By Meera Palaniapppan
If your child suffers from a condition or disease, whether it may be asthma, allergies, or even cancer, you may wonder if they would be able to participate in a clinical trial. But what do clinical trials entail, especially for children?
Clinical Trials
Clinical trials can be of great significance as they unveil the answers to specific health questions that researchers have developed. Researchers conduct studies to test a medication, drug, treatment, or more in order to see the effects that it would have on a larger population. They have individuals take part in these studies whether they suffer from a condition or are healthy to make sure that a medication or treatment is safe and works. By doing this, they are able to have an immense impact on the lives of so many, constantly improving healthcare around the world.
There are several ways to go about setting up a clinical trial. The several ways that these research methods can be conducted are through observation, case studies, surveys, longitudinal study, cross-sectional study, single-blind, or double-blind procedures.
Observational Study
An observational study allows researchers to look at human behavior in the real world, allowing them to determine what people do in the real world and why they do it. A laboratory observational study involves monitoring participants’ behaviors in a controlled setting which can reduce outside factors and variables and can solely focus on the variable that is being changed, which can be the medication or treatment being given.
Case Study
A case study involves a very detailed investigation of a singular individual or a very small group, giving insight into rare conditions and providing suggestions for future research. Case studies can also generate new material for future research to take place and provide opportunities to test new treatment and apply research.
Survey
A survey is a technique that allows researchers to gather information through questioning individuals on their attitudes and behaviors which can be especially beneficial for gathering difficult-to-observe data.
Longitudinal Study
A longitudinal study involves the study of merely one group for an extended period of time. Having the same participants within the study allows for researchers to observe patterns and developmental changes over a long time. This is useful for testing treatments that require in-depth research over time.
Cross-Sectional Study
A cross-sectional study compares groups of several different ages that are all treated at the same time. This means that the study takes place over a shorter period of time and allows researchers to gather the effects of a treatment for all age groups at once.
Single-Blind Procedure
A single-blind procedure is when the participants are unaware of whether or not they have received a placebo drug or the actual treatment but the researchers are aware and keep track of the effects on the individuals.
Double-Blind Procedure
A double-blind procedure is similar to a single-blind procedure except the researchers are also unaware of who has received the treatment or the placebo. This is used in order to reduce bias within experiments.
Phases of a Clinical Trial
There are several ways to conduct a clinical trial, but there are a certain set of phases that a clinical trial follows. This consists of phase I, phase II, phase III, and phase IV. Phase I includes a smaller group who are given a drug and this dosage increases depending on whether or not they experience severe side effects. If the treatment is safe, it moves onto the next phase. More individuals are introduced in phase II, and the researchers still focus on if the treatment is safe and works on a larger group of people. If it is able to function still, it moves into phase III where participants are divided into a control group that gets the standard treatment and an experimental group that gets the new treatment being tested to see if there is a clear advantage of one over the other. After phase III, the FDA reviews the trial and makes sure that the treatment is safe for all patients. In phase IV, doctors continue to study the effects of a treatment that the FDA has approved. This process is very in-depth and detailed in order to provide concrete evidence that the treatment is safe and advantageous before it becomes accessible to more people.
Importance of Pediatric Clinical Trials
Since there are already many clinical trials that include adults, you may wonder why there should be separate clinical trials for children. Children are very different from adults developmentally and will not react to treatments the same way. They are a very difficult group to study as children can vary from infants to adolescents, all in very different stages. That means that their stage of development, bone growth, hormonal changes, and emotional behaviors will all be very different from one another. There is a misconception that children are just “small adults”, which is simply not the case. Giving a child the same medication, just in a smaller dose, does not mean that they will experience the same results of reactions. Children are very different from adults anatomically and these should be considered when prescribing a treatment. Because of this, pediatric clinical trials cannot be lumped together as one. Instead, they must be chosen carefully in order to get the most beneficial information to help more pediatric patients. Pediatric clinical trials can offer a larger population of children to receive the same benefits of treatment and level of medical treatment that adults are able to have.
Finding Clinical Trials and Enrolling Your Child
The amount of clinical trials out there for children is constantly expanding. Researchers and doctors are constantly looking to develop and improve treatments by testing new drugs, vaccines, medications, procedures, and more. Deciding what would be the best care to give your child can be difficult, so it may be helpful to consult your child’s doctor and talk to your family about it to evaluate the benefits and risks that come with a clinical study. Most often parents didn't want to take part in a clinical trial due to factors such as time, external obligations, treatments that were scary or painful for children, or potential side effects. However, those who chose to enroll their children wanted to help other children or people with the same condition or disease and expose their child to such research from which they could also benefit. The main takeaway is that pediatric clinical trials are incredibly valuable for improving medicine but are essentially voluntary, so it is okay to weigh out the pros and cons if you are thinking about partaking in a study.
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