|Jean Burns offers a comment at the Parkinson’s Disease 2014 conference held earlier this year at NIH.
Twelve years ago, Jean Burns’ life was quite full. A military wife, she had lived in Germany and the U.S. and was working as a software trainer, web developer and ESL (English as a second language) instructor. But in 2003, her life changed: She was diagnosed with Parkinson’s disease, which led her to shift gears and make room for yet another role—clinical trials participant.
“I found my first trial on the web,” Burns said. “I signed up 6 months after my diagnosis because I wanted the chance to have a promising treatment as early as possible.”
Using her web skills, she searched the Internet for information about PD and taught herself about clinical trials. She quickly understood their importance and the vital role of participation. “Before me there were hundreds and thousands of other people with PD who participated in clinical trials. Their participation gave me the ability to have the medications I take today,” she said. “If no one participates, there will be no new treatments and no cure.” So, Burns not only participates, she advocates and promotes clinical research as well.
Clinical trials are research studies that involve people. Some test new therapies, new ways of using known treatments or methods of disease detection or prevention. Others help researchers learn important fundamental information about disorders. Most treatments used today are the results of past clinical trials.
Burns’ first trial—called PRECEPT or Parkinson Research Examination of CEP-1347 Trial—tested a potential neuroprotective drug called CEP-1347 that researchers thought would slow or even stop the progression of PD. Although the drug did not perform as hoped and the trial was later stopped, Burns kept the faith. Her first trial led to a second, long-term follow-up trial called PostCEP.
Since then she has participated in many studies. In fact, she is currently involved in an NINDS trial at the Clinical Center.
“I’m especially proud of being in PRECEPT and PostCEP because they have given researchers a lot of data about PD,” she said. “We were the first large group to be considered a control group for PD.”
Of course, participation is one of the key requirements for a clinical trial. However, it is also one of the most difficult elements for most trials to fulfill.
|Burns said the difficulty of patient travel should be a consideration in clinical trial planning.
People take part in trials for many reasons. Healthy volunteers may participate to help others or to help advance science. Participants with an illness may participate to receive access to what might become the newest treatment or to gain access to additional care and attention from clinical staff.
The flip side is that there also are many reasons that keep people from participating. Reasons vary and range from potential health risks that may be associated with a study medication to scheduling conflicts and travel costs. For research conducted at the Clinical Center, participants typically incur little cost, but that is not the case for all trials.
According to Burns, there are also disease-related issues that hamper participation. “Another barrier that is little understood by ‘healthy’ people is the fatigue we have with PD,” she explained. “Traveling by plane is a form of torture. On paper, asking me to travel on Tuesday for an appointment on Wednesday morning and then return travel on Wednesday afternoon seems reasonable. But it is totally exhausting for a person with PD who lives in a western state like Arizona with a 5-hour plane ride each way. I have done it but it takes me several days to recover once I get home.”
To overcome these barriers as well as others, Burns suggests that researchers include patients in the planning stages of trials. “Have more patients as members of institutional review boards to ensure that patient volunteers are treated respectfully and with care. And, include patients when you have conferences or meetings or need input before making decisions that affect our lives,” she said.
Burns also suggests that people considering trial participation do their homework. “Take your time,” she said. “Research. Learn everything you can about the trial. Don’t join a clinical trial unless you feel very sure. Call the study nurse and ask questions. List the pros and cons.”
Her trial experiences are well documented in her private blog—Pdblogger.com—and web site she co-founded—PDPlan4life.com. Through these sites, she and her fellow advocate, Sheryl Jedlinski, share personal experiences about living well with PD. NIH also provides a web page, Clinical Trials and You at www.nih.gov/health/clinicaltrials as well as Clinicaltrials.gov (www.clinicaltrials.gov), a searchable database of federally and privately supported clinical studies conducted in the U.S. and around the world. The Michael J. Fox Foundation offers a trial finder web site for PD trials, https://foxtrialfinder.michaeljfox.org/.
“You don’t have to sit back and take the disease as it comes—you can fight back,” said Burns. “Participating in clinical trials is my way of fighting back.”