The association NETSTAP e. V.
NETSTAP e.V. is a non-profit association of committed pediatricians, mainly from private practices and some outpatient clinics throughout Germany. Our mission is to improve and innovate medical care and drug therapy for children and adolescents and to make it as safe as possible.
Through NETSTAP, physicians and physician assistants are particularly well trained in dealing with children and adolescents in clinical studies and are connected through their own protected intranet network in cooperation with Kinderumwelt gGmbH.
At NETSTAP, we put a lot of thoughts into safe and forward-looking therapeutic procedures.
NETSTAP foundation
The impetus for founding NETSTAP at the start of this millennium was the realisation that clinical research involving and for children in Germany – particularly amongst GPs – was still very much in its infancy. Only a few paediatricians working in private practice were involved in clinical trials, as they lacked the necessary qualifications and the structural facilities in their practices to do so. Numerous medicines for children – for example, in allergology, respiratory medicine, infectious diseases and many other therapeutic areas – had not been adequately investigated in high-quality scientific trials, with the result that the proportion of off-label use of these medicines in paediatrics, particularly in neonatology, remains very high. Similarly, outpatient paediatric practice is not infrequently faced with the dilemma of having to resort to off-label medication, thereby effectively hindering sound paediatric research.
After all, for a wide variety of reasons, the pharmaceutical industry’s interest in high-quality scientific studies involving children has been, and remains, significantly lower than that in studies involving adults. Children have often been, and still are, regarded as ‘little adults’. However, it is no longer sufficient for marketing authorisation to rely solely on studies in adults, provided that a new medicinal product also promises to be beneficial for children and adolescents. In accordance with an EMA requirement, data from clinical trials involving children must always be submitted for new authorisations of medicines containing patent-protected active substances. Consequently, it is now mandatory to conduct appropriate paediatric trials.
History
| 1998 | Start of an investigator initiated trial on sublingual immunotherapy (German multicenter study initiated by of NAPPA) |
| 2001 | Foundation of the Network of Pediatricians for Clinical Studies in Allergology and Pneumology (NETSTAP e.V.) |
| 2002 | First advanced training offer for GCP training. Since then NETSTAP offers 2-3 certified trainings per year at regular intervals in order to qualify investigators / investigator assistants according to GCP. |
| Since 2004 | repeated presence on various annual meetings such as German Allergy Congress, German Society for Pediatrics and Adolescent Medicine as well as regional congresses (NAPPA/NDGKJ/WAPPA/SGKJ), where occasional GCP taster courses are held in addition to NETSTAP member meetings. |
| 2008 | Amendment of the statutes in order to be able to initiate practice-relevant research in pediatrics in a well-founded manner for a much broader circle of indications than before. Since then the association is called: NETwork of Pediatricians for Clinical Studies in Ambulant Pediatrics, the abbreviation NETSTAP remains. |
| 2018 | Member of Enpr-EMA (European Network of Paediatric Research) at the European Medicines Agency. |
| 2019 | First own NETSTAP meeting in Friedrichsdorf. |
| 2022 | Second NETSTAP meeting in Friedrichsdorf. |
Special feature
It is important to the association that its members have the possibility to influence the content and design of studies. Ideally, this is achieved by seeking dialogue by sponsors with NETSTAP as early as possible, ideally when planning clinical trials, e.g. on the part of a pharmaceutical company. This is to ensure that the studies which will be conducted are of scientifical and clinical relevance to the pediatric medicine and the concerned patients.
Independent networks are of paramount importance, especially for pediatrics. This remains to be noted as a result of numerous meetings at European level, namely in regular discussions at the European Medicines Agency in the network of the “European Network of Paediatric Research” (Enpr-EMA), where NETSTAP has been a member since 2018 and is both listed as a Category I multidisciplinary network and is now involved in the internal Coordinating Group (CG).
The reasons for this particular importance are manifold:
- On the one hand, in the context of drug approval testing, the Pediatric Committee (PDCO) at the EMA attaches particular importance to network participation in clinical trials of drugs, whose approval can usually be assessed much more favorably.
- On the other hand, a network creates considerably improved possibilities for reliable recruitment due to multilocal branching as well as internal support, which has become increasingly difficult today, not least due to the partly inflationary increase in administrative tasks.
Look at the pediatric study landscape in Germany, it can be stated that NETSTAP, as a nationwide network in pediatric and adolescent medicine, now has a unique charactaristic, especially thanks to its proven organizational structure and reliable consistency for over 20 years.
** Note: In the case of occupational or functional titles, all genders are always meant