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Questionable Industry-Sponsored Postneonatal Pediatric Studies in Slovenia
Klaus Rose1, David Neubauer2, Jane M Grant-Kels3
1Pediatric Drug Development & More, klausrose Consulting, Riehen, Switzerland.
Current Therapeutic Research, Clinical and Experimental
|August 8, 2019
Summary
Most industry-sponsored pediatric studies mandated by US and EU laws lack medical value and are unethical. These studies, often using placebo or substandard treatments, harm children and exclude them from effective therapies.
Area of Science:
- Pediatric pharmacology
- Clinical trial ethics
- Regulatory science
Background:
- US and EU pediatric laws mandate industry-sponsored studies based on the 'therapeutic orphans' concept.
- This concept suggests children are discriminated against in drug treatment and development.
Purpose of the Study:
- To investigate the medical validity and utility of international pediatric studies conducted in Slovenia.
- To critically evaluate the ethical implications of these industry-sponsored trials.
Main Methods:
- Analysis of international industry-sponsored pediatric studies with Slovenian centers.
- Data sourced from www.ClinicalTrials.gov.
Main Results:
- Most studies lack medical or scientific value, despite regulatory justification.
- Some studies expose children to placebo or substandard treatments, causing harm.
- Trials are medically redundant and deter patients from innovative therapies.
Conclusions:
- Pediatric studies mandated by US/EU regulations represent an abuse of children and adolescents.
- Institutional review boards/ethics committees must critically review and suspend questionable studies.
- These studies exclude young patients from beneficial research and should be rejected if unethical.
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