Clinical research healthy volunteer studies

In this section, a brief summary of the nature, frequency, and consequences of adverse drug reactions (ADRs) in two clinical situations is presented. There are ADRs experienced by healthy volunteers and patients participating in clinical studies with potential new medicines and those experienced by patients who are prescribed licensed medicines. A review of these two situations points to areas of success with the current practices for non-clinical safety pharmacology testing but also identifies some areas where further research might lead to new or better safety pharmacology tests. Prior to reviewing the literature, some... 

The clinical part of the study was conducted with participation of 116 adolescent patients aged from 10 to 18 years hospitalized by the Department of Pediatrics for examination and treatment of chronic dyspeptic complaints. The control group comprised 38 age matched healthy volunteers. The Regional Research Ethics Committee of Ukraine approved the study. 

Eight healthy male subjects with a mean age of 34.1 years volunteered for this study. During their participation in the study, they resided on a clinical research unit. The subjects had extensive histories of illicit drug use that included recent ingestion (within the past 2 years) of opiates, marijuana, stimulants, alcohol, and sedative-hypnotics, although they were not dependent on any drug (except nicotine). 

All research involving human subjects (apart from wholly noninterventional, observational studies), including academic research and Clinical Pharmacology studies in healthy volunteers, fall within the scope of the Directive. The latter, hitherto, had a much lighter administrative burden or even no regulatory oversight at all in some MS. The need now to provide the same amount of information and be subject to RA review just as much as later phase clinical research has led to some complaints, especially in the academic community. 

In another survey conducted by the clinical section of the British Pharmacological Society over a one-year period from 1986 to 1987, 8163 healthy volunteers received drugs for research purposes.Potentially life-threatening adverse effects were reported in 0-04% and moderately severe adverse effects in 0-55%, with no lasting sequelae. The three severe reactions were skin irritation and rash requiring hospitalisation, anaphylactic shock after an oral vaccine, and perforation of a duodenal ulcer after multiple-dose non-steroidal anti-inflammatory drug all made a complete recovery. The results were similar to those reported in the earlier ABPI survey and the authors concluded that the risk involved in these studies is very small... 

Since most oral AChEIs exhibit a dose-dependent relationship with undesirable cholinergic adverse effects, researchers have in recent years been focusing on slow-release administration to minimize the fluctuations in plasma concentration [67, 68]. Ye and coworkers have developed transdermal patches containing 4 mg of hupA with the average daily dose of 0.456 mg absorbed [68]. A recent clinical study on 30 healthy volunteers revealed that the transdermal administration provided continuous drug delivery over 120 h and the pharmacokinetic behavior in vivo... 

Provision of adequate competent medical staff is essential for the safe and ethical conduct of studies in humans. Decisions about whether a volunteer fulfils the entry criteria for a healthy subject or should be withdrawn from a study, how to respond to an unexpected adverse event and when to discontinue a study can prove challenging to the most experienced physician. Similarly, research nurses need many organisational and other skills over and above those that they acquired during their basic clinical training. Scientific staff must be competent in the techniques that will provide the essential data. All must be properly briefed about what will be required of them during the course of a study, and must be fully familiar with local standard operating procedures (SOPs) in compliance with good clinical practice (GCP). 

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