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1.
Hunter P 《EMBO reports》2011,12(2):110-112
The 2001 EU Clinical Trials Directive aimed to harmonize the regulation of medical research, but achieved the opposite. Various attempts are underway to update the directive to make it easier to safely conduct medical research in Europe.Medical research, similarly to finance and business, works best with light regulation; however, protecting patients during clinical trials, and afterwards when treatments have been approved, requires regulation. Attempts to square this circle and the challenge of testing sophisticated drugs and therapies have resulted in increasingly strict regulation of clinical research, particularly in Europe''s leading medical research powers Germany, France, the Netherlands and the UK. There is growing concern among these countries with established pharmaceutical industries that clinical trials are increasingly hard to conduct; in fact, the number of applications has declined significantly during the past decade (Cressy, 2010).There is growing concern among these countries with established pharmaceutical industries that clinical trials are increasingly hard to conduct…Meanwhile, the number of applications for clinical trials has increased in the USA, Canada and some southern European countries, notably Italy and Spain, where the regulatory touch has been lighter and combined, in some cases, with financial incentives, according to Paul Stewart, Dean of Medicine at the University of Birmingham in the UK. There is a danger therefore that Europe''s leading research nations could lose their competitive edge in medical research at a time when radical new treatments are on the horizon. “Europe''s weight in clinical research is diminishing,” commented Markus Hartmann, senior consultant at European Consulting & Contracting in Oncology (Saarbrücken, Germany), which provides advice about medical regulatory affairs. The risk of falling behind extends beyond drug-based therapies to surgery and medical devices, Hartmann added. He explained that the European Commission now considers medical devices and drugs as ‘products'' that can be sold in the internal market, and therefore require a common and harmonized regulatory framework.Hartmann, along with other researchers, traces the recent decline in European clinical trial activity back to the European Union (EU)''s Clinical Trials Directive (CTD) 2001/20, which was supposed to provide a common framework for unifying regulation within the EU by 2020. “The Clinical Trials Directive is contributing to this effect, but is not the only factor,” said Hartmann.The root cause of the problem might be growing aversity to risk—which puts more emphasis on patient protection even when this is not necessary—but the EU directive has certainly fuelled this mood. “That initial EU Directive was actually quite a sensible document, but what was crazy was the legal creep that followed,” said Stewart. “What the lawyers did was legislate for the worst possible scenario, instead of seeing the directive as a facilitating document enabling people to go and do research.”The directive actually had the opposite effect from the original intent: it led to even more regulatory fragmentation within the EU. This was first identified in a 2006 report, co-authored by Hartmann, which cited significant divergence in the national implementations of the EU directive (Hartmann & Hartmann-Vareilles, 2006). France was found to have the strictest regime, in which all trials including those involving cosmetics were rigorously supervised.The directive actually had the opposite effect from the original intent: it led to even more regulatory fragmentation within the EUThis divergence still exists. “Basically, the lack of harmonisation has not been resolved, as the Clinical Trials Directive has been transposed into national legislation in the form of laws, ordinances and rules of implementation that still differ in so many procedural and technical aspects,” said Hartmann.Moreover, although the 2001 directive underlined maintaining current levels of patient protection, Hartmann argued that it has done little if anything to improve safety. “Do not forget the TeGenero disaster with compound TGN1412, tested in spring 2006 in a Northern London hospital,” he said. “This was Europe''s largest clinical research catastrophe so far and happened in the UK, after the UK switched from a very liberal trial notification system, where phase I trials with healthy volunteers were even exempted from notification or authorisation, to the provisions laid down by the Clinical Trials Directive.”These problems have now been acknowledged by both national governments and the EU itself, according to Liselotte Højgaard, chair of the Standing Committee of the European Medical Research Councils, and a medical imaging specialist at the University of Copenhagen in Denmark. “We have had very many meetings in Brussels about the issue […] and in the last year the EU has become convinced it is a problem,” she said. As a result the directive is going to be redrafted well before it runs its full 20-year course. “We have been invited to help them draft a new directive,” said Højgaard. “That is a major achievement.”The aim is to learn from previous mistakes and frame the new document to encourage harmonization and a reduction in bureaucracy and paperwork. “We must make it easier to implement in each member state,” commented Højgaard, who added that the approval process also needs to be streamlined so that clinical