convencionais. A presente dissertação foi elaborada com base na realização do estágio curricular na empresa “Grupo Natura Empreendimento S.A”, em que o objetivo foi a caracterização das águas minerais naturais (águas termais) dos Estabelecimentos Termais de Longroiva, Cró e Manteigas. No presente estudo foi recolhida informação em relação à localização das termas em termos geográficos e geológicos e hidrogeológicos. Neste trabalho foi realizado um ensaio metodológico com vista à implementação de um método para determinação quantitativa da concentração do H2S, através do método do potenciométrico, para a avaliação do sulfureto de hidrogénio. Nesta abordagem foram testados vários tipos de recipientes, tipo de preservação e ainda a determinação em laboratório ou in situ. Para a caracterização hidrogeoquímica das águas minerais naturais foram realizadas 5 campanhas de amostragem. No laboratório foram realizadas as análises químicas através do ICP-MS e cromatografia iónica. Os resultados do ensaio metodológico permitiram concluir que o método potenciométrico é o indicado para uma larga gama de valores de concentração de H2S devendo a sua determinação ser efetuada preferencialmente in situ e utilizando uma solução antioxidante de sulfureto (SAOB - sulfide antioxidant buffer). As águas apresentam fácies hidrogeoquímicas semelhante (bicarbonatada sódica) e são tendencialmente súlfureas distinguindo-se entre elas nas concentrações de elementos vestigiais, em especial o As, Ba, Li, W e Zn, Este estágio permitiu ainda contactar com as diferentes terapias utilizadas nos Estabelecimentos Termais. Throughout history, Man has search health benefits through the use of hot springs waters. Although its therapeutic effectiveness is currently recognized, most mechanisms of action remain unknown. Scientific studies documenting the therapeutic efficacy of the thermal waters are scarce, and it is necessary to correlate the composition of the thermal waters with the treatment of different pathologies to give credibility to the thermal treatment as a sustainable alternative to conventional treatments. The present dissertation was based on the curricular internship at the "Grupo Natura Empreendimento S.A", aiming the characterization of the natural mineral waters (thermal waters) of the Longroiva, Cró and Manteigas thermal establishments. Information was collected regarding spa location and also regarding geographic and geological and hydrogeological terms. In this work a methodological test was carried out aiming the implementation of a new approach for the quantitative determination of H2S concentration using an Ag / AgS Selective Electrode. This approach tested several types of containers, type of preservation and the determination in laboratory or in situ. For the hydrogeochemical characterization of the natural mineral waters, 5 sampling campaigns were carried out. In the laboratory, the chemical analyzes were performed through ICP-MS and ion chromatography. The results of the methodological study allowed us to conclude that the selective electrode method is suitable for a wide range of H2S concentrations values, preferentially in situ and using a sulphide antioxidant buffer (SAOB). The waters present similar hydrogeochemical facies (sodium bicarbonate), distinguishing between them the trace elements concentrations, especially As, Ba, Li, W and Zn, This internship also allowed to contact with the different therapies used in the Thermal Establishments.

Chronic technology and business process disparities between High Income, Low Middle Income and Low Income (HIC, LMIC, LIC) research collaborators directly prevent the growth of sustainable Global Health innovation for infectious and rare diseases. There is a need for an Open Source-Open Science Architecture Framework to bridge this divide. We are proposing such a framework for consideration by the Global Health community, by utilizing a hybrid approach of integrating agnostic Open Source technology and healthcare interoperability standards and Total Quality Management principles. We will validate this architecture framework through our programme called Project Orchid. Project Orchid is a conceptual Clinical Intelligence Exchange and Virtual Innovation platform utilizing this approach to support clinical innovation efforts for multi-national collaboration that can be locally sustainable for LIC and LMIC research cohorts. The goal is to enable LIC and LMIC research organizations to accelerate their clinical trial process maturity in the field of drug discovery, population health innovation initiatives and public domain knowledge networks. When sponsored, this concept will be tested by 12 confirmed clinical research and public health organizations in six countries. The potential impact of this platform is reduced drug discovery and public health innovation lag time and improved clinical trial interventions, due to reliable clinical intelligence and bio-surveillance across all phases of the clinical innovation process.

The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs. The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing regulatory affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company's regulatory affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO. This survey indicated that outsourcing in regulatory affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in regulatory affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present.

CRO National Cancer Institute Aviano have developed different repositories overtime to fit with the different library users needs: scientific output assessment or attendants access to the educational resources. These repositories lacks of overall integration and interoperability. Sometimes archives overlap or use different metadata standards. This affects the interoperability with other archives and the persistence of data. These data need to be managed and disclosed to other institutions, professionals and laymen as well. The CRO Scientific and Patients library in collaboration with University of Trieste developed CRO OpenDocuments (COD), the Institutional Repository for scientific and educational resources. COD has been developed exploiting DSpace-CRIS: chosen for its unique features like metadata standardization (Dublin Core / CERIF oriented), possibility to manage, collect and expose data of all the Research aspects (papers, journals, people, organization units, project...). Following the OpenAIRE Guidelines the interoperability with other archives is granted. We migrated data from the scientific papers, grey literature, CROnews institutional free press, Farmaci&Tumori independent drug bulletin archives. We also included the repository of the Patient Education & Empowerment program resources, specifically addressed to patients. COD had some relevant outcomes in the institution organization: the redefinition of an institutional policy for Open Access and Digital Right management.

