Paediatric studies
Here you will find answers to frequently asked questions about paediactric studies.
What needs to be considered in paediatric trials?
The German Medicines Act (Arzneimittelgesetz, AMG) stipulates special safety provisions for minors participating in clinical trials. For all minors the provisions of § 40 AMG Section 40 sub-section 4 of the AMG apply; in addition, for minors suffering from a disease the regulations of § 41 AMG Section 41 sub-section 2 AMG shall be adhered to.
Do special documents have to be submitted for paediatric trials?
Pursuant to Section 40 sub-section 4 number 2 of the German Medicines Act (Arzneimittelgesetz, AMG), a paediatric trial may only be conducted if clinical trials performed on adults or other research methods cannot be expected to produce satisfactory test results according to medical knowledge.
Pursuant to Section 40 sub-section 4 number 4 of the German Medicines Act (Arzneimittelgesetz, AMG), a paediatric trial may only be conducted if it subjects the person concerned to as little burden and other foreseeable risks as possible. Both the degree of burden and the risk threshold shall be defined specifically in the trial protocol and monitored constantly by the investigator. In addition, the protocol must include a description of how this constant monitoring of the degree of burden and the risk threshold will be performed by the investigator.
We recommend describing as early as in the cover letter, how these regulations will be implemented.
How often are paediatric trials currently submitted for authorisation at the BfArM?
Currently, approximately 6 % of all clinical trials conducted in Germany and approved by the BfArM are paediatric trials. Most often, clinical trials on minors are conducted in the fields neurology and psychiatry, respiratory tract, and gastroenterology.
| 2004 | 2005 | 2006 | |
|---|---|---|---|
| total | 273 | 1093 | 1249 |
of these: paediatric trials | 19 | 70 | 65 |
| percentage (%) | 6,6 | 6,1 | 5,0 |
Distribution of requests for authorisation of clinical trials on minors with respect to indication:
| indicationt | percentage distribution |
|---|---|
| anaesthesiology, algesiologye | 2,2% |
| antiinfectives | 8,8% |
| eyes | 2,9% |
| endocrinologye | 9,6% |
| gastroenterology | 14,0% |
| skint | 12,5% |
| oto-rhino-laryngology | 1,5% |
| cardiovascular diseases | 7,3% |
| neurology and psychiatry | 16,1% |
| oncology, immunology, blood | 7,3% |
| respiratory tract | 14,7% |
| rheumatology and radiology | 2,2% |