How social media is impacting the face of clinical trials

I have been invited to speak at a conference to be held in Boston, Sept. 13-14, 2012.  http://www.theconferenceforum.org/DisruptiveInnovationsInClinicalTrials-Overview.html

The conference is about "disruptive" thinking in clinical trials. In other words, they want to shake up the traditional ways of approaching research and the patients involved, and take into consideration that, for better or worse, social media WILL play a part in all of this.

The reason for my invitation

I started this blog in 2007 to chronicle my experience in the TRANSFORMS clinical trial for the new MS drug Gilenya which is currently the only pill form of therapy FDA approved to reduce relapses in relapsing-remitting MS.

The idea for the blog was borne out of my frustration in trying to find any information about clinical trial experience from a patient's point of view. I was apprehensive about becoming a human lab rat and wanted someone to show me that it was okay and that they had been through it already.

Finding no such example, I decided to start the trial despite the lack of reassurance, and blog it from start to finish in hopes of offering those other potential trial patients something to find when they googled "clinical trial patient" in the future.

Along the way something unexpected happened. I gained readers who spread the word and shared my experience through other forms of social media. I was soon hearing from other trial participants -- many of whom were in the same clinical trial. We developed a camaraderie formed around our mutual trial experiences and sought to form a group to stay in contact.

I started a Yahoo group which was quite active for a while. It was private, by invitation only, and new members had to *prove* their membership in one of the Gilenya clinical trials to gain access to our group.

We shared our experiences, comparing notes and even questioning whether or not we ought to be doing so. But the human nature part of the equation took over and we were all driven to share and all of us felt comforted by the odd little community we had formed.

The Yahoo group was difficult for me to manage. It was not visually intuitive to me and my MS brain just couldn't get the knack of it. Instead, I opted to host a private forum on my own web space. It served the purpose until we were hacked and discovered posts of pornography littering our boards.

Finally we landed on a private group on Facebook. There we stayed until the drug attained FDA approval in September 2010.

After the trials were over, another group member decided to found the Facebook group "Gilenya (Fingolimod) Support Group" which is very active today with nearly 1,000 members. Many of the original trial members from our Yahoo group are still there, and remain active in helping new patients navigate their way through starting therapy. We are all there comparing notes, reassuring each other, and directing one another to seek medical advice rather than rely on a consensus on a Facebook group.

At the time, I had no idea that my blog, or the groups we formed afterward, was anything close to ground breaking.

Turns out that the pharmaceutical world was watching. Now I have an invitation to stand before those who shape the future of clinical trials and educate them on the e-patient and how we use social media to stay connected. 

Just as with the clinical trial, I don't want to face this alone. I want to bring with me the voices of as many clinical trial participants and I can gather.

 If you were in a clinical trial of ANY SORT, any medication for any disease, and had the chance to stand before those who are at the very top of these trials, what would you tell them? What would you ask them? What would you want them to know? It is YOUR CHANCE as an anonymous clinical trial subject, normally viewed as a set of test results, statistics, percentages, to be heard as the human being you are; to give feedback and suggestions about your experience.

I am going to be gathering as much info as I can about what clinical trial patients are concerned about most, and I am going to bring it -- on behalf of all of us -- to the attention of the top level people from all of the pharmaceutical companies who preside over clinical trials everywhere.

If you would like your voice to be heard, please take this anonymous survey I have created. http://www.surveymonkey.com/s/JQQKDN9

On September 14th during my portion of the conference, it will be live-tweeted on Twitter and as the date approaches I will let you know how you can join in.

I'm very honored to be given this opportunity to represent clinical trial patients everywhere and in particular the e-patient who is internet savvy and engaged in social media. Hopefully it will start a conversation with people in research that will effect change for the better for all of us.

PLEASE HELP SPREAD THE WORD!!
Blog it, Tweet it, Facebook it, email it, use two tin cans and a string... I don't care how you help me spread the word, but let everyone know that this is our chance to be heard.

A recap of my ms experience - Part 3 - joining the clinical trial

If you're just joining us, you can read parts 1 and 2 here to get up to speed:

Part 1: Diagnosis
Part 2: Starting Therapy

~*~*~*~*~*~*~*~*~*~*~

I stayed on Copaxone for the next eight years. The whole time I continued relapsing 3-4 times a year with such terrible relapses it often took a good three months to recover, so I was basically in one stage of a relapse or another continually.

My neurologist, whom I trusted implicitly with my ms, did not seem alarmed by my relapse rate, nor did he suggest I try switching therapies. He just insisted I had an aggressive case of ms and I should stay on the Copaxone and treat acute attacks with IV steroids. I didn't know any better, so I went along with the plan.

