5 Things You Should Know About Clinical Research

I have been in clinical research for over 10 years now. I started out with the utmost intentions…to help people. As I got further and further into the field I learned more and more about what goes on behind the scenes before your drug makes it to market. This is the reason behind my philosophy of only relying on pharmaceutical drugs in certain circumstances, like life-threatening scenarios or illnesses where there may not be an alternative way to treat them.

I encourage you to always do your own homework with regards to any medications – whether prescription (Rx), over-the-counter (OTC), herbal, homeopathic, aromatic, whatever. It’s important to know what you’re using in general.

Here are at least 5 things that everyone should know about clinical research:

1. Typically clinical trials do not represent real world scenarios

Clinical trials are controlled, with the exception of Phase 4 studies and I will get to that in a moment. They include specific criteria that either allow or prohibit certain patients into the study. For example, populations with certain medical histories may not be allowed in particular studies. Or if you end up enrolled in the study you can be removed if you end up taking certain medications while you’re taking the drug in question (also known as the investigational product or IP).

Trials are generally classified into four phases. Phases 1-3 are done before the product is approved by the US Food and Drug Administration (FDA) and Phase 4 trials are after the drug is approved and out on the market. During Phase 4 trials, which is when anyone is now taking the drug, any and all adverse effects are captured to basically find out more about what happens when the drug is taken long term. This is where a drug can be recalled if too many negative adverse effects start occurring.

2. Drugs are not tested in a lot of children

According to the FDA, only 20–30% of approved drugs have been labeled for use in children. By necessity, doctors routinely give drugs to children off label. So when you come out of the doctor’s office with a prescription, the medicine may or may not have been approved for children.

Children are considered a vulnerable population when it comes to clinical trials (pregnant women, the elderly, prisoners and mentally disabled individuals are among the remaining vulnerable populations). Because of that it is harder to conduct clinical trials with children and consent to enroll a child in a clinical trial can also be tricky.

When children aren’t old enough to provide consent (or assent in this case), parents are put in charge of making the decisions for them. The decision to enroll the child can end up biased. For example, if the child has a really severe illness the parent may be desperate to seek medical treatment for their child even if it is under investigation and depending on the age of the child, the child may not have any say in the matter.

3. Children are not small adults

Due to the above reason, many medications are not even approved for children. Parents should not give an adult dose of any medication to a child as it can result in an overdose. Even giving a child half of an adult dose can be unsafe and still can result in an overdose.

Children metabolize drugs a whole lot differently than an adult. Even amongst each other, children are very different. For example, a 2 day old baby will need a different dose than a 6 month old baby. And a 6 month old baby will need a different dose than a 12 month old baby. And then, a 12 month old baby will need a different dose than a 2 year old would…and so on and so forth.

4. Drugs are not typically tested in pregnant women

Pregnant women are vulnerable because of the developing baby they are carrying. That in itself is a vulnerable time so to add a drug to the mix is considered unethical. Some women, however, must take medication for one reason or another, even while they’re pregnant.

Because clinical trials usually do not enroll pregnant women, the data that is collected about drugs during pregnancy is mostly due to the mother taking the drug while pregnant and her pregnancy was tracked to the end. Once the baby was born, the outcome – good or bad – was recorded and kept on file. Drug labels normally indicate whether or not anything is known about the drug in pregnant women.

5. The purpose of clinical trials is to collect data. Period.

Data collection is what’s needed by the FDA to review in order to make the decision of approving (or rejecting) the drug for market. If you ever have the opportunity to enroll in a clinical trial you must always keep in the back of your mind that it is for research only. Nothing else. Your condition may get better, but it can also get worse or stay the same.

In the case of Phase 1 trials, where only healthy volunteers are used (except in oncology trials because oncology drugs are too potent for healthy people), there is the potential that things could really go wrong. Phase 1 studies are the first time the drug is being tested in humans, so essentially, phase 1 trial volunteers are literally human guinea pigs. Phase 1 studies are also the phase where the lives of many compounds end due to too many negative adverse reactions.

Resources for You

US Food and Drug Administration – Inside Clinical Trials: Testing Medical Products in People

FDA Policy for the Protection of Human Subjects

Clinicaltrials.gov – a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

American College of Clinical Pharmacy: Research in Women and Special Populations