sou · GWB37 · 2008-02-28 00:00:00 — Skapa ett nationellt program omfattande för global hälsa. Clinical research is a prerequisite for evidence-based and know- ledge-controlled high quality health service. It is the link between the laboratory and the patient – the work of clinical researchers is a guarantee that new knowledge rapidly reaches the health service and that important problems encountered by the latter are brought back into research. However, in different contexts several stake- holders have long indicated that Swedish clinical research has lost ground and is in need of considerable investment, not least in view of increased global competition. The Government has commissioned Professor to carry out an inquiry on the situation regarding clinical research, considering the needs and conditions of both the health service and research. The terms of reference include describing the prerequisite for clinical research in terms of organisation, allocation of resour- ces and research quality and also to shed light on industrys pre- conditions for carrying out clinical trials in . Based on these analysis, an action plan is presented with the aim of enhancing the quality of clinical research and providing researchers with a good work. The current shared responsibility for, and financing of, clinical research is not appropriate for research and its implementation in the health service. In all the countries that are successful in the area of clinical research, the university hospitals fall under a single authority. The division of responsibility issue and the forms for collaboration between the state, health service and the business sector will therefore be further analysed. The position Swedish cli- nical research hold internationally and the areas that are our strongest will be elucidated in the international evaluation to be carried out in the course of 2008. Additional proposals will be pre- sented in connection with the final report on 31 2009. The Inquirys definition of the concept clinical research refers to research that presupposes the structures and resources of the health service and whose objective is to solve problems of bad health or to identify factors leading to better health. This definition is inclusive rather than exclusive and has strong support among representatives of county councils and universities. A better basis for clinical research The action plan generally aims to enhance the quality of Swedish clinical research, strengthen recruitment and give clinical resear- chers a better work. In order to implement these investments, additional resources of in total SEK590 million a year, million of which in the form of new public funds, will be needed over the next five years. It is important to under- score that the measures do not just mean new financial contribu- tions to clinical research but also that they are necessary if is to receive full return on the substantial investments that have already been made in this area. From an international perspective, Swedish clinical research has clear competitive advantages: good education, a high proportion of devoted and research-trained staff in the health service, assets in the form of public health data registers, national healthcare quality registries and biobanks, patients who willingly take part in research projects and a good national health service. also has a long tradition in the area and for many years clinical research contribu- ted to the strong position Swedish industry holds today. Further- more, holds a strong position in the area of global health and infectious diseases with well established international coope- ration. All this adds up to competitive advantages that many other countries do not have. Swedish clinical research should therefore not be satisfied with being good enough – it has the potential to be world class! A new tactic characterised by prioritisation and collaboration Swedish clinical research must position itself in a stronger interna- tional competition. The ability to offer attractive environments – where new knowledge and hence new treatment methods and pharmaceutical products can be created – decides which countries make new advances and which countries lag behind. Moreover, there are major challenges both in and at the global level. The increasing proportion of elderly people, common diseases and health inequality put pressure on our research capacity. In the third world widespread infectious diseases such as HIV/AIDS, malaria and tuberculosis hold back whole nations in poverty. In order to be capable of meeting future challenges successfully, we must change tactics regarding clinical research. The key to suc- cess is the ability to identify the best researchers, give them good opportunities to carry on their activities and achieve good results. This calls for measures characterised by prioritisation and coopera- tion between the various stakeholders involved in clinical research. ranked eight in the world Several observations suggest that Swedish clinical research has dif- ficulties to such an extent that its quality has declined in recent decades compared with other countries. Researchers point to pro- blems in the form of lack of time, low merit value for research, poor career opportunities and a heavy administration. Industry points to a lack of research doctors and a declining interest in coo- perating in clinical trials. The Health service report difficulties in implementing research results in a shrinking economy. The univer- sities need increased faculty support and point out that the divided responsibility creates considerable problems. Receding quality can be clearly read in the bibliometric analysis commissioned by the Inquiry in which is ranked eight as regards citation of articles on clinical medicine. The breadth of Swedish clinical research is still relatively good, but there is lack of cutting edge research. The resources are not allocated to