Then one day my neuro I'd been with all along had a stroke. His practice abruptly shut down while he struggled to recover. I was without a neurologist.

Since my small town only had one other neurologist who wasn't seeing new patients, my primary care physician (PCP) became my ms lifeline. Every time I'd feel some new numbness, weakness or burning, I'd run to him. He kept insisting that the things I was coming to him with were ms related and I really needed a new neurologist. The catch was, in order for me to see a new doctor, I would have to drive out of town to do so. That terrified me. I hate trying to navigate in strange places almost as much as I fear driving on the interstate. I was defiant. 

One day he just put his foot down and, before I had left his office, he had his nurse schedule me an appointment with a neurologist out of Jacksonville, FL. A Dr. Kantor I'd never met.

The appointment was a good month away and in the meantime I got an Momentum magazine in the mail. In the back of the magazine is a section that outlines all the promising therapies coming down the pipeline. All the stuff currently in clinical trials. I read about a trial that was soon going to be recruiting patients called the TRANSFORMS trial to test efficacy and safety of a new drug called Fingolimod. What was exciting to me about this trial was the fact that it lacked a placebo. Rather it would be testing 2 different doses of Fingolimod in a head to head comparison study with FDA approved Avonex.

 It was to be a double blind study meaning neither patient or study center would know what the patient was on. In order to accomplish the blinding, it would be necessary for the study patient to take a pill once a day AND do a shot once a week. Either the pill or the shot would be the "placebo", but not both. So the patient would either take a sugar pill all week while giving themselves a shot of Avonex once a week, or they would be taking Fingolimod all week while giving themselves a shot of sterile water once a week.

Around the same time that I got that Momentum magazine, I also got a flyer in the mail from the local ms support group. I was excited to see their upcoming guest speaker was going to be my new neuro. How convenient! I could go meet him before I had my appointment and maybe get a little one on one time with him and ask him about the clinical trial.

Turns out I didn't have to ask. When he spoke at the support group meeting, Dr. Kantor was full of energy and very excited to talk about many things -- including the fact that he was lead investigator for the TRANSFORMS trial that was currently recruiting.

When I had my appointment, finally, we discussed all the things unique to being in a clinical trial and in particular the known risks associated with Fingolimod. I met with the study coordinator who gave me a thick stack of papers call the "informed consent" to take home and read through. It basically outlined what the study would be about and then went on to list any and all possible side effects or adverse reactions that were known to be associated with the medicine. Since Fingolimod had been trialed earlier in kidney transplant patients (at a much higher dosage), there were many known possible risks to consider.

It was a very intimidating and scary document considering I can't even take a Tylenol without reading the package insert and wondering how many of the possible side effects I might suffer. (Hence the "hypochondriac" in my blog's tag line.)

I ended up signing it and before I knew it I was under the microscope. Not literally, of course, because that would have to be one big microscope, but I felt like I was being thoroughly poked and prodded and constantly monitored. I had never had such acute attention paid to the minute details of my health and I felt surprisingly "safe" within the clinical trial.

This is where I have to leave off so you can catch a break and get on with your day...

I will try to finish this up and condense the trial into a single blog post only recapping the highlights. Not an easy task for someone fond of huge, paragraph-ish run-on sentences.

That's why I can't do Twitter. I can't get to the point in 140 characters or less.

Upcoming Topics I Have Planned

I know I have really slacked off on my blogging, but I do think about it a lot. Does that count?

Here is a list I have compiled of topics I have been kicking around and will try to cover in the near future.

• Tips for accessibility in the home
• When you partner is not supportive
• Part 3 of my MS journey
• Finding your voice to be proactive
• Crutches for the mind - tips on dealing with brain fog

You see? My brain is staying busy but I just haven't applied myself to the keyboard. I figured by compiling the list it would make me feel more obligated to follow through. Let's test that theory and see how long it takes me to post again. Don't start counting until Friday night. I'll be out of town until then.

Great MS Video found on Facebook Gilenya Support Group

A patient very new to Gilenya posted this video she made on Facebook and I was so moved by it that I wanted to share it with the rest of the world. Please take a look and share it with others. :)




PS, I know that popcorn I told you to make at the end of my last post is way past stale, but I promise to write Part 3 of my MS Story very shortly... by this weekend for sure since I'm going out of town tomorrow (actually later today since it's 2am now) to speak to a group of MSers about Gilenya. If you're in or near Venice, FL and want to come out, I'm speaking at:

Crossroads American Grill
385 US 41
Venice, FL

Thursday, May 3 - 6pm