Clinical studies/trials interpretation

Poor adherence to the schedule of taking the study medication will obviously confound interpretation of the efficacy and safety of the drug. There is usually good compliance in clinical pharmacology studies, especially those conducted in units where drugs are administered by the staff. However, in clinical research trials adherence to medication may be poorer. 

Any interim analysis that is not planned appropriately (with or without the consequences of stopping the trial early) may flaw the results of a trial and possibly weaken confidence in the conclusions drawn. Therefore, such analyses should be avoided. If unplanned interim analysis is conducted, the clinical study report should explain why it was necessary and the degree to which blindness had to be broken, and provide an assessment of the potential magnitude of bias introduced and the impact on the interpretation of the results. (ICH, E9, 4.5)... 

Use and extrapolation of efficacy data The effects of treatments on efficacy endpoints can be used for several different purposes. They may be used to set a new hypothesis in further clinical studies. This is particularly the case for unexpected findings, such as a negative result despite a well conducted trial, or a positive result which is difficult to interpret, such as failing to show a difference between several doses of a... 

Why would you include an older established drug in a clinical trial You might suppose that this would be to see if the new drug is better. That is what I had assumed until I read the FDA memo, but the memo made me wonder. Why should the absence of another drug in the study make it harder to interpret a failure to find a difference between the new drug and a placebo ... 

Such studies provide important information for a better interpretation of the toxicity observed in animals, and aid in the selection of not only the proposed initial human dose but of the dose-escalation scheme and the frequency of dosing in the clinical trial(s). Further, once such exposure data are available in humans, the data can be used to better correlate the human and animal findings. Toxicity studies should be performed in the same species used to assess exposure. Often, exposure and toxicity are measured in the same study, particularly when nonrodents are used. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

NDGA also inhibits 5-LO in a variety of systems [65-68]. In vivo, antiinflammatory activity has been reported in lipopolysaccharide (LPS)-in-duced knee inflammation in rats [69] and in AAE and croton oil induced ear oedema [70,71]. However, in a 14-day clinical trial in psoriasis, no efficacy was seen following topical application of NDGA [72]. Although this compound has been used as an archetypal 5-LO inhibitor in many studies, the general antioxidant properties of this compound require caution in these interpretations. 

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