Patient safety good clinical practice

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

Clinicians are usually most concerned about external validity of trials of potentially dangerous treatments. Complications of medical interventions are a leading cause of death in developed countries. Risks can be overestimated in trials, particularly during the introduction of new treatments when trials are often carried out with patients with very severe disease, but stringent selection of patients, confinement to specialist centers and intensive safety monitoring usually lead to lower risks than in routine clinical practice. Trials of warfarin in non-rheumatic atrial fibrillation are a good example. Prior to 2007, all trials... 

Evidence based medicine then provides the foundation of good practice but does not directly address the safety issue, which is why care known to be effective is not delivered to the patient. From our point of view, the most important point is that an evaluation of a clinical practice has led to questions of a psychological nature and towards core patient safety issues of error and human behaviour. These themes emerge more strongly in the next section, which addresses some criticisms of the report s approach to patient safety. 

Today, a growing activity to improve patient safety in all domains of medicine is reality. This chapter deals with patient safety research in general, but is also about strategies to implement this evidence in the daily clinical work treating patients on dialysis. Good clinical research practice has been well established for some years. In the domain of dialysis access, further basic, clinical, epidemiological and health service research will be important to further improve patient safety as a whole. 2015 S. Karger AG, Basel... 

ADEs and medication errors can be extracted from practice data, incidents reports from health professionals, and patient surveys. Practice data include charts, laboratory, prescription data, and administrative databases, and can be reviewed manually or screened by computer systems to identify signals. A method of ADE and medication error detection and classification has been presented that is feasible and has good reliability (Marimoto et al. 2004). It can be used in various clinical settings to measure and improve medication safety. 

In addition to the physical and mechanical properties, ecological safety and good wear comfort are important for patient acceptance and the desired success of therapy. In practice, compression bandages made of a large variety of materials are applied on patients in many different clinical circumstances, and a carefiil selection of appropriate products is needed before the application of bandages or stockings on patients. 

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