Are You Up For The Challenge? #ctdesign @Lilly_COI Launches Patient-Centric ChallengePost

Before the term "Patient-Centric" was coined

Let 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
• User-friendliness
• 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-Centric

I 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!

#livingwithMS - World MS Day 2013 - Getting Their Tweet On

I recall when I was first diagnosed with MS. I spent several years with my back turned toward the truth. I avoided the local MS group as they seemed to be sad and depressing. Lacking hope. I was so fearful of my own uncertain future that part of me just refused to believe I even had MS.

It was easier to deny than accept. Facing the truth would mean accepting the fact that I have an incurable, unpredictable, potentially disabling disease.

But somewhere along my path, well after my entrance into the TRANSFORMS clinical trial, and even after starting this blog, I became comfortable with facing my disease head on.

I believe my experience with Novartis' Go Program and becoming a patient speaker did more for me that I gave back to them. I learned to accept that I do have MS, that it's not the end of the world, and that with my voice I can reach out and make a difference to others who have MS.

It wasn't until I overcame my fear of public speaking that I came out of my shell and embraced, albeit reluctantly, health activism. But with the single act of accepting my own MS, for better or worse, I have freed myself and realized a passion I didn't think possible.

When opportunity knocked, I went through the door. So that is how my own personal MS motto came about. "Just keep putting one foot in front of the other." Simple, but there's a lot to be said for a pragmatic approach.

When I am speaking or writing on the topic of MS or my experience as a clinical trial patient, I have a sense of purpose. You can go a lifetime without ever knowing that feeling, but I have been blessed.

Tomorrow is World MS Day 2013, when the whole world joins together to recognize–and spread awareness of–multiple sclerosis.

I have been given the opportunity to help raise awareness of MS yet again! www.healthline.com has invited me to participate in a Tweet Chat on the topic of World MS Day 2013. The event will take place live on Twitter at 11 a.m. ET.

I'm inviting everyone to join in or at least follow along by using hashtag #livingwithMS. It should be an awesome event! I will have the honor of tweeting alongside, Samantha Schech, a Client Service Consultant with the Multiple Sclerosis Association of America (MSAA); Ayesha Ali, Campaigns Manager at MSIF; and Ceri Angood, Director of Programs at MSIF.

Won't you join us?

======================
UPDATE: Today's article on Healthline.com just published. Read about the "nuts and bolts of what goes into the making of World MS Day, and find out what comes from all that awareness and fundraising:
http://www.healthline.com/health-news/ms-world-ms-day-raises-awareness-and-funds-052813

Subject #0008 Version 2.0

My part in the historic TRANSFORMS trial which helped bring the long-awaited, first ever, pill form of treatment for multiple sclerosis (MS) to market ended with my exit date of 1/20/2011. I remember being terrified to start that trial. It contrasted sharply to the day the extension ended and they had to physically toss me from their study center back into the cold, cruel, unsupervised world.

They did so with a vague promise of a future "Extended Study" as soon as everything is lined up. I would be the canary in the coal mine, offering advance notice to those newly started on the drug in case something were to go terribly wrong over the long term.

I kept my study coordinator's cell number on speed dial and would occasionally call to be the squeaky wheel in need of grease, pestering her about when that study might start.

More than two years passed and I gave up hope. Friends in my MS circle who had also taken part in the early trials for Gilenya were sharing news of starting the long-term study. I was as disappointed as that one kid in grade school who comes in on Monday to hear all the happy chatter about the birthday party they missed over the weekend. Nobody invited me.

Then one day I got an email from my old study coordinator asking if my mailing address had changed. She's the kind that likes to remember you with a card on your birthday or at Christmas so I figured it was something along those lines. Making one last feeble attempting at getting my squeaky wheel greased, I wrote back saying the address was the same and inquired if she heard anything about the long-term trial.

Much to my surprise, the email I got in reply, which contained no exclamation points but was brief and to the point merely stated "I'm sending you the IC to look over for the long term trial." The "IC" being the Informed Consent. She probably sent me the email because she knew a phone call would result in maniacal screeching on the other end of the line.

