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PubMed2003

Is it ethical to conduct placebo-controlled clinical trials in the development of new agents for osteoporosis? An industry perspective.

To represent industry on the topic of this conference, position papers were obtained from six pharmaceutical and biotechnology companies. Despite their holding a wide range of positions in the market with regard to prevention and treatment of osteoporosis, all companies were unanimous in their concerns about the ability to conduct randomized placebo-controlled clinical trials (PCTs) in the future. The clinical research environment contains conflicting directives. Regulatory agencies strongly prefer (even insist on) PCTs as a requirement for drug approval, while many physicians, human studies institutional review boards, and informed patients believe that it is no longer ethical to place osteoporotic patients on placebo because effective therapies are now available. PCTs offer the best means of calibrating the absolute efficacy of a new agent and identifying its side effects against a "neutral" background. Are comparison-controlled clinical trials (CCTs) using an approved drug the answer? No. Examples are given that illustrate that such trials require very large numbers of patients to show "non-inferiority" (approximately 15,000-20,000) or "superiority" (approximately 30,000) compared with an existing approved therapy. Such studies are not only impractical, but also accumulate a greater number of fractures during the course of clinical research in both the new treatment and control (active comparator) groups than would occur in PCTs. Total adverse experiences and exposure of patients to investigational agents is considerably greater when CCTs rather than PCTs are used. Based on this analysis, industry recommends that regulatory approval of new agents for osteoporosis be based on (1) conduct of PCTs in patients at low risk for fracture (e.g., T-score < -2.5 and no previous osteoporotic fracture); (2) use of bone mineral density as an end-point for the indication "to preserve or improve bone mass"; (3) a 2-year, rather than 3-year, trial period; (4) demonstration of no adverse effect on bone quality preclinically; (5) extrapolation of clinical trial results to higher risk patients; (6) an option for the sponsor to perform additional fracture end-point studies postapproval to obtain an indication for "treatment to reduce the risk of fractures specifically in the spine, hip, or both"; and (7) the option to file for a "prevention" claim before a "treatment" claim.

Controlled Clinical Trials as Topic↗
PubMed2003

[Publication standards for clinical research sponsored by the pharmaceutical industry].

The role played by the private sector, in particular the pharmaceutical industry, in funding research has been growing at an accelerated pace in recent decades. So much so, in fact, that the private sector has become the primary funding source of clinical trials in some countries. As a result, pharmaceutical companies exercise ever-growing control over not only the design of clinical trials but also the publication of their results. The conflicts of interest involved in this kind of situation can lead to ethical breaches (for example, suppression or distortion of results or the intimidation of investigators), and it is crucial to take concrete steps to guard against such breaches. This is exactly what a Working Group made up of members of the pharmaceutical industry itself has done, preparing a series of guidelines for that industry in order to promote good publication practices. These guidelines, which were just recently published in English, represent an important step in efforts to achieve greater transparency and accountability in the presentation of results of research funded by manufacturers of pharmaceutical products. Although the guidelines, now translated into Spanish in this piece, are subject to future revisions, they are a valuable starting point for further discussion of a problem that deserves the urgent attention of the scientific community.

Biomedical Research↗
PubMed2003

Ethical aspects of placebo in migraine research.

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.

Adolescent↗
PubMed1990

Harmonization of guidelines for toxicity testing of pharmaceuticals by 1992.

In the past there has been considerable disagreement between various regulatory authorities regarding the type and design of animal tests that should be required before a new medicine can be used ethically and safely in the clinic. However, regulatory variations have largely been removed within politically and geographically similar regions (e.g., the U.S.A., the European Community, the Nordic countries) and there now appears to be a consensus regarding the value of harmonizing international requirements. In order to assist the process of harmonization, a detailed table of preclinical toxicity requirements in the U.S.A., Canada, Japan, and the European Community for each test (acute, subacute, chronic, carcinogenicity, mutagenicity, reproduction) has been compiled. This has been circulated to the relevant regulatory authorities to ensure that it accurately reflects current requirements. The major differences between authorities were found to be the duration of chronic, repeated-dose tests and the design of reproduction studies. International pharmaceutical companies were asked to complete a questionnaire, indicating how they design their preclinical testing program to comply with varying regulatory requirements. Most of the respondent companies indicated that chronic tests of longer than 6 months were conducted solely to comply with some regulatory requirements. Many companies repeat reproduction studies in order to comply with Japanese requirements. This emphasizes the need to harmonize these guidelines and discussions are currently underway to attempt to develop protocols acceptable to the FDA, the EC, and the Japanese Ministry of Health and Welfare.

Animals↗