Hospitals recruiting

The first consideration, as always, will be safety information that can be obtained more safely in healthy subjects, which may subsequently reduce risk to patients, should prompt a debate on whether it is wise to progress according to plan or whether an additional study should be performed in healthy subjects. Another option that may be considered is to proceed with the planned study in patients but to admit them to hospital or a clinical investigation unit for all or part of the dosing period. However, this might not be feasible because suitable facilities and staff are not available or because the anticipated rate of patient recruitment might be considered unacceptably slow. 

The budget must be set, the means of payment agreed and contractual arrangements for premature trial termination decided. In addition, the legal contract should include payments, if any, when a study subject drops out or when it is impossible to evaluate an individual subject (e.g. protocol violations by an investigator, such as recruitment of subjects who do not meet the inclusion criteria - which are an indication for extra clarification of protocol requirements). There should be a clear understanding of the costs and expenses that the site s institution or hospital will absorb and what the sponsor will pay for either directly or indirectly. 

Similarly, hospitals were not able to advertise their involvement into clinical studies. There are detailed regulations as to what hospitals can advertise, and they were amended in April 2001 so that the hospitals can recruit patients by means of mass media. 

Patient recruitment advertisement often appears in major newspapers or leaflets, which are delivered with newspapers, as most households prescribe one or more major newspapers. Some CROs established call centres to handle patient/volunteer applications or queries regarding the clinical trial and introduction of participating hospitals. 

Effects of G-CSF (color) or placebo (black line) on absolute neutrophil count (ANC) after cytotoxic chemotherapy for lung cancer. Doses of chemotherapeutic drugs were administered on days 1 and 3. G-CSF or placebo injections were started on day 4 and continued daily through day 12 or 16. The first peak in ANC reflects the recruitment of mature cells by G-CSF. The second peak reflects a marked increase in new neutrophil production by the bone marrow under stimulation by G-CSF. Treated patients in this study had fewer days of neutropenia, days of antibiotic treatment, and days of hospitalization. They also had a lower incidence of infections. (Normal ANC is 2.2-8.6 x 109/L.) (Modified and reproduced, with permission, from Crawford et al Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991 325 164.)... 

The availability of scanning equipment and trained personal, specific contraindications, patient claustrophobia, and the safety of the sometimes very ill or uncooperative stroke patients limit the feasibility of stroke MRI during the scan. To determine the true feasibility of MRI requires a prospective study in all patients presenting with suspected stroke. Singer et al. (2004) found that only 80% of 144 stroke patients recruited at the hospital door could be examined with MRI. Others reported even smaller numbers between 54% and 62% of the patients in whom MRI was feasible (Barber et al. 2005 Hand et al. 2005 Schramm et al. 2004). According to Barber et al. (2005) and Hand et al. (2005), feasi-... 

Now take an essentially sound experimental design. We want to determine the average elimination half-life of a new anti-diabetic drug in type II diabetics aged 50-75, within Western Europe. We recruit several hospitals scattered throughout Western Europe and they draw up a census of all the appropriately aged, type II diabetics under their care. From these lists we then randomly select potential subjects. 

In a study with Callahan et al., " the effectiveness of hair, urine, and meconium analyses for identifying cocaine use was compared and validated by self-reports. The correlation between drug levels in the hair of mothers and babies was also investigated, but this was done under conditions where treated hair was not excluded from the study. The study involved 59 mother-infant pairs. The women had given birth at a teaching hospital and were recruited for a prospective study comparing neurobehavioral outcome of cocaine-exposed infants with that of control infants. 

The availability of capital resources is equally important. As mentioned, the current health care system— including the emergency, acute, and chronic care components—are all operating at maximal capacity. However, EMS vehicles, ED and hospital beds, and operating rooms will be needed in differing levels based on the incident (Auf der Heide, 2006 Pesik et al., 2001). For the EMS system, planners must know and address mutual aid issues. In upstate New York, Rural Metro Medical Services provides EMS in many cities and has a plan to shift resources between cities in event of crisis. Thus, additional ambulances, communications equipment, and maintenance facilities can be deployed throughout the region. In other areas, mutual aid compacts must be in place to allow for the immediate recruitment of as many additional EMS units as are needed (Auf der Heide, 2006). 

The Women s Bureau of the Red Cross recruits women across the nation to make surgical dressings, hospital garments, and refugee clothing for sister Red Cross societies and military hospitals in war-torn Europe, the beginnings of what becomes the Red Cross Production Corps. 

A third variety, so-called delayed-onset heparin-induced thrombocytopenia has also been described in several reports. In 12 patients, recruited from secondary and tertiary care hospitals, thrombocytopenia and associated thrombosis occurred at a mean of 9.2 (range 5-19) days after the withdrawal of heparin nine received additional heparin, with further falls in platelet counts (32). In a retrospective case series, 14 patients, seen over a 3-year period, developed thromboembolic complications a median of 14 days after treatment with heparin (33). The emboli were venous (n — 10), or arterial (n — 2), or both (n — 2) of the 12 patients with venous embolism, 7 had pulmonary embolism. Platelet counts were mildly reduced in all but two patients at the time of the second presentation. On readmission, 11 patients received therapeutic heparin, which worsened their clinical condition and further reduced the platelet count. 

The AMA discontinued its nascent registry of adverse reactions in 1970 and launched a Pilot Drug Surveillance Study in an effort to compile information that was more amenable to comparative analysis. Unable to recruit physicians as reliable data collectors, council members mimicked the FDA and turned to hospitals as a more controlled setting. The pilot study s objectives explained... 

Experimental design. This MRL is based on the results of the Seychelles Child Development Study (SCDS), a series of evaluations on a population in the Seychelles Islands. The chronic oral MRL for methylmercury is based upon the Seychelles Child Development Study (SCDS), in which over 700 mother-infant pairs have, to date, been followed and tested from parturition through 66 months of age (Davidson et al. 1998). The SCDS was conducted as a double-blind study and used maternal hair mercury as the index of fetal exposure. Enrollees were recruited by the head nurse/hospital midwife by asking the mothers if they wished to participate in the study when they arrived at the hospital for delivery. The first 779 who did not decline participation became the mothers in the study cohort. Of the initial 779 mothers enrolled in the study at parturition, 740 remained at the predetermined child testing age of 6.5 months,... 

In 1956 Oddis joined the American Hospital Association (AHA) in Chicago as the staff representative for hospital pharmacy. In 1960 he was recruited by ASHP and the American Pharmaceutical Association (APhA) as secretary of ASHP and director of the Division of Hospital Pharmacy at APhA. When the APhA position was dissolved a few years later, Oddis became full-time chief executive officer at ASHP, a position he held until his retirement in 1997. 

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