the best research What is known as the agreement is the most important link between the state and the county councils regarding responsibility for clinical research. Under this agreement, the state compensates the county councils for their clinical research undertakings (the funds). Clinical research in has a total budget of over billion a year. The two largest sources are the funds (billion) and the county councils own R&D funds (bil- lion). In addition there are university funds and resources from research councils, foundations and the EU. However, financing is very fragmented and the funds are chiefly distributed without any or with only regional competition. This means there is no gua- rantee that the funds support the best projects. The activity-related distribution model that is primarily used measures quality retros- pectively and this means it is difficult for new and truly innovative ideas to obtain support. The routines for following up and evaluating the research finan- ced by the funds and the county councils own R&D funds are generally weak. Although ambitious work is now in progress at several county councils, there are considerable differences and there is no uniform strategy. A clear national process for follow-up and evaluation is needed to be able to make future prioritisations. Leadership needs to be developed and strengthened Health service leaders play a very important role for the develop- ment and quality of clinical research in that they are responsible for recruitment of new staff to clinical departments and for ensuring that the environment meets the needs of clinical research, above all in the form of time for research. Today, however, responsibility for this is not sufficiently clear. Research is often be sacrificed in order to meet clinical efficiency demands. The leaders of the county councils must clearly specify that executives are charged with developing research in cooperation with the university. leaders with research experience need to be recruited and at univer- sity hospitals this should be self-evident. The measures are as follows: Better follow-up and evaluation: Request the (in Health Care) to create a national system for follow-up and evaluation of ALF-funded research. Request to assemble and publish research accounts from all county councils. Develop leadership and clarify the role of the leaders in the health service, particularly at the university hospitals. Clinical research in is facing a generation shift. In the coming ten-year period, 250 research-trained doctors are expected to retire annually. In order to retain a high quality in health and care, research and education, this loss of knowledge and experience must be replaced. The basis for recruitment to clinical research consists primarily of research-trained specialists, who have over 15 years trai- ning behind them before being able to embark on a research career of their own. , the long training period requires early and rapid efforts to cover future recruitment needs. 80 per cent of the research-trained body of physicians are doc- tors aged 45 or more. With an average age of 42 among the over 200 doctors a year receiving their MD/PhD a rejuvenation is not to be expected either. Thus, most doctors make a late start to their research career, which results in a scarcity of experienced resear- chers. In the long term this risks having repercussions on the qua- lity of research and recruitment of new researchers. For the individual researcher, research training is of no clear merit value and financial benefit. For many years it has been more beneficial to concentrate on clinical work rather than on a research career. Nevertheless, there are many doctors who are pre- pared to go into research. For them, specially adapted positions are needed that provide for long-term research work. the past 15 years, the number of research-trained staff with other types of training, for example nurses and phy- siotherapists, has increased considerably. Despite the fact that in the health service there is a great need to introduce new knowledge relating, inter alia, to nursing, there are largely no positions that utilise this research competence. A poll of senior leaders in the health service commissioned by the Inquiry clearly shows the need for more positions at different levels that give the health services doctoral staff time for research. Interest in such posts has proved to be extensive when different research have advertised posts. A considerable national priority on positions allowing time for research is needed. The measures are as follows: Strengthened recruitment and clearer career: Create 10 national research schools. Create 160 new junior and senior positions with time for research. Increased support to clinical research infrastructure is required The infrastructure is both the environment the researcher works in and the tools research is dependent on. It is therefore decisive for the results attained. Many of the countries with high clinical research ambitions are now making major investments in infra- structure. does not have a national strategy in this regard. Clinical research presupposes access to inter alia high tech equipment, compatible IT systems, biobanks and different regis- ters. This is costly infrastructure of national and sometimes also international interest that can be utilised by several research teams. It is therefore essential to organise and focus resources. The national healthcare quality registries are examples of natio- nal infrastructure which together with health data registers offer unique opportunities for research through their individual-linked data on progress of disease, diagnosis, treatment and result. However, the registries are underfinanced and need to be made more accessible. Translational research is about transferring knowledge from basic research via clinical research to the health service. The pur- pose being to achieve patient