Are clinical studies too bureaucratic?
Clinical studies are subject to evaluation by cantonal ethics commissions and to inspections by Swissmedic – the national agency for therapeutic products. Does Switzerland place too many restrictions on clinical research?
Image: Valérie Chételat
Image: Valérie Chételat
Ten years ago, you were able to begin a clinical study on patients within just a few weeks of setting up the protocol for it. Today you need to submit far more complicated information to the ethics commission, and if you’re studying a drug, you also need an evaluation from Swissmedic, the national agency for therapeutic products. These bureaucratic hurdles mean it can now take between six months to a year before you are actually allowed to start your research. The number and size of the documents you need to submit is increasing, as is the number of audits and inspections to which you’re subjected.
It is indisputable that the topmost propriety has to be the safety of the patients. They need to have the study explained to them comprehensively so that they can make a responsible decision about whether or not to participate. We also have to improve the quality of our research. Ethics commissions and Swissmedic play an important role in all this, and keep watch to ensure good clinical practices are upheld.
But are the authorities achieving their aims with these measures? No. The long, complicated information given to the patient isn’t read by anyone any more, let alone understood. This does nothing to ensure patient safety, but only provides legal safeguards for the sponsor. Even when it comes to everyday activities such as reading a study protocol, you have to conform to a prescribed standard operating procedure (SOP). This bureaucratisation no longer bears any relation to the actual risk involved in the study.
All this leads to additional personnel expenses. In the face of all this documentation, good common sense is often completely lost. The issues that are actually important and relevant for both the patient and for the researchers are simply forgotten. This doesn’t result in greater patient safety. On the contrary, there is a risk that real safety signals will be overlooked amidst all the irrelevant formalism of the bureaucratic procedures.
Young doctors are being suffocated more and more by admin, and this often scares them away from a career in research. This increasing bureaucratisation is preventing innovative, high-quality studies and is gobbling up resources that ought more sensibly to be invested in the science itself and in the test subjects. The result is that the number of independent studies initiated by researchers themselves will decline – especially in comparison with the financially powerful studies sponsored by the pharma industry. This is a bitter loss. If Switzerland is to remain efficient and attractive as a centre of research, this excessive bureaucracy urgently has to be reined in.
Research is a precious asset. But there’s a lot at stake: the need to protect participants in a study and the need to produce reliable results. So the quality requirements for research are correspondingly high. Ethics commissions endeavour to do their part when it comes to quality control. Planning has to be precise, and studies have to be conducted in a well-thought-through, standardised manner. Everything has to be documented carefully. That’s not bureaucracy, but a natural matter of course – and this applies regardless of the involvement of any authorities.
These requirements aren’t new. The internationally recognised rules for Good Clinical Practice have applied to academic research into therapeutic products in Switzerland since 2002 – because when it comes to participant safety and data validity, there is no difference between medical and industrial research.
Only after having assessed the fulfilment of scientific, ethical and legal requirements do ethics commissions issue authorisations to research projects. A significant proportion of applicants are notified of deficiencies and then have to clear administrative hurdles. This in itself is a sign that it’s not large-scale bureaucracy that is the problem: it’s usually unsatisfactory planning and a lack of quality awareness on the part of the scientists that is to blame.
For example, the research question might be unclear, or the design of the study might be inadequate to answer it. The assessment criteria for success might not have been properly defined, the statistical planning might be deficient, or perhaps it has not been properly determined who in the study team should take on what responsibilities. Risk-minimising measures might not have been exhausted, data protection regulations might have been interpreted too generously; and often, the information to be supplied to the patient is simply incomprehensible. The greater the number of deficits in an application, the longer it takes before it can finally be approved.
Many results cannot be repeated, and a quarter of all studies are discontinued prematurely; these two facts offer objective proof of quality deficits on the part of researchers. The scientific community itself has introduced measures to deal with the current problems. Clinical trial units at university hospitals have a fundamental role to play here. They will hopefully play an even bigger role than ethics commissions in solving the basic problems. The problem isn’t bureaucracy, but insufficient capacity for the planning and quality control of academic research. If there were greater capacity for this, we would be complaining about fewer shortcomings.
