Spanish Paediatric Clinical Trials Network (RECLIP)

Transcription

1 Spanish Paediatric Clinical Trials Network (RECLIP) Enpr-EMA Annual meeting 2017 (London) Cristina Serén Trasorras Operational Manager of RECLIP

2 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

3 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

4 Timeline Official constitution 21-Nov-2016 Concept idea RECLIP Statetment of intent of Founders members Expression of interest for new members Approvalof new members IMI2 C4C short proposal submitted Meeting with Director of isciii Enpr-EMA Workshop Aug Sep Oct Nov Dec Jan Feb Mar Apr May SOPs development SOPs development Clinical trials proposal an participation Services portfolio and sustainability plan

5 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 Signature of the adherence document by the head of pediatrics (or equivalent) and by the institution 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 Thematic centres Emerging centres Consolidated networks Thematic networks

6 Classification criteria and integration of new members Categories of participation in RECLIP. INTEGRATION PLAN Categories of participation in RECLIP Consolidated 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. 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 prominently in 1 scientific programs defined by RECLIP. - Developing at least 5 clinical trials annually in the subject. Emerging 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. 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

7 Partners Clinical Nodes Thematic networks and scientific societies ECAPN (HUB)

8 RECLIP Capabilities ( ) CLINICAL TRIALS RECRUITED PATIENTS STARTED CLINICAL TRIALS ( ) ,89% 25,18% PHASE I PHASE II 74,31% Commercial RECRUITED PATIENTS ( ) ,00% 15,68% PHASE I PHASE II ,82% PHASE III 13,10% PHASE IV 25,69% Non-commercial 62,01% PHASE III 17,32% PHASE IV

9 Transversal thematic areas of RECLIP

10 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 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. RESEARCH GROUPS CLINICAL TRIALS 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. 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. 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.

11 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 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. RESEARCH GROUPS CLINICAL TRIALS 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. 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. 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.

12 Organization and governance GENERAL ORGANIZATION CHART Leadership body 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. Advisory 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. Management body General Management Coordinator: General Management Coordinator is the responsible for the administrative, economic and financial management of the activities in RECLIP. 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 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 areas of RECLIP (e.g. Neonatology, Vaccines&Infections, Oncology, Neurology, Cardiology, etc.) supported by Thematic Networks and centres of RECLIP.

13 Ongoing activities since Nov 2016 Official constitution 21-Nov st Self-assessment Enpr-EMA TEDDY involvement Enpr-EMA TC with Spanish networks RECLIP at Medicamentos Innovadores Meeting IMI2 C4C short proposal submitted PEDCRIN call for proposals Enpr-EMA Workshop Nov Dec Jan Feb Mar Apr May 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

14 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

15 Funding sources 5 patients included 2 Clinical Trials Ongoing 2 Clinical Trials under Feasibility process Jan Feb Mar Apr May 2017 Presentation of RECLIP and its capabilities to several Pharmaceutical companies and CROs in order to set-up future collaborations

16 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.

17 - contact@reclip.org Cristina Serén Trasoras -