The European Society of Cardiology
A research project focusing on uncommon aspects and novel markers in congestive heart failure
Critical evaluation of multicentre research management
a Department of Cardiology, IRCCS Policlinico San Matteo, Pavia, Italy
b Molecular Diagnostics, Cardiovascular and Transplant Pathology Laboratory, Transplant Research Area, IRCCS Policlinico San Matteo, Pavia, Italy
* Correspondence: Tel.: +39 382 503157; fax: +39 382 503159 (E-mail: l.tavazzi{at}smatteo.pv.it).
Introduction
In 1999, a research project was funded by the Ministry of Health to the Institute of Research and Care University Hospital Policlinico San Matteo of Pavia with the aim of focusing on translational, orphan and modelling research in congestive heart failure (CHF). Centres involved in the project had the specific objectives of contributing to:
- • the aetiology and diagnosis, by investigating:
- – animal models of frequent CHF-causing disease (the ischemic model);
- – clinical models (based on non-invasive tools) that could address clinicians to the identification of familial and non-familial forms with the specific aim of better oriented aetiological research, early diagnosis, and prevention of adverse events;
- – non-cardiac diagnostic tools that could help aetiology identification: the skeletal muscle biopsy in patients with dilated cardiomyopathy,
- – clinical models (based on non-invasive tools) that could address clinicians to the identification of familial and non-familial forms with the specific aim of better oriented aetiological research, early diagnosis, and prevention of adverse events;
- • highlight the patho-physiology of CHF:
- – right ventricular dysfunction, immune activation, and mechanism of arterial stiffness in CHF;
- – spontaneous human models able to provide insights into the mechanisms of factors that have a negative impact on the outcome: CHF in systemic sclerosis and pulmonary hypertension in HIV patients,
- – spontaneous human models able to provide insights into the mechanisms of factors that have a negative impact on the outcome: CHF in systemic sclerosis and pulmonary hypertension in HIV patients,
- • non-pharmacological treatments and bridge to transplantation for end-stage patients, novel pharmacological, non-conventional treatments such as anti-cytokine therapy and ventilatory assistance in acute CHF.
- • new management models to promote de-hospitalisation and humanisation of CHF medicine: telemedicine.
- – animal models of frequent CHF-causing disease (the ischemic model);
The above items (Fig. 1) were explored by the different groups of investigators participating in the project and generated several products that should have had:
- • translational effects on the current clinical practice in the single centres, as well as at national levels, and
- • educational impact on investigators who shared reciprocal comparisons and evaluation of their products
- • educational impact on investigators who shared reciprocal comparisons and evaluation of their products
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Scientific contributions were published in national and international cardiology journals, and further contributions have been planned for the present joint editorial initiative after revision by the scientific committee of the project.
The project was funded with 500,000
and included 14 centres for a duration of 2 years that was prolonged to 3 years with the approval of the Ministry of Health. Therefore a mean amount of about 35,000 was available for each centre and this had to cover 3 years of activity.
The measurement of the proportion between investment and results is a difficult task: benchmarking models are not available for research funded with public resources. However, useful information on how to plan, manage and optimise research funded with public contributions could be derived by interrogating partners on their experience and results. The present introductory editorial aims at recording the perception of investigators involved in the plan, and to gather their evaluation on the management as well as the considerations of the plan coordinator on the management of research.
Materials and methods
To obtain homogeneous data on the single evaluation of the investigators of the project, a questionnaire was used, listing a series of questions on the difficulties encountered during the project, as well as on the match between plans, expectations and results. The questionnaire was submitted to the investigators at the end of the project, and the answers were evaluated.
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Results
In general, all partners agreed that the experience of the scientific collaboration was satisfactory. Results were graded as sufficient with respect to the overall activities that were necessary to perform the research. None of the investigators gave full marks for the cross match between results and activities that were performed to the aims of the project. Overall, the costs for personnel and consumables were higher than the funds.
Administrative difficulties were mostly concentrated on the delay of availability of funds. Within the same country, the overall amount of funds detracted by the single administration differed from centre to centre. The percentage of overheads applied by the administration offices of the different centres varied from 10 to 50. For all research units, the funds of the present project were considered as a co-financing, joining other funds from different projects whose aims were partly different but addressed to the same field of investigation.
