Before the term "Patient-Centric" was coinedLet me take you back. The year was 2007. I was at my wit's end, ready to pull the plug and give up. I was suffering one relentless MS relapse after another and seeking relief by any means possible. I read about the TRANSFORMS trial (Gilenya, Novatis AG) in the back of an MS Focus magazine. I decided I was desperate enough to get on the hamster wheel in the proverbial lab rat's cage.
But it was 2007. My cell phone wasn't smart, and the research study as it appeared on www.ClinicalTrials.gov was not in the least inviting for a patient who was both terrified and out of hope.
But I had no alternative to finding out what being a patient would mean. There weren't even any blogs out there describing it at the time. I got my Informed Consent document and it looked like exactly what it is: a legal document that states I agree, after reading every horrible thing known or suspected about what I may or may not ingest or have performed on me, to willfully partake in the study knowing that I might be the reason they discover some terrible side effect through what is known as an Adverse Event.
Between the study description on www.ClinicalTrials.com, which looked like a page ripped from a college chemistry textbook, and the informed consent, which appeared for all the world to look like my Last Will & Testament, I was not left feeling all warm and fuzzy about the idea of joining.
To someone born a hypochondriac, with the same genetic makeup of her mother who is a world class worrier, all of this was rather foreboding to say the least. But that was nearly six years ago.
When I look back now, joining that trial was the single most courageous thing I have ever done. It was also the most life-changing. I was one of the lucky ones who was randomized into the arm of the study that got the, now approved, .5mg dose of Fingolimod from the very first day. My last documented relapse was in April 2007.
The fact that I have been relapse-free this long has allowed me to concentrate on other things in my life. Like advocating for future clinical trial patients, which is why I am excited to share this bit of news with you....
Making Clinical Trials Less "Clinical"Eli Lilly's project, Clinical Open Innovation, is all about transparency and sharing information in the world of research, with the end goal being a cumulative effort at moving healthcare forward to benefit everyone. To quote directly from their "About" page:
Eli Lilly Clinical Open Innovation is founded on the belief that drug development processes must improve, and that open innovation methods can be used to make clinical development better. We’re a small group of Lilly employees coming from diverse educational and professional backgrounds in disciplines like pharmacy, philosophy, IT, English, sales and management. We’re interested in working with you to make a difference.
As it turns out, they aren't all hype. They have recently taken the subject of making clinical trials more "patient-centric" by the horns and have launched a contest to actually DO something about it.
On June 14th they posted the contest on their own blog at Lilly Clinical Open Innovation. This contest is open to all, with huge cash prizes.
It's a brilliant idea to gather all the great minds of designers, patients, healthcare professionals–anyone who wants to enter–and let them loose on the task of making clinical trial information found on www.ClinicalTrials.gov more user friendly for the person seeking to become a clinical trial patient. This data, as well as the Informed Consent, are getting a What Not To Wear makeover.
The contest takes place on ChallengePost and you can get all the details there.
From Lilly COI's blog post:
We’re inviting all patients, healthcare providers, web developers, designers and others to help redesign the clinical trial protocol and informed consent document with the patient’s needs in mind through our Clinical Trial Visualization Redesign Challenge.
We’ll provide a sample clinical trial protocol, its informed consent document and associated ClinicalTrials.gov record reference. Your mission, should you choose to accept it, is to transform those documents into resources for patients that improve the:
- Visual appeal
- Potential for web and mobile applications
- Clinical trial experience for patients.
I have been invited to be on the panel of judges selecting the lucky winners. I bring to the panel the unique perspective of having "been there, done that" with my own personal clinical trial experience. I am honored to have been considered for this role and really excited to get to see all the entries first hand.
So spread the word! This is a project that will have far reaching implications for years to come as all of the entries, according to the rules, will become open source and fall under the Creative Commons Attribution 3.0 Unported License. This means there is no price tag on genius. Share and share alike for the common goal of making research take a huge leap forward in the name of progress.
None of what is created will be thrown away or lost in the shadows of the winning entry's spotlight, for everything created for this challenge post has the potential to be utilized in the future, bringing information to a new breed of clinical research partners (i.e. the patients) in a way that is meaningful, relevant and easy to understand.
Not only that, but doing so using a digital, portable format patients are becoming increasingly dependent on in all other areas of their lives. It makes sense that research partners be engaged in a way that is both familiar and convenient for them. This can only have a positive impact on the patient retention rate and help with their study compliance.
Putting the Patient in Patient-CentricI am excited to think that there might soon be a time when patients who are sick and tired of being sick and tired can consider research as not just the "when all else fails and I'm ready to die or join a trial" option, but as a viable treatment option, opening new avenues to explore. They might have the opportunity to effectively battle whatever disease with a new treatment years before it becomes readily available to all.
One day maybe research will be viewed as a lottery of sorts. Yes, there are great risks, hence the need for the informed consent. But there is huge potential for personal reward as well as the knowledge that by doing your part in joining a trial, you are helping to advance science for all. I feel like I won the lottery when I joined the TRANSFORMS trial and was literally given back my Quality of Life.
And when you get right down to it, isn't that what research is all about? The never ending quest to strive to improve the Quality of Life for all mankind? No matter how you slice it, that's the goal.
Making the process of finding and joining those trials more inviting and easier to understand can only be a good thing. The audience this contest is intended to reach is none other than the very brave souls needed for any research to happen in the first place. You can't have patient-centric trials without patients.
Cheers to Eli Lilly for sponsoring this event and making "patient-centric" be something more than a catch phrase.
Good luck to all who enter, and I thank you on behalf of all future clinical trial patients who will one day benefit from your creativity. I hope it's not lost on any of the contestants that you are part of something much greater than this contest.
So, with that said....
Let the designing commence!