SMA Policy Committee: related links
New links
SOMO briefing paper on ethics in clinical trials
The report highlights 22 cases of unethical clinical trials in developing
but also developed countries.
From the report:"Even though the overview below is necessarily incomplete and biased towards unethical trials that have caught some publicity, some general observations can still be made.
Firstly, unethical trials have occurred around the world, in both developed
and developing countries. In some cases, the trials had not been approved by an ethical review committee or institutional review board, or approval had
be given for an unethical trial design. Hence there appear to be flaws, and
sometimes rather serious ones, in the regulatory systems of various
countries.
Secondly, the research organizations involved range from relatively unknown local companies to leading multinational corporations. This might be surprising, given that large multinational corporations usually have clear
public commitments to high ethical standards in clinical trials.
Thirdly, some of the unethical trials are of a recent date, some were even
being carried out in 2005 or 2006. Although it is sometimes argued that
instances of unethical clinical trials are isolated and outdated, this is
not always true. Note that some older cases have been included in the
overview as well, mainly because the developments following these trials are
still going on.
And finally, the nature of ethical concerns appears to be rather diverse and
relates to all paragraphs of the DoH summarized above. The lack of
voluntary, informed participation and adequately informed consent are
probably the most common problems. Trials with experimental drugs of which the safety for testing in humans had not yet been established may be among the most alarming examples."
A working group has been formed in the Netherlands to discuss the issue. For more information, contact:
Annelies den Boer, project coordinator pharmaceuticals, Wemos, Tel
+31-20-4352050, mobile +31-6-30051233, e-mail: annelies.den.boer@wemos.nl;
Francis Weyzig, SOMO researcher, Tel +31-20-6391291, mobile +31-6-27511852,
e-mail: f.weyzig@somo.nl
Links
About Clinical Trials and Complementary and Alternative Medicine from the National Center for Complementary and Alternative Medicine
This fact sheet will provide you with an introduction to clinical trials and to trials of complementary and alternative medicine (CAM).
AIDS Clinical Trials Information Service (ACTIS)
Central resource for current information on federally and privately funded clinical trials for AIDS patients and others infected with the human immunodeficiency virus (HIV). This service is a Public Health Service (PHS) project provided collaboratively by the National Institute of Allergy and Infectious Diseases, the Food and Drug Administration, the National Library of Medicine, and the Centers for Disease Control and Prevention.
AIDS Education Global Information Serive (AEGIS): Clinical Trials
The following information is made available as a public service and does not constitute endorsement by ÆGIS or any other organization. It is the responsibility of the user to evaluate this information based on individual needs and community standards prior to use.
The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies.
ClinicalTrials.gov Resources Information
Pediatric AIDS Clinical Trials GroupAn Introduction to Clinical Trials, Participation in Clinical Trials, Glossary, General Information on Clinical Trials
The PACTG, a joint effort of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute for Child Health and Human Development (NICHD), encompasses the mission for HIV-infected pregnant women and children that the Adult AIDS Clinical Trial Group (AACTG), the Community Programs for Clinical Research on AIDS (CPCRA), the AIDS Vaccine Evaluation Group (AVEG), the Division of AIDS Treatment Research Initiative (DATRI), and the pharmaceutical industry-sponsored studies represent for HIV-infected adults.
Veritas Medicine is a free confidential resource providing access to clinical trials and information on treatment options.
Supercourse: Clinical Trial Concepts
Claudia Scala Moy, Ph. D.
The Society for Clinical Trials
The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design and conduct of clinical trials and related health care research methodologies.
National Reference Center for Bioethics Literature
Links to Pharmaceutical Related Sites -- from the Tufts Center for the Study of Drug Development
The National Information Resource on Ethics & Human Genetics
BIOETHICS Information Retrieval Project
The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)
The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is an independent international cooperative project designed to facilitate the development of the ethical review of biomedical research. The project develops out of the capacity-building activities of TDR of the World Health Organization (WHO) in drafting, translating, distributing, and implementing the Operational Guidelines for Ethics Committees That Review Biomedical Research.