trial teams do not have to repeat the same steps at different stages of the approvals process. “One of the things we are thinking about here in Denmark is whether we can make a one-stop-shop approvals process so you don''t have to go in and send an application to the medicinal agency, and also to the ethical committee, and also to clinicaltrials.gov,” said Højgaard. She hopes this new structure will be in place by the time Denmark holds the EU presidency in early 2012, and will encourage the rest of Europe to adopt a similar approach.The aim is to learn from previous mistakes and frame the new document to encourage harmonization and a reduction in bureaucracy and paperworkHartmann also acknowledges progress on the harmonization front. He cited the Voluntary Harmonisation Procedure (VHP), which was introduced in early 2009 by a network of national authorities, the Clinical Trials Facilitation Group (CTFG). It was set up precisely to coordinate implementation of the 2001/20 directive across EU member states, with little success at first. Now, the VHP allows applicants to submit protocols for trials to be conducted in many EU countries to the respective authorities, which agree on an assessment. “Then in a subsequent step, the applicant can submit the protocol to the national authorities for authorisation,” said Hartmann. “The VHP pilot aims to prevent divergent outcomes in the trial authorisation process, for example when a protocol approved in one country is blocked in another country.”These developments could eventually lead to a Europe-wide agency dedicated to clinical research regulation, along the same lines as the European Research Council for fundamental research, which Højgaard described as a great success. Such an agency would organize trials across the whole continent through a single streamlined approvals process, thereby covering a population of 500 million people.Attempts to amend the EU 2001 directive have also been welcomed by big funding bodies such as the Wellcome Trust in the UK, a charitable foundation that funds medical and clinical research globally. “We recently issued a response to a public consultation paper from the European Commission, Assessment Of The Functioning Of The “Clinical Trials Directive” 2001/20/EC, in which we highlighted areas where the Directive could be streamlined to reduce bureaucracy, while maintaining an appropriate regulatory framework,” said David Lynn, Head of Strategic Planning and Policy at the Wellcome Trust. “We would like to see a more risk-based approach to regulation of clinical trials, a rationalisation of the multiple layers of bureaucracy and the approvals process.”Bureaucracy notwithstanding, a fundamental problem is finding the right balance between risks associated with different drugs or therapies. The 2001 directive has instead led to a one-size-fits-all approach, according to Stewart. “Part of the work we''ve been doing at the level of the UK Clinical Research Consortium is to look at risk–benefit analysis, so that you have a lower level of regulation on some things and higher on others that are unproven.” If, for example, an existing drug turns out to be effective against a disease for which it was not originally developed, it would not be necessary to conduct thorough safety trials. This was the case with aspirin, initially developed as a pain killer over a century ago, which also protects against both vascular disease and bowel cancer (ATT Collaboration, 2009; Din et al, 2010). During these trials, safety was still an issue as the drug was being used in a different context, but, even so, it was clear that acute side effects were highly unlikely.Bureaucracy notwithstanding, a fundamental problem is finding the right balance between risks associated with different drugs or therapiesWhile medical regulations in Europe err on the side of safety, they do little to regulate and harmonise the reporting of results after trials have occurred. The results from many clinical trials are never published as they fall victim to reporting bias for various reasons, notably because the pharmaceutical companies providing funding have an interest in promoting results favourable to their products and suppressing negative findings. A recent study by the Institute for Quality and Efficiency in Health Care (IQWiG) in Cologne, Germany, confirmed widespread publication bias in the past, which harmed patients through under-reporting of side effects (McGauran et al, 2010).“The most prominent example of harm caused by publication bias is probably the case of Class I anti-arrhythmic drugs,” said Beate Wieseler, deputy head of IQWiG''s Drug Assessment Department. In this 1980 trial, 9 of 49 patients with suspected acute myocardial infarction who were treated with a class I anti-arrhythmic drug (lorcainide) died, compared with only one patient in the placebo group, and yet the investigators ludicrously dismissed this as chance (Cowley et al, 1993). The results of the trial were not published until 1993 and, although the development of lorcainide was discontinued for commercial reasons, the investigators concluded that as a result of this delay in publication, the continuing use of class I drugs had led to several unnecessary deaths.By the same token, ineffective drugs have sometimes gained market approval after over-reporting of their benefits, in some cases ignoring other, more negative, studies. Wieseler and colleagues found that studies reporting positive results for a particular drug were published in higher impact journals and were more likely