NameTEDDY - European Network of
Excellence for Paediatric Clinical Research
TypeIndipendent, muldisciplinary, multinational Network aimed at:
- planning, designing and performing paediatric clinical trials and studies at national and international level covering different specialty area
- implementing good practices, SOPs and tools to develop studies and research on medicinal products in an international framework
- providing methodological expertise to set up and manage paediatric clinical trials and other paediatric research
- developing educational, informative and empowerment tools for children and families
Streetvia Nicolò Putignani 178
Postal code70122
TownBari
CountryItaly
Telephone 1+39 0382 25075
Telephone 2+39 080 97 51 974
Mobile phone
Fax+39 0382 536544
Web sitewww.teddynetwork.net
Email for general enquiriesteddynetwork@cvbf.net
First nameAdriana
Second nameCeci
Telephone+39 0382 25075
Mobile phone
Emailadriceci.uni@gmail.com
First nameDonato
Second nameBonifazi
Telephone+39 080 97 51 974
Mobile phone
Emailceo@cvbf.net
The data in this document are
‘current’ as of
September 15th, 2016
State how this document can be accessed by the publicwww.teddynetwork.net
Year of foundation2005
Paediatric age ranges of study participants covered by the network
All paediatric ranges (0-18 years of
age)
Preterm and / or term newborn
✔ Yes
Infants from 1 month to less 24 months of age
✔ Yes
Children from 2 years to less than 12 years of age
✔ Yes
Adolescents from 12 years to less than 18 years
✔ Yes
Specialities / Conditions coveredMultispecialty
MultispecialityCovered conditions include:
Haematology
Pain
Anesthesiology
Neurology
Neonatal Infections
Immunology
Infections
Speciality or disease specific
NA
Conditions coveredIron overload, Pain in oncologic patients, Neuropathic pain, Sedation in PICU, Neonatal sepsis, Neonatal Meningitis, Epilepsy, Neurometabolic diseases
Procedure / intervention specificNA
Number of collaborating countries17

List all collaborating countries: Europe: Cyprus, Czech Republic, France, Germany, Greece, Italy, The Netherlands, Poland, Romania, Spain, Sweden, UK.
Outside Europe: Albania, China, Egypt, Israel, Tunisia.
Number of collaborating centres42

List all collaborating centres:
Please refer to attached Annex 1
Type of activity/studies
Clinical studies✔ Yes
Experimental research✔ No
Experimental research- Clinical methodology
- Epidemiology
- Biostatistics
- Ethics
- Regulatory
- Health Technology Assessment
- Education and training
- Clinical trials facilitation
- Pharmacovigilance
- Communication to paediatric patients (patients empowerment, consent and assent preparation)
Number of completed trials

Number of ongoing trials
4

5
Total number of participants
actually recruited each year

184
Proportion of eligible
participants actually recruited each year

Describe way of screening and
participant recruitment
80%

Screening and participants' recruitment is carried out via participating centres. For each clinical trial, a feasibility study is carried out to evaluate centres' recruitment capacity and their compliance to the protocol requirements.
Total number of collaborating centres100
Academic (investigator) initiated studies
Number of ongoing and completed clinical trials
Absolute number: 9

Proportion of all studies: 100%
Number of paediatric specialities covered by paediatric trials
6
Number of paediatric conditions covered by paediatric trials
6
Number of other ongoing research studies / programs
3
Indicate the proportion of public funding
Proportion of academic initiated studies: 75%
Proportion of budget: 90%
Number of registered study participants (all studies)
3522
Industry-sponsored trials
Number of ongoing and completed trials
0
Number of paediatric specialities covered by paediatric trials
0
Number of paediatric conditions covered by paediatric trials
0
Number of registered study participants (all studies)
0
Existence of an identified contact person for external enquiries✔ Yes

Enquiries are collected through a contact form published on the Network's website and forwarded to Partners according to the subject of the request.
Existence of an internal steering committee ✔ Yes

