Spanish Paediatric Clinical Trials Network (RECLIP) Enpr-EMA Annual meeting 2017 (London) Cristina Serén Trasorras Operational Manager of RECLIP
Spanish Paediatric Clinical Trials Network RECLIP, formally constituted on November, 2016, is created on the basis of the clinical strength of major paediatric hospitals, combined with primary health care centres and thematic research networks that develop relevant activity in paediatric clinical research. Thematic networks and scientific societies ECAPN
Endorsements and collaborative entities INSTITUTIONAL ENDORSEMENTS SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES MEDICAL ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY NATIONAL TRADE ASSOCIATION OF THE SPANISH BASED PHARMACEUTICAL INDUSTRY COLLABORATIVE ENTITIES / SOCIETIES SPANISH CLINICAL RESEARCH NETWORK SPANISH PEDIATRIC SEPCIALTIES SOCIETY
Timeline Official constitution 21-Nov-2016 Expression of Statetment interest for new of intent of members Approvalof new Meeting with Founders members IMI2 Director of isciii members Concept idea C4C short RECLIP proposal Enpr-EMA submitted Workshop Sep Oct Nov Dec Jan Feb Mar Apr May Aug 2017 2016 SOPs development SOPs development Clinical trials proposal an participation Services portfolio and sustainability plan
Classification criteria and integration of new members Since its implementation RECLIP has a representative number of centres that provides all the capacities and operability necessary for its proper functioning. Nevertheless, RECLIP behaves like an integrating network of all those centres and entities that want to join the initiative. For this purpose, RECLIP will define the criteria and conditions for the incorporation of new entities into the network structure. INTEGRATION PLAN SYSTEM OF DECISION AND INCLUSION OF NEW ENTITIES THROUGH THE ESTABLISHMENT OF DEFINED REQUIREMENTS Three categories of Signature of the adherence An information questionnaire participation in the network document by the head of will be requested with specific will be established based on pediatrics (or equivalent) and by quantitative and qualitative the fulfillment of the indicators the institution requirements. Thematic Consolidated Emerging centres centres centres Thematic Consolidated networks networks
Classification criteria and integration of new members Categories of participation in RECLIP. INTEGRATION PLAN Categories of participation in RECLIP Consolidated Thematic Emerging centres centres centres Centres with the following criteria: Centres with the following criteria: Centres with the following criteria: - Working in less than 2 scientific programs defined - Having an own management structure - Having an own management structure by RECLIP and/or less then 5 clinical trials per and clinical trials platform, dedicated and clinical trials platform, dedicated theme. staff with a Management Coordinator of staff with a Management Coordinator the centre. of the centre. - Not having a clinical trials platform (or limited), being difficult the own management of clinical trials - Working prominently in 1 scientific - Working in at least 2 scientific activity. programs defined by RECLIP. programs defined by RECLIP. - The hub of RECLIP will provide support in the - Developing at least 5 clinical trials - Developing at least 5 clinical trials annually in the subject. management of the clinical trials developed by annually per theme. emerging centres (offering support as a CRO). - The hub of RECLIP will mainly offer advisory and training activities for emerging centres. The final decision on the integration of new centres or entities in RECLIP will depend on the Executive Committee. Admissions of new centres or entities will be opened once a year. LAST CALL FOR NEW CENTRES WAS OPENED FROM 15 DEC-30 DEC 2016
Partners Clinical Nodes Thematic networks and scientific societies ECAPN (HUB)
RECLIP Capabilities (2011-2016) CLINICAL TRIALS RECRUITED PATIENTS STARTED CLINICAL TRIALS (2011-2016) RECRUITED PATIENTS (2011-2016) 10,89% 25,18% 74,31% 5,00% 15,68% 1102 Commercial PHASE II PHASE I 8322 PHASE II PHASE I 13,10% 50,82% 25,69% 166 17,32% 62,01% Non-commercial PHASE IV PHASE III PHASE IV PHASE III
Transversal thematic areas of RECLIP
Networks capabilities: ID & vaccines - RITIP Translational Research Network in Paediatric Infectious Diseases (RITIP) contributes to the improvement of clinical practice in paediatric infectious diseases . RITIP contributes to avoid infectious diseases them The Network encompasses "all" those aspects of by developing preventive measures to improve the paediatric infectious diseases in order of modifying prognosis through an optimal diagnosis and clinical practice, avoiding infections through treatment, in order to get appropriate and suitable prevention and improving their prognosis through drugs for children better diagnosis and treatment. RESEARCH GROUPS CLINICAL TRIALS TRAINING PROGRAM RITIP is constituted of 9 research RITIP is its the translational arm of The training program are supported by groups belonging to 8 hospitals of National Network of Clinical Trials in RECIVAC are focused on clinical trials. In 4 autonomous communities. The Infectious disease and vaccines addition, RITIP has specific training activities research activity includes topics in (RECIVAC) has a platform of maternal delimited in two Master Program: Paediatric diseases that affect the immune vaccination centres and performs tests on Infectology and Paediatric Infectious system, respiratory, neurological, all the levels of care, including primary Diseases. tropical, etc. care, emergency, and hospitalization.
