The following blog post is by Jeri Burtchell.
Jeri is a renowned patient advocate, with first-hand experience participating in clinical trials. Her ideas, passion and willingness to share via her blog and in speaking engagements help to clarify how clinical research works, its value, and where there needs to be further focus on the needs of the patient.
The opinions expressed by Jeri are her own, and do not necessarily reflect those of the Lilly COI Team.
In mid 2007 I laid on my back staring at the ceiling, trying to talk myself out of suicide. After eight years of battling multiple sclerosis I was sure there was no hope of ever seeing an improvement in my quality of life. The thought of my family’s certain sorrow over my tragic death forced me to find an alternative. I pushed myself to make one last effort at self-advocacy and hopefully change my life. I was ready to entertain drastic measures.
Allow me to introduce myself. My name is Jeri Burtchell, but from 2007 until 2011 I was also known as Subject #0008. I was part of the TRANSFORMS clinical trial conducted by Novartis to study Fingolimod (now Gilenya) as a disease modifying therapy for the treatment of multiple sclerosis.
I remember when I took the first step down that life changing path. I had just come from an appointment with my new neurologist who, it turned out, was also lead investigator for the Fingolimod trials in our area. I left his office with what appeared to be the clinical trial’s rendition of War and Peace tucked under my arm. I was expected to take this Informed Consent home, read it thoroughly, and then base my decision to hand my life over to science on what I read within. I was terrified.
Finding some human warmth in cold science
Revealed within were all the known risks and side effects of the study medication and how they intended to monitor me for signs of any adverse events. It was all very cold, precise, medical jargon that left me feeling doubtful that I might find relief from my unrelenting MS attacks in this medication.
I was alarmed at being faced with things I took very seriously like macular edema, possible asthma-like symptoms, heart issues, liver issues, etc. I spent a lot of time at the computer Googling these things. I tried to find anything about clinical trials that would describe what it’s like to be a patient, but everything I found was from a research point of view. What I needed to hear was someone’s encouraging words of their own successful trial experience. All I heard was crickets.
So I made up my mind that if I couldn’t find it on the internet, I was going to put it on the internet. I would blog my clinical trial from start to finish. That’s exactly what I did. You can find the story in its entirety at www.gilenyaandme.com. I started with the baseline tests, taking pictures of the MRI machine, the CT machine, the PFT contraptions, the OCT test, etc. I explained each test as it was explained to me, laid out my pre-test fears and anxieties, and followed up with what actually transpired.
Before my Randomization Day I had previously been the kind of person who had to read the patient insert front to back before taking an aspirin for a headache. I would talk myself into believing I’d probably bleed to death, so I’d forego the aspirin and suffer the headache. Now here I was ingesting an unknown substance.
The experience of the patient matters
My clinical trial lasted a year with several extensions I was invited to join. Overall, it would be a four year journey I will never regret taking. I pushed myself out of my comfort zone into unknown territory in search of an improved quality of life. I was desperate for some relief from my disease.
I believe I was a typical example of a person who would seek out a clinical trial. Distraught, out of options, and vulnerable. In my own case, I was also suicidal so I had a unique perspective when considering whether or not I might die from taking part in the study. I was already entertaining taking my own life, so what was there to lose?
The flip side of the trial experience is that of the research team. These are people who have a passion to make a difference in the health of other human beings. They have dedicated their lives to research, however most of them have never met a real live clinical trial participant.
In 1948 there was a groundbreaking clinical trial conducted by the Medical Research Council involving the use of streptomycin to treat pulmonary tuberculosis. This study was the first to use proper randomization, double blinding, and control subjects. It set the standards for all future clinical trials.
But nothing ever really changed on the patient side of the experience. Except for being given the informed consent and a choice in participation, the subject is still the faceless donor of data. No further thought, it seems, has ever been given to what it must actually be like to experience all that poking and prodding.
The world today is far different from that of 1948. We have the internet now, and social media, and commercials on TV urging us to talk to our doctors about free samples of prescription medications. But join a trial and you are sent right back to the middle of the last century. Hopefully, that is about to change. I have been asked to speak up about what my experience was like and to share that with researchers. It started when Craig Lipset of Pfizer contacted me for an interview. His team is trying to come up with innovative approaches to traditional clinical trials and he had never seen anyone blog a study before. Our phone conversation led to an onstage interview this past September in Boston at the Disruptive Innovations to Advance Clinical Trials conference.
That is when my list of patient-centric ideas for clinical trials started to evolve. In order to increase recruitment and retention of study subjects (so integral to any trial) I came up with a simple plan: Treat subjects like human beings and conduct your study in such a way as to have the least impact on their everyday lives. Here are a few of my ideas:
- Hand out a trial brochure accompanying the informed consent. Make it the Chamber of Commerce version of what to expect. Photos of the test equipment and smiling, reassuring faces of study center employees, along with short descriptions of what to expect written in language the average person can understand will go a long way toward putting anxieties at ease.
