AnnMarie Ciccarella: On the Importance of Clinical Trials

Clinical trials save lives.

Research is where the answers lie.

Without research, there are no clinical trials.

Without clinical trials, people do and will continue to die.

Without people, trials can not take place.

So the real question is this. Have you stepped up?

Too many people equate participation in clinical trials with being a lab rat. Let's take a moment to dispel some myths or clarify some facts. First the basics.

The very first basic simple truth: Navigating clinicaltrials.gov can be extremely frustrating, even to the most seasoned doctors. Since the very first step is knowing where to look for these things, there are platforms out there to help make the process easier. Social media is changing the way researchers and participants connect. We should be doing this faster, better and more efficiently.

Now some background and general facts.

Clinical trails must adhere to the highest standards to protect trial participants. There are laws in place to ensure the risk associated with any research is no greater than the normal risks inherent in every day living.

When you make a choice to participate in a clinical trial, first and foremost, you will always receive the best evidence-based medical care currently approved and being used to treat the condition or disease being studied.

With those two things in mind, yes, there are risks associated with clinical trials but any new medication that is granted approval to proceed to human testing has already undergone rigorous studies in a petrie dish, on a lab slide and generally, in animal studies. Only after the safety has been established throughout that process, can a drug proceed to trials using real people. Human clinical trials run in phases, too. For this conversation, let’s focus on the last leg of the human trials, the Phase III trial.

By the time a drug is approved for phase III trials, the researchers have already determined its safety, identified most of the short term side effects and it’s already shown the new drug or drug combination may be more beneficial than the current standard of care. And that’s the biggest and most important reason to consider joining a trial for which you may be eligible.

I wish that I had paid more attention to this when I was diagnosed with invasive breast cancer. I know there are trials I would have sought to join. The thing is, the guidelines are set in stone and if you choose a treatment before knowing all of the available options, you can’t unring the bell. You may have excluded yourself from being among the first to gain access to a drug that could take years to become available to the rest of us. The process from trial to results to publication to approval is long.

Few of us are told to look at clinical trials as our best first choice for treatment and when we are diagnosed with a serious disease like cancer, the knee jerk reaction? Get.It.Out. Preferably yesterday. For those whose disease has spread, the sense of urgency takes an exponential leap. And this is the moment to stop. Breathe. Explore every option. And then make a decision.

To paraphrase my friend, Jack Whelan, why settle for standard of care when participating in research may actually be a better course of treatment?