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
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
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
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.
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.
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.
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.
Feel like (or know someone who might want to start) participating in a clinical trial, but have hesitations because of valid concerns? All you probably need is some handholding – and a good dose of information that will ease your worries. Sift through these common concerns and take comfort in the idea that, at the end of the day, participating in clinical trials will definitely be for the best of those concerned.
Sure It Helps… But What About Me?
We know that clinical trials serve the purpose of identifying what does and does not work when it comes to medicine as well as health care. This is so health practitioners know how to best treat diseases. Many people are wont to ask:
• Is the treatment being tested on me safe? While every trial will come with some form of risk, trust that before the treatment gets to you it should have already passed as many tests as possible. Remember: clinical trials play only a minor part in the entire research that goes into developing new forms of treatments. A great deal of tests during the discovery, creation, purification and lab treatment (for both cell as well as animal studies) are undergone before doing human clinical trials.
• Will the treatment be out as soon as positive results are made? Most likely, no. Notwithstanding differences in treatments and medications across a very wide field of medicine, it can take a few years before a medicine or a treatment to get approval after it has undergone and completed several rounds of clinical trials. This is an extra measure of safety and effectiveness that can also determine – through several rounds of testing in different populations – if there is but a subset of the population that the treatment can work for.
• Will I be forced to take or do things I do not want to do? Everything that will be performed on participants will be described in detail prior to them giving their consent to be part of the trial. Apart from hoping to get more answers about health conditions through clinical trials, there is also the need to establish a sense of trust in the would-be participants by being very transparent about what will go on during the trial. If any prospective participant is not comfortable with even the minutest detail, he or she has the right to forgo participation.
For The Greater Good
Still feeling a bit iffy? Don’t be. Joining a clinical trial will always come with some initial feelings of hesitation, apprehension and even fear. But as always, these usually stems from the fear of the unknown. What is important is to be aware of what goes on and deciding on whether one is comfortable about all these things. There will be more questions – more particular ones, at that – about clinical trials, but these three are good to start out with. At the end of the day, participants still get a great deal of benefit out of joining because they were able to help themselves (i.e. having access to treatments and medications with a great potential) and helping the greater populace thanks to the new information that comes out after a clinical trial.
We all know that clinical trials matters a lot when it comes to the discovery of new information in the field of medicine and healthcare. This information is used to advance the field so as to help solve matters of illnesses and other health conditions, critical or otherwise. But the general state of clinical trial participation could actually use a lot of help, as there are many instances wherein progress cannot be made due to lack of volunteers. Let’s review why clinical trial participation is an imperative to further emphasize the need for improvement in this area.
Worth Looking Into
One’s participation in a clinical trial study already generates a number of benefits on the individual and/or personal level as well as on a larger scale:
1. The benefit of being able to play an active role in personal health care. Taking part in a clinical trial for a health issue that concerns you is already a great step in the direction of being proactive about yourself. Apart from wellness rules such as sleeping early, eating healthy foods and exercising regularly, taking it to the level of clinical trial research means discovering more about your condition beyond what you read and hear about from doctors, health magazines, Internet articles and more.
2. The benefit of treatment accessibility. Whether a clinical trial is testing a new drug, procedure or anything in between, you can already consider yourself lucky to have access to these things before anyone else. This works in your favor by being able to address health issues before they worsen or before you reach a time wherein your condition may no longer be reversible or things are too late to treat.
3. The financial benefits that come while being treated. As a clinical trial participant, you can be sure that money is being spent on you – and for you – in order to help know more about your condition or to treat an existing condition. Bear in mind that this is money that does not come out from your pocket. Just ask yourself: Would you be able to do or afford this kind of treatment on your own? For some, there is also the added benefit of being given a stipend for their participation. If you are looking to take part in vital medical research and earn a respectable sum for your time and effort, then participating in a clinical trial is a good thing to look into.
4. The benefit of helping future generations. When you participate in a clinical trial, you are not only helping yourself but also generations well beyond your time. As many diseases and health conditions are hereditary, there is a high chance that any one of yours may be passed on to your children, grandchildren, and their children and beyond. If you can do something now to change the way their condition is handled, wouldn’t you want to take it?
Hitting Two Birds With One Stone
With clinical trial participation, trust that you are doing a world of good to yourself, your family and the future generations. In our limited time on earth, there is no better way to leave a legacy than knowing that you were able to spend some of it furthering a cause that can help solve or treat a medical condition today and in decades to come.
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