benefits. The development of transla- tional research in is therefore of vital importance and will give access to common infrastructure of various kinds. Through () within the , the state funds, among other things, expensive equipment and national research plants. KFIs total budget for 2007 was about million. Of this, around 10 per cent went to the area. KFI has estimated that Swe- den needs to invest million (2009–2012) in infrastructure that clinical researchers, among others, can utilise. The university hospitals must be considered the hub for clinical research Through their important role in training and research, the univer- sity hospitals are a natural hub for clinical research. They offer a hospital environment with access to research-trained staff, proxi- mity to the academy, patients, patient data and equipment. How- ever, university hospitals are not usually regarded as a unique research environment but simply as large hospitals with highly spe- cialised care. Executive staff do not have a clear mandate to ensure that their clinics and departments live up to the role of a research centre, which is connected with the fact that there is no demand for research from the leadership. This approach may also be noti- ced when the county councils discuss privatisation where the research assignment is easily forgotten. A lack of time and resour- ces and a less positive attitude to research are mentioned as reasons for this. Research positions and research funds must be steered towards the university hospitals to a greater extent and they should also be given an accentuated responsibility for implementation work in relation to other health and care. In particular, primary cares link to research needs to be improved. The complex responsibility role and the system with two stake- holders obstruct the operations of university hospitals. All assignments – both the actual health and care and training and research – are equally important and should furthermore be of high quality and carried on in parallel which imposes great demands on organisation and clear division of responsibility. The present system with two responsible authorities – the county council and the university – who are responsible for different parts of the assignment is not appropriate as far as clinical research is concer- ned. Regional research centres to be given an increasingly important role Research carried on outside the university hospitals has an impor- tant function in stimulating the research culture in the health ser- vice and making efforts to ensure that the sector becomes more disposed to change as far as accepting new knowledge is concerned. Nowadays, parts of training take place outside the uni- versity hospitals, which requires a broad research base throughout the country. and more patients are treated outside the uni- versity hospitals and in order to be able to involve them in research projects, regional research centres of high quality are needed. A precondition here is that these centres are linked to, and actively collaborate with, a university hospital. The model applied in the region – with a number of regional clinical research cen- tres linked to universities and funded in collaboration with the county councils – is interesting and could serve as a model. The measures are as follows: Increase support to translational research, biobanks and techni- cal platforms by million a year. Improve the national healthcare quality registries and make them accessible. Develop the university hospitals as a hub for clinical research. Research should lead to better health In the health area there are several major problems to solve. Swe- dens ageing population and the major common diseases challenge Swedish researchers. research is however also a global task. Since has several internationally reputed researchers and well developed cooperation with developing countries in , and Latin , we have good opportunities for contribu- ting to research that combats ill health and thereby poverty. The objective of all research is that in the long term it should give people better health with improved quality of life and reduced costs to society as a result. The use of research results goes from basic and clinical research via clinical studies and innovations to the health service. However, in order to succeed in transferring research results to patients, funding is needed in all phases of the research process. Many different research support clinical research but none of these has the clear task of supporting imple- mentation of the research results. In a worst case scenario, pharma- ceutical products and treatment methods resulting from research never reach the patient and the quality of the health service is not raised. Statistics from the show that the number of non-sponsored (academic) clinical studies has gradually declined over the last ten years, which is connected with the fact that they are costly and there are no obvious . Industrys contribution to progress in research in the health and area must also be seen as part of the implementation of research results. In this context, industry calls for improved opportunities for cooperation with the universities and the health service so as to be able to develop new innovations. research is no longer subject-based and a project may comprise everything from molecular biology experiments to clini- cal trials. This requires increased cooperation between researchers from different fields of research and, at the national level, an autho- rity with a cohesive grip on health research that is able to identify the major challenges in the area. The current organisation compri- sing the which finances basic research and () which funds public health research, is not appro- priate. Countries such as the and have suc- cessfully reformed their organisation and collected together their research resources in the health area. Under its terms of reference, on