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Posted on 16. November 2017

Participating in Clinical Research

By Abbie Cornett

Clinical research is an invaluable part of developing new strategies and treatments for diseases, but that doesn’t mean participation is the right choice for all. Before deciding to participate, patients need to understand the difference between the two types of studies, gather all available information and understand their rights.

Many times, the terms “study” and “trial” are used interchangeably. Yet, while they sound similar, they can be very different. In a clinical study, also called observational research, participants are observed1 through the collection of blood, tissue or other samples, but drugs are not used. While studies don’t test drugs or treatments, they are still a very important means of gathering data for treatment of diseases. Clinical trials, on the other hand, test drugs, treatments and interventions to prevent, detect, treat or manage various diseases or medical conditions.2 Usually conducted in five stages, they are carefully set up and follow strict scientific guidelines, and represent the final stages of a long research process.

Many patients with chronic illness choose to participate in trials and studies because of potential benefits such as receiving regular medical attention, gaining access to new research and treatments and being more active in their own care. But, patients need to be aware of potential downsides. While clinical trials have very strict protocols to protect participants’ health, they still involve a certain amount of risk, just as all medical care does. For example, there are possibilities of complications such as serious or life-threatening side effects that require medical treatment. Other drawbacks to both trials and studies are the requirement for frequent lab work, visits to the study site or even overnight stays in the hospital, all of which require a lot of time.

Patients and their family members need to be well-informed about any trial they are considering, and they shouldn’t be afraid to ask questions. The National Institutes of Health recommends asking some of the following questions prior to entering:3

  • Why do researchers feel the approach they are studying will work?
  • What will be the benefits of the study in the short- and long-term?
  • What are the risks?
  • Will patients be able to take regular medications while in the trial?
  • Who approved the study, and how is it funded?
  • How long will patients be required to participate?
  • What is the financial obligation for treatment or participation such as travel costs?
  • How will the data be interpreted, and who will check the safety and results of the gathered data?

As part of the informed consent process, patients have the right to know all of the important information about a study or trial so they can make informed decisions about participating. For instance, patients should be aware that once they become part of a trial, they can withdraw at any time.

Clinical trials and studies offer hope for thousands of people each year. It’s true that being part of this research can be a very rewarding experience, but patients should first have a complete understanding of what is involved before committing to it. Feel free to contact me if you are interested in participating in a trial or study, or have any questions about guidelines for participation.


References

  1. What’s the Difference Between Clinical Research, Studies and Trials? Scientific Solutions, Dec. 8, 2008.
    Accessed at www.scientistsolutions.com/forum/clinical-research-new-understanding-clinical-trials/what-s-difference-between-clinical.
  2. World Health Organization. Clinical Trials.
    Accessed at www.who.int/topics/clinical_trials/en.
  3. National Institute of Health. Clinical Research Trials and You: The Basics.
    Accessed at www.nih.gov/health-information/nih-clinical-research-trials-you/basics#4.


Abbie Cornett is the patient advocate for IG Living magazine. She can be reached at patientadvocate@igliving.com or (800) 843-7477 x1366.

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Comments (1) -

Wayne
1:12 PM on Friday, November 17, 2017

Myself, I'm in a long-term clinical study at the National Institutes of Health, I was enrolled in 2010, the year after I was diagnosed with CVID.  Because of the complexities of hypogammaglobulenimia, I would be VERY hesitant to participate in a treatment study!

The study at NIH is quite nice.  They pay for me to fly out for a few days, do all sorts of probing that are, for me, nothing more than inconvenient.  No, I don't like the PFT or the 5-minute walk, but it reveals more information about me for me and my doctors, and it increases the amount of information that the researchers have to draw on.    It also keeps an eye on some stable conditions, so if anything ever changes, we'll have a nice alert and people to reference.

One of the great things is that they perform procedures that would cost me a lot of money out of pocket, and would be difficult to get done locally!  I needed an endoscopy to monitor my acid reflux, the doctor tried doing it with conscious sedation and couldn't get the probe past my gag reflex.  I didn't try to fight him, but I'm kind of sensitive there: I need full sedation and my guy doesn't do that.  Well, NIH will do it.  On my next trip, not only will they be doing an endo, they'll be doing a special type of it that involves planting a microchip with a transmitter in my esophagus that will monitor for acid events and intensity: equipment that is probably not readily available to my GI doctor.

And it's at no cost to me: part of the study.

But the best thing is that I have two friends who live in the DC area that I get to see when I'm there!  One I hadn't seen since high school, the other I used to work with!  So I always have a good time, and will put up with some poking and prodding in the name of science and seeing my friends.  My only expenses is meals, knickknacks, and baggage check fees.

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