to be picked up by other publications and the mass media.Many cases of reporting bias, especially involving suppression of negative results, occurred 10 or more years ago. According to Stewart the situation has improved, although he concedes that, almost inevitably, journals will be drawn towards positive results given the increasing competition for readers and advertisers. “Whether publication bias goes on to the same extent now is debatable,” said Stewart, pointing out that clinical trials now have to be registered in Europe and the USA so that the data is public, even if it is not published in a journal.There will inevitably be some risk of bias in research funded by pharmaceutical companies, which, after all, are in the business to make money. It is therefore important to support ‘investigator-driven'' trials that are independent of any company, and it is here that the Wellcome Trust has an important role. “The Wellcome Trust supports the proposal for Investigator Driven Clinical Trials as joint collaborations across Europe,” said Lynn. “We fund academic clinical trials, which are usually independent of drug company interests.”Independent money for academic clinical trials has indeed been more crucial during the past few years, since the EU 2001/20 directive tends to favour research funded by drug companies with the money and resources to overcome the increasingly high bureaucratic hurdles. Lynn commented that universities had not been well served by recent legislation. “Academic institutions are less-well resourced and equipped than commercial sponsors to deal with the bureaucratic burden imposed by the Directive,” he said.In some cases these burdens have caused even young scientists to give up on promising research because they cannot stomach the paperwork involved…In some cases these burdens have caused even young scientists to give up on promising research because they cannot stomach the paperwork involved, according to Højgaard. “For the first time in my life as a boss, I had the experience when I came in to a morning conference and asked one of the young consultants ‘shouldn''t we do a clinical study on this'' and he said ‘no I simply haven''t got the energy for all this paper workload''.” This experience spurred her to lobby for change. Critics such as Højgaard and others therefore hope that the redrafting of the amendment and the ensuing changes in national legislation will liberate European medical research from the regulatory shackles that have held it back. 相似文献
2.
Howard Wolinsky 《EMBO reports》2010,11(9):664-666
Despite the scientific community''s overwhelming support for the European Research Council, many grant recipients are irked about red tapeThere is one thing that most European researchers agree on: B stands for Brussels and bureaucracy. Research funding from the European Commission (EC), which distributes EU money, is accompanied by strict accountability and auditing rules in order to ensure that European taxpayers'' money is not wasted. All disbursements are treated the same, whether subsidies to farmers or grants to university researchers. However, the creation of the European Research Council (ERC) in 2007 as a new EU funding agency for basic research created high hopes among scientists for a reduced bureaucratic burden.… many researchers who have received ERC funding have been angered with accounting rules inherited from the EC''s Framework Programmes…ERC has, indeed, been a breath of fresh air to European-level research funding as it distributes substantial grants based only on the excellence of the proposal and has been overwhelmingly supported by the scientific community. Nevertheless, many researchers who have received ERC funding have been angered with accounting rules inherited from the EC''s Framework Programmes, and which seem impossible to change. In particular, a requirement to fill out time sheets to demonstrate that scientists spend an appropriate amount of time working on the project for which they received their ERC grant has triggered protests over the paperwork (Jacobs, 2009).Luis Serrano, Coordinator of the Systems Biology Programme at the Centre for Genomic Regulation in Barcelona, Spain, and recipient of a €2 million ERC Advanced Investigator Grant for five years, said the requirement of keeping time sheets is at best a waste of time and worst an insult to the high-level researchers. “Time sheets do not make much sense, to be honest. If you want to cheat, you can always cheat,” he said. He said other grants he receives from the Spanish government and the Human Frontier Science Programme do not require time sheets.Complaints by academic researchers about the creeping bureaucratization of research are not confined to the old continent (see Opinion by Paul van Helden, page 648). As most research, as well as universities and research institutes, is now funded by public agencies using taxpayers'' money, governments and regulators feel to be under pressure to make sure that the funds are not wasted or misappropriated. Yet, the USA and the EU have taken different approaches to making sure that scientists use public money correctly. In the USA, misappropriation of public money is considered a criminal offence that can be penalized by a ban on receiving public funds, fines and even jail time; in fact, a few scientists in the USA have gone to prison.By contrast, the EU puts the onus on controlling how public money is spent upfront. Research funding under the EU''s Framework Programmes requires clearly spelt out deliverables and milestones, and