A clinical trial also referred to as an intervention or experimental study, is part of the different types of clinical studies that aim to test a particular intervention for use in human populations. The intervention may be in the form of medicine, devices, procedures, etc. A number of medications, devices, procedures, and diagnostic materials are intended for use among the human population. However, before such interventions can be allowed by regulatory authorities, it must be clearly established that they are safe, effective, and efficacious for their intended use. The process of demonstrating the efficacy, effectiveness, and safety of the intervention employs principles of a clinical trial to establish these critical factors for them to be allowed to be used to treat, prevent, or manage ill-health.

One of the many uses of clinical trials is to establish a new molecule’s effectiveness in treating or managing a particular health condition of interest. If the claim is that a particular medicine can treat and eradicate a particular type of skin infection or lower blood pressure, people who have that particular ailment of interest will be recruited to receive the claimed medicine to determine its effectiveness, following some standard guidelines that can be replicated to give the same result at any time elsewhere. If the medicine treats that illness, or condition and is based on pre-defined conditions, we can say that the new molecule is effective in treating that condition.

The same applies to diagnostic, surgical, or medical devices. A simple medical device like a wheelchair or electronic blood pressure monitor, or complex devices like scanners or defibrillators, will require human testing for a particular indication or anytime there is a claim of its use for a new indication. So, no one will just claim the effectiveness of a manufactured product for clinical consumption without it going through some testing in the human population.

You may have heard the simple old proverb that “one man’s meat is another man’s poison,” which could mean that what is good for one may not necessarily be good for another. Just as family members may have a preference for eating nuts, in part due to unpleasant experiences from consuming it, or just unease at the sight of nuts.

In the same way, people respond differently to the use of a particular medicine that cannot be explained by mere intuition. The response by the body system may be unpleasant for a number of people or even lead to death. Apart from the aforementioned, could it be possible that medicine has taken over a decade ago can have a sustained effect, even on an unborn child at the time of conception? This is some of the critical information that needs to be available for medicines to be seen to be safe for consumption.

Also, it is important to establish that the government has a responsibility for the protection and safety of its citizens, as such, it will take the necessary steps to ensure that its population is safe from any form of unpleasant experiences and, in that way, maximize the productive potential that leads to economic good for that population.

Clinical trials are often conducted in conditions that will allow for close monitoring of participants, or human subjects, who are receiving the intervention for a particular indication. Most of the time, it starts in a clinical setting, like a hospital, where it ensures that some type of condition for any participant to be eligible for the trial is met for inclusion.

Some likely criteria may be related to age, which most of the time will be applicable in trying a medicine that lowers blood pressure because of the increased risk with age. Another factor is the sex of the participants, especially for women of childbearing potential or pregnant females, where the condition is defined to allow or exclude subjects with such characteristics from the study.

The type of study will definitely influence where the subject should or can be throughout the cycle of the trial.

Clinical trials require expertise and experience from a broad range of specialists from different disciplines. They include clinicians, biostatisticians, programmers, data managers, analysts, etc. Follow this link to learn more about personnel and roles in clinical research.