Central retinal artery occlusion: local intra-arterial fibrinolysis versus conservative treatment, a multicenter randomized trial.

Purpose: The reported outcomes of central retinal artery occlusion (CRAO) with or without treatment vary considerably. Although local intra-arterial fibrinolysis (LIF) using recombinant tissue plasminogen activator (rtPA) is a promising treatment, outcomes have not been compared in randomized trials.

Design: Prospective randomized multicenter clinical trial (the European Assessment Group for Lysis in the Eye Study) to compare treatment outcome after conservative standard treatment (CST) and LIF for acute nonarteritic CRAO.

[The Coordinating Centres for Clinical Trials Network. Objectives and significance for research sites].

In the late 1990s a funding program was set up by the federal German government to help keep stride with developments in the international research arena. Within this programme, Coordinating Centres for Clinical Trials ("Koordinierungszentren für Klinische Studien", KKS) were established at 12 German universities aiming at supporting all processes of academic clinical trials according to international standards. A close network infrastructure was chosen in order to reap maximum benefit from synergy effects and to promote the harmonisation of standards.

[New clinical technologies in drug development].

The integration of functional imaging and therapeutic nuclear medicine technologies mainly in the early phases of drug development (clinical technologies implementation, CTI) is a relatively young option, which has amply influenced drug development concepts in the pharmaceutical industry. Over the past 15 years, the greatest risk reduction in drug development decision making has resulted from the earlier involvement of drug metabolism in the optimization stage of drug design rather than the late-stage characterization of target molecules. Go/no-go decisions of drug development programs and drug dosage can also be inferred from these techniques, which lead to decreases in time and costs.

Multicenter study of the European Assessment Group for Lysis in the Eye (EAGLE) for the treatment of central retinal artery occlusion: design issues and implications. EAGLE Study report no. 1 : EAGLE Study report no. 1.

Background: The natural course of central retinal artery occlusion (CRAO) often leads to legal blindness in the affected eye. To date, none of the conservative therapies had proven effective in retrospective studies. In 1991, a new minimally invasive therapy was started in patients with an acute CRAO.

Good clinical practice: historical background and key aspects.

Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described.