requires researchers to adhere to strict accountability and auditing rules. Not surprisingly, this comes with an administrative burden that has raised the ire of many scientists who feel that their time is better spent doing research. Serrano said in a major research centre such as the CRG, the administration could minimize the paper burden. “My administration prepares them for me and I go one, two, three, four, five and I do all of them. You can even have a machine sign for you,” he commented. “But I can imagine researchers who don''t have the administrative help, this can take up a significant amount of time.” For ERC grants, which by definition are for ‘blue-skies'' research and thus do not have milestones or deliverables, such paperwork is clearly not needed.Complaints by academic researchers about the creeping bureaucratization of research are not confined to the old continentNot everyone is as critical as Serrano though. Vincent Savolainen at the Division of Biology at Imperial College London, UK, and recipient of a €2.5 million, five-year ERC Advanced Investigator Grant, said, “Everything from the European Commission always comes with time sheets, and ERC is part of the European Commission.” Still, he felt it was very confusing to track time spent on individual grants for Principal Investigators such as him. “It is a little bit ridiculous but I guess there are places where people may abuse the system. So I can also see the side of the European Commission,” he said. “It''s not too bad. I can live with doing time sheets every month,” he added. “Still, it would be better if they got rid of it.”Juleen Zierath, an integrative physiologist in the Department of Molecular Medicine at Karolinska Institutet (Stockholm, Sweden), who received a €2.5 million, five-year ERC grant, takes the time sheets in her stride. “If I worked in a company, I would have to fill out a time sheet,” she said. “I''m delighted to have the funding. It''s a real merit. It''s a real honour. It really helps my work. If I have to fill out a time sheet for the privilege of having that amount of funding for five years, it''s not a big issue.”Zierath, a native of Milwaukee (WI, USA) who came to Karolinska for graduate work in 1989, said the ERC''s requirements are certainly “bureaucracy light” compared with the accounting and reporting requirements for more traditional EU funding instruments, such as the ‘Integrated Projects''. “ERC allows you to focus more on the science,” she said. “I don''t take time sheets as a signal that the European Union doesn''t count on us to be doing our work on the project. They have to be able to account for where they''re spending the money somehow and I think it''s okay. I can understand where some people would be really upset about that.”…governments and regulators feel to be under pressure to make sure that the funds are not wasted or misappropriated…The complaints about time sheets and other bureaucratic red tape have caught the attention of high-level scientists and research managers throughout Europe. In March 2009, the EC appointed an outside panel, headed by Vaira Vike-Freiberga, former President of Latvia, to review the ERC''s structures and mechanisms. The panel reported in July last year that the objective of building a world-class institution is not properly served by “undue cumbersome regulations, checks and controls.” Although fraud and mismanagement should be prevented, excessively bureaucratic procedures detract from the mission, and might be counter-productive.Helga Nowotny, President of the ERC, said the agency has to operate within the rules of the EC''s Framework Programme 7, which includes the ERC. She explained that if researchers hold several grants, the EC wants recipients to account for their time. “The Commission and the Rules of Participation of course argue that many of these researchers have more than one grant or they may have other contracts. In order to be accountable, the researchers must tell us how much time they spend on the project. But instead of simply asking if they spent a percentage of time on it, the Commission auditors insist on time sheets. I realize that filling them out has a high symbolic value for a researcher. So, why not leave it to the administration of the host institution?”Particle physicist Ian Halliday, President of the European Science Foundation and a major supporter of the ERC, said that financial irregularities that affected the EU over many years prompted the Commission to tighten its monitoring of cash outlays. “There have been endless scandals over the agricultural subsidies. Wine leaks. Nonexistent olive trees. You name it,” he said. “The Commission''s financial system is designed to cope with that kind of pressure as opposed to trusting the University of Cambridge, for example, which has been there for 800 years or so and has a well-earned reputation by now. That kind of system is applied in every corner of the European Commission. And that is basically what is causing the trouble. But these rules are not appropriate for research.”