Been There, Done That — Sound Advice If Considering Clinical Trial Participation

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

For the September 2015 Life Science Leader article, A Behind The Scenes Look At The Patient Clinical Trial Experience, I interviewed three people who participated in medical research. The goal of the discussion was to learn about their personal experiences in order to pass on any useful information that could help biopharmaceutical executives better design and execute future clinical trials. I also asked them if they had any advice for people considering participating in a clinical trial. Here is what they had to say.

Dr. Jan Vesseur (63-year-old male who participated in a 2012 multiple-myeloma clinical trial in the EU): “Read the information very well. Ask your clinician about the consequences of participating for you personally. Make sure you understand the burden you will have to endure by participating in the trial, as well as the possibilities for your therapy in the future. I think people have to ask more questions of their doctor. Not all doctors are eager to field all these questions, because it’s time consuming. But when you take part in a trial it’s important to have as much information as possible. In addition, once diagnosed, be sure to ask proactively about the possibility to take part in trials. In the Netherlands, we know that not all clinicians advise people on all the possible trials there are for patients, especially in cancer. It’s important to have the most sophisticated therapy that is available in your country, which sometimes requires getting involved in a clinical trial. Not all hospitals participate in medical research. Be prepared to go to hospitals that are actively involved in conducting trials. Finally, be willing to do your own research as to what trials for your disease are being conducted in your geographical area. The unfortunate reality is, despite their best efforts, that not all clinicians are aware of the most current research being conducted for your disease.”

Jan Vesseur shares that he is very active on Twitter. If you have further questions about his clinical trial experience, perhaps you can connect with him at @JanVesseur.

Laura Roix (65-year-old female currently participating in the FibroGen FG3019-067 open-label portion of a clinical trial for idiopathic pulmonary fibrosis[IPF]):“I strongly believe that people need to do their research in order to make an educated, informed decision. As patients, we don’t do that enough and are just going to the doctor hoping they will fix us. My career background of being a former HR consultant required me to be very detail-oriented. That being said, as we are in the age of the Internet, when you are doing your research you have to be willing and able to sort through the garbage to find out what clinical trial will be best for you. Just because a doctor recommends it or a friend tells you about a study, doesn’t mean it’s good for you. Yale [where she participated in her trial] was good for me. They gave me the paperwork and told me what each clinical trial was. I don’t know if every research center is the same, when it comes to clinical trials.           But I know people, and I know that they walk in the door and say, “Well, whatever one you think is best for me, doc. Give me the pill, and I’ll take it. No doctor ever told me to go to Yale. The doctor who did the biopsy on me was the head of a pulmonary department at the hospital where I was originally diagnosed, yet he didn’t recommend getting into a trail. The words out of his mouth should have been, ‘You need to go to Yale.’”

Laura Roix admits to initially becoming interested in participating in a clinical trial because of her terminal illness. However, she has moved from participant to advocate. Roix has given testimony before the FDA and today functions as the administrator for two Facebook groups “IPF & PF Stinks!” and “Our Proud PF Moments, Milestones, & Attaboys”

Victoria Fenty (a 33-year-old female who participated in medical research in 2012 for evaluating a new approach to assessing proper placement of an FDA-approved contraceptive device, Essure. She recently agreed to have her newborn son participate in circumcision research. Both research initiatives are being conducted by the Mayo Clinic in Rochester, MN.): “Get all of the information in a way that you understand. With Essure, I was just like, ‘Oh okay, where do I sign?’ I learned from that experience. So when I was approached by Mayo while at the hospital to see if I was interested in having my son participate in the circumcision research, I was asking questions. Be sure they explain it in such a way that you can really understand. Don’t pretend you get it, if you really don’t get it. For example, when the guy handed me the piece of paper regarding the circumcision research, I asked him to explain it. I still didn’t really understand because the research was different, as there wasn’t a product they were testing. I asked them to explain it in nonmedical terminology. Don’t worry about them thinking you are stupid. You will look more stupid if you sign yourself up for something that you don’t truly understand.”

Pros And Cons Of Medical-Research Participants Using The Internet

All three of the people interviewed admit to using the Internet to learn more about clinical trial opportunities and their disease/problems. For example, Jan Vesseur learned about PatientsLikeMe, a for-profit online patient community, after agreeing to participate in the multiple-myeloma trial. Though he had to discontinue the trial, he feels that his data will be useful to someone, and thus, why he decided to share it with PatientsLikeMe. Laura Roix attributes Inspire, an online patient community that partners with respected national patient advocacy organizations, and PatientsLikeMe for encouraging her to get to a research hospital to learn about getting involved in a clinical trial. Victoria Fenty admits she didn’t use social media to do much research about Essure until after she found out she was pregnant. “I was Googling everything trying to find out about pregnancy and Essure, and the number one thing that popped up was a Facebook group,” she says. “I requested to join and they accepted me.” Fenty says the group was very helpful in informing her about where to report things (i.e., FDA MedWatch). She also found the group to be very helpful in sharing issues and experiences. However, Fenty reminds us that many people have very different issues. “A lot of times on the Facebook page people will blame everything on Essure, and that's not always the case,” she concludes.