Are surgical trials with negative results being interpreted correctly?

Background: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings.

Study Design: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008.

Conflicts among multinational ethical and scientific standards for clinical trials of therapeutic interventions.

Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.

A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

Background: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods.

Methods: The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008.

Traditional knowledge and intellectual property.

Biotechnological inventions are sometimes based upon the traditional knowledge of indigenous communities about the beneficial properties of plants and animals. Some institutions have adopted the uniqueness of traditional knowledge approach, which maintains that the indigenous communities have sui generis rights to a share of the profits from these inventions. Others have adopted the protection of inventive steps approach, which maintains that the inventors are entitled to the full profits from the invention if it involves a non-obvious and novel inventive step.

Intellectual property, state sovereignty, and biotechnology.

The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration.

Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials.

Ethical issues in clinical trials in developing countries.

The vertical transmission trials conducted in a variety of developing countries by researchers from more developed countries illustrate a variety of crucial ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. This paper examines each of these issues separately.

A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

Background: Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee.

Methods: A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery.

Noncompliance with medical follow-up after pediatric intensive care.

Objectives: To describe the medical follow-up ordered, the health care utilization, the appointment compliance, and the risk factors associated with noncompliance in patients who are discharged after a pediatric intensive care unit (PICU) stay.

Methods: A prospective, analytic, cohort study of 111 critically ill children, age 1 day to 16 years, who were admitted to a 30-bed PICU in an urban, tertiary-care, pediatric teaching hospital compared children who were compliant with medical follow-up with those who were not. The main outcomes measured were emergent and unscheduled physician visits during the first 6 weeks after hospital discharge; compliance with ordered medical follow-up after hospital discharge; and comparisons of socioeconomic, demographic, and medical need factors between compliant and noncompliant children.

The role of philosophy in public policy and bioethics: introduction.

As various societies have created public commissions to help develop proposals for public policies relating to issues in bioethics, philosophers have sometimes been called upon to serve on the staff of, or to provide consultation to, these public bodies. This issue of the Journal is devoted to examining problems that arise as one tries to articulate the proper role of philosophers serving in these capacities. It includes articles by Frances M.