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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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At least 253 records · Page 14Linked to original sources
PubMed2003

Developing a management plan.

Many complex issues are associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program. A previous article focused on the definition and scope of specialty pharmaceuticals. This article explores the mechanics of developing and managing a specialty pharmaceutical program, specifically, authorization management.

Biotechnology↗
PubMed2004

Resource guide 2004. Blood glucose. Monitors and data management systems.

Before you buy a blood glucose monitor (also known as a blood glucose meter), check with your doctor and diabetes educator. Make sure the one you choose is well suited to your particular needs. You might want to have one at home and one for use at school or the office.

Blood Glucose Self-Monitoring↗
PubMed2004

[Clinical trials--historical development, regulation and updated data].

Medical research is a broad discipline in which clinical trials bridge between research and practice. During the 20th century, modern concerns regarding the ethical and clinical aspects of clinical trials led to the development of international standards and regulatory procedures that guide research in clinical trials. The rapid development of pharmaceuticals, biological products and medical devices facilitates an increase in the number and magnitude of the clinical trials that are performed worldwide. This overview surveys the historical and regulatory basics of clinical trials, and provides data on the extent and costs of clinical trials conducted throughout the past years, with a special emphasis on Israel.

Clinical Trials as Topic↗
PubMed2004

[Placebo-controlled trials in schizophrenia].

BACKGROUND: Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. PURPOSE: The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. METHODS: Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. DISCUSSION: Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. CONCLUSIONS: We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow-up procedures for the study as determined by the local Helsinki Committee; and appointment of a supervisory mechanism by the administration of the medical institution where the study is being performed.

Clinical Trials as Topic↗