All partners performed research activities in their own field of interest and expertise: none modified their interest for the given project. All were running research in the field of CHF and the majority of centres had other parallel projects funded with other resources that integrated the overall costs.
When asked about improvement of the multi-centric collaboration, all agreed upon a potential implementation of the processes. The involvement of the majority of the partners in the clinical activity for more than 50% of their time, plus the other ongoing plans of research (similar in terms of the general field of research but different on the specific projects) obligated researchers to make use of their free time to carry out research.
Among suggestions for improving the collaboration among centres, all investigators underlined the need for improving communication among investigators and increase the time dedicated to research. Finally, all would be happy to take part in similar projects in the future and underlined collaboration and knowledge progression as the major benefits of the project.
Scientific results
Overall, the project generated both positive and negative results. Currently, it is easy to highlight the former, less gratifying and sometimes less easy to inform the clinical and scientific community about the latter. Negative results do not have the same opportunities for publication in scientific journals as the positive ones. This is a risky situation: in order to obtain funding, it is necessary to show evidence of a good scientific career. This relies on accepted publications. Accordingly a tendency to move towards more productive but less original fields might be favoured. Anyway, the original results of the research contained in the present issue reflect the original aims and plans. Results are summarised in Table 1.
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Discussion
What can be learnt from this analysis?
- 1. Mismatch between the expectancies and the results: none of the investigators were fully satisfied with the collaborative project. Administrative and fund-related problems weighed upon this evaluation. The Italian, as well as other EU countries, setting of research funding is quite complex. Calls come out from the Ministry of University and Research, Ministry of Health, and private foundations. For the majority of research groups, an overall budget for the completion of a full research plan is met by adding funds from different sources. In other words, although each single project has to maintain its individual specificity, the overall plan and research activities are run by integrating small contributions from many different sources. This strategy reflects the profile of "fragmentation" of resources, obligating researchers to spend a lot of time writing proposals, and scientific and administrative reports.
- 2. Research is under-funded: the ratio between available funds and the number of applications is usually disproportionate. Furthermore, criteria that make a proposal eligible include the networking implementation among centres. This is true for both national and EU strategies. A project involving 14 centres lasting 2 or 3 years is under-funded with 500,000
. Furthermore, there is a disproportion between the planned and funded activities. In general, projects are funded by about 50–60% of the requests. The resulting effects include: reduction of the activities (i.e. the sample size), and/or oversimplifying of the methods, and/or re-addressing the plans to partial activities. This is a negative starting point: it implies that each investigator has to recalculate costs and times, to re-plan the project and to modify the feasibility plans. In general, re-planning the project abates the values of the objectives.
- 3. The price of this research programming approach is paid by researchers and patients whose benefits in terms of health do not proportionally reflect the financial contribution (actually small) that each citizen in Italy, as well as in other EU countries and in Europe, pays for scientific research.
- 4. Time for research and motivation. The consensus among investigators of the use of free time to perform research could be considered positive because it implies a strong motivation, but negative when realising the mismatch between investments and activities. The relevance of a given research project usually lies in its conceptual value at the time of planning and submission. However, the fast evolution of knowledge often makes a topic or an idea less valuable, or even obsolete by the time of approval and the research conclusion. This is particularly true for multi-factorial and common diseases such as CHF, which a multitude of research centres are dealing with, while plans can be better respected for rare diseases in which few expert centres are involved.
- 5. Getting together the fragmentation of the resources the limitations of the budgets, the exhaustive bureaucracy (administrative difficulties, complex reporting) the long evaluation and the screening processes of proposals may discourage investigators and re-address time and resources versus easily feasible researches, such as clinical trials i.e. professionally planned and organised by private committers. The final risk is that of missing the individual credibility and the independent research.
- 2. Research is under-funded: the ratio between available funds and the number of applications is usually disproportionate. Furthermore, criteria that make a proposal eligible include the networking implementation among centres. This is true for both national and EU strategies. A project involving 14 centres lasting 2 or 3 years is under-funded with 500,000
In the present competitive scientific world, there is the risk that individual strategies and investments are addressed to the individual career rather than to need-based programs. We should remember however that public research funds come from the entire community and should therefore generate a good return to the community.
Footnotes
Study supported by Research Grants: "Progetto Strategico: Chronic Heart Failure" Ministry of Health " IRCCS Policlinico San Matteo of Pavia, Italy.
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