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.
- 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.
- World Health Organization. Clinical Trials.
Accessed at www.who.int/topics/clinical_trials/en.
- 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 firstname.lastname@example.org or (800) 843-7477 x1366.