Evaluation of the Public Organisa- tion of Research Funding shall consider whether the system for research funding should be changed. The Inquiry Chair will submit her report not later than 28 2008. The measures are as follows: Increased health focus and better implementation of research results: Replace the current with a . Create a national programme comprising million a year for implementation and innovation. Create a national website for clinical research. Create a national programme comprising million a year for global health. Utan en väl fungerande klinisk forskning stagnerar hälso- och sjukvårdens utveckling och medborgarna kan inte garanteras en högkvalitativ och vetenskapligt baserad vård. Utan en klinisk forskning av högsta klass är det också omöjligt att ta ansvar för framtidens patienter. Den medicinska forskningen i har traditionellt sett haft mycket hög kvalitet och hävdat sig väl i inter- nationell konkurrens. En stark inhemsk läkemedelsindustri har också förstärkt ställning som ledande forskningsnation. har det emellertid i flera sammanhang och från olika aktörer kommit signaler om att den kliniska forsk- ningen till följd av ändrade ekonomiska och organisatoriska förut- sättningar i hälso- och sjukvården fått en allt svårare situation, med befarad sämre kvalitet och en svagare internationell position som följd. publicerade t.ex. redan i novem- ber 1998 utredningen Den kliniska forskningens kris och pris1 vilken konstaterade att rådets projektanslag för patientnära forsk- ning minskat sin andel från 1985/1995/96. Samma analys visade att förlorat sin framskjutna position bland de mest citerade länderna. har i olika underlag till regeringen, bland annat inför den senaste forsk- ningspolitiska propositionen, pekat på de kvarstående problemen. Regeringen gav professor i uppdrag att utreda den kliniska forskningens situation med hänsyn tagen till såväl hälso- och sjukvårdens som forskningens behov och villkor. I uppdraget ingår att beskriva organisatoriska frågor, 1Den kliniska forskningens kris och pris, 5. 2Utredningen av den kliniska forskningens behov och villkor samt förslag till åtgärdsplan. resurstilldelning och forskningens kvalitet liksom att belysa företa- gens förutsättningar för att genomföra kliniska prövningar i Sve- rige. Utifrån dessa beskrivningar ska utredaren lämna förslag till en åtgärdsplan för att stärka den kliniska forskningens situation och främja hög kvalitet i svensk klinisk forskning. Kommittédirektiv finns i sin helhet i bilaga 1. I detta delbetänkande görs översiktliga beskrivningar och analy- ser av de för åtgärdsförslagen relevanta frågorna. I slutbetänkandet, som ska avlämnas , avser Utredningen att återkomma med en internationell utvärdering av svensk klinisk forskning, en analys vad gäller mäns och kvinnors förutsättningar att bedriva klinisk forskning samt en fördjupad utvärdering av för- utsättningarna för kliniska prövningar. Vidare kommer en mer in- gående analys att göras av ansvarsfördelningen gällande klinisk forskning och universitetssjukhusens roll i sammanhanget. Utredningen har inhämtat underlag genom gemensamma möten med företrädare för landstingens och universitetens ledningar i , , , , och . Övriga landsting har ombetts svara på ett frågeformulär. Tre hearingar har ägt rum: med företrädare för forskningsfinansiärerna, med företrädare för läkemedelsindustrin samt med företrä- dare för patientorganisationerna. Ett antal möten har även ägt rum med representanter för övriga aktörer inom området, t.ex. BIO. Besök har gjorts vid () samt vid . har genomfört en registerstudie vad gäller rekrytering och återväxt och har gjort en bibliometrisk analys av den svenska kliniska forskningens genom- slag i internationella tidskrifter. Vidare har ett antal verksamhets- chefer intervjuats av . Där- utöver har information inhämtats genom litteraturstudier. Under arbetet med åtgärdsplanen har Utredningen haft sex expertsammanträden med livliga och givande diskussioner. Arbetet har bedrivits i nära samarbete med Delegationen för samverkan inom den kliniska forskningen. Kontakter har också tagits med företrädare för forskningsvärlden och hälso- och sjukvården i , , , och . Det närmast följande kapitlet innehåller åtgärdsplanen. Därefter följer i kapitel 3 en bakgrundsbeskrivning som belyser forskning- ens roll, ansvaret för densamma, finansiering samt några interna- utblickar. Till bakgrunden hör även en intervjusstudie bland ett antal verksamhetschefer. Kapitel 4 t.o.m. 7 innehåller där- efter närmare redovisningar av de förhållanden som lett fram till förslagen i åtgärdsplanen. 2 Förslag till åtgärdsplan Den globala konkurrensen kräver en ny taktik Det är i en hårdnande internationell konkurrens som svensk klinisk forskning ska hävda sig. Förutsättningen för vår utveckling inom detta område bestäms i hög grad av skeenden på den globala arenan. Globaliseringen medför att gränser öppnas. För ett litet land som innebär detta både hinder och möjligheter, särskilt inom sjukvårdens och den kliniska forskningens område. Kommunikationen och samarbetet mellan nationerna ökar. Vi får ökad tillgång till varandras kunskaper, som konkurrensen om forskare och resurser skärps. Förmågan att erbjuda attraktiva miljöer – där ny kunskap och därmed nya behandlingsmetoder och läkemedel kan skapas – avgör vilken nation som vinner ny mark och vilken som halkar efter. måste genomföra kraftfulla och långsiktiga satsningar för att klara den internationella konkurren- sen. Att kunna identifiera de bästa kliniska forskarna, ge dem goda möjligheter att bedriva sin verksamhet och få genomslag för forsk- ningens resultat är nyckeln till framgång. För att klara detta behöver en ny taktik, baserad på samverkan och priorite- ringar. Nuvarande myndighetsstrukturer, finansieringsformer och attityder fungerar inte längre. Allt detta måste förändras för den kliniska forskningens del, om vi vill att den även ska präglas av hög kvalitet och vara konkurrenskraftig.