Biomedical Research Workflow Management System(BRWMS)
Ministry of Health - General Direction for Scientific Research and Health Innovation

A. Problem Analysis

 1. What was the problem before the implementation of the initiative?
The research funded by the Ministry of Health (MoH) concerns the National Health Service (NHS). It aims at reaching patients by improving the diagnosis of care and service organization. It is defined translational research as it starts into a laboratory, but it reaches human beings in a defined timeframe, at the same time that patients provide suggestions to researchers and bring them back to the laboratory (bench to bed, bed to bench) thus confirming to be part of the translationNHS deals with men’s health, which is a primary asset. The scenario is therefore complex and vulnerable as many elements might affect it, but research is an incomparable procedure to know, let know and change, even deeply, our NHS. It is necessary that citizens understand that transparency is an essential element for rules which, above all, should be shared both by researchers and simple citizens. Research is characterized by change and contradiction. Elements which might be considered as certain could become unworthy only a few years later. Research should substantially convince NHS personnel that traditional and consolidated procedures might be doubtful and that there is a need to certify positive outcomes of new principles (under all aspects, from survival to costs for the collectivity). Therefore, they should constantly search for the best possible, demonstrated, efficient and effective solution, and carry it out in the shortest time in order to radically change the history of some diseases. The parties involved in this challenge for a cultural change are the MoH, the Regions, healthcare providers, the productive and financial world, and at last citizens. The scenario is complex and any progress should be introduced carefully by assessing benefits and costs. All of this change needs resources aimed at reaching these objectives. Firstly, no division should appear among decision-makers (MoH, other Ministries, Regions, etc.). It is important that NHS might access necessary resources to carry out the researches. The Ministry of Health funds, with the help of current research, 48 healthcare centers (IRCCS) and with finalized research the specific projects of all NHS. Secondly, professionals should be considered a valuable resource when they feature the specific expertise and they are oriented to change, thus representing the best researchers. Therefore, the interlocutor should be the single individual rather than the institution. For this purpose, neither limitations in topics nor interferences should be imposed. To guarantee this principle it is evident that the assessment system should be clear, easy to check, and parallel with what professionals experience in the NHS domain. A shared system should be adopted, rather than a perfect one. It is relevant that ideas circulate and outcomes reach decision-makers. Hence it is crucial that information on current and finalized research projects outcomes is easily accessible. Ideas and researches might lead to an immediate or real advantage for the citizen patient, for example in the case of a new cure or technology, but they also might have repercussions on the productive world.

B. Strategic Approach

 2. What was the solution?
The above described concept should be clearly understood to explain why the Ministry of Health exploits the information systems not only to efficiently organize the workflow, but also because it really needs to be clear, make better assessments, communicate and check results. This is guaranteed by a simple system which is coherent with the organization of announcements of competition, and the identification of indications and requirements of current research. This initiative started more than 10 years ago when members of the association against cancer (ACC), onchologic IRCCS, decided to adopt a system allowing the sharing of publications, personnel, clinical trials, etc. among all the subjects that participated to the research, in order to plan together their activities. The Ministry of Health in 2007 extended this system to all IRCCS, and by adding the communication module, it allowed to avoid communications from and to institutes. Therefore, there is a heritage of researches, publications, personnel and various activities (from biobanks to clinical trials) that since 2007 has been filed into the system. The current research module has been integrated with the finalized research module which allows to present projects individually, and for institutions to run checks (the only check on NHS membership), to automatically introduce projects to foreign reviewers, to maintain the written review, to take part for researchers to an announcement of competition, to check reviews when the process is closed. Considering the MoH budget constrain, the Institutes evaluation, on the basis of internationally recognized criteria, become mandatory, as well as - for the project-based funding - the quality of proposals and their expected results. Therefore the MoH decided to submit the proposals to external peer reviewers for the evaluation, through a partnership with the USA National Institutes of Health (NIH) and Italian Scientist and Scholars of North America Foundation (ISNAFF). In addition, a strategic priority was that of guaranteeing a significant budget to the proposals submitted by young researchers, portable across different Institutions. To support these strategic changes, a significant reform of organizational processes and therefore the availability of a new release of the information system, have been required. Consequently, in 2009 the MoH planned the development of Biomedical Research Workflow Management System, an ICT tool that could encompass the complete research funding workflow (proposal submission, evaluation, administrative monitoring, and results exploitation). The Workflow implementation allowed the MoH to increase the efficiency and the research funding management, guaranteeing a better resources allocation, reducing red tape and avoiding fragmentation and duplication. In the period 2010-2012, the system managed more than 9300 proposals for a total funding of 323 M€. Another relevant contribution our initiative provided to public administration innovation arises from the support to the pooling of research capability that will drive integrated science, covering the whole cycle from basic to applied research and from research to innovative clinical practice. In fact, by promoting the open access to the results of publicly funded Biomedical Research, the Italian MoH contributes to support the development of “smart research information services“ that are fully searchable and allow results from research projects to be easily accessed by other European Public Administrations and researchers. The knowledge contained into the system must be available to everyone: this is the future objective. The combined system of care, scientific, outcome data should qualify all NHS services. IRCCS could be the first to exploit this knowledge which should then be expanded to others. The system itself could provide open source applications provided by other authorities to facilitate or improve services. This is possible by departing from a solid basis and exploiting a spread technology which makes easy to access information.

