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Giving Back Through Participation: Maddie’s Clinical Trial Experience

In this article, we report on Maddie’s experiences as a participant in a healthy volunteers study about hives and cold weather. As someone who also works in the field of research herself, Maddie fully understands how important it is for research institutes to run clinical trials to further gain knowledge about illnesses and other conditions that affect the human body. According to Maddie, this understanding pretty much led to her decision to participate in this particular clinical trial that aims to determine a normal response (also called the ‘control’) to cold.

A ‘Healthy’ Volunteer Study


The kind of study that Maddie participated in is one that is for healthy volunteers. This means participants must generally be in the pink of health and should pass certain requirements that clinical trials state, i.e. body mass index, age, weight and others. In this particular healthy volunteer study, it was stated that participants ought to have no allergies to pollen or food as well.

A Warm and Assuring Environment


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Maddie’s clinical trial experience took place in what was a clean, sterile room filled with medical equipment and what one might usually find in a doctor’s office. It was warm, well lit and assuredly dispelled any notions of clinical trial environments having a cold and detached vibe. Maddie is assisted through the entire procedure by the facilitating researchers, nurses and other assistants at the center. Interaction between Maddie and the people conducting the clinical trial was nothing short of warm and responsive, replete with friendly banter and an earnest concern over her comfort and well being.

The Task at Hand


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To gather information necessary for the trial, Maddie had to undergo three things: hold her arm in a bucket of ice cold water for five whole minutes, have one of the nurses collect from her a blood sample and being observed for any physical responses shortly after removing her arm from the tub of ice cold water. The first task had the objective of searching for signs of hives while she described what she is feeling. The blood sample collected from her is meant to determine how a normal response will compare to an abnormal on. The third task is data gathering on her physical responses. All of these will help people understand how hives develop and ultimately lead to new information that will help clinical researchers understand how to control such a condition.

Simplicity and Comfort Assured


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The tasks Maddie had to undergo in the clinical trial were fairly simple, endurable and most importantly – will bring a large amount of vital information necessary to learn more about a common condition such as hives. Maddie’s experience of participating in the clinical trial leads one to the conclusion that such practices emphasize not just the end result – which is information, new medication and scientific breakthroughs – but also how well participants are treated during the entire course of the trial. The research team that worked on the trial stresses the need for normal volunteers like Maddie, as their participation provides important information on what really does happen when they use average persons as points of comparison.
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A Phase-By-Phase Guide to Clinical Trials

Have you ever wondered what goes on in a clinical trial? While the procedures and medicines will definitely vary, there is one thing that the majority of clinical trials have in common – and that is to conduct their studies in phases. The phases in a clinical trial simply represent the different stages that the medicine or treatment needs to undergo in order to be determined as safe and effective enough for later distribution to the public. Medicines usually get tested against a control treatment, which is usually a substance that has no active treatment (otherwise known as a placebo) or against an existing treatment that has already established itself as a standard.

Once the volunteers are gathered, the need to establish safety becomes more complicated so the use of phases in clinical trial testing and the need for regulation becomes all the more important.

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The Four Phases


There usually are four phases in many clinical trial processes:

Phase 1 Trials: The first time a medicine will be tried on humans will obviously come with some risk, so researchers are careful to only administer small doses and increase it incrementally if there are only minor or no side effects. This is also called dosage-ranging study, as research work to calculate the right dose for treatment.

Phase 2 Trials: With better information on the best dosage for the medicine being tested, the study now undergoes Phase 2 trials. Here, the new medicine is then tested on a much larger group of people – usually those who are ill so that researchers have a much better idea of how the treatment affects them on a short-term basis.

Phase 3 Trials: When medicines have successfully passes the first two phases, these are again tested in much larger groups of ill people and is then compared to the placebo or the current existing treatment. Here, clinical researchers aim to determine if the new medicine will be much better than the one being used and to see if there are any important side effects. Doing the numbers talk, a Phase 3 trial will usually involve participants that number in the thousand and the duration of this phase can often go on for more than a year.

Phase 4 Trials: This final stage comes about when the new medicines have successfully passed Phases 1-3 and have secured marketing licenses. When a medicine has a marketing license, it means it can be distributed or purchased by those who need it with the aid of a prescription. There is still a lot of testing that goes on in Phase 4 trials; these are to further test the medicine’s effectiveness, safety and side effect while already being used in actual practice. For many, Phase 4 trials are usually not required but can really say a lot about how much the researchers want to determine medicine safety and effectiveness.

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No legal medicine may be bought at the pharmacy without undergoing the phases in a clinical trial – whether these medicines require a prescription or not. Suffice to say, those that do make it to the pharmacist’s sales drawers have the mark of safety and effectiveness that can only be given by a successful clinical trial.
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