Networks capabilities: neonatology - SAMID Maternal and Child Health and Development Network (SAMID) has a multidisciplinary collaborative structure through which it intends to optimize maternal and child health in the health National System. The SAMID Network aims to influence the prevention The Network promotes integral health and the of different pathological processes by improving the prevention of fetal and paediatric pathology which diagnosis and treatment throughout most stages may have long-term consequences is the outcome of illness. chronic diseases in adulthood. RESEARCH GROUPS CLINICAL TRIALS RESEARCH AND TRAINING PROGRAM SAMID is constituted of 12 research The clinical trials are collaborative and The main aim of the Training program is to groups within to 11 hospitals of 7 involve various groups of the network enhance the research activities of all SAMID autonomous communities. In as well as for other outside groups. members. All training activities developed addition, there are 23 Affiliated The clinical trials developed are and carried on are related to main areas of its clinical groups which are a firm multicentre national and international Research Program. support to enhancer the with extensive recruitment. translational research in terms of maternal and child health.
Organization and governance Leadership body GENERAL ORGANIZATION CHART 1 Steering Committee : Steering Committee is the supreme organ responsible of making decisions by consensus of all participants of RECLIP. General Coordinator: General Coordinator ensures that RECLIP activities are 2 performed in accordance with global strategies and organizational structure and management. Executive Committee: Executive Committee helps the General Coordinator to 1 3 make decisions on urgent matters that are then reported to the STEERING COMMITTEE. 2 3 Advisory body Ethics Advisory Board: EAB ensures ethics adequacy in pediatric linical research performed at RECLIP and advices on any related subject to the 4 leadership body. 4 5 9 Scientific Committee: Scientific Committee is the scientific advisory body for 8 5 research activities developed by RECLIP and composed by clinicians of 6 7 participant centres. 6 International Advisory Board: International Advisory Board is a group of international experts that provides external scientific advice and expertise. 10 Patient advisory Board: Patients Advisory Board ensures the implication of 7 patients and families in the design and processes that will take place during 11 the clinical trial. Management body General Management Coordinator: General Management Coordinator is the 8 responsible for the administrative, economic and financial management of the activities in RECLIP. 9 Technical Office : Technical Office provides technical support in the economic, administrative and human resources areas of RECLIP . Management Coordinator Centres . Each centre will have a management 10 coordinator in charge of the integral management of the clinical trials activity of the centre. Scientific structure Scientific Programs: Specific scientific programs defined for each research 11 areas of RECLIP (e.g. Neonatology, Vaccines&Infections, Oncology, Neurology, Cardiology, etc.) supported by Thematic Networks and centres of RECLIP.
Ongoing activities since Nov 2016 1 st Official Newsletter constitution 21-Nov-2016 Enpr-EMA www.reclip.org IMI2 TC with C4C short Spanish proposal networks @ReclipSpain submitted TEDDY RECLIP at PEDCRIN call involvement Medicamentos Self-assessment Enpr-EMA for proposals Innovadores Enpr-EMA Workshop Meeting Apr Mar May Nov Dec Feb Jan 2017 2016 Definition and further development of thematic areas Development of sustainability Plan of RECLIP Official endorsement acquisition Strong involvement in IMI2 proposal SOPs development and approval
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