DECEMBER 12, 2018
by Kathy Birkett
How many people do you know who have participated in a clinical trial?
A clinical trial or research study involves human volunteers (also called participants) and is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies.
Family caregivers may not realize that clinical trials/studies not only help their own older adults learn more about their disease process but can help others when science is advanced toward improved treatments and even cures.
People who may qualify to enter clinical trials don’t have to be at the end of their life, grasping for a miracle.
Clinical trial research can help learn more about diseases affecting older loved ones, including dementia, Parkinson’s, pain, migraines, eczema, rheumatoid arthritis, and Crohn’s disease, to name only a few studies currently ongoing.
With so many opportunities available, what keeps many of us from joining the fight to help those suffering from chronic diseases or at risk in the future?
Barriers to Clinical Trial Participation
Speaking to caregivers and those who could benefit from research studies, it becomes clear there is not only misinformation about research studies but also fear of participating that keeps many from becoming a part of a study.
- Awareness of what to expect, time involvement in both duration of the study and travel, potential risks and benefits, how your data is protected, and lack of learning about how you have impacted change are often cited as reasons that keep people from joining.
- There may also be a lingering belief that trials are only for those with end-stage medical diagnosis, such as terminal cancer. This is no longer the case, as science yearns to discover the cause of disease, how to prevent illness, how to best treat specific diagnosis, how family members of someone with a chronic disease such as dementia may progress themselves, best courses of action to adjust pharmaceutical interventions, or test non-pharmacological means such as lifestyle changes, formulating vaccines for prevention, or cures to stop debilitating diseases in their tracks.
- Technology and global scientific collaboration have done much to advance scientific knowledge of disease and treatment. But are they effectively communicating with potential participants?
- Frustration with clinical trials for those who have once participated because they never heard from researchers again once their piece of the process was completed may keep others away from joining too. Perhaps someone you know never heard if the medication or treatment worked or will be used to treat others. Most people want to know the outcome, but researchers often don’t share the data or results with participants once the trial is closed.
- Oftentimes, reading research trial information about eligibility requirements and actual involvement in the trial (what it hopes to accomplish and how it will be achieved) can be confusing and difficult for most people to understand, which keeps them from moving forward to join.
These factors can become obstacles that people, especially family caregivers, don’t have time or energy to try to overcome, especially because the long-term benefit of doing so is hard to assess.
Fortunately, there are ways to learn more about clinical trials and their benefits that don’t require us to be scientists to understand.
Plain-Language Summaries Improve Understanding and Transparency
Medical jargon and scientific terms can be difficult to the point of being unreadable for many people, limiting their enrollment in research studies or even impacting their effective participation once enrolled.
There is a movement to make information sharing about clinical research trials accessible to every person and it is called plain-language summaries (PLS). These summaries are written so that the pages of scientific terminology in a research study are condensed into a short form that is easier to understand. PLS provide the lay public with information about clinical research in language that is easy to understand and are required by law in the European Union (EU), although not currently in the United States.
In the EU, plain-language summaries must be provided for one year after the close of the trial. They are required to be provided in all languages of the countries in the union, as are the materials provided at the start of the study, with inclusion of an English version for all.
In the U.S., it is up to trial sponsors to provide plain-language summaries, and many are now making this information available to increase participation so that the study can yield meaningful results. But not all researchers do so, which means helpful (and hopeful) clinical trials are still not accessible by some due to the inability to be aware of and comfortable about the particular study.
Some truly beneficial studies may even be hard to find, as the use of jargon instead of everyday speech impedes their discovery.
Plain-Language Summaries Encourage Participation
Many people are disappointed when they are not fully informed or able to understand the results of the trial they helped or to be provided any information once the study closes. However, PLS can offer understandable results after the close of a study, which most participants appreciate.
According to a 2017 Perception and Insight Study by The Center for Information & Study on Clinical Research Participation (CISCRP), 91 percent of[DG1] study participants indicated that wanting to learn the results of the study is very important. Unfortunately, only about half of participants are told the results once they are done.
A PLS will contain information for potential participants or their family caregivers in digestible chunks, in an easy-to-understand format. Everyday language, instead of medical or scientific terminology, is used. There are also often images to help explain or illustrate information for better understanding.
If more trials had PLS, it is very likely that more caregivers and seniors would feel comfortable and in control of their decision about entering a trial, as well as sharing their experiences with others to encourage them to do the same.
Having information that reduces fear and increases awareness will hopefully increase the participation rate, yielding benefits that can be achieved when clinical trials get the amount and diversity of participants that are needed to successfully run a research study.
Questions to Answer Before Joining
If you or someone you know is interested in joining a clinical trial, here are some questions from CureClick (adapted from resources provided by ClinicalTrials.gov, a service of the National Institutes of Health) you may find helpful to aid in your understanding of the program and the importance of your participation.
- What is being studied?
- Why do researchers believe the intervention being tested might be effective?
- Why might it not be effective? Has it been tested before?
- What are the possible interventions that I might receive during the trial?
- How will it be determined which interventions I receive (for example, by random selection)?
- Who will know which intervention I receive during the trial? Will I know? Will members of the
research team know? - How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
- What will I have to do?
- What tests and procedures are involved?
- How often will I have to visit the hospital or clinic?
- Will hospitalization be required?
- How long will the study last?
- Who will pay for my participation?
- Will I be reimbursed for other expenses?
- What type of long‐term follow‐up care is part of this trial?
- If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
- Will results of the study be provided to me?
- Who will oversee my medical care while I am in the trial?
There are many diseases that family caregivers and seniors would like to see an end to in their lifetimes.
Through participation in clinical trials that advance science to find effective prevention, treatments, and cures, we all benefit.
This article originally appeared on Senior Care Corner.
About the Author
Kathy is Senior Care Corner’s expert on the lives and care of senior adults, expertise she has gained through over 30 years working with seniors, families and other caregivers in both her professional and personal lives. Kathy has a passion for advocacy, education and improving the life of seniors and is a champion for caregivers.
