Asking a research question
Clinical trials are experiments using patients to determine the value of a treatment or intervention. There are two key components to the experimental approach: objective results rather than plausible reasoning to support conclusions, and that the trials are prospectively planned and conducted under controlled conditions in order to provide definitive answers to well-defined questions. All clinical trials involving patients should be conducted under the regulations for Good Clinical Practice and by suitably trained investigators.
Observational studies
In observational studies, the investigators are passive rapporteurs and the treatment assignment, investigations and follow-up procedures are out of the control of the investigators and conducted with no considerations about the validity of the subsequent attempt at comparison. Such studies are a weak basis for causal inferences about relationships between the treatments administered and the outcomes observed. Observational studies are generally the only feasible approach for epidemiological assessment of disease aetiology. Acute observations in poorly structured therapeutic settings can lead to the development of valuable ideas that can be tested in the laboratory or in clinical trials. Observational studies are rarely satisfactory alternatives to clinical trials.
Phase I clinical trials
The objectives of a phase I trial are to determine the maximum tolerated dose (MTD) of drug for a given schedule and route of delivery, the pattern of adverse effects and toxicity, and to measure the antitumour activity. Pharmacokinetic studies are often conducted in parallel, and at the end a recommended dose for phase II evaluation is determined. Patients considered for such cancer studies are those who have a good performance status as well as adequate organ function and for whom there is no effective alternative treatment available.
Phase II clinical trials
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