 3. How did the initiative solve the problem and improve people’s lives?
The initiative can be easily and very positively benchmarked with a clear evidence of a substantial contribution to the innovation process in the Public Administration. Such a knowledge and “all-levels-subjects-active-in research” relationship management gave rise to a series of spontaneous processes that naturally integrated the resources made already available by the MoH to foster and support the health research activities of the beneficiaries of its research plan. Additionally, the intrinsic visibility of information contained in an official repository, that represents the majority of the Italian health research funding and activity effort, could, spontaneously again, create a substantial “smart research information service“, as a direct consequence of the governmental status of the MoH. This is a very important by-effect (entirely positive) of the information management specifically designed to support, primarily the submission, evaluation and awarding processes. Innovative semantics applied to the repository of information naturally stemming from the above mentioned activities (submission, evaluation and awarding) is a warrant of visibility and enhanced exploitation potential for the researchers and for the Public Administration both fundamental pillars of the leadership in innovation pursued by the Industry.

C. Execution and Implementation

 4. In which ways is the initiative creative and innovative?
As mentioned above, the Biomedical Research Workflow Management System has been implemented since 2005. The main achievements arising from the project development have been the following: -Starting from 200 proposals in 2005, in 2013 the system was able to manage more than 4,000 proposals. -Consequently, the researchers connected to the system increased yearly, until the current number of 13,000 users. -All the information is available online, both for the reviewers (NIH) activities and for the management of the communication between MoH and research community, through a Customer Relationship Management (CRM) tool. More in details: Year: 2005 Key developments: The Research Workflow Management System started from the initiative of the 7 Italian Excellence Cancer Institutes. Main activities: Design and implementation of the first prototype, aimed to manage common research activities funded by the MoH Current research budget (publications, clinical trials, ....). Year: 2006 Key developments: Extension of the workflow system to the 35 Institutes belonging to the National network. Main activities: Software functionalities improvement (researchers directory, scientific research impact factor, …) and technological infrastructural assessment - database, connectivity, ...). Year: 2007 Key developments: The workflow system has been extended to cope with all the MoH yearly funded research activities, both current and finalized. Main activities: Training activities and the enabling of a specialized call center service have been planned to support researchers and reviewers. Year: 2008 Key developments: The system was adopted for the management of the first call for proposal submitted by young researchers. Year: 2009 - 2010 Key developments: Design and development of the on-line evaluation module by external reviewers (reviewers directory, curricula, …) in partnership with the National Institutes of Health (NIH) and Italian Scientist and Scholars of North America Foundation (ISNAFF). Main activities: Complete digitalization of the research funding workflow (proposal submission, evaluation, administrative monitoring, results exploitation). Year: 2011 - 2012 Key developments: Improvement of administrative and scientific monitoring of the projects with the introduction of the electronic folder. Main activities: Design and implementation of a new release (Workflow 2.0) for the upgrade to new technological standards. Year: 2013 - 2014 Key developments: The Workflow management system has been integrated to a Customer Relationship Management (CRM) tool. Main activities: All the proposals information and the communications among the research stakeholders have been made available online. Starting from the year 2010 the Workflow system has substituted all the different means of communication previously used, in a single flow entailing a unique identification of the contact persons, that were included in a specific database referring to all the Institutional subject defined by law (about 100 institutions, as divided: 48 healthcare centers - IRCCS, 10 veterinary institutes - IZS, 21 Regions and Autonomous Provinces, the National Institute for Insurance against Accidents at Work – INAIL, the National Agency for regional health services - AGENAS, and the Italian National Health Institute - ISS). Furthermore such system, put in place by the MoH at a national level, has been already taken into use by some Regions for their internal management.

