Work package 2: User needs and requirements
Brief description and aims of work
WP2 will elaborate on the user needs and requirements for the proposed technological and clinical research infrastructure to develop an environment that is able to run tools for clinical decision support and VPH by different endusers (e.g. clinicians) with the goal to drive common clinical practise to personalized medicine. This will provide the clinical perspective of the project and will take into account the state of the art, the state of research and the state of practice in the healthcare domains addressed by the p-medicine project. This WP will address the needs for developing a seamless, secure and consistent integration of clinical care data provided by hospital information systems and clinical trials as well as clinical and basic research data. It will address the technological requirements (in conjunction with all other WPs) from the clinical application standpoint to build an environment facilitating VPH research. As requirements might change during the evolution of the project the specification of user needs and requirements will continuously be updated.
In this WP UDUS will determine the user requirements and specifications for the integration of the p-medicine infrastructure into ECRIN data management systems and in developing applicable use cases as the fundament for the system validation step to guarantee GCP compliance of the data management tools during clinical trials. UDUS will bring in extensive experiences in the development of criteria for evaluation and validation of IT structures and data management applications. These experiences will be utilized in this project for the validation of integrating clinical trials applications in the p-medicine infrastructure.
As there are requirements for high performance computing, petascale facilities will be used in order to execute the p-medicine Oncosimulator simulation codes with the highest possible numerical accuracy and speed. The latter refers to a clinical tumour containing a number of cells of the order of 10^9 where cell descriptive states, statuses and times for each cell are stored and handled autonomously. Such an approach leads to enormous computational needs and therefore petascale computing will be exploited in order to strictly define the numerical accuracy of the routine executions of the codes in which cell clustering is adopted. The latter, leading to generally small discretization (quantization) errors, is adopted in order to render the codes executable on conventional systems. High performance computing using the Distributed European Infrastructure for Supercomputing Applications (DEISA) facilities will be performed in order to execute the molecular mechanism codes.
The main points that will be investigated are:
- User needs and requirements
- for clinicians
- for IT people to develop VPH tools for clinical decision support
- for clinical and basic researchers to strengthen VPH modelling
- for education and training of clinicians and the scientific community to enhance the use of IT in clinical care
- for patients to support patient empowerment in clinical care
- Needs and requirements for tools, methods and services for VPH research regarding
- the interaction between the p-medicine environment and the VPH Toolkit
- the secure and safe storage of data
- the seamless integration of clinical care data, trial data, hospital information system data and research data
- the process for evaluation and validation of tools, methods and services
- the process for the certification of ‘Good Clinical Practice’ (GCP) compliant tools
The WP will start with a review of relevant clinical decision making tools and will report on respective guidelines (e.g. ICH and GCP). Available tools, methods and services from the VPH Toolkit will be critically evaluated for their usability in the p-medicine environment. Legal and ethical regulations will be considered during the whole life-span of the project. In this WP the clinical scenarios proposed by the clinical partners participating in p-medicine will be described, analyzed and detailed into user requirements.
Thus the objectives of this WP are:
- To define user needs and requirements for tools, methods and services for VPH research focused on clinical usage (see above)
- To review current guidelines for the validation and certification of tools and software to make them GCP conform for usage in clinical trials and in daily clinical practice
- To ensure the empowerment and safety of patients in daily clinical care and to increase their participation in clinical trials
- To facilitate the process of bringing state-of-the-art knowledge in the decision process of treating physicians leading to personalized medicine
The definition of requirements on basis of scenarios will be based on the approach from the European Commission’s funded ESPRIT 21903 ’CREWS’ (Cooperative Requirements Engineering With Scenarios) long-term research project . We will use a simplified version of the process in order to extract requirements from scenarios, defined as “facts describing an existing system and its environment including the behaviours of agents and sufficient context information to allow discovery and validation of system requirements”. The requirements engineering process can be decomposed into three activities:
- elicit requirements from various individual sources;
- insure that the needs of all users are consistent and feasible; and
- validate that the requirements so derived are an accurate reflection of user needs.
After elicitation at the very beginning of the process we will need to revise the requirements in an iterative process many times, as they evolve and tend to generate further requirements. As an answer of the validation process within p-medicine we will consider, whether the current version of the requirements specification adequately defines the user’s requirement, and, if not, how we have to change or expand them further.
The techniques we will use during the requirements elicitation phase of the project include questionnaires, scenarios, prototyping and observations. The complexity of the domain, which is addressed by the p-medicine project necessitated that a spiral process of requirements analysis, elicitation, documentation and validation is adopted. Specific techniques have also been selected for the elicitation, negotiation and agreement of requirements as well as their validation. These techniques are scenarios and prototyping. This work package will define scenarios as detailed use cases, and provide the user requirements necessary to guide the activity in all the other work packages.