Ethics & Regulations
Trial support
In order to facilitate all aspects of ethics and regulatory issues regarding pediatric trial activities in Germany general information is collected and evaluated by members of the GermanNetPaeT consortium. Not only to foreign sponsors a set of general documents is provided:
Regulatory & Start-up Guideline
Information about general regulatory & ethical issues in study start-up processes of paediatric clinical trials in Germany
Study Implementation Plan
Information about general regulatory & ethical issues and about further supporting documents & services that are offered by the GermanNetPaeT
Ethics & Paediatric Trials
Controversial ethical issues regarding children and adolescents will be discussed on national level involving e.g. representatives of the ethics committees of universities and states, representatives of the Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V., patient representatives , etc. The resulting position statements and reports shall be used to support sponsors' ethics submissions and foster clinical research in paediatrics.
Issues as following will be considered:
Informed Consent in Paediatric Trials
Biobanking in Paediatric Trials
Incidental Findings in Paediatric Trials
Paediatric Trials with healthy Volunteers
Moreover an up-to-date database about the involvement of paediatric experts in the ethics committees of all German universities and states will be established and made available.
Harmonisation of Documents & Procedures
Cost Calculation Working Group
This working group aims to develop a common basis for cost calculations in paediatric clinical trials in Germany. In workshops and web-based conferences relevant information, templates and recommendations will be established (e.g. model-based trial calculation, harmonisation of trial costs, etc.).
Contracting
This working group aims to develop general templates for contracting with regard to paediatric clinical trials in Germany. In workshops and web-based conferences relevant information, templates and recommendations will be established.
Current knowledge is compiled in common model contract clauses for clinical trials with medicinal products in adults, which have already been developed and released for regular use (in German and English) by representatives of academia (Deutsche Hochschulmedizin, KKS-Netzwerk) and industry (Verband der forschenden Pharma-Unternehmen (vfa)) on German level.
Model Contract Clauses "Clinical Trial Agreement"
Model Annex "Obligations within the scope of a clinical trial involving medicinal products"
Model Annex "Data protection declaration of consent"
GermanNetPaeT in close collaboration with the KKS-Netzwerk will adopt these documents for clinical trials in children.
Study specific SOPs
Training & Education
Workshop & Training
Together with the Network of Coordinating Centers for Clinical Studies (KKSN) and GermanPaeNet study centres an intensive exchange of experiences, limitations, and future perspectives will be initiated to promote and improve paediatric trial activities in Germany through continuous training and education.
One ultimate goal is the development of new and highly practice-related web-based training modules covering all relevant issues and requirements to conduct clinical trials in children for specific professional groups (e.g. study nurses, study coordinators, paediatricians and investigators). GCP conform requirements as well as general issues will be considered to complement the mandatory general GCP courses.
Patient Involvement
Young Persons' Advisory Group (YPAG)
At the Center for Paediatric Clinical Studies (CPCS) at the University Hospital Tübingen the establishment of a Young Persons' Advisory Group (YPAG) is currently in progress under the leadership of Prof. Axel Franz. These activities are supported by and used for the GermanNetPaeT initiative from the beginning. The YPAG comprises children and adolescents of different age groups who are specifically trained to give advice with regard to healthcare, clinical trials and research in paediatrics. Ultimate goal is to foster patient centricity through the involvement of patients right from the start (i.e. early in trial design) and to raise general awareness of the importance of clinical trials in children and adolescents.