…financial irregularities that affected the EU over many years prompted the Commission to tighten its monitoring of cash outlaysNowotny is sympathetic and sensitive to the researchers'' complaints, saying that requiring time sheets for researchers sends a message of distrust. “It feels like you''re not trusted. It has this sort of pedantic touch to it,” she said. “If you''ve been recognized for doing this kind of top research, researchers feel, ‘Why bother [with time sheets]?''” But the bureaucratic alternative would not work for the ERC either. This would mean spelling out ‘deliverables'' in advance, which is clearly not possible with frontier research.Moreover, as Halliday pointed out, there is inevitably an element of fiction with time sheets in a research environment. In his area of research, for example, he considers it reasonable to track the hours of a technician fabricating parts of a telescope. But he noted that there is a different dynamic for researchers: “Scientists end up doing their science sitting in their bath at midnight. And you mull over problems and so forth. How do you put that on a time sheet?” Halliday added that one of the original arguments in establishing the ERC was to put it at an arm''s length from the Commission and in particular from financial regulations. But to require scientists to specify what proportion of their neurons are dedicated to a particular project at any hour of the day or night is nonsensical. Nowotny agreed. “The time sheet says I''ve been working on this from 11 in the morning until 6 in the evening or until midnight or whatever. This is not the way frontier research works,” she said.Halliday, who served for seven years as chief executive of the Particle Physics and Astronomy Research Council (Swindon, UK), commented that all governments require accountability. In Great Britain, for instance, much more general accountability rules are applied to grantees, thereby offering a measure of trust. “We were given a lot of latitude. Don''t get me wrong that we allowed fraud, but the system was fit for the purpose of science. If a professor says he''s spending half his time on a certain bit of medical research, let''s say, the government will expect half his salary to show up in the grants he gets from the funding agencies. We believe that if the University of Cambridge says that this guy is spending half his time on this research, then that''s probably right and nobody would get excited if it was 55% or 45%. People would get excited if it was 5%. There are checks and balances at that kind of level, but it''s not at a level of time sheets. It will be checked whether the project has done roughly what it said.”Other funding agencies also take a less bureaucratic approach. Candace Hassall, head of Basic Careers at the Wellcome Trust (London, UK), which funds research to improve human and animal health, said Wellcome''s translation awards have milestones that researchers are expected to meet. But “time sheets are something that the Wellcome Trust hasn''t considered at all. I would be astonished if we would ever consider them. We like to work closely with our researchers, but we don''t require that level of reporting detail,” she said. “We think that such detailed, day-by-day monitoring is actually potentially counterproductive overall. It drives people to be afraid to take risks when risks should be taken.”…to require scientists to specify what proportion of their neurons are dedicated to a particular project at any hour of the day or night is nonsensicalOn the other side of the Atlantic, Jack Dixon, vice president and chief scientific officer at the Howard Hughes Medical Institution (Chevy Chase, MD, USA), who directs Hughes'' investigator programme, said he''d never heard of researchers being asked to keep time sheets: “Researchers filling out time sheets is just something that''s never crossed our minds at the Hughes. I find it sort of goofy if you want to know the truth.”In fact, a system based on trust still works better in the academic worldInstead, Hughes trusts researchers to spend the money according to their needs. “We trust them,” Dixon said. “What we ask each of our scientists to do is devote 75% of their time to research and then we give them 25% of their time which they can use to teach, serve on committees. They can do consulting. They can do a variety of things. Researchers are free to explore.”There is already growing support for eliminating the time sheets and other bureaucratic requirements that come with an ERC grant, and which are obviously just a hangover from the old system. Indeed, there have been complaints, such as reviewers of grant applications having to fax in copies of their passports or identity cards, before being allowed sight of the proposals, said Nowotny. The review panel called on the EC to adapt its rules “based on trust and not suspicion and mistrust” so that the ERC can attain the “full realization of the dream shared by so many Europeans in the academic and policy world as well as in political milieus.”In fact, a system based on trust still works better in the academic world. Hassall commented that lump-sum payments encourage the necessary trust and give researchers a sense of freedom, which is already the principle behind ERC funding. “We think that you have to trust the researcher. Their careers are on the line,” she said. Nowotny hopes ERC will be allowed to take a similar approach to that of the Wellcome Trust, with its grants treated more like “a kind of prize money” than as a contract for services.She sees an opportunity to relax the bureaucratic burden with a scheduled revision of the Rules of Participation but issues a word of caution given that, when it comes to EU money, other players are involved. “We don''t know whether we will succeed in this because it''s up to the finance ministers, not even the research ministers,” she explained. “It''s the finance ministers who decide the rules of participation. If finance ministers agree then the time sheets would be gone.” 相似文献
3.
