Research. Clinical trials. To say that I’m passionate about these is an understatement. That’s because It became apparent to me in my early years in medicine that the way to make the biggest impact for patients was to conduct research and clinical trials. I’ve been practicing medicine for 37 years and conducting research for 30 years, both in the area of pediatrics and pediatric infectious diseases.
For instance, during my pediatric training back in 1981, Hib, a serious infection caused by the bacteria Haemophilus influenzae type b, and pneumonococcus, a type of streptococcus bacteria, would frequently cause life-threatening infections of the blood, lungs, brain and bone. Now, in the US, the number of serious infections caused by Hib or pnueumococcus have dropped by over 95%; DIRECTLY due to the vaccines to prevent these infections.
Before a vaccine may be used in clinical practice, it must undergo a rigorous process. This includes laboratory testing, clinical trials and review and approval by the FDA. The process can take 5-10 years or more, but is worth it to find new knowledge, treatments and cures.
More awareness is needed – because without people participating in clinical trials, these ground-breaking treatments would never make it to the market. And the staggering statistic is that only a tiny fraction of eligible people participate in clinical trials. Those people will never fully know how grateful I, and all of humanity, are for their decision to help advance science and the goodness it can provide.
To further understanding and awareness for clinical trials (and hopefully encourage more participation!), I’d like to share my top six reasons why clinical trials are so important:
Top 6 Reasons Why Clinical Trials Are Important
The results can affect many more patients
This is one of the main reasons why I started conducting research in the first place. As a doctor taking care of patients, I can see maybe 20 patients in a day. But if I conduct a clinical trial and ultimately bring a new treatment to market, I can potentially impact thousands or even millions of lives. Similarly, when you participate in a clinical trial, the treatment you seek may or may not be available to help with your condition now, but it might help many other people in the future.
They bring new treatments to market
Every product that is utilized in clinical practice – from new medicines to vaccines and devices – have been rigorously tested in many phases of clinical trials before they are ever used a doctor’s office or surgical suite. Without clinical trials participants, the discoveries and advances won’t happen!
They provide good information
Let’s say I have five licensed drugs available to me to treat a particular condition. I write a prescription for a patient and if it works, great. If not, we’ll try a different one. It’s trial and error. But, if I conducted a clinical trial with these two drugs, I can systematically test to determine which one is more effective. It’s essentially quality improvement.
They test safety and efficacy
We want to make sure that a new treatment or device is safe and effective before it is brought to market and used in clinical practice. There are four different phases of clinical trials as well as many regulatory bodies (FDA, USDA, OHRP, IRB) overseeing the safety and efficacy before it gets approval. After a treatment goes to market, there are safety checks as well.
They take out a physician’s bias
As physicians, we want to do what’s best for our patients. But sometimes we get unintentionally biased in thinking that a new drug is better than an old one. Sometimes it’s not. The only way we can know for certain is by conducting clinical research. It helps us to be systematic in our practice and provide better clinical care. Again, our continued striving for quality improvement.
Kids are not little adults
Only a small minority of the drugs and vaccines we use in kids are actually tested on them. I have heard people say, “Why do we need to do studies with children? They are just little adults.” This is an incredibly flawed statement for many reasons. Children and adults have a difference in physiology and variances in metabolism. So, it’s critically important to test drugs and vaccines with kids as the subjects of the research. When testing for a vaccine for a childhood disease, we will often start in adults because we’re making sure that it’s safe. If we are able to demonstrate safety in adults, we then work our way down to older children. If that works, then we’ll test on younger children for safety and efficacy.
I hope that I have helped underscore the importance of clinical trials and the necessity of volunteer participants to make discoveries happen. Study participants are truly the unsung heroes of medical advancements. Without them, things like penicillin, the DTap vaccine and mammograms would have never made it to clinical practice.
Two of the most notable discoveries from Cincinnati Children’s are the Rotavirus and Sabin oral polio vaccines. You can read more about all of our research discoveries here.
Please help us generate more awareness by sharing this post with your friends, families, and colleagues. I’d also love it if you considered participating in a clinical trial as well. You can find our full list here.