- Create a calm environment for the patient. I’m not talking about a complete remodel of your study center. Just the simple act of having the staff remove their lab coats can dramatically change how a test subject feels. Take a look around and put yourself in their shoes. Would walking in here make you feel welcome or stress you out?
- Gang lots of little tests into one day-long event. That way, if your trial patient works for a living, they don’t have to repeatedly ask for time off and risk losing their job.
- Help solve transportation issues. I had to travel two hours one way to the study center. I am terrified of driving on the interstate even though it was the most direct path to get there. Help patients find alternate driving routes or arrange transportation, reimburse them for cabs, buses, gas — whatever their out of pocket expenses might be to get to your center. They are already offering up their very lives to science; don’t ask them to pay for anything else.
- Feed them. My trial required a six hour observation on Randomization Day. I was given meal tickets to the cafe located in the medical complex so I could eat. If you are going to ask them to give more than a couple hours of their time, whether it’s in a waiting room or undergoing tests, they are going to get hungry.
- If the drug is approved, assure the patient doesn’t pay for it. Part of my choice to enter the study was that I had no medical insurance. I would receive study medication for free, but also medical care for my MS. I was excited to learn my drug won FDA approval but mortified at the thought of my trial ending. It meant I would no longer be able to take it without financial help. It only seems fair that if I agreed to risk my life to help a drug company bring a drug to market, I should be recognized for my part by receiving that medication for free as long as I needed it. To go from “here, take this and let us watch what happens to you,” to “If you want more, it will cost you,” is a slap in the face of trial patients everywhere. Fortunately, in my case, Novartis offers an excellent patient prescription assistance program. I don’t currently have to pay, but free-for-life-no-strings-attached would be an even better perk.
- Offer patients mobile apps. There’s an app for everything else under the sun, why not apps for patients participating in clinical trials? Apps to remind them to take medications, apps to gather information such as heart rate or blood pressure, apps that are designed like a game so that, based on a patient’s compliance, they are rewarded in the clinical trial game. Whoever invented Angry Birds knew something about recruitment and retention whether they know science or not.
- Set up online support areas. Humans are social creatures, but clinical trials are designed to avoid patient interaction or socializing. I have news for researchers: you are NOT going to prevent test subjects from finding one another. The internet is a big place and Google will bring us together. Before you have a coronary at the thought of us swapping information that could lead to unblinding, consider this: patients have the most to gain – and the most to lose – from your research. The last thing they want is to sabotage your data. Give them a place that is study-specific, secure, and monitored by a third party to head off any unintentional conversation that could lead to unblinding. Taking part in a clinical trial is a scary experience and at times it can be lonely. When you find others who are in your same situation, it’s only natural to reach out to them.
- Provide an online information center. Even if the idea of a social support group for trial patients never gets off the ground, at least offer a repository of easy to understand, up-to-date information about the trial medication to which patients can have access. If you can help your participants avoid the landmines of misinformation that will come up on an internet search and give them direct access to factual information, you might have a more relaxed, trusting, and compliant test subject.
- Unblind participants as quickly as possible. Regardless of whether you need any further data from your subjects, once you cut them loose from a trial they need to resume their lives. Quite often that means addressing other health issues. Their doctor cannot make informed decisions regarding their treatment without knowing what medications they may or may not have been taking. As soon as you are done collecting data unblind the patient. Send them a letter directly if you still need to keep the study centers blind, but let them have their lives back.
These are just some of the ideas I have for improving the patient experience in a clinical trial. Even without any of these changes, if I had it to do over again, I would not hesitate to take part in the TRANSFORMS trial again. I went from thoughts of suicide to becoming a patient advocate and the journey that brought me to this point took me straight through that trial. Novartis and their team of researches literally gave me back my quality of life.
I believe we are on the precipice of an exciting change in the way clinical trials are conducted. The fact that Big Pharma cares what Little Jeri has to say is indicative of a desire for change. We need more open conversation about what it means to be patient-centric. We have focus groups for what people want to eat at a fast food restaurant; why not focus groups that explore the patient side of clinical trials? The more you learn from the subjects themselves about what they liked – or hated – about their experience, the more knowledge you have when designing your next trial. Your study can only succeed with proper patient recruitment and retention. Addressing the needs of the people you hope to recruit and retain is key.
I believe nothing is impossible. We have the science and the potential to conquer even the most daunting diseases. Changing the face of clinical trials to be more appealing to the participants in a patient-centric fashion can only help to achieve success faster. It starts with remembering that we are not just “subjects”, but we are partners in science. I’m not just “Subject #0008”; I’m a participant and my name is Jeri.