P Hunter 《EMBO reports》2012,13(9):795-797
A shortage of skilled science labour in Europe could hold back research progress. The EU will increase science funding to address the problem, but real long-term measures need to start in schools, not universities.Scientists have always warned about the doom of research that could result from a shortage of students and skilled labour in the biomedical sciences. In the past, this apocalyptic vision of empty laboratories and unclaimed research grants has seemed improbable, but some national research councils and the European Union (EU) itself now seem to think that we may be on the brink of a genuine science labour crisis in Europe. This possibility, and its potential effects on economic growth, has proven sufficiently convincing for the European Commission (EC) to propose a 45% increase to its seven-year research and development budget of 45%—from €55 billion, provided under the Framework Programme (FP7), to €80 billion—for a new strategic programme for research and innovation called Horizon 2020 that will start in 2014.This bold proposal to drastically increase research funding, which comes at a time when many other budgets are being frozen or cut, was rigorously defended in May 2012 by the EU ministers responsible for science and innovation, against critics who argued that such a massive increase could not be justified given the deepening economic crisis across the EU. So far, the EU seems to be holding to the line that it has to invest more into research if Europe is to compete globally through technological innovation underpinned by scientific research.Europe is caught in a pincer movement between its principle competitors—the USA and Japan, which are both increasing their research budgets way ahead of inflation—and the emerging economies of China, India, Brazil and Russia, which are quickly closing from behind. The main argument for the Horizon 2020 funding boost came from a study commissioned by the EU [1], which led the EC to claim that Europe faces an “innovation emergency” because its businesses are falling behind US and Japanese rivals in terms of investment and new patents. As Martin Lange, Policy Officer for Marie Curie Actions—an EU fellowship programme for scientists—pointed out, “China, India and Brazil have started to rapidly catch up with the EU by improving their performance seven per cent, three per cent and one per cent faster than the EU year on year over the last five years.”According to Lange, Europe''s innovation gap equates to a shortage of around 1 million researchers across the EU, including a large number in chemistry and the life sciences. This raises fundamental issues of science recruitment and retention that a budget increase alone cannot address. The situation has also been confused by the economic crisis, which has led to the position where many graduates are unemployed, and yet there is still an acute shortage of specialist skills in areas vital to research.This is a particularly serious issue in the UK, where around 2,000 researcher jobs were lost following the closure of pharmaceutical company Pfizer''s R&D facility in Kent, announced in February 2011. “The travails of Pfizer have affected the UK recruitment market,” explained Charlie Ball, graduate labour market specialist at the UK''s Higher Education Careers Services Unit. The closure has contributed to high unemployment among graduates, particularly chemists, who tend to be employed in pharmaceutical research in the UK. “Even among people with chemistry doctorates, the unemployment rate is higher than the average,” he said.The issue for chemists, at least in the UK, is not a skills shortage, but a skills mismatch. Ball identified analytical chemistry as one area without enough skilled people, despite the availability of chemists with other specialties. He attributes part of the problem to the pharmaceutical industry''s inability to communicate its requirements to universities and graduates, although he concedes that doing so can be challenging. “One issue is that industry is changing so quickly that it is genuinely difficult to say that in three or four years time we will need people with specific skills,” Ball explained.So far, the EU seems to be holding to the line that it has to invest more into research […] to compete globally through technological innovation underpinned by scientific researchAlongside this shortage of analytical skills, the UK Medical Research Council (MRC) has identified a lack of people with practical research knowledge, and in particular of experience working with animals, as a major factor holding back fundamental and pre-clinical biomedical research in the country. It has responded by encouraging applications from non-UK and even non-EU candidates for doctoral studentships that it funds, in cases where there is a scarcity of suitable UK applicants.But, the underlying problem common to the whole of Europe is more fundamental, at least according to Bengt Norden, Professor of Physical Chemistry at the University of Gothenburg in Sweden. The issue is not a shortage of intellectual capital, Norden argues, but a growing lack of investment into training chemists, which in turn undermines life sciences research. Similarly to many other physical chemists, Norden has worked mainly in biology, where he has applied his expertise in molecular recognition and function to DNA recombination and membrane translocation mechanisms. He therefore views a particularly acute recruitment and retention crisis in chemistry