The present work focuses on the study of healthcare networks as key tool for innovation creation and spreading, by deploying the emergent paradigm of Open Innovation. The study analyses the organisational methods through which bio-pharmaceutical companies open their innovation processes and enter into a relationship with external subjects called Contract Research Organizations (CROs) for the exchange of technology and knowledge. The paper describes the results of a survey conducted in the Italian bio-pharmaceutical sector, which showed how the high potential of Italian CROs has yet to be fully expressed, and outlining the ways through which the logic of openness is being exploited in the Italian context. The paper also tries to give some insights to the existing research on Open Innovation, studying the adoption of this approach in an industry where the adoption and implementation of openness-driven practices has been so far rather under-researched.

Tēmas aktualitāte: pēdējos gados zinātniskās literatūras dati norāda par pētījumiem par NLR, PLR, MPV, CRO lietošanu psoriātiskā artrīta (PsA) pacientu slimības aktivitātes un terapijas efektivitātes novērtēšanā (Kim D.S. et all 2015), (Fu H. et all 2015), (Kisacik B. et all 2008), (Yazici S. et all 2010). Pētījuma mērķis: Izvērtēt PsA pacientu CRO, EGĀ, NLR, PLR un MPV rādītāju noteikšanas nepieciešamību ārstēšanas laikā. Metodes un materiāli: Pētījums izstrādāts P. Stradiņa KUS Reimatoloģijas centrā. Pētījumā iekļauti 39 pacienti, kuriem bija diagnosticēts PsA. PsA pacienti tika sadalīti divās grupās – pēc slimošanas ilguma, un pēc saņemtās terapijas. Šo grupu ietvaros analizējām CRO, EGĀ, NLR, PLR un MPV rādītājus un savstarpēji tos salīdzinājām viena terapijas gada ietvaros. Dati tika iegūti no pacientu ambulatorajām kartiņām un tika veikta šo datu retrospektīva analīze. Abu grupu dalībniekiem no medicīniskās dokumentācijas tika analizēti šādi dati – pacientu vecums, dzimums, slimības ilgums, saņemtā terapija, CRO, EGĀ, MPV, neitrofilo leikocītu skaits, limfocītu skaits un trombocītu skaits. Pētījuma pacientu CRO, EGĀ, MPV, NLR, PLR dati tika ņemti no divām vizītēm ar gada starpību, un tika salīdzināti savā starpā. Pētījumā tika izvērtēts, vai CRO, EGĀ, MPV, NLR, PLR rādītāji var tikt izmantoti PsA aktivitātes izvērtēšanā, ņemot vērā pacientu saņemto terapiju. Rezultāti: Visu PsA pacientu terapijas efektivitātes izvērtēšanai var izmantot CRO (p = 0,001), NLR (p = 0,001),un PLR (p = 0,001) rādītājus, kuri samazinās efektīvas terapijas rezultātā. PsA pacientiem ar vidēji smagu un smagu PsA - slimības aktivitātes novērtējumam var izmantot CRO ( p = 0,001), EGĀ (p = 0,004), NLR (p = 0,001) un PLR (p = 0,001) rādītājus. PsA pacientiem, kas slimo ilgstoši terapijas efektivitātes izvērtēšanai var izmantot CRO (p = 0,007), NLR (p = 0,002) un PLR (p = 0,007) rādītājus. Secinājums: Pētījumā tiek pierādīta NLR un PLR lietošanas nepieciešamību PsA pacientiem Latvijā terapijas efektivitātes izvērtēšanā., Background: in recent years, scientific literature data indicate a studies on the NLR, PLR, MPV, CRP use in assessment of psoriatic arthritis (PsA) activity and treatment effectiveness (Kim D.S. et all 2015), (Fu H. et all 2015), (Kisacik B. et all 2008), (Yazici S. et all 2010). The aim of the study: to evaluate the need for CRP, ESR, NLR, PLR, MPV in PsA treatment efficiency assessment. Materials and methods: The study was developed in P. Stradiņa CUS Rheumatology center. The study included 39 patients who were diagnosed with PsA. PSA patients were divided into two groups – for duration of the illness and for treatment. Within these groups we analysed CRP, ESR, MPV, NLR and PLR and compared them within one year of treatment. Data were obtained from the patient medical records and was conducted a retrospective analysis of this data. The study examined whether CRP, ESR, MPV, NLR, PLR can be used in PsA activity evaluation taking into account received treatment. Results: for PsA treatment efficiency evaluation we may use CRP (p = 0,001), NLR (p = 0,001), PLR (p = 0,001), that decreases with increased efficiency of treatment. In cases when PsA has a moderate or severe activity – CRP (p = 0,001), ESR (p = 0,004), NLR (p = 0,001) and PLR (p = 0,001) may be used for the assessment of disease activity and treatment efficiency. In group of PsA patients suffering from PsA for long duration of time we can use CRP (p = 0,007), NLR (p = 0,002) and PLR (p = 0,007) for assessment of efficiency of treatment. Conclusion: the study indicates that NLR and PLR may be used in evaluation of PsA efficiency of treatment in Latvia.