TEDDY Scientific Coordinating Committee.
Existence of an external advisory / steering committee directing the reporting party
✔ Yes

TEDDY Strategic Planning Board
Existence of a website✔ Yes

www.teddynetwork.net
Existence of newsletter✔ Yes

Electronic newsletter
Existence of an internal database(s) for disease, condition, treatment and / or outcome ✔ Yes

For each study a disease database is created. The number and the disease type of each patient are collected and stored for guiding future trials. Individual patients data are not included. A survey is ongoing to collect more data from existing databases at each TEDDY participating center.
Outcome database is also available for Thalassemia patients (Italian multiregional Thalassemia Patients Registry).
Provisions to ascertain data protection and data security ✔ Yes

Databases are managed according to the current rules.
SOPs are developed to guarantee data protection and data security.

e-CRF (electronic Case Report Form), combining technology, simplicity, privacy and data security, in order to comply with the GCP (Good Clinical Practice) and regulations on the protection of people's safety and well-being are developed.
Procedure(s) to access the database by third parties✔ Yes

Databases are not accessible by third parties outside the Data Controller disposition.
Access to personal data is not allowed.
For each project requiring data sharing for analysis and study conduct, TEDDY proposes a ‘Data Sharing Agreement’ (DSA) to be signed by all the participants.
DSA should include at least details on:
- Type of data to be transferred and future use
- Data controller responsibilities (data protection and security)
- Centre responsibilities (data integrity and anonymisation/no-reidentification allowed)
Access to external databases
/registries
✔ No
Standardised process to access an external database(s)✔ No
Number of peer-reviewed publications in the last 5 years
Provide exact reference(s)
62

Please refer to Annex 2 Listed publications have been either performed on behalf of the Network or derived by TEDDY activities.
Number of competitive grants obtained in the last 5 years7
Access to expert groups ✔ Yes

PA/UNEPSA- European Paediatric Association, SIOP Europe, EU Society for Paediatric Endocrinology (ESPE), EU Society for Paediatric Infectious Diseases (ESPID), EU Respiratory Society (ERS), Società Italiana per le Malattie Respiratorie Infantili (SIMRI), EU Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), Società Italiana di Pediatria (SIP), Societé Francaise de Pediatrie, Asociación Española de Pediatrïa (AEP), Sociedad Española de Infectología Pediátrica (SEIP), Società Italiana di Ricerca Pediatrica (SIRP), Thalassaemia International Federation (TIF), Società Italiana di Farmacologia (SIF), European Society of Developmental Paediatric and Perinatal Pharmacology (ESDPPP).
Capacity to answer external scientific questions ✔ Yes

Among others, TEDDY includes expertise in:
- clinical trial management;
- methodological aspects of clinical research, innovative/traditional studies design, monitoring and statistical evaluation, recruitment capacity;
- formulations;
- pharmacovigilance and longterm studies;
- ethics (advise on documentation to submit to the ECs including assent forms tailored by age, ethical provisions including third countries);
- PKPD studies (population PK study modellisation, extrapolation).
Standardized procedures for assessment of:
Site feasibility✔ Yes

Assessed case by case on the basis of a ‘feasibility questionnaire’ prepared according to the peculiarities and needs of each specific trial.
Participant recruitment✔ Yes

The Network is able to ensure the participation of third countries in some therapeutic areas. A consistent and meaningful communication with site personnel is promoted and established and study progresses for each trial are timely communicated through regular newsletters and updates and alerts on the Network and projects websites.
Regular monitoring visits are performed to verify that the patients safety and well-being are protected, the reported trial data are accurate, complete, and verifiable from source documents and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Budget calculation for studies✔ Yes

The Network regularly provides budget calculations for clinical trials and agreements, including financial distribution site by site.
Documented adherence to Good Clinical Practice (GCP) guideline ✔ Yes

The Network has set up a ‘trial management infrastructure’ including SOPs, data management and drug management plans, pharmacovigilance and monitoring plans, in order to deal with the complexity of multinational and multi-centre clinical trials. It has also implemented a unique procedure and a unique CTA ‘package of documents’, all in compliance with GCP and CTs Directive.
The procedures will be updated to take into account what required by the new CTs Regulation and related guidelines.

