Trial design and patient safety -- the debate continues

Article Abstract:

The US Office for Human Research Protections (OHRP) in the Department of Health and Human Services has criticized the institutional review boards (IRBs) of some hospitals participating in research on acute respiratory distress syndrome (ARDS). OHRP believes the IRBs did not collect sufficient data to determine the actual risks to the participating patients. However, some researchers believe the National Institutes of Health is better qualified to examine patient safety issues in medical research.

United States, Legal issues & crime, General services, Safety and security measures, Company legal issue, Cases, Investigations, Clinical trials, Patients, Acute respiratory distress syndrome, Adult respiratory distress syndrome, United States. Department of Health and Human Services

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HIV infection--a new drug and new costs

Article Abstract:

Enfuvirtide is the new antiretroviral agent for patients with drug-resistant human immunodeficiency virus (HIV) infection that inhibits the infusion of HIV type 1 (HIV-1) with CD4+ cells and heralds an era of new approaches to treatment. However, this new medication is very expensive as in the US the wholesale acquisition cost for a year's supply is just under $20,000 and hence it is suggested that this medication must be combined with other antiretroviral drugs.

Science & research, Care and treatment, Research, HIV infection, HIV infections, CD4 lymphocytes, Highly active antiretroviral therapy

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