Systems and Regulatory Issues

Even more exciting than the Apple Watch: ResearchKit

Last Updated: Jun 9, 2015
Linda Parreco's Image

Embedded in the splashy debut of the Apple Watch, was something that the clinical trials world will find pretty interesting. Apple introduced a new open source tool called ResearchKit. Along with academic partners, Apple developed and launched 5 clinical trial apps built with the ResearchKit tool. One of the apps introduced in the rollout is called "Share the Journey: Mind, Body and Wellnes after Breast Cancer." Developed at Dana-Farber, the app tracks the recovery path of breast cancer survivors. Instead of collecting data with paper surveys, study participants respond in real time to questions about changes in their daily mood, fatigue levels, and signs of cognitive difficulties. Another app, GlucoSuccess, allows diabetics to participate in a research study that gives feedback on how their diet and exercise patterns impact their daily glucose readings. I got all quivery with excitement, downloaded the 'MyHeart Counts' app, watched the embedded video (nicely done), clicked through the eligibility critieria, walked through the consent (a plain language beauty!), opted to share my data with only Stanford researchers, and agreed to participate. I received the complete consent form via email. I know how to contact the IRB or and I know how to leave the study. A lot of self-control was required to slow down and read all of the information. A big change from my normal behavior of rapidly clicking and downloading new apps. My participation will give me a prediction of my risk for future heart attack and stroke. And with my user reported data, they will never know if I reported my age and weight correctly.

On the one hand, there is a lot of excitement in the lay press about the opportunity to reach vast numbers of potential trial participants and potentially crack the slow-accrual problem. The Apple roll out video cites the example of sending out 60,000 letters to recruit 300 study participants.  On the other hand, there are a number of issues that give us pause. All of the questions that you might expect are appearing in media posts about ResearchKit-- about issues like confidentiality, de-identification of data, data security, identify verification, and the process for obtaining informed consent. 

I've been on the MyHeart Counts study for 3 days and here's the deal. I have a couple of small questions. No big deal, but there doesn't seem to be a way to get them answered. Short of calling the phone number for the Stanford IRB. As excited as I was to dive in to the latest cool thing, I must say that I do miss the interaction that meeting with study personnel would provide. Or maybe a virtual community for study participants. I bet one of them could answer my question. We'll see how it goes.

In the meantime, the Parkinson's app enrolled 7406 people in 6 hours. Wow!

What do you think about this new approach? Will you give it a try? 

Marge Good's Image

Linda,

A great blog!  I must say I am on the fence about this.  I too would appreciate the in-person, "hands on" discussion that is so important in cancer clinical trials.  It will be quite interesting to see how this evolves over time and for what research focuses. The Parkinson's app enrollment is phenomenal and speaks to the interest in the disease as well as the technology that can bind people together! 

Keep us in the loop!

Marge Good

Linda Parreco's Image

I just read today that the MyHeart Counts study registered 10,000 participants in the first day!

GraceMishkin's Image

Such an interesting launch for the research and tech worlds!  

I'm curious if many other people slowed down to read the informed consent, or if they assumed the content was relatively ignorable like so many online agreements.  Hopefully, we'll be able to see information about how long users spent on the  form.  With online surveys, it may be common for a participant to "read" the informed consent for just 2 seconds before clicking.  Will that be acceptable for this type of longer-term study, or will additional steps be required? 

Another concern is the representativeness of participants.  According to a 2013 Pew survey, even within the select pool of smartphone users, iPhone owners are less likely than Android owners to be Black, have a high school education or less, or have an annual income of less than $30,000/year (http://www.pewinternet.org/2013/06/05/smartphone-ownership-2013/).  

That said, I think this is an important step forward, and I can't wait to hear more!

Grace

tracycermak's Image

The relatively new use of this type of technology in the clinical trials field is very exciting. Like you, I immediately made my way to the available apps and downloaded the My Heart Counts study. In less than a minute I was able to breeze through the consent and get started. How exciting! Or is it?