 5. Who implemented the initiative and what is the size of the population affected by this initiative?
The Biomedical Research Workflow Management System was designed by General Direction for Scientific Research and Health Innovation (at the time Directorate General for Health and Biomedical Research) with the Supervision of National Health Bodies and Institutions of the Italian Ministry of Health in partnership with Consorzio di Bioingegneria e Informatica Medica (CBIM). CBIM is a no-profit research institution, founded in 1992 by the University of Pavia and some Scientific Biomedical Research Institutes, with the aim of promoting ICT based innovative services in the Healthcare area. CBIM since its foundation worked in the design and management of several Italian large scale Hospital Information Systems. CBIM, in addition to design, also managed the implementation and management of the information system in all its aspects: software development, database management, training, operational support. Since 2009, the Biomedical Research Workflow Management System has been delivered in cooperation with Consortium GARR that represents Italian Research & Education Network. It plans and operates the national high-speed telecommunication network for University and Scientific Research.
 6. How was the strategy implemented and what resources were mobilized?
The initiative was implemented and funded exclusively through resources belonging to the General Direction for Scientific Research and Health Innovation.

 7. Who were the stakeholders involved in the design of the initiative and in its implementation?
1.Implementation of the Biomedical Research Database in terms of Institutes, Researchers, Publications, Clinical Trials, Research lines and topics, Proposals. Since 2005 more than 15,000 Researchers, 80,000 Publications, 12,000 Proposals, have been included. 2.According to the National regulation, beneficiaries of the MoH finalized funding are about 100 Institutional subjects (48 healthcare centers - IRCCS, 10 veterinary institutes - IZS, 21 Regions and Autonomous Provinces, the National Institute for Insurance against Accidents at Work – INAIL, the National Agency for regional health services - AGENAS, and the Italian National Health Institute - ISS). The introduction of the Biomedical Research Workflow Management System allowed more than 10,000 subjects to access the research network, thereby increasing the transparency of funding and procurement procedures. 3.Implementation of the International Reviewers Directory, based on specific expertise, in order to guarantee the correct correlation between reviewers and proposals. In addition, the MoH enabled a system functionality for on-line monitoring of evaluation process and results. Through this system of "open" peer review, all research stakeholders are able to verify the evaluation results in a completely transparent model, thus increasing the quality of the biomedical research. Through the complete accessibility to the judgments expressed by the international scientific reviewers and the possibility of resubmitting a modified application in the following years, the quality of the submitted projects has improved, with a great increase of the Italian research competitiveness at a global level. 4.The workflow system implementation makes available both governance information (number of projects funded for institution, project results, impact ...) and the electronic folder of any specific project (startup date, upgrade status, scientific and administrative reports...). The networking among researchers, Institutions and MoH could guarantee a knowledge sharing at different levels thereby increasing the benchmark and quality of the biomedical research. 5.In addition, the ICT tools allow an easy communication across Public Administration actors and private stakeholders (more than 7.000 messages per year posted in the system).