Bild: Valérie Chételat
Ten years ago, you were able to begin a clinical study on patients within just a few weeks of setting up the protocol for it. Today you need to submit far more complicated information to the ethics commission, and if you’re studying a drug, you also need an evaluation from Swissmedic, the national agency for therapeutic products. These bureaucratic hurdles mean it can now take between six months to a year before you are actually allowed to start your research. The number and size of the documents you need to submit is increasing, as is the number of audits and inspections to which you’re subjected.
It is indisputable that the topmost propriety has to be the safety of the patients. They need to have the study explained to them comprehensively so that they can make a responsible decision about whether or not to participate. We also have to improve the quality of our research. Ethics commissions and Swissmedic play an important role in all this, and keep watch to ensure good clinical practices are upheld.
But are the authorities achieving their aims with these measures? No. The long, complicated information given to the patient isn’t read by anyone any more, let alone understood. This does nothing to ensure patient safety, but only provides legal safeguards for the sponsor. Even when it comes to everyday activities such as reading a study protocol, you have to conform to a prescribed standard operating procedure (SOP). This bureaucratisation no longer bears any relation to the actual risk involved in the study.
All this leads to additional personnel expenses. In the face of all this documentation, good common sense is often completely lost. The issues that are actually important and relevant for both the patient and for the researchers are simply forgotten. This doesn’t result in greater patient safety. On the contrary, there is a risk that real safety signals will be overlooked amidst all the irrelevant formalism of the bureaucratic procedures.
Young doctors are being suffocated more and more by paperwork, and this often scares them away from a career in research. This increasing bureaucratisation is preventing innovative, high-quality studies and is gobbling up resources that ought more sensibly to be invested in the science itself and in the test subjects. The result is that the number of independent studies initiated by researchers themselves will decline – especially in comparison with the financially powerful studies sponsored by the pharma industry. This is a bitter loss. If Switzerland is to remain efficient and attractive as a centre of research, this excessive bureaucracy urgently has to be reined in.
Bild: Valérie Chételat
Research is a precious asset. But there’s a lot at stake: the need to protect participants in a study and the need to produce reliable results. So the quality requirements for research are correspondingly high. Ethics commissions endeavour to do their part when it comes to quality control. Planning has to be precise, and studies have to be conducted in a well-thought-through, standardised manner. Everything has to be documented carefully. That’s not bureaucracy, but a natural matter of course – and this applies regardless of the involvement of any authorities.
These requirements aren’t new. The internationally recognised rules for Good Clinical Practice have applied to academic research into therapeutic products in Switzerland since 2002 – because when it comes to participant safety and data validity, there is no difference between medical and industrial research.
Only after having assessed the fulfilment of scientific, ethical and legal requirements do ethics commissions issue authorisations to research projects. A significant proportion of applicants are notified of deficiencies and then have to clear administrative hurdles. This in itself is a sign that it’s not large-scale bureaucracy that is the problem: it’s usually unsatisfactory planning and a lack of quality awareness on the part of the scientists that is to blame.
For example, the research question might be unclear, or the design of the study might be inadequate to answer it. The assessment criteria for success might not have been properly defined, the statistical planning might be deficient, or perhaps it has not been properly determined who in the study team should take on what responsibilities. Risk-minimising measures might not have been exhausted, data protection regulations might have been interpreted too generously; and often, the information to be supplied to the patient is simply incomprehensible. The greater the number of deficits in an application, the longer it takes before it can finally be approved.
Many results cannot be repeated, and a quarter of all studies are discontinued prematurely; these two facts offer objective proof of quality deficits on the part of researchers. The scientific community itself has introduced measures to deal with the current problems. Clinical trial units at university hospitals have a fundamental role to play here. They will hopefully play an even bigger role than ethics commissions in solving the basic problems. The problem isn’t bureaucracy, but insufficient capacity for the planning and quality control of academic research. If there were greater capacity for this, we would be complaining about fewer shortcomings.