All studies conducted under TEDDY Network umbrella have received approval by ECs and CAs.
Documented adherence to the ethical considerations for clinical trials in children ✔ Yes

Ethical approval has been obtained for all studies. Provisions highlighted in the 'Ethical considerations' document, including acceptable blood volumes and frequency of sampling in children, have been taken into account in all studies.
In addition TEDDY has published the results of the TEDDY Survey on the ethical requirements for the paediatric population.
Finally specific recommendations tailored to parents, children, industry, GPs,
pediatricians and other medical professionals, and European and National Institutions have been prepared by the Network starting from the principles outlined in the Ethical Considerations.
Documented adherence to ethical considerations✔ Yes

Approval by Independent Ethics Committees including paediatric expertise is always requested and obtained for clinical trials and other studies as per national and local regulations.
Availability of Standard Operation Procedures (SOP)✔ Yes

SOPs are available for clinical trials activities as requested by ICH GCP guidelines and shared among partners by request. A list of SOPs to be implemented in a clinical trial is available at the TEDDY website (https://www.teddynetwork.net/sops-for-paediatric-clinical-trials/).
Capacity to monitor studies (academic trials, industry sponsored trials) ✔ Yes

All studies conducted under the TEDDY umbrella are submitted to monitoring procedures in
accordance with GCP and other relevant rules related to each specific study, as specified in the Study’s Monitoring Plan.
A Site Initiation Visit is performed before the first patient is enrolled in order to ensure that everything in ready at each clinical site.
Regular monitoring visits are performed to verify that the patients safety and well-being are protected, the reported trial data are accurate, complete, and verifiable from source documents and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Once all patients have concluded the study and the database is locked and ready for statistical analysis, a close-out visit occurs.
Capacity to monitor performance of collaborating centres✔ Yes

The Network has the facilities to perform project and trial management activities to monitor performance. Metrics and indicators are adopted case by case.
Quality control and quality assurance, traceability and data safety✔ Yes

Internal SOPs are available for clinical trial activities as requested by ICH GCP guidelines:
– Data Management Plan
– Data Security
– Data Handling
– Audit Plan
– Audit Visit
– Handling of no-conformity
Evidence of collaboration with regulatory authorities ✔ Yes

TEDDY participated and participates in many public consultations (e.g. guidelines, concept papers, reflection papers) with the EC, the EMA and the National Competent Authorities, such as:
- Public consultation on "Summary of Clinical Trial Results for Laypersons" (August 2016)
- Public consultation on the revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" (August 2016)
- Survey for Enpr-EMA networks regarding Young Persons Groups (April 2016)
- Contribution to the Enpr-EMA data collection for the 10 year report to the European Commission on the public health effects of the Paediatric Regulation (November 2015)
- Contribution to the topic of transition from paediatrics to adults clinical care settings by providing documents on Thalassaemia and HIV infection patients (May 2015)
- Enpr-EMA request for information to develop a Global Paediatric Clinical Trials Network (October 2014)
- Stakeholder consultation for Horizon 2020 Societal Challenge "Health, demographic change and wellbeing" for the programming exercise 2016/2017 (September 2014)
- Contribution to amendments proposed by GRiP (Global Research in Paediatrics, FP7- HEALTH – 2010-261060) to the draft Regulation on Clinical Trials on medicinal products for human use (May 2013)
- Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC (February 2011)
- Ethical Considerations for Clinical Trials Performed in Children (2007)
- EMA Assessment of paediatric needs and Priority-List of Off-patent medicinal products for paediatric studies (2007, 2008)
- Guideline on Conduct of Pharmacovigilance for Medicines used by the Paediatric Population (2006)
- Draft guidance on ‘specific modalities’ for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles (2006)
- Reflection Paper on the use of Pharmacogenetics in the pharmacokinetic evaluation of medicinal products (2006).
Capacity to provide competent consultation to regulatory authorities✔ Yes

