Questions On Clinical Trials!?

In health care, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.

Due to the sizable investment a full series of clinical trials may become, the burden of paying for all the necessary people and services is usually borne by the sponsor who may be the pharmaceutical or biotechnology company that developed the agent under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization (CRO).

assess the safety and effectiveness of a new medication or device on a specific kind of patient (e.g., patients who have been diagnosed with Alzheimer’s disease)

assess the safety and effectiveness of a different dose of a medication than is commonly used (e.g., 10 mg dose instead of 5 mg dose)

assess the safety and effectiveness of an already marketed medication or device for a new indication, i.e. a disease for which the drug is not specifically approved

assess whether the new medication or device is more effective for the patient’s condition than the already used, standard medication or device (“the gold standard” or “standard therapy”)

Effects of wholegrain components on metabolic biomarkers: a four-week intervention study in ‘at risk’ subjects

04 December 2008: HydroCortisone in Severe Acute Pancreatitis

Evaluation of the bioavailability of bioactive wheat bran components from bread rolls
(a few of them)

A placebo is a substance or procedure a patient accepts as medicine or therapy, but which has no verifiable therapeutic activity. Susceptibility to the placebo effect (roughly 30% in the human population) may be “genetically determined