spanish paediatric clinical trials network (reclip) · presentation of reclip and its capabilities...
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Spanish Paediatric Clinical Trials Network (RECLIP) Enpr-EMA Annual meeting 2017 (London)
Cristina Serén Trasorras
Operational Manager of RECLIP
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.
Spanish Paediatric Clinical Trials Network
ECAPN
Thematic networks and scientific societies
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
2016 2017
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 of intent of Founders members
Expression of interest for new
members
SOPs development SOPs development
Meeting with Director of isciii IMI2
C4C short proposal
submitted
Classification criteria and integration of new members
Nevertheless, RECLIP behaves like an integrating network of all those centres and entities that want to join the initiative.
Since its implementation RECLIP has a representative number of centres that provides all the capacities and operability necessary for its proper functioning.
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: - Working in less than 2 scientific programs defined
by RECLIP and/or less then 5 clinical trials per theme.
- Not having a clinical trials platform (or limited), being difficult the own management of clinical trials activity.
- The hub of RECLIP will provide support in the management of the clinical trials developed by emerging centres (offering support as a CRO).
- The hub of RECLIP will mainly offer advisory and training activities for emerging centres.
Emerging centres
Thematic centres
Centres with the following criteria: - Having an own management structure
and clinical trials platform, dedicated staff with a Management Coordinator of the centre.
- Working in at least 2 scientific programs defined by RECLIP.
- Developing at least 5 clinical trials annually per theme.
Centres with the following criteria: - Having an own management structure
and clinical trials platform, dedicated staff with a Management Coordinator of the centre.
- Working prominently in 1 scientific programs defined by RECLIP.
- Developing at least 5 clinical trials 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
Classification criteria and integration of new members
Partners
Clinical Nodes ECAPN
(HUB)
Thematic networks and scientific societies
RECLIP Capabilities (2011-2016)
STARTED CLINICAL TRIALS
(2011-2016)
Non-commercial
Commercial 1102
166
PHASE III
PHASE I
PHASE IV
PHASE II
74,31%
25,69% 13,10%
10,89% 25,18%
50,82%
RECRUITED PATIENTS
RECRUITED PATIENTS (2011-2016)
PHASE III
PHASE I 8322
PHASE IV
PHASE II
17,32%
5,00% 15,68%
62,01%
CLINICAL TRIALS
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.
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.
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.
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 members. All training activities developed
and carried on are related to main areas of its Research Program.
The SAMID Network aims to influence the prevention of different pathological processes by improving the
diagnosis and treatment throughout most stages of illness.
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.
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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
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General Management Coordinator: General Management Coordinator is the responsible for the administrative, economic and financial management of the activities in RECLIP.
Management body
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Scientific structure
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2 3
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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
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11
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Technical Office: Technical Office provides technical support in the economic, administrative and human resources areas of RECLIP .
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Management Coordinator Centres. Each centre will have a management coordinator in charge of the integral management of the clinical trials activity of the centre.
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Organization and governance
Ongoing activities since Nov 2016
2016 2017
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
Services portfolio and sustainability plan
Design and planification
Site selection
Regulatory support
Start-up and management
Recruitment and follow-up, P2P
Scientific communication
Training and ongoing support
Funding sources
2017
May Jan Feb Mar Apr
Presentation of RECLIP and its capabilities to several Pharmaceutical companies and CROs in order to set-up future collaborations
2 Clinical Trials Ongoing
2 Clinical Trials under Feasibility
process
5 patients included
Funding sources
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 outstanding support from the ISCIII through a call which would strenght the sustainability of the network during its first steps.