as being a drag on both fundamental and applied research across the life sciences. “The recruitment crisis is severe,” Norden said. “While a small rill of genuinely devoted‘young amateur scientists‘ still may sustain the recruitment chain, there is a general drain of interest in science in general and chemistry in particular.” He attributes this in part to sort of a ‘chemophobia'', resulting from the association of chemistry with environmental pollution or foul odours, but he also blames ignorant politicians and other public figures for their negative attitude towards chemistry. “A former Swedish Prime Minister, Goran Persson, claimed that ‘his political goal was to make Sweden completely free from chemicals'',” Norden explained by way of example.Scientists themselves also need to do a better job of countering the negative perceptions of chemistry and science, perhaps by highlighting the contribution that chemistry is already making to clearing up pollution. Chemistry has been crucial to the development of microorganisms that can be used to break down organic pollutants in industrial waste, or clear up accidental spillage during transport. In fact, chemistry has specifically addressed the two major challenges involved: the risk that genetically engineered microorganisms could threaten the wider environment if they escape, and the problem that the microorganisms themselves can be poisoned if the concentration of pollutants is too high.A team at the University of Buenos Aires in Argentina has solved both problems by developing a material comprising an alginate bead surrounded by a silica gel [2]. This container houses a fungus that produces enzymes that break up a variety of organic pollutants. The pores of the hydrogel can limit the intake of toxic compounds from the polluted surroundings, thus controlling the level of toxicity experienced by the fungus, whilst the fungus itself is encapsulated inside the unit and cannot escape. Norden and others believe that if such examples were given more publicity, they would both improve the reputation of chemistry and science in general, and help to enthuse school students at a formative age.…Europe''s innovation gap equates to a shortage of around 1 million researchers across the EU, including a large number in chemistry and the life sciencesUnfortunately, this is not happening in schools, according to Norden, where the curriculum is failing both to enthuse pupils through practical work, and to inform them of the value of chemistry across society: “school chemistry neither stimulates curiosity nor does it promote understanding of what is most important to everybody,” he said. “It should be realized that well-taught chemistry is a necessary tool for dealing with everyday problems, at home or at work, and in the environment, relating to function of medicines, as well as what is poisonous and what is less noxious. As it is, all chemicals are presented simply as poisons.”Norden believes that a broader cultural element also tends to explain the particular shortage of analytical skills in chemistry. He believes that young people are more inclined than ever before to weigh up the probable rewards of a chosen profession in relation to the effort involved. “There seems to be a ‘cost–benefit'' aspect that young people apply when choosing an academic career: science, including maths, is too hard in relation to the jobs that eventually are available in research,” he explained. This ‘cost–benefit'' factor might not deter people from studying subjects up to university level, but can divert them into careers that pay a lot more. Ball believes that there is also an issue of esteem, in that people tend to gravitate towards careers where they feel valued. “Our most able graduates don''t see parity in esteem between research and other professions being represented by the salary they are paid,” he explained. “That is an issue that needs to be resolved, and it is not just about money, but working hard to convince these graduates that there is a worthwhile career in research.”Our most able graduates don''t see parity in esteem between research and other professions being represented by the salary they are paid,Lange suggests that it would be much easier to persuade the best graduates to stay in science if they were able to pursue their ideas free from bureaucracy or other constraints. This was a main reason to start the Marie Curie Actions programme of which Lange is a part, and which will be continued under Horizon 2020 with a new name, Marie Skłodowska-Curie Actions, and an increased budget. “The Marie Curie Actions have been applying a bottom-up principle, allowing researchers to freely choose their topic of research,” Lange explained. “The principle of ‘individual-driven mobility'' that is used in the Individual Fellowships empowers researchers to make their own choices about the scientific topic of their work, as well as their host institutions. […] It is a clear win–win situation for both sides: researchers are more satisfied because they are given the opportunity to take their careers in their own hands, while universities and research organizations value top-class scientists coming from abroad to work at their institutes.”Lange also noted that although Marie Curie Fellows choose their own research subjects, they tend to pursue topics that are relevant to societal needs because they want to find work afterwards. “More than 50% of the FP7 Marie Curie budget has been dedicated to research that can be directly related to the current