In an an effort to increase awareness and understanding about Clinical trials we are going to create a series (the series is called ‘Clinical Trials Primer‘) of posts on the basics of Clinical Trials . To kickstart, we begin with addressing the question ‘What are Clinical Trials?’ (as we routinely get patient emails asking this same question).
Clinical Trials are medical research studies or research trials (also known as Randomized Controlled Trials) that are conducted on human beings to study the effectiveness of a medication, treatment method, investigational technique, or effects of certain natural elements for a human medical condition. Thousands of such trials are running in the United States alone for hundreds of medical conditions.
To further, distinguish, clinical trials are of two types:
1. Interventional Clinical Trials: These trials refer to medical research studies, wherein the investigators administer or assign a particular treatment method, medication, or any other type of intervention to a group of volunteers and the effects on the volunteer’s health condition is noted and measured.
2. Observational Clinical trials: These refer to clinical trials where the investigators do not actively administer any treatment method or drug to the participants. Rather, the researchers observe and measure the health condition of the participants in their natural environment, usually in a point in time or over time.
It is sometimes mistakenly believed that participating in a clinical trial is akin to being experimented upon. However, clinical trials do not treat humans as guinea pigs. In fact, clinical trials are always the last stage in the developmental of any treatment or interventional technique. The clinical trials take place only after enough safety and efficacy data has been collected through non-clinical methods or in animal models. Also, strict protocols (standard procedures) are to be followed when selecting/accepting volunteers for the clinical trial.
Why Clinical Trials?
Clinical Trials are a crucial step in the process of developing a new treatment or diagnostic technique or establishing the values of a pre-existing technique. No amount of non-clinical trials and animal testing procedures can substitute for the importance of actual human studies.
Since, human lives are at stake, before beginning with a Clinical trial, the researches have to do a thorough check of the efficacy of the treatment process. A clinical trial is recommended only if the initial non-clinical results show a promise of success. According to the norms of ethical medical research, unnecessary human interventional studies are always avoided.
Also, before beginning with a full-fledged Clinical trial study, the investigators conduct a pilot study with a small sample population. The sample size (number of participants in the study) is increased only if positive and safety complying data is collected. Also all clinical trials have to get approvals from local institutional ethics review committees (also known as Institutional Review Boards [IRBs]). The FDA also has stringent requirements for the conduct of clinical trials.
Thus, Clinical trials are crucial medical researches that aim at developing or establishing better treatment or diagnostic techniques for the betterment of human lives.
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