Double Blind Trial. This Is a Study

¶ … double blind trial. This is a study where neither the researchers or the participants know what they will receive. First and foremost, it removes any potential for bias, as there are no preconceived notions from the participants or those studying the reactions of the trial. Such studies often also "follow less restrictive methodological standards than phase III studies in terms of patient selection, comedictation, and other design issues," (Muller, 2011). Essentially they have greater room to better replicate real world scenarios. They are also much more able to be generalized than studies with more restrictions. However, there are also some downsides to double blind trials. For example, there is a much greater variance that the research will have to deal with. This is "caused by the different kinds of confounders as well as problematic design issues" that can lead to "wrong conclusions," (Muller, 2011). When there are issues it is more difficult for the researchers to trace what went wrong and generate more accurate results. The level of evidence can thus be compromised and so such studies are often not used when there is a need for very specific conclusions.

Different scenarios require various methodologies. Placebo trials are effective for cases where the condition or issue being studied is not of a sensitive manner (Lewis, 2002). Also, there are ethical concerns where placebo-based trials are appropriate in drug trials that are not set in life threatening situations. Moreover, placebos are appropriate when there are no comparable drugs on the market. On the other hand, there are comparator trials. Comparator trials are appropriate when a comparable drug is already on the market, and researchers are testing a new alternative or a generic form. The use of comparator methods can help increase reliability by providing a way to gather results when the use of a placebo fails to generate the right scenario for the study design to be effective.

Part 2

Bio markers are conditions that help measure a biological state. They are biological observations that give researchers clues as to a study participant's physical and biological state. They are often chemical substances derived from bodily fluids that help researchers understand the biological impact of a drug or the biological health of a participant at any given time. These are incredibly useful for researchers in clinical studies because they help provide empirical evidence in changes of biological states in response to a drug introduced during a clinical trial. Biological markers can help show signs of otherwise difficult to observe conditions, like schizophrenia.