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SMART: Small Medicines Advanced Research Training

Periodic Reporting for period 2 - SMART (SMART: Small Medicines Advanced Research Training)

Reporting period: 2017-04-01 to 2018-12-31

IPCZD is a large tertiary paediatric hospital, having a strong interest in paediatric research. SMART Project was aimed to raise IPCZD staff’s research profile and increase capacity in providing innovative paediatric research methods such as PK-PD, Modelling&Simulation (M&S), data extrapolation and suitable dosage forms identification. This represents both a specific IPCZD’s need (IPCZD has a solid experience in providing and collecting paediatric PK-PD data but is does not use this data in the contest of innovative study’ methodologies) and a globally recognised research need. Actually, paediatric clinical research is affected by many methodological ethical and logistic hurdles requiring new methods to be generated and developed through large and experienced scientific communities involving different expertise and having a composite background. Methods such as M&S and extrapolation aimed to optimise evidence synthesis, while minimising evidence generation represent at today the more promising frontier of the paediatric research.
To improve the level of high-quality paediatric research in Poland, it was proposed a composite training programme addressing staff from IPCZD including lessons (e-learning and face to face), staff exchanges and schools. Three internationally-leading research institutions, CVBF in Italy, UCL in the United Kingdom and AMU in France contributed to the training programme by providing specific expertise in paediatric clinical trial government and developing, M&S and Extrapolation applications, new formulation generation. All these institutions have a solid experience and previous participation in large paediatric research Networks and Consortia. As IPCZD staff will enhance its know-how on paediatric trials and drug development, the institution is expected to be candidate to assume a leading role in the paediatric research European framework, also becoming attractive for private-public collaborations.
The SMART final result seems to confirm the validity of this kind of project since the primary aim to gain a greater expertise of the IPCZD staff as well as their integration in the most advanced international context in the specific sector, has been fully realised.
SMART experience should be seen as an example of success to be repeated in similar contexts with particular reference to underfinanced research types such as pediatrics or rare diseases and to countries with a strong drive towards innovation but with little potential in terms of infrastructures and multidisciplinarity.
With the main aim to raise IPCZD staff’s research profile and increase their research capacity in designing, conducting and evaluating paediatric trials, a series of activities were planned and implemented. Firstly, the SMART educational curriculum was presented to the potential candidates who have been evaluated and admitted to the programme. An ad hoc questionnaire was designed and administered to understand trainees’ expectations for the training programme as well as their professional profiles and competences. Moreover, topics and scientific contents on the basis of educational needs, were identified and discussed among the Partnership.
At the end of the project, all the foreseen training and educational activities, were designed and implemented. In particular, the e-learning course was completed in September 2016, two SMART schools were held, the 1st one in Bari (Italy) in September 2016 and the 2nd one in Jachranka (Poland) in March 2018. Two face-to-face meetings were organised in order to select the trainees, identify their training needs and to plan the future actions for publications purposes. Last but not least, the Final Open Workshop was organised and held in Warsaw (Poland) in November 2018. It was aimed at evaluating the staff gained competences and the general results. During this event, all the SMART trainees participating in the training programme, presented their training projects to a wide, public audience which included both scientific and general audience as well as all the interested stakeholders and the pharmaceutical companies.
Furthermore, a series of scientific publications were foreseen as a result of the staff exchanges and training projects produced in the framework of the SMART training programme. The publications are five and were published by the Polish Journal “Standardy Medyczne-Pediatria” (2018, vol. 15, supplement 1. ISSN:978-83-89809-40-7).
The SMART project was focused at improving IPCZD staff abilities in performing innovative paediatric research through the implementation of the training programme. At the end of the project, the impact of the initiative has been fully achieved. In fact, IPCZD has recently participated in three national and international research projects:
1. EPTRI – European Paediatric Translational Research Infrastructure (European Union’s Horizon 2020 research and innovation programme - H2020 INFRADEV-01-2017 - GA No. 777554), started in January 2018. EPTRI is a new infrastructure driving the innovation in paediatric research aimed to speed-up the paediatric drug development process. This project aims to cover the technological gap affecting the field of paediatric therapies and medicines development from human development and early stage drug development phases to paediatric medicines formulations. The Ministry of Science and Higher Education of Poland officially supported the EPTRI project since the submission phase, with a political letter of endorsement, recognising the need of the transnational research for paediatric medicines research to lead to an enhancement of paediatric research and to a wider implementation on Key Enabling Technologies (KET) for drug development. IPCZD is WP Leader of WP10 focused on Ethics issues and is member of all the other Work Packages dealing with Governance and Sustainability, Context Analysis, Paediatric Biomarkers and Biosamples, Paediatric Pharmacology, Paediatric Medicines Formulation and underpinning the paediatric studies.
2. c4c – conect4children. Collaborative network for European Clinical Trials for Children (This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389. The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA), started in May 2018.
In c4c IPCZD coordinates nationally the participation to the project in WP2 “Organisation and Governance of the pan European Paediatric Clinical Trials Network” and WP7 “Planning and Execution of Clinical Trials”.
3. POLPEDNET – The Polish Peadiatric Clinical Trials Network involving the Children’s Memorial Health Institute of Warsaw, the University Children’s Hospital of Cracow, the Institute of Mother and Child of Warsaw and the Polish Mother’s Memorial Hospital of Łódź. IPCZD represents the National Hub of POLPEDNET.
In terms of specific IPCZD staff abilities, five publications, based on the staff exchange experience, have been recently accepted by the Polish Journal “STANDARDY MEDYCZNE”. Furthermore, Agnieszka Czajkowska and Aleksander Wisniewski, trainees of the SMART project, have been involved since 2018 in 2 European projects (c4c and ID-EPTRI) and will also be involved in POLPEDNET as well as in other activities where they will be able to use the new acquired competencies.