Clinical Studies Explained

What Are Pilot Studies?
Pilot studies usually enroll only a small number of patients, sometimes as few as a dozen or less, and are conducted for a few weeks to a few months. The primary objective of pilot studies is to identify the preliminary effectiveness of a new substance or treatment, define proper dosing, and determine side effects and safety.

What Are Double-Blind Placebo-Controlled Studies?
A placebo-controlled study is a method of investigation of a drug/treatment in which an inactive substance (a placebo) is given to one group of participants, while the substance being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. A placebo has no treatment value.

Double-blind means that neither the patient nor the physician knows which participants are receiving the experimental treatment and which ones are getting the placebo. By using this approach, the expectations of neither the patients nor the doctors about the experimental drug can influence the outcome. The results are fully objective. Double blind is considered the golden scientific standard for clinical trials.

Randomized Controlled Trials
Randomized means assigned by chance. In randomized controlled trials, patients are randomized to a group receiving either the new treatment/drug or the placebo. Neither the patient nor the physician chooses who gets the new treatment or the placebo.

Statistical Significance
Statistical analysis is used in clinical trials to gather relevant information concerning the properties of the target population from the observations of those same properties in the trial sample. These inferences require that the research questions be translated into numerical statements of relationships of those population properties. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed. Experts in the medical community determine statistical significance. P values are widely used to convey the probability of observed effects. By convention, P values less than 0.05 are interpreted as being “statistically significant.”

Who Sponsors Clinical Trials?
Clinical trials are very costly and usually sponsored by the pharmaceutical industry, large organizations, and even individuals; however, such sponsorship often involves bias in the data. Matthias Rath Company stands unique and independent in this area, as it reinvests profits into clinical trials, the sponsorship of various research projects, and Cellular Medicine research with the mission to achieve Health for All by 2020 and to eradicate the most detrimental diseases.

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Read about Matthias Rath Company clinical trials.
Read the results of clinical studies.