 8. What were the most successful outputs and why was the initiative effective?
The Biomedical Research Workflow Management System has been implemented with the Agile methodology that provides opportunities to assess the direction throughout the development lifecycle. By focusing on the repetition of abbreviated work cycles the agile methodology is described as “iterative” and “incremental.” In an agile paradigm, every aspect of development (requirements, design, …) was continually revisited. The team, composed of MoH personnel and CBIM engineers and developer, has re-evaluated the direction of the project every month. This “inspect-and-adapt” approach to development greatly reduced development costs and time of activation of the services because the team’s work cycle was limited to a month; stakeholders had recurring opportunities to calibrate releases for success in the real system. Agile development helped MoH to build the right solution. Instead of committing to market a piece of software that hasn’t been written yet, Agile allowed to continuously replan the Biomedical Research Workflow Management System release to optimize its functionality.

 9. What were the main obstacles encountered and how were they overcome?
The main obstacle was represented by the initial resistance opposed by the institutional subjects involved in the process, that at first had problems in adapting to such an innovative ICT tool. It took some time to accept the new system, that substituted all the different means of communication previously used in a single flow, and was accessible only through a personal password, entailing a unique identification of the contact persons, that were included in a specific database referring to all the Institutional subject defined by law (about 100 institutions, as divided: 48 healthcare centers - IRCCS, 10 veterinary institutes - IZS, 21 Regions and Autonomous Provinces, the National Institute for Insurance against Accidents at Work – INAIL, the National Agency for regional health services - AGENAS, and the Italian National Health Institute - ISS). Such problems were gradually overcome thanks to the clear identification of the centers of stewardship and by establishing the obligatoriness to comply with the Workflow System; furthermore, special cycles of training, exercised in single institutions and plenary sessions, were implemented. Other occasions of training and moments of synthesis and sharing of subsequent pathways are represented by the annual conventions dedicated to the research system.

D. Impact and Sustainability

 10. What were the key benefits resulting from this initiative?
•Increased efficiency in resource allocation. The Biomedical Research Workflow Management System adoption made the significant increase of project-based funding policy possible and easily deployable. Starting from a budget of 38M€ (19% of MoH budget) for 1115 proposals in 2008, the system adoption allowed the management of a 134M€ funding (29% of MoH budget) for 3796 proposals in the 2011-2012 call. •Better service delivery and time saving. The ICT platform availability ensures that the online peer to peer review by the external (NIH and ISNAFF) referees can be faultlessly carried out. The average time to complete the proposal review is about 6 Months, a period that is extremely short if the scarcity of resources allocate to the process is taken into account. •The Biomedical Research Workflow Management System adoption highly increased the efficiency in tasking the MoH personnel for activities specifically related to the submission, process of peer-review, and awarding of research proposals. A staff of only 24 persons (46% of MoH Research DPT personnel) is involved in the administrative and scientific monitoring and in attending to all the other activities related to the management of any given call for proposals. •The adoption of a Customer Relationship Management (CRM) tool spontaneously improves the bidirectional communication between the MoH and the Research community, resulting in a better and wider involvement of direct users. •The implemented solution guarantees a thorough and transparent process. The whole research funding workflow after the submission is available online to the researchers and an annual report is published by the MoH on specialized newspapers. •Smart research information services are generated and these are fully searchable and allow the results from research projects to be easily accessed by other Public Administrations and researchers, thereby facilitating the scientific cooperation and organizational knowledge sharing. •Efficacy measure: the scientific production is measured on the basis of the most common indicators (Impact factor, H-Index, Impact factor/Number of researchers, Funding/Impact factor), ensuring a valid degree of international comparability. A scoreboard reflecting the Institutions performances in terms of scientific output is made by the MoH with monitoring purposes on the impact of the funding effort. This is greatly enhanced by the CRM and the Smart Research Information System.

