Linde, Mattias and May, A. and Limmroth, V. and Dahloef, C. (2003) Ethical aspects of placebo in migraine research. CEPHALALGIA, 23 (7). pp. 491-495. ISSN 0333-1024, 1468-2982
Full text not available from this repository. (Request a copy)Abstract
Randomized placebo-controlled clinical trials have been the 'golden standard' during the last decades in the development of new drug therapies. This scientifically valid approach has recently been questioned in the fifth revised version of the Declaration of Helsinki, which states that the use of placebo-controlled clinical trials is only acceptable when no proven treatment exists for the studied disease. The World Medical Association further claims that no national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the statements in the declaration. In spite of this, the document is not generally accepted as the world ethical standard, as demonstrated by its lack of adoption by many professional associations. In the evaluation process for a drug to be approved in many countries today, clinical investigators at the hospitals and researchers at the pharmaceutical companies are obliged to use study protocols that would be rejected if the new declaration were to be fully adopted. Adherence to the clinical trial guidelines of the International Headache Society could also mean violation of the new Helsinki declaration of ethics. Some ethics committees have already adopted the new declaration, which has caused concern among clinical investigators, who find this document to be vastly out of the line with common practice. At the moment, the situation is unclear and debated with increasing polarity concerning the scientific and ethical issues regarding the use of placebo in clinical trials.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONTROLLED TRIALS; CLINICAL-TRIALS; ISSUES; DECLARATION; HELSINKI; CHILDREN; DESIGN; HEALTH; clinical trials; ethics; migraine; placebo; research design |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Sep 2021 12:09 |
| Last Modified: | 01 Sep 2021 12:09 |
| URI: | https://pred.uni-regensburg.de/id/eprint/38641 |
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