Differences Between Research and Medical Therapy

Sometimes medical research may seem very similar to the regular treatment or "therapy" your child is receiving, or has received in the past.

Both often take place at a hospital or clinic. The principal investigator leading a research study may be a doctor, and may even be the same physician who is providing your child with medical therapy. Medical therapy - like medical research - may have risks.

But there are differences between medical research and medical therapy. Understanding these differences can be helpful as you talk to the investigators and decide whether or not your child should participate in a study.

Let's look at some of these differences:

First, the sole purpose of medical therapy is to treat a particular child's illness or injury, and improve this child's health. The primary purpose of medical research is to gain knowledge so that treatment can be improved for ALL children. In other words, direct benefit for a specific child is not the main goal. However, some research may offer health benefits for the children participating. And in research involving any significant risk, the balance between possible risks and benefits must be at least as good for the research as it is for the current standard therapy.

Next, medical therapy can be adjusted to meet the needs of individual patients. One drug may be substituted for another, or perhaps the timing of a treatment can be changed. On the other hand, for a research study to meet its scientific goals, the treatment for children in the study needs to follow the study design, or "protocol." If parents want changes in the treatment that aren't allowed by the protocol, they may withdraw their child from the study but can't have the protocol itself changed. Of course, there may be benefits to a child whose treatment follows the strict requirements of a protocol.

Another difference is that parents agree to medical therapy only to improve their own child's health. Together with their child's doctor, they choose the therapy that (based on current knowledge) is thought to be the best for their child. In contrast, parents may give permission for their child to participate in research for several reasons. They may hope their child's health will improve, but they may also want to help other children.

The primary responsibility of the health care providers involved in therapy is to treat your child's illness and improve your child's health. When health care providers conduct research, they are also responsible for following the directions of the study protocol. For example, if the study requires some children to receive the experimental treatment and others to receive the current standard treatment, the investigator must follow the rules for how children will be selected for each group.

Sometimes, therapy and research occur at the same time. To tie these concepts together, let's look at a child with hepatitis C - which is an infection that happens when a certain virus infects the liver. The current standard treatment, or medical therapy, for hepatitis C includes taking certain medicines for one year, along with having regular blood tests to make sure the medicine is working.

Now let's say the treating physician is also participating in research that's studying whether or not a new medicine should be added to the standard medicine. In this example, the original medicine is considered standard treatment or medical therapy. The experimental medicine and additional tests are considered research. Studying the experimental medicine can help doctors decide whether or not it should become part of the standard therapy.

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