Reboot: Clinical trials protocols for patient understanding 13

In the world of presenting and understanding information, there is no doubt that smartphones and the iPad have given us a fresh take on how information can be presented to the user. It’s under this notion that a challenge was recently run to help re-design and re-imagine the Electronic Medical Record (EMR).

For those who have never seen an EMR file, they are filled with text and are heavy in data but lack any sort of design to make them usable to a wide audience. See Exhibit A below.  Edward Tufte would be appalled.

Sample EMR

The Health Design Challenge, run in cooperation with the US Department of Health and Human Services, prompted over 230 submissions to modernize the Electronic Medical Record. The winning submission is called Nightingale and was designed by Gravity Tank.  According to those behind the submission, the web and mobile app make EMRs:

  • understandable
  • dynamic
  • personalized
  • and holistic

The presentation is much clearer and actionable, for both the physician and the patient.  Patients, or their caregivers, can track their health progress and have a much better understanding and ownership of their health data.

To visualize how Nightingdale helps make EMR information be useful and meaningful to a wider audience, click the screenshot below for a full PDF overview of their approach and design.

Nightdale screenshot

Applying these learnings to clinical trials

Just as EMR information presentation has much room for improvement, so do clinical trial protocols.  Taking the learnings from the Health Data Challenge and applying them to clinical trials, what can we learn?

According to Wikipedia:

In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions.

The protocol document answers many questions for potential trial participants including:

  • Objective(s) of the trial
  • Risk/Benefits of participation in the trial
  • Who can participate in the trial (inclusion and exclusion criteria)
  • What the screening process looks like
  • Study duration and participant interaction (schedule of events)
  • How data will be collected and what it will be used for
  • How outcomes will be measured and analyzed (statistic analysis plan)

The protocol is the heart of clinical research – it defines the what and the how of the study.  But it is lengthy (often 50-80 pages), full of dense text, and rife with scientific terminology and subject matter that can be disconnecting to the patient. For a picture of the length and complexity of a protocol document, see this sample template.  Here is an actual protocol available through PLOS.

The protocol represents the controlled scientific method for the clinical trial.  This is important and critical.  However, it (nor it’s companion Informed Consent Document) doesn’t do a good job of conveying the study in a patient-friendly form.  If we evaluate it from a patient user-friendly lens, there are many ways to make the protocol document can be re-imagined. Much like Nightingale and others are doing for EMRs, we believe if protocol representation were re-built from a participant (patient) point-of-view, we could all benefit.

How protocols might be re-invented

Let’s start with taking off our scientific hats and listening to questions patients have about clinical trials.  There are many that come to mind, some of which we’ve heard through our guest bloggers:

  • What are the risks and benefits of my participation?
  • How will my doctor play into the study?
  • What/when do you need me to do if I participate?
  • Does this study have placebos or parts of its design that won’t lead to my improved health?   Then why would I participate?
  • How do logistics and reimbursement for my costs happen?
  • Many more…

Reinventing the study design representation would greatly improve understanding and answers the key questions of patients.  For example, imagine a ‘study timeline map’ that would lay out the patient journey on the study: screening procedures, patient visits with interventions and procedures,  follow-up care and results sharing, etc…

By visualizing the clinical trial protocol in a mobile and web-friendly manner, we also enable the use of related data sources. For example –  the logisitcs of traveling to the site.  It is easy to imagine the use of a map mashup that would allow the patient to see – both before and during the study – what logistics options are available to them, from directions to public transit to hotel accommodations.

We’ve already explored ideas that could make trials more engaging and rebooting the clinical trial protocol design document for patients would be a great start.  We’ll be exploring with some sample web and eventually mobile apps over the months ahead.  We welcome your ideas and feedback on our prototypes (watch for release soon).  We even hope to challenge the external community, much like the Health Design Challenge, to innovate on study representation for patients.

So, with a patient in mind, how would you visualize a clinical trial protocol?

13 comments

  1. You are spot on! Why is it in a company of >35,000 employees so few have themselves or a family memember, participated in a clinical trial. We need to design studies and their associated protocols with people / patients at the center. Would I want to participate in this trial? Why not? What information to I want to know about the procedures and investigational product? Why can’t I have all of the information, reminders of things I would need to do, and someone to answer questions available on my computer or iPhone. . .like my financies, insurance, or travel.

    Developing new medicines to meet unmet medical needs is a very difficult business, it is one we have chosen. . we need to do a much better job of including the people we are seeking to help.

    jeff

  2. This blog post and Jeff K’s response is spot on. Thank you. It give me food for thought as I prepare my written comments to submit to the FDA’s ALS specific hearing on February 25th.

    I appreciate you all getting into the world of unmet medical needs. ALS would be happy to have one medication to treat the disease, so we really appreciate the open and innovating way you are approaching ways to find medications.

    The key really needs to be having the patient involved in every step of the process…they can provide insights that will change the world of clinical trials!!! Thank you.

  3. Thanks for comments. We are serious about better connecting our trial designs to patients and listening to their perspectives. 2013 should be a watershed year for our efforts. Jenny, I’m glad this provided food for thought. Best of luck in your FDA discussion.

  4. I love that we as a company are backing up our words with action to make the patient our focus, especially when creating protocols and informed consent documents.
    Not only would I enjoy having an app with a timeline of my visits and associated logistical help, like maps and nearby hotels, but I would also want to know about the tests I’d be taking at each visit. For example, something along the lines of: ‘Tomorrow you will have your blood drawn for something called PK/PD, which stands for “pharmacokinetics and pharmacodynamics.” This means that your blood will be analyzed to help determine how the drug behaves in your body. It will show how long the drug stays in your body, how your body uses it and other information to help figure out the best timing and dose for this drug.’
    Learning not only what will be done but why helps make a richer experience and really allows a person to understand how his or her efforts are contributing.

  5. Thanks, Maria. Great idea on bridging not just the what will happen but the why. Feel free to reach out to me or the team if you have more ideas. We’ll also soon be starting a feedback forum to collect and dialog on ideas. Stay tuned.

  6. Thanks for this informative article and move towards patients our willing participants in clinical trials! Having gone through cancer treatments with both of my parents and being from a large family of five, I think it would be wonderful for families to possibly have access as well (permisson granted of course per HIPPA laws) as communicating to each other about appointments and scheduling was extremely difficult during a very stressful time in our lives.

  7. It’s wonderful to feel like we’re getting some traction in this space…finally! I believe it all comes back to the age old analogy of “What’s in it for me?” or in our case “What’s in it for the patient?” I challenge myself everyday using this analogy. If we walk through a day/week/month in the patients shoes, then compare how that day/week/month would look if on a clinical trial we would see how different life on a trial can be. Do we ever truly take the time when planning and designing trials to do this properly? And remember different doesn’t necessary mean bad, different can be good in many ways. The key is to be honest with ourselves and proactively develop strategies that address major points of difference in our best attempt to make different as good as it can possibly be for the patient. And please please please don’t forget that walking in the shoes of a patient in the USA often takes a completely different path to a patient in Japan, China, or India. Let’s challenge ourselves to think globally when coming up with solutions!

    • Jade, VERY well said. The % of patients participating in clinical trials continues to decline. We need to ask THEM why . . . . LISTEN . . .seek their INPUT. . . .and INCORPORATE it. In many ways people are people. . .but we are not all the same.

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