What I went through to participate in this study was not infomed consent. There is definitely a record of my consent somewhere, but even I have no idea what I consented to. This is similar to how I download and accept terms to all of the apps that I have on my phone. I simply go through the motions and assume that I'll be fine.

I'm concerned about a slippery slope. Sure, this study is minimal risk and our data is probably fine, but what if it's not? What if the results of this study (or any other study on our phone) make their way to our health or life insurance companies?

My suggestion is to definitely continue to utilize this type of technology. As a participant in a seven year clinical trial where I must complete my handwritten diary every day, I have practically begged the study team to come up with an app or a system that would allow me to submit my daily progress via my phone. Of course, this would all be done after I sat with a knowledgable member of the study team and went through informed consent.

To speak to your point about having a question and not knowing how to find answers: Consent is not a one time deal in research, it is an ongoing process. In the case of these apps, they are lacking a mechanism to capture the spirit of informed consent.

Finally, with all that being said, I will continue to download any new pertinent app that comes out. I want to support researchers and innovative technology. I will, however, be dropping out of the My Heart Counts study because my fitbit broke months ago and my iPhone is too big to carry around with me at all times.

Thanks for writing this article, Linda. I look forward to observing how this new technology impacts our field from both the researcher and participant standpoint.

GraceMishkin's Image

Tracy, I love your point about how these apps lack a mechanism for an ongoing consent discussion.  It seems like there are opportunities for relatively quick fixes -- an online forum that is pushed out to participants, regular check-in questions that re-confirm consent -- but also a lot of uncertainty.  What should an ongoing electronic consent process look like?  I'm not sure we know...

LMByrne's Image

Linda, Grace and Tracy, you all make excellent points. Most likely a small fraction of the total number consented read the consent document. There is no substitute for direct interaction with study personnel, however, isnt it wonderful to see new technology used to promote research endevours! Inviting people to participate, is essential! Thank you for sharing these apps. 

 

Linda Parreco's Image

LMBYRNE--thanks for your post. No doubt, your comments echo the sentiments of many! Balancing our value for personal interaction with the opportunities offered by new technology.

I read something just today on this topic that was really helpful. This post by Jim Gearhart, "eConsent Mashup: FDA Guidance vs ResearchKit"  compared the consent process used in the MyHeart Counts app to the new FDA draft guidance document, "Use of Electronic Informed Consent in Clinical Investigations." Acknowledging the areas of challenge (identify verification, HIPAA requirements, and electronic signatures), Gearhart concludes, that "it looks like ResearchKit could make implementing electronic informed consents much easier than it has been before." 

Linda

rgossen's Image

Great discussion, everyone! I agree that while ResearchKit is exciting, it is not without challenges. I'm doing a series of fairly detailed guest posts about ResearchKit over at Lilly's Clinical Open Innovation (LCOI) blog. The first part of the series is available here:

http://portal.lillycoi.com/2015/06/03/apple-researchkit-part-1-introduct...

I look forward to hearing your take on ResearchKit as details continue to emerge. Thanks for sharing your thoughts.

 

 

Ellen Richmond's Image

Hi Rahlyn - Thanks for sharing the link to you guest post.  I agree with you that  ResearchKit is likely to have a great big impact on awareness and that it addresses the pace of the slow progress that clinical trials typically follow.  Here are some other random thoughts/questions.  Do you know how well the apps are working for the studies that are using them, in terms of numbers of participants accrued or almost as importantly numbers of interested individuals? Also, do you know if ResearchKit is  really accessible to non-Apple smartphone users?  The skewed population that pure Apple users would involve would be a serious challenge.  Regarding the issue of face-to-face, in person interactions between HCP and participants, I would imagine that a hybrid approach (i.e., e-contact combined with in person contact) is probably the way that this works, right?  That would certainly be necessary for drug trials, wouldn't it? 

Ellen

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