Although I read it cover to cover, there wasn't anything in there that could dissuade me from joining. I have been waiting 2 years, 4 months, and 3 days for this stack of papers to be in my grubby little hands, but who's counting?

So, here we go again! I had my entrance tests all done on May 17, 2013 when I officially began this long term study. I went armed with my camera and made sure everyone knew "I'm blogging this", but I think most of them just thought I was weird.

The shots I got–for your viewing pleasure

 There is a Quality of Life questionnaire this time, same as before. When I see these questions, like, "Do you feel you are a burden to others?" or, "Does you MS make you feel alone?", I feel so sad for anyone that has to answer yes in order to be truthful. What our MS robs from us is often more invisible and less obvious.

 One of the best perks about the study is being able to go back to the generic, utilitarian bottles. Who cares that they aren't pink and orange with a catchy logo? I love my pills no matter what
they look like on the outside–it's what's inside that counts! And these bottles are so much easier  to manage for those of us suffering from the disease. Who has time for "slide this out, flip this down, try to push a pill through industrial-grade aluminum without crushing it, and then TRY to get the whole thing all flipped, folded and slid back to normal"?

 They have an all new, state of the art, peg test now! Nothing but the best this time around! See this post for the jack-o-lantern bowl we used last time and you will no longer wonder why I scored better this time.

The story goes that the nurse who first used the pumpkin bowl to administer the test did so without authorization, however, for the sake of consistency throughout the remainder of the trial, we were forever punished with that slippery, contoured, deep sided pumpkin bowl. I do not miss it at all. And now everything seems to be a uniform (Gators?) shade of royal blue or light blue.

  I had forgotten that half of my bodily fluids would have to stay behind, sucked out of me via a sharp, pokey needle, the likes of which I thought I'd never have to face again. I had forgotten the First Rule of Clinical Trial Visits: fluff up your veins by drinking lots of water to make blood drawing easier.

 The very last picture I got was of their brand new MRI machine. This replaced the old monstrosity they had, requiring the removal of an entire wall to get the swap made.

The surprise MRI was the only scary part for me this time around. You see, I had no idea it was even scheduled for the 17th, so I did not prepare by adequately fretting about this for a week prior and–more importantly–getting a Rx from my doctor for some Xanax. I'm still  50% hypochondriac, it turns out, and I am more than 20% Drama Queen.

When the study coordinator emailed at 4:45pm on the 16th to ask if I planned to come up early so I could complete paperwork and other testing prior to my 11am MRI, I didn't even bother to hit "reply".

I whipped out my cell phone and hit speed dial for her number instead.

"What do you mean the MRI is tomorrow??"

"I wondered why you never replied to my email asking if you were okay with that time."

"So, is it the same machine as last time? Because that's a short machine and I could deal with the MRI in that thing. Then even if I had Xanax, which I don't think I do, it just ends up being recreational anyhow."

"No, they replaced the MRI machine with a brand new one last year. It's much bigger."

"Bigger around, or in length?" (because in this case length DOES matter! They have to put your head in the middle of the tube to get the images, and that's not so bad in a 4 foot tube; less fun in an 8 footer.)

"Well, I don't know really. I know it's big."

So I spent that night and the next day tearing the house apart looking for a bottle containing exactly half of one Xanax. The other half of the pill was the one I took at my last MRI upon exiting the TRANSFORMS trial on January 20, 2011.

I finally found the pill the next morning, and even though I did take it, I think it just had a placebo effect. It was old and there was only half a pill. At any rate, I was  able to lay in that tube long enough for them to get pictures of my brain without freaking out and squeezing the emergency bulb, shouting "GET ME OUT OF HERE!"

Oh, you think that's funny? Heh. I've done it before.

So this is the second time around and I'm older and wiser now. Well, older anyhow.

This is Subject #0008 all over again, but I know the drill.

You're looking at version 2.0.