Academic research in oncology is declining and the bureaucratic burden is a major contributory factor. Established researchers are frustrated by the administrative requirements imposed by their organisations, and the next generation of oncologists is being deterred from getting involved in research by the barriers encountered by their colleagues. Prof. Fabrice André, Director of the Research Division at Institut Gustave Roussy, Villejuif, France, discusses the main areas of concern and the ongoing changes to administrative procedures that will lead to a revival of academic research in oncology.
How has bureaucracy in academic clinical research changed over the last decades? Has there been a move from deregulation to overregulation?
Academic clinical research is essential for testing new ideas and concepts and, in the 1990s and early 2000s, academics could carry out this type of research quite quickly and cheaply without a significant burden of bureaucracy. That has now changed. Administration has become the biggest part of academic research and this makes it more expensive. As a result, it is becoming almost impossible to do anything other than clinical trials sponsored by pharmaceutical companies. There is undoubtedly an important place for pharmaceutical research oriented to new drug efficacy. However, there is a need for other types of research oriented towards new strategies, prevention, combinations, medical devices and exploration of patient populations and issues, such as survivorship, not yet included in pharmaceutical development. Without these, there will be a negative impact in the longer term because we will lose the creativity supplied by academic research. We need both academic and pharmaceutical research – not one or the other.
The current bureaucracy of clinical trials means that talented young people are no longer interested in having an academic career because 60% of what used to be a space of freedom-to-operate is now occupied by administrative work. Reducing bureaucracy and restoring effective research opportunities will automatically lead to new interest in academic research.
What are the main areas of bureaucratic burden?
There are three major areas of bureaucratic problems – data security, data capture and quality control, and partnership agreements between institutions. We all want to ensure that patient information is secure but the way that the EU General Data Protection Regulation (GDPR) is being applied makes it extremely difficult to move research forward and to share data. There is little or no evidence of patient data ever becoming de-anonymized during clinical research and we need to be able to access public databases. But the fear of personal details being released has led to overregulation, resulting in a reduction in research.
Unnecessary data capture and quality control is another aspect of excessive administration. In most studies, there is no need to analyse more than 50 variables at each time point but the trend for excessive data granularity is pushing administrative costs up so much that it is making studies impractical.
Administrative delays in setting up partnership agreements for researchers in different institutions to work together, or between institutions and regulators/ethical committees, are a major source of frustration. Multiple signatures and validations are now required to bring organisations together for collection, storage and analysis of data and samples, and this delays study completion by many months or even years.
Administrative delays in setting up partnership agreements for researchers in different institutions to work together, or between institutions and regulators/ethical committees, are a major source of frustration.
How can these problems be addressed?
The first step is to get those in senior positions like chief research officers or research directors to acknowledge that academic research is important and can make a significant contribution to medical advances. Without that, we will make no progress. We also need them to understand that research does not need so much administration, it does not need to take up 60 or 70% of the budget. Instead, we can do administration-light, pragmatic studies where the funds are spent on what really matters – the research itself.
We also need more integrated research, for example for clinical and translational studies. In some US institutions, there have already been major efforts to reduce bureaucracy by integrating the different stages of research, such as clinical studies, sample storage, profiling and analysis into a single workflow without administrative barriers.
In Europe, we have been slower to do this, and our more fragmented approach means that more administration is needed to fill the gaps. But we are making progress and integration of efforts is certainly the way forward.
Are you optimistic that academic research can make a come-back?
It is not a question of being optimistic or pessimistic. It is a question of whether people can work together to restore the balance between research and administration. That includes clinicians, patients and those who run our hospitals and institutions. To do that, we need to regain a belief in academic research and not just leave it to pharmaceutical companies and biotech to do all the clinical trials.
Part of the responsibility is for clinicians to create value and show the practical benefits of academic research on patient care. We also need patients to become aware of the bureaucratic issues that are slowing research and we should encourage them to support our efforts to reduce overregulation. They can have a powerful voice in helping us break down the administrative barriers and get academic research back into oncology.