Experts proposed by TEDDY are/have been members of:
- Paediatric Committee (PDCO)
- Committee on Herbal Medicinal Products (HMPC)
- European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- Paediatric Working Group at the Italian Medicines Agency (AIFA)
- Paediatric Working Group at the Spanish Medical Agency (AEMPS)
- Paediatric Expert Group at the German Medical Agency (BfArM)
- European Society of Developmental Paediatric and Perinatal Pharmacology (ESDPPP)
Formal meetings for clinical trials If yes, provide number✔ Yes

Investigators’ meetings and scientific project meetings are organized for each planned trial and scheduled before the starting and during all the crucial phases until the end of the trial.
In addition TEDDY has prepared and makes available 19 e-learning courses aimed to increase the researchers awareness and capacity to conduct GCP paediatric trials.
Training courses given over the last 2 years
✔ Yes

1. DEEP Scientific Open Meeting “Challenges and Opportunities of conducting clinical trials in paediatrics” (Padua, Italy, April 15th, 2016)
2. Regulatory and practice in paediatric trials and studies (Warsaw, Poland, September 22nd-23rd, 2015)
3. Deep Scientific Open Meeting: Networking and innovation for local development (Tirana, Albania, May 18th, 2015)
4. Health and Biotechnology (Castellaneta Marina, Italy, October 2nd -4th, 2014)
5. Biotech and Innovative Science to meet Patient Needs (Bari, Italy, September 30th- October 2nd, 2013)
TEDDY has set up an e-learning platform (available at www.teddylearning.org) and has distributed the following online courses, which are going to be updated in the framework of the SMART EU project (Horizon 2020):
“Children are not little adults”
• “The European Paediatric Regulation”;
• “Paediatric status and off-label use of drugs in children”;
• “Clinical trials involving children - Methodological aspects”;
• “Clinical trials involving children - Ethical aspects”;
• “Pharmacoepidemiology and drug utilisation in childhood”;
• “Pharmacovigilance and drug adverse reactions in paediatrics”;
• “Innovative medicines and orphan drugs for children”;
• “Therapeutic needs in the paediatric population” .
Training courses received over the last 2 years ✔ Yes

1. Pharmacovigilance reports in clinical trials (AIFA training course, Rome 2-4 September 2013)
2. Workshop on Extrapolation and Evidence Synthesis in the Development and Therapeutic Use of Medicines in Children (Glasgow, 11 June 2013)
3. Online training course on Good Clinical Practice (March 2013)
4. EudraVigilance - Electronic Reporting of ICSRs in the EEA (EMA- London, 21-23 May 2012)
5. Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Training Course (London, 8-9 March 2012)
Promotion of participation in clinical trials in countries with limited resources✔ Yes

TEDDY studies involve clinical centres located in non-EU countries.
Support is provided for implementation of European ethical and methodological high level standards.
Albania, Egypt, Tunisia.
Involvement of patients, parents or their organisations in the protocol design✔ Yes

Protocols contents and procedures are shared with patients associations. Of note, one of TEDDY members is a Patients Confederation (Childhood Cancer International).
Involvement of patients, parents or their organisations in creating the protocol information package✔ Yes

Patients and families are involved in the preparation of information packages for patients and parents (videos, leaflets, etc.) also through the organisation of focus groups.
TEDDY is also investigating the possibility to establish an Italian YPAG (Young Persons Advisory Group) to be involved in the design of pediatric studies and in the preparation of consent/assent forms.
Involvement of patients, parents or their organisations in the prioritisation of needs for clinical trials in children
✔ Yes

Patients and their organisations are involved in the definition of therapeutic needs.