Clinical Trials: Participants and How They Are Protected

Clinical Trials

This is a phrase that most people probably know from their favorite medical show or from hearing it in the news, especially while COVID was wreaking havoc on the world. Companies like Clinical Ink were at the forefront of these trials, working on ways to keep us safe. For the purposes of this article, it’s essential to really understand what a clinical trial is and what the different kinds of trials are. Once we’ve covered those basics, we’ll take a look at who is allowed to participate in these trials and how they are protected while they do.

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What is a Clinical Trial?

In a clinical trial, the subjects are given specific treatments of medications by the doctors running the trial. For our purposes, we’ll refer only to the medical treatment aspect of these trials, as there are several different kinds of trials that are run. These trials might be to test out a new medical approach to the condition in question compared to the “placebo” treatment, which is really no treatment at all. Usually, at the start of these trials, it’s unknown whether the treatment is effective or harmful, hence the reason for the trial. As the treatments of medications begin to take effect, the doctors in charge of the trial can make notes on their efficacy and any side effects or adverse reactions that might appear.

There are a few different reasons that a clinical study might be conducted.

  • First, of course, is the reason that we have mentioned. To see whether or not and how treatment works on a control group.
  • The second is finding ways to prevent the onset or further development of a disease. 
  • The third is finding ways to prevent a recurring condition from coming back in patients who have already had it.
  • Fourth is finding different ways to identify a condition very early on.
  • Fifth is finding ways to improve quality of life and supportive care for patients with chronic illnesses or diseases.

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Who Can Participate In A Clinical Trial?

Naturally, since any given clinical trial has stringent parameters, there are limits to who can participate in a given trial. In the trial protocol, these parameters are referred to as “eligibility criteria.” One trial may need participants who have the illness or condition that the trial is testing around, while another may need completely healthy or non-infected participants, and some trials may need both. Eligibility or exclusion criteria may be based on the above or on age, ethnicity, gender, previous medical history, other conditions, or the stage of the condition in question.

How Are Trial Participants Protected?

First and foremost, any participant in a clinical trial or study must give informed consent. To be adequately informed, the trial researchers must provide the potential participants with all known possible outcomes of the trial, as well as all known possible dangers. Of course, since a trial is an exploration into the unknown, there are a lot of unknown factors. The informed consent process should provide as much information as the researchers have to give the potential participant as much clarity as possible so that they can make an informed decision. In addition to this process, there may be question and answer sessions for potential participants and other activities to measure their understanding of the process as it has been detailed to them.

Even if a participant has signed their consent, this does not constitute a binding contract, and participants may withdraw from trials at any time. It is essential to confirm this information before participating in any clinical trial.

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Clinical trials are moderated and watched over by review boards. Any federally funded study will face a federal review board, to whom they must justify their methods throughout the trial. An Institutional Review Board consists of doctors, community members, and researchers who are there to make sure that trials are conducted ethically and that the participants are protected as much as they can be. While trials do have unknown factors, this board’s job is to make sure that risks are minimized as far as possible and are relative to any potential benefits. Trials may also be monitored by data safety and monitoring boards. Any trials not adhering to the binding strict medical and ethical protocols will be shut down.

Final Word

If you are an individual looking to participate in a clinical trial for whatever reason, we hope that this information has been helpful. Now that you know what you can expect, you can step forward into the unknown as prepared as possible.

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