Patient Centricity at #DIA2015

I have the honor and the privilege of speaking on a panel at the Drug Information Association today about patient centricity in clinical trials.

What? What does that have to do with diabetes?

Everything.

Did you know that less than 1% of the global population participates in clinical trials, but that clinical trials are what provides us with new drugs and treatments? Without them, we wouldn’t have new drugs and devices?

Clinical trials often have issues recruiting patients and getting patients to stay in studies through to completion. Reasons for recruitment and drop out rates can include: issues with traveling to a clinical trial site, exclusions due to age or lab results, and the complexity of the trial (including invasive procedures). What if these issues were minimized because the clinical trial was patient-centric?

What is patient-centric?

We’ve heard the term “patient-friendly” bandied about when discussing organizations that speak on a level that patients can understand. These are the companies who share disease education in an easily digestible way (infographics overload sometimes!) and provide ways to contact the company if further information is needed. When you apply the term “patient-friendly” in clinical trials, it means, in my opinion, the clinical trial personnel can talk to the patient without sounding too… well… clinical. And here’s the difference between “patient-friendly” and “patient-centric” – Patient-centricity means listening to the patient, talking with the patient, and sharing with the patient at every point in the clinical trial timeline.

Patients Aren’t Stupid

We’re not. We understand that without new drugs and devices, our care is the same as it ever was. However, many of us don’t know what’s involved with a clinical trial and the role that we play in helping to get new drugs and devices to market. If we slog through clinicaltrials.gov and read the gobbledygook that is all clinical and zero layman, we’re still left to reach out on our own to get more information and see if we qualify. Most people don’t bother to go that far. And the opportunity to help, to get access to investigational drugs and treatments from the get go, to be a part of the future of healthcare is wasted.

What Needs To Happen

A successful clinical trial, much like everything else, needs clear, understandable, two-way communication between patients and the key people running the trial at every stage. It’s no longer acceptable to bring a token patient to help recruit for a trial. That’s not “patient-centric.” Patients actively participating in developing trial protocols, patients sharing thoughts and potential issues surrounding adherence to a trial – or what might prevent people from participating – and having those who run the trial listen and make changes based on the feedback given – that is “patient-centric.” Understanding the patient (and we aren’t just one patient – all of us are unique, so having “one patient speak for all” isn’t good enough) and incorporating that understanding goes a long way.

Patients want to help. Patients want to be at every table that may help their health or the health of a loved one. Patients need to know if trials are available that they can easily participate in and have an understanding of what is needed and wanted from them – and why they should participate. Communication is key.

Have you thought about participating in a clinical trial?

Take your time to look through the available clinical trials available worldwide. (There are many available for Type 1 and Type 2 diabetes.) Some involve taking investigational drugs. Others involve using a device. All will have a list of “thank you for your interest, but you don’t fit what we’re looking for…” criteria, but take the first step. Be the patient and step into this world. Get involved and while the study may not help you, it may help someone else.

For me, I want to be at the table from the very beginning to the very end. Why? Because at the end of a trial, I’m the patient… hopefully being able to use the new drug or device that I helped bring to life. I want to be patient-centric to other patients.

BBK Worldwide and the Michael J. Fox Foundation will be sharing their thoughts this afternoon on stage alongside me. Grateful for the opportunity. Grateful to speak from the patient perspective.

Grateful to those who participated in clinical trials so that I can wear an insulin pump and a CGM. I’m just trying to pay it forward.

Disclosure: BBK Worldwide paid for my travel and lodging to speak at DIA 2015. My thoughts and words are my own. Always. Like you could shut me up. 

0 comments

  1. StephenS

    SO THRILLED that you are participating in this discussion. As a participant in three clinical trials, while not being allowed to participate in about twice as many, I can still say that clinical trial participation is extremely worthwhile and fulfilling.

    I will say, also, that those running trials in just about every location in which I’ve volunteered have been slow and not organized in gathering patients for trials. I can’t tell you how many times I’ve called or sent e-mails asking to participate in upcoming trials and been told that recruiting is complete, “but we’ll keep your information if another trial comes up”, and I never get another call or e-mail. Ever. Every trial I’ve been a part of, I have had to lobby for and basically work to sell myself as a participant. I won’t stop trying, but it is frustrating.

  2. Scott Strumello

    To some extent, I feel like much of the talk these days about patient voices and the like is popular, but many don’t truly take it to heart. When it comes to clinical trials, we need to stress that this is not necessarily a benign, helpful experience, and its certainly no place to get treatment. As Alex O’Meara who occasionally writes for “A Sweet Life” noted in his book “Chasing Medical Miracles: The Promise and Perils of Clinical Trials” eloquently wrote: “Clinical trials are not medical treatment. You might benefit from a trial, but that is not the reason the trial is being done. The trial is being conducted to gather data – period, end of story.” His own website has a page entitled “Advice for Subjects” (see http://ow.ly/OxlfC for that) which is really worth reading before you decide to enroll. Remember, as a trial participant, you may drop out of a trial at ANY TIME.

    Entering a clinical trial also has risks to the patient (remember, these are not yet FDA approved treatments for a reason). I often hear stories of people who enter trials hoping to get treatments for their condition. They are virtually guaranteed disappointment. Not only might the treatment not be approved, but there might be other issues which are discovered in those trials. Also, the drug or medical device might be available to participants during the trial, but when its done, your access to those treatments also disappears.

    My main concern is that people don’t enter clinical trials with rose colored glasses on. There may be benefits, but there’s no guarantee of that. Know why a trial is being conducted and make sure you know what your rights are as a trial participant.

  3. sstrumello

    To some extent, I feel like much of the talk these days about patient voices and the like is popular, but many don’t truly take it to heart. When it comes to clinical trials, we need to stress that this is not necessarily a benign, helpful experience, and its certainly no place to get treatment. As Alex O’Meara who occasionally writes for “A Sweet Life” noted in his book “Chasing Medical Miracles: The Promise and Perils of Clinical Trials” eloquently wrote: “Clinical trials are not medical treatment. You might benefit from a trial, but that is not the reason the trial is being done. The trial is being conducted to gather data – period, end of story.” His own website has a page entitled “Advice for Subjects” (see http://ow.ly/OxlfC for that) which is really worth reading before you decide to enroll. Remember, as a trial participant, you may drop out of a trial at ANY TIME.

    Entering a clinical trial also has risks to the patient (remember, these are not yet FDA approved treatments for a reason). I often hear stories of people who enter trials hoping to get treatments for their condition. They are virtually guaranteed disappointment. Not only might the treatment not be approved, but there might be other issues which are discovered in those trials. Also, the drug or medical device might be available to participants during the trial, but when its done, your access to those treatments also disappears.

    My main concern is that people don’t enter clinical trials with rose colored glasses on. There may be benefits, but there’s no guarantee of that. Know why a trial is being conducted and make sure you know what your rights are as a trial participant.

    • theperfectd

      ::points to Scott, stands up, and applauds loudly, inserting a wolf whistle::
      All you’ve said is spot on. Part of the discussion at DIA was about the need to understand the mindset of the patient and to not set them up with false expectations.

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