 11. Did the initiative improve integrity and/or accountability in public service? (If applicable)
Considering the needs and the aims that leaded to the Biomedical Research Workflow Management System implementation, the system has been based on the requirements of researchers and the MoH and, thus, represents a powerful tool for institutional and scientific communication. Therefore, the system aimed to spread basic and applied innovative research results to: •Support other Health Authorities and Health Managers. Increased networking exchange of experience in data and benchmarking is necessary in the Health sector, at National (Italy) as well as at the International level. This feature is focused on the exchange and dissemination of tested and proven best practices arising from funded applied research (yearly more than 320 healthcare innovation projects). This can help National and International authorities in replication and scaling up of successful cases. •Empower consumer health information access. It’s widely assumed that the access to information is a basic mechanism for people empowerment both as Patients and as Healthy Citizens. Because the NHS encompasses 48 Scientific Institutes with high specialization in different Medicine areas (Cardiology, Neurology, Pediatrics, Oncology, …), constituting the Italian Excellence Centers Network, the MoH aims to realize a session including information about the more updated trends, treatments and therapies for each specialization. This could empower the citizens with better quality information and more choice regarding appropriateness of care and affordability of Healthcare services. •Leverage higher private health sector investments. According to the EC eHealth Action Plan 2012-20120 – Innovative Healthcare for the 21st Century, the potential market of eHealth is emerging as a new market alongside Pharmaceuticals and the Medical Devices sector. Updated information on the public MoH investments in Research & Innovation could represent a new approach to bringing the results of applied research and innovation projects to the market as well as to support the private sector decisions on where to invest in R&D and innovation. Every year about 5,750 clinical trials with more than 120,000 patients enrolled are carried out by the NHS.

 12. Were special measures put in place to ensure that the initiative benefits women and girls and improves the situation of the poorest and most vulnerable? (If applicable)
The implemented ICT system, in addition to the reduced costs through a shared system of communication and work, has promoted new forms of collaboration, stimulating a strong cooperation in a completely transparent model among all the different subjects involved in the whole process of the scientific research funded by the MoH, starting from the single researcher up to the different institutions and administrations participating in the process. The simplicity of the system has progressively allowed the MoH to foster the active participation to every phase of the Call for grant and to the subsequent steps of the research process of every single researcher, as testified by the number of people interested in the system that has increased exponentially, increasing in the last few years from 100 (the Institutional subjects that must be involved according to the law), to 3,000 (Institutional subjects plus Principal Investigators), up to 13,000 (Institutional subjects plus Principal Investigators plus every researchers directly involved in the research projects) in this last Call for grant. The results have entailed the promotion of an active and effective collaboration between government, regional and national institution and administration, researchers, leading to the achievement of shared goals and valuable outcomes, such as the increased quality of the funded scientific and biomedical research. Furthermore the system, put in place by the MoH at a national level, has been already taken into use by some Regions for their internal management. Thanks to the implementation of a transparent peer-review process, the comparison and confrontation with the external international experts worldwide have guaranteed the optimization of the projects submitted, with a potential benefit to the scientific world and to all citizens. Last but not least, the enhancement of the process and the procedures, including the extreme transparency and the possibility for every researcher to examine the international judgment and comments expressed in the peer-review phase of assessment, has boosted the goal of meeting the international standards, increasing the competitiveness of the Italian research worldwide, with a growing number of international scientific publications produced by the financed research projects. In addition to the selection of the best projects, the tool has also allowed a transparency in the monitoring of the state of the researches activities finances, both scientifically and administratively, thanks to the uniformity of the adopted procedures and to the implementation of standard and detailed reporting forms with transparent information. So far, the system has allowed the mapping of the actual state of the Italian scientific research, both in terms of quality and of topics. At the same time is in course of implementation an effective process of monitoring and evaluation of the real outcomes of the research projects, in order to actually measure the results of the financed activities on the health status of the citizens. Another future objective is making the knowledge contained into the system available to everyone.

Contact Information

Institution Name:   Ministry of Health - General Direction for Scientific Research and Health Innovation
Institution Type:   Government Agency  
Contact Person:   Maria Novella Luciani
Title:   Doctor  
Telephone/ Fax:   0039-0659943000/0659946032
Institution's / Project's Website:  
E-mail:   n.luciani@sanita.it  
Address:   via G.Ribotta 5
Postal Code:   00144
City:   Rome
State/Province:   Italy
Country:  

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