European union ethical considerations for clinical trials on medicinal products conducted with the paediatric population

European Journal of Health Law

Volumn 15, Issue 2, 2008, Pages 223-250

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Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RADIOISOTOPE; VACCINE;

ADULTHOOD; AGE; ASSAY; BLOOD SAMPLING; BLOOD VOLUME; BODY WEIGHT; CHILD SAFETY; CLINICAL PRACTICE; CLINICAL TRIAL; COMPENSATION; CONTROLLED STUDY; DISTRESS SYNDROME; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; EUROPE; FEAR; GROUPS BY AGE; HEALTH INSURANCE; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LEGAL ASPECT; MARKETING; MATURITY; MEDICAL ETHICS; MEDICAL INSTRUMENTATION; MEDICAL LIABILITY; MEDICAL RESEARCH; MEDICINAL PRODUCT; METHODOLOGY; PAIN; PEDIATRICS; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

ADOLESCENT; AGE FACTORS; BIOMEDICAL RESEARCH; CHILD; CHILD WELFARE; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; EUROPEAN UNION; FEMALE; HUMANS; INFORMED CONSENT; MALE; MINORS; PUBLIC POLICY; RISK;

EID: 53549108038     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180908X333228     Document Type: Review

References (8)

1. DIRECTIVE 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L 121, 1.5.2001, p. 34.
2. This is a legal term and applies under exceptional conditions: Minors can become emancipated through certain actions, such as marriage.
3. Rescue refers to treatment that may be given on top of trial medications to avoid danger or distress, for example pain treatment, as soon as the patient reaches a defined level.
4. Escape refers to prompt removal of subjects whose clinical status worsens or fails to improve to a defined level in a trial.
5. http://www.emea.eu.int/pdfs/human/press/pos/1742401en.pdf.
6. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
7. Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
8. Commission guideline on excipients, the Final Concept Paper Good Pharmaceutical Practices for extemporaneous dispensing, and the Reflection Paper on Formulations of choice in the paediatric population.