Changing the Public Perception: Why Clinical Trial Participation is Needed
Clinical study participant Nina Martinez and AbbVie researcher Maurizio Facheris encourage people to help advance science by participating in clinical trials.
Demystifying Fears Around Clinical Trials
Despite clinical trial research being vital to progress against diseases, public perception poses a huge barrier against people joining the quest for new treatments.
Eighty-one percent of people feel that clinical research is very important to the development of new medicines.1 However, in the case of cancer, the participation rate in trials among adult patients is extremely low (approximately 3 percent) despite rising cancer rates.4,5
In the search for answers around why people may be hesitant to participate in clinical trials, we talked with Nina Martinez, who is living with HIV and has participated in multiple clinical research studies, and Maurizio Facheris, M.D., medical director, neuroscience development, AbbVie.
Martinez was diagnosed with HIV in 1991 after acquiring the disease through a blood transfusion as a baby and is an advocate for clinical trial participation.
Facheris is also passionate about clinical trial participation and leads several clinical development programs in neuroscience at AbbVie. He formerly oversaw clinical trial activity with the Michael J. Fox Foundation.
Together, Martinez and Facheris discuss the importance of clinical trials and why participation is necessary to uncover new and uncharted paths for future disease treatments.
Why are clinical trials so important?
Martinez: I’m truly the end product of clinical trials. Early on children with HIV were given doses of medicines that were detrimental to them since there was no real dosing for children at the time. Children aren’t miniature adults. Because of others participating in those clinical trials, I was able to get the appropriate dosing when I was diagnosed with HIV at 8 years old.
I volunteered for my first study when I was 19 years old at Georgetown University. At the time, I was already a lifelong survivor of HIV. Although I didn’t have a need for clinical trials — having already beaten the odds in many ways — I wanted a way to find out why and give back to the process that helped save my life. Since that initial study, I’ve participated in nine different studies ranging from observational to a clinical trial.
Facheris: If people want better medication or better treatments for their diseases, participation in clinical trials is important and necessary.
In medical research, all westernized countries require clear research and evidence that a medicine does what it is designed to do. What people may not realize is that it is a requirement by regulatory bodies, such as the U.S. Food and Drug Administration, that before approval for use medicines be given to humans through clinical trials to show that first they do not cause harm and second they do exactly what they are supposed to do.
“We can work with the best minds, the greatest scientists, have the best equipment or computers and spend a lot of money on research, but if we don’t have people to actually test the treatments, we cannot advance the science.”
Why should people participate in clinical trials?
Facheris: As a physician, I often hear people say, ‘I don’t want to be a guinea pig’ when asked why they don’t want to participate in a clinical trial. However, there are numerous observational studies that aren’t invasive and equally important to research.
We can work with the best minds, the greatest scientists, have the best equipment or computers and spend a lot of money on research, but if we don’t have people to actually test the treatments, we cannot advance the science. The only way we can advance research is through clinical trials. Some people complain there is no advancement, but yet they don’t put themselves in the process to try and help.
Martinez: I agree Maurizio. Nothing upsets me more than people saying they don’t want to be a guinea pig. Guinea pigs can’t walk away. Guinea pigs can’t give consent and guinea pigs are unable to process information related to a study. I’m not a guinea pig because I get to ask questions and choose to get involved. I can get up and walk away or stop anytime I want. People are forgetting that protections have been put in place for patients who volunteer. But, most people are afraid of things they haven’t experienced.
It is a definite learning curve for patients who may want to participate. I suggest getting all the information you need to make an informed decision on whether you should consider participating. Ask those questions and if you don’t get the information you need, walk away.
To advance science, clinical trials need a wide variety of participants with different disease backgrounds, age, race and ethnicity to help shape what works and what doesn’t. I encourage people who don’t see themselves in the science to change the narrative and get involved.
What would you say to someone on the fence about joining a clinical trial?
Martinez: Some people just need an example to look to. We all have headaches and we may or may not have taken medicine to alleviate those headaches. If you think about it, even the safest drugs had to go through clinical trials before they could be available for you and me to take.
Or, some people are hesitant to get involved in a clinical trial because it wasn’t suggested by their doctor. However, many doctors don’t suggest clinical trials to their patients on a regular basis. Patients need to understand they are in control and can initiate that conversation with their doctor or look for clinical trials on their own.
Facheris: I agree Nina. In my mind, the patient and doctor trust relationship is important, yet patients should understand that they hold the responsibility. They should feel empowered to get involved, learn more and know what clinical trials are out there for their disease area.
Unfortunately, approximately 80 percent of clinical trials fail to meet enrollment timelines2and nearly a third (30 percent) of Phase 3 study terminations are due to enrollment difficulties, making recruitment the single biggest reason for trial failure.3 New treatments cannot be developed and science cannot progress without the help of people like you, Nina.
The Healthy Volunteer Perspective
“I participate in clinical trials since it is a great way to use your health for a greater good, to learn about and participate in science … If folks are nervous or unsure, I remind them that research is only as good as the data that’s collected – and someone needs to volunteer to participate.”
-Rachel Pryzby, a healthy clinical trial volunteer.
What else should people know?
Facheris: I wish people understood what it takes to get from start to finish in the drug development process. From discovery and development to first in human testing, then onto approval, it is approximately 12 to 15 years for any treatment to be approved.
A great deal of work and resources go into the process necessary to get a treatment to market and then many drugs fail between Phase 2 and 3. And by that time, millions of dollars have been spent on those potential treatments. There are many reasons for the failures, but it’s unfortunate if one of those reasons is due to inadequate clinical trial participation.
Martinez: We need to frame our failures as successes. People tend to be motivated by outcomes. I think people should understand that the contributions they can make now to the clinical trial process can significantly help move the dial forward for people five to 10 years down the road. We need to tell them that none of this is done in vain and their participation will help us advance science – if not immediately for them, for others like them in the future.
To learn more about what’s involved in the U.S. clinical trials process, visit Clinical Trials and Me.
1- 2015 Center for Information and Study on Clinical Research Participation (CISCRP) Perceptions & Insights Study – All Respondents (n=12,009)M
2 - Hess, Jon, “Web-Based Patient Recruitment,” Cutting Edge information, http://www.cuttingedgeinfo.com/process/?ref=122
3- Li, Gen, PhD, MBA and Gray, Robert, MBA, “Performance-Based Site Selection Reduces Costs and Shortens Enrollment Time,” Monitor, December 2011. Based on analysis of 5,000 terminated clinical trials.
4- Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary; Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Washington (DC): National Academies Press (US); 2010. https://www.ncbi.nlm.nih.gov/books/NBK50895/
5- World Health Organization: Cancer Fact Sheet http://www.who.int/mediacentre/factsheets/fs297/en/
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