Monitors, clinical trial

Souza, K. Small, R.D. The use of total quality management principles in placing and monitoring clinical trials. Drug Info. J. 1995, 29, 695-703. 

Dr David Blowers, an international pharmaceutical physician who has conducted and monitored clinical trials and studies exclusively in China, feels that ... 

Gould AL (1992) Interim Analyses for monitoring clinical trials that do not materially affect the type-I error rate. Statistics in Medicine 11 55-66. 

In health and biophysical monitoring, they can be used for cardiovascular monitoring, monitoring the vital signs of infants, monitoring clinical trials, health and fitness, home healthcare, hospitals, medical centers, assisted-living units, etc. 

Please describe planned study population. Choice of participants should be appropriate for the indication proposed. Subjects should not have enrolled in a clinical trial during the preceding 12 weeks. Please describe how special populations such as women of childbearing age, children and the elderly will be handled in this study. Please comment on the special need for close monitoring due to safety considerations. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Gebski V, McNeil D, Coates A, Forbes J. Monitoring distributional assumptions and early stopping for a prospective clinical trial using Monte Carlo simulation. StatMed 1987 Sep 6(6) 667-78. 

Prospective sources include encounter data, which may or may not be contained in EHRs patient data input and randomized, prospective clinical trials. Advantages of prospective sources to inform interactive software include the ability to control and monitor the circumstances of data collection reduction (as a result of randomization) of sources of bias potential minimization of missing data potential to modify design of data collection ability to verify data accuracy and ability to validate and further test assumptions and modify existing programs. 

The widespread acceptance and use of the Internet as a means for communication in clinical trials has revolutionized the way clinical trials information is disseminated among the various individuals and collaborating organizations running and monitoring these trials. A trial s web site provides trial... 

Differences in the systems used to regulate clinical trials in Australia and the Netherlands illustrate how the delegation of authority affects the ability of the central agency to monitor the working of the entire system. In Australia, all approved clinical trials must be notified to the TGA. There is no such reporting requirement for the MEB in the Netherlands. Information about the number and details of clinical trials conducted in the Netherlands is therefore not readily available to the MEB. 

There is a paucity of clinical trial evidence comparing the benefit of diuretics to other therapies for symptom relief or long-term outcomes. Additionally, excessive preload reduction can lead to a decrease in CO resulting in reflex increase in sympathetic activation, renin release, and the expected consequences of vasoconstriction, tachycardia, and increased myocardial oxygen demand. Careful use of diuretics is recommended to avoid overdiuresis. Monitor serum electrolytes such as potassium, sodium, and magnesium frequently to identify and correct imbalances. Monitor serum creatinine and blood urea nitrogen daily at a minimum to assess volume depletion and renal function. 

Upon stabilization, placement of a pulmonary artery (PA) catheter may be indicated based on the need for more extensive cardiovascular monitoring than is available from non-invasive measurements such as vital signs, cardiac rhythm, and urine output.9,10 Key measured parameters that can be obtained from a PA catheter are the pulmonary artery occlusion pressure, which is a measure of preload, and CO. From these values and simultaneous measurement of HR and blood pressure (BP), one can calculate the left ventricular SV and SVR.10 Placement of a PA catheter should be reserved for patients at high risk of death due to the severity of shock or preexisting medical conditions such as heart failure.11 Use of PA catheters in broad populations of critically ill patients is somewhat controversial because clinical trials have not shown consistent benefits with their use.12-14 However, critically ill patients with a high severity of illness may have improved outcomes from PA catheter placement. It is not clear why this was... 

CrCl greater than or equal to 30 to less than 50 mL/minute) and severe (CrCl less than 30 mL/minute) renal impairment respectively. Renal function monitoring is recommended prior to initiation and periodically thereafter. Adverse events in clinical trials included nasopharyngitis (5.2%), upper respiratory tract infection (6.3%), and headache (5.1%). Currently, no significant drug interactions are known. 

The most common adverse effect with omalizumab is injection-site reaction, reported in 45% of patients in clinical trials. Other adverse effects include viral and upper respiratory tract infections, sinusitis, headache, and pharyngitis. Rare cases of malignant neoplasms and anaphylaxis were reported during clinical trials of omalizumab in asthma. Patients should be monitored for at least 2 hours following the injection so that anaphylaxis and/or injection-site reactions may be managed.25... 

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