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Regulatory issues in human gene therapy.

Protection of human subjects is the ethical and legal responsibility of investigators conducting clinical trials. Public concerns regarding recombinant DNA technology led to additional levels of oversight which are unique to human gene therapy trials. The deaths of a normal volunteer and a gene therapy subject in the late 1990s led to an intensification of oversight with new initiatives that impact gene therapy as well as other clinical investigators. This paper will review the current oversight agencies and identify areas of evolving regulations that pose particular challenges to gene therapy investigators.

Clinical Trials as Topic↗
PubMed2001

Overview of the results of recent beta blocker trials.

Results of the studies published or reported within the last 2 years provide convincing evidence that beta-blockers can decrease mortality in patients with chronic symptomatic heart failure because of left ventricular systolic dysfunction. The Cardiac Insufficiency Bisoprolol Study (CIBIS)-II and Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF) trials showed a 34% reduction in all-cause death with bisoprolol and metoprolol therapy in patients with class II-III heart failure. Data from Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS), with a 35% mortality reduction, extended this benefit to class IV patients treated with carvedilol who do not require intravenous diuretics or positive inotropes. Ongoing beta-blocker studies address new topics, such as treatment of older patients, in whom diastolic heart failure may be more common, and direct comparison of different drugs. Although the use of beta-blockers for heart failure tends to increase, implementation of the knowledge from the trials in clinical practice still remains a challenge.

Adrenergic beta-Antagonists↗