societal challenges, such as an ageing population, climate change, energy shortage, food and water supply and health,” he said. “This demonstrates that researchers are acting in a responsible way. Even though they have the freedom to choose their own research topics, they still address problems that concern society in general.” In addition, Marie Curie Actions also encourages engagement with the public, feeding back into the wider campaign to draw more people into science careers. “Communicating science to the general public will be of importance as well, if we want to attract more young people to science,” Lange said. “Recently, the Marie Curie Actions started encouraging their Fellows to engage in outreach activities. In addition, we have just launched a call for the Marie Curie Prize, where one of the three Prize categories will be ‘Communicating Science''.”Another important element of the EU''s strategy to stimulate innovative cutting edge research is the European Research Council (ERC). It was the first pan-European funding body for front-line research across the sciences, with a budget of €7.5 billion for the FP7 period of 2007–2013, and has been widely heralded as a success. As a result, the ERC is set to receive an even bigger percentage increase than other departments within Horizon 2020 for the period 2014–2020, with a provisional budget of €13.2 billion.Leading scientists, such as Nobel laureate Jean-Marie Lehn, from Strasbourg University in France, believe that the ERC has made a substantial contribution to innovative research and, as a result, has boosted the reputation of European science. “The ERC has done a fantastic job which is quite independent of pressures from the outside,” he said. “It is good to hear that taking risks is regarded as important.” Lehn also highlighted the importance of making it clear that there are plenty of opportunities in research beyond those funded, and therefore dictated, by the big pharmaceutical companies. “There is chemistry outside big pharma, and life beyond return on investment,” he said. Lehn agreed that there must be a blend between blue sky and goal-oriented research, even if there is an argument over what the blend and goals should be.…the ERC has made a substantial contribution to innovative research and, as a result, has boosted the reputation of European scienceThere is growing optimism that Europe''s main funding bodies, including the national research councils of individual countries, have not only recognized the recruitment problem, but are taking significant steps to address it. Even so, there is still work to be done to improve the image of science and to engage students through more stimulating teaching. Chemistry in particular would benefit from broader measures to attract young people to science. Ultimately, the success of such initiatives will have much broader effects in the life sciences and drug development. 相似文献
4.
Philip Hunter 《EMBO reports》2013,14(12):1047-1049
EU-LIFE, which represents 10 European life science research institutes, has reopened the debate about how to fund research at the European level by calling for the budget of the European Research Council to be drastically increased.For more than a decade, European scientists have lobbied policy makers in Brussels to increase European Union (EU) funding for research and to spend the money they do provide more efficiently. This debate eventually led to the establishment of the European Research Council (ERC) in 2007, which provides significant grants and does so on the sole criterion of scientific excellence—something for which the scientific community pushed. As such, there seemed to be consensus about how to judge and fund science at the European level, including in the debate about the EU''s Horizon 2020 funding scheme—the EU''s framework for research and innovation—which will spend €80 billion over the next seven years (2014–2020). The conclusion seemed to be that the ERC should continue to support basic research on the basis of excellence, whereas other parts of the programme would focus on large cooperative projects, improving the competitiveness of Europe and meeting societal challenges such as climate change and public health.But a new body called EU-LIFE—set up in May 2013—has reopened the debate about how to fund science and is campaigning for a greater focus on rewarding excellence, even at the expense of funding projects on the grounds of fairness or to correct imbalances between EU member states. EU-LIFE was founded by 10 institutions including the Centre for Genomic Regulation (CRG; Barcelona, Spain), the Institut Curie (Paris, France) and the Max Delbrück Centre (Berlin, Germany), partly to provide a collective voice for mid-sized research institutes in the life sciences that might lack influence on their own (Institute Advanced grant Starting grant Proof-of-concept grant Total ERC grants Total ERC funding (million €) Centre for Genomic Regulation (Spain) 3 9 1 13 19.0 Free University of Brussels (VIB; Belgium) 5 14 1 20 33.3 Institut Curie (France) 7 11 – 18 34.5 Max Delbrück Centre for Molecular Medicine (Germany) 4 4 – 8 15 Instituto Gulbenkian de Ciência (Portugal) 1 4 – 5 7.8 Research Centre for Molecular Medicine of the Austrian Academy of Sciences (Austria) 1 2 1 4 5.1 European Institute of Oncology (Italy) 3 1 1 5 8.7 Central European Institute of Technology (Czech Republic) – – – – – The Netherlands Cancer Institute (Netherlands) 6 4 – 10 19.5 Institute for Molecular Medicine Finland (Finland) – – – – –