Critical analysis of the confounding of clinical trials

To provide a comprehensive overview of issues confounding clinical trials, Chapter 2 will discuss the parties involved in the research and development of medications and detail the individual responsibilities of each. However, the ambition of these individual entities often produces a conflict of interest especially when profits are involved [9]. Organizations and individuals such as insurance corporations, pharmaceutical companies (sponsors), pharmacy benefit managers, investigators (doctors/medical professionals) and most importantly patients, are all involved in carrying out clinical research and have definitive responsibilities they are required to follow for unbiased results. However, many rules are overlooked and biases go unrecorded causing the “good” in these institutions to be marred with unethical behavior and unreliable results [1]. After the completion of this section, the biases each entity, including investigators, can and do bring about in the clinical research process will be clear. It is sometimes not particularly obvious as to how selection bias can occur therefore the means of confounding trials by investigators is discussed in Chapter 3. Chapter 4 will provide a critical analysis of the randomized clinical trial quality guidelines presented in the Consolidated Standards of Reporting Trials (CONSORT) Statement. This document serves to increase the accuracy and precision of results reporting of clinical trial results, however does not include repercussions for falsely recording data. Real trials where biasing events have occurred and caused the confounding of trials continue to be published despite the existence of such guidelines. Some of these trials proceed further, in some cases to be fully published and accessible to the public, with no adequate consequences or repercussions. Even if there are consequences for biasing actions, they are not sufficient or efficient enough to ensure the protection of patients exposed to biased studies or the results of such studies. Critical analysis of these “guidelines,” requires familiarity with current standards for the conduct of clinical trials in the Consolidated Standards of Reporting Trials (CONSORT) statement introduced in this chapter. Lastly, Chapter 5 will propose and detail a new selection bias detection mechanism entitled the rank correlation coefficient