Spanish Paediatric Clinical Trials Network (RECLIP) Enpr-EMA Annual - - PowerPoint PPT Presentation
Spanish Paediatric Clinical Trials Network (RECLIP) Enpr-EMA Annual meeting 2017 (London) Cristina Sern Trasorras Operational Manager of RECLIP Spanish Paediatric Clinical Trials Network RECLIP, formally constituted on November, 2016, is
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.
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
Aug May Sep Oct Nov Dec Jan Feb Mar Apr
Approvalof new members
Services portfolio and sustainability plan
Concept idea RECLIP Enpr-EMA Workshop
Clinical trials proposal an participation
Official constitution 21-Nov-2016 Statetment
Founders members Expression of interest for new members
SOPs development SOPs development
Meeting with Director of isciii IMI2 C4C short proposal submitted
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
An information questionnaire will be requested with specific quantitative and qualitative indicators
Three categories of participation in the network will be established based on the fulfillment of the requirements. Consolidated centres Emerging centres Thematic centres Signature of the adherence document by the head of pediatrics (or equivalent) and by the institution Consolidated networks Thematic networks
Categories of participation in RECLIP.
INTEGRATION PLAN Categories of participation in RECLIP Consolidated centres
Centres with the following criteria:
by RECLIP and/or less then 5 clinical trials per theme.
being difficult the own management of clinical trials activity.
management of the clinical trials developed by emerging centres (offering support as a CRO).
training activities for emerging centres.
Emerging centres Thematic centres
Centres with the following criteria:
and clinical trials platform, dedicated staff with a Management Coordinator
programs defined by RECLIP.
annually per theme. Centres with the following criteria:
and clinical trials platform, dedicated staff with a Management Coordinator of the centre.
programs defined by RECLIP.
annually in the subject.
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
(HUB)
STARTED CLINICAL TRIALS (2011-2016) Non-commercial Commercial
166
PHASE III PHASE I PHASE IV PHASE II
74,31% 25,69% 13,10% 10,89% 25,18% 50,82%
RECRUITED PATIENTS (2011-2016) PHASE III PHASE I
PHASE IV PHASE II
17,32% 5,00% 15,68% 62,01%
Translational Research Network in Paediatric Infectious Diseases (RITIP) contributes to the improvement of clinical practice in paediatric infectious diseases.
TRAINING PROGRAM
RITIP is constituted of 9 research groups belonging to 8 hospitals of 4 autonomous communities. The research activity includes topics in diseases that affect the immune system, respiratory, neurological, tropical, etc.
RESEARCH GROUPS
RITIP is its the translational arm of National Network of Clinical Trials in Infectious disease and vaccines (RECIVAC) has a platform of maternal vaccination centres and performs tests on all the levels of care, including primary care, emergency, and hospitalization.
CLINICAL TRIALS
The training program are supported by RECIVAC are focused on clinical trials. In addition, RITIP has specific training activities delimited in two Master Program: Paediatric Infectology and Paediatric Infectious Diseases. RITIP contributes to avoid infectious diseases them by developing preventive measures to improve the prognosis through an optimal diagnosis and treatment, in order to get appropriate and suitable drugs for children The Network encompasses "all" those aspects of paediatric infectious diseases in order of modifying clinical practice, avoiding infections through prevention and improving their prognosis through better diagnosis and treatment.
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.
RESEARCH AND TRAINING PROGRAM
SAMID is constituted of 12 research groups within to 11 hospitals of 7 autonomous communities. In addition, there are 23 Affiliated clinical groups which are a firm support to enhancer the translational research in terms of maternal and child health.
RESEARCH GROUPS
The clinical trials are collaborative and involve various groups of the network as well as for other outside groups. The clinical trials developed are multicentre national and international with extensive recruitment.
CLINICAL TRIALS
The main aim of the Training program is to enhance the research activities of all SAMID
and carried on are related to main areas of its Research Program. The SAMID Network aims to influence the prevention
diagnosis and treatment throughout most stages
The Network promotes integral health and the prevention of fetal and paediatric pathology which may have long-term consequences is the outcome chronic diseases in adulthood.
GENERAL ORGANIZATION CHART
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 performed in accordance with global strategies and organizational structure and management. Executive Committee: Executive Committee helps the General Coordinator to make decisions on urgent matters that are then reported to the STEERING COMMITTEE.
1 2 Leadership body
Ethics Advisory Board: EAB ensures ethics adequacy in pediatric linical research performed at RECLIP and advices on any related subject to the leadership body. Scientific Committee: Scientific Committee is the scientific advisory body for research activities developed by RECLIP and composed by clinicians of participant centres. International Advisory Board: International Advisory Board is a group of international experts that provides external scientific advice and expertise. Patient advisory Board: Patients Advisory Board ensures the implication of patients and families in the design and processes that will take place during the clinical trial.
Advisory body 3 4
General Management Coordinator: General Management Coordinator is the responsible for the administrative, economic and financial management of the activities in RECLIP.
Management body 5 8 11 Scientific structure 1 2 3 4 5 6 7
Scientific Programs: Specific scientific programs defined for each research areas of RECLIP (e.g. Neonatology, Vaccines&Infections, Oncology, Neurology, Cardiology, etc.) supported by Thematic Networks and centres of RECLIP.
8 9 10 11 6 7
Technical Office: Technical Office provides technical support in the economic, administrative and human resources areas of RECLIP .
9
Management Coordinator Centres. Each centre will have a management coordinator in charge of the integral management of the clinical trials activity
10
May Nov Dec Jan Feb Mar Apr
Enpr-EMA Workshop Enpr-EMA TC with Spanish networks
Official constitution 21-Nov-2016
Self-assessment Enpr-EMA IMI2 C4C short proposal submitted
1st Newsletter
www.reclip.org
RECLIP at Medicamentos Innovadores Meeting TEDDY involvement PEDCRIN call for proposals
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
@ReclipSpain
May Jan Feb Mar Apr
Presentation of RECLIP and its capabilities to several Pharmaceutical companies and CROs in
2 Clinical Trials Ongoing 2 Clinical Trials under Feasibility process 5 patients included
RECLIP, is currently involved in the start-up of a Pan-European Paediatric Clinical Trials Network, in the framework of the IMI. University Hospital of Santiago de Compostela, will be the spanish partner representing RECLIP, with the fully collaboration and involvement of RECLIP members. The Institute of Health Carlos III is the main Public Research Entity funding and carrying out biomedical research in Spain. For the adequate development of its activities, RECLIP needs the
through a call which would strenght the sustainability of the network during its first steps.