Reacting to #ResearchKit

OpenClinica_AppleRK Apple, Inc. has a remarkable ability to capture the world’s attention when announcing “the next big thing.” They have honed their well-known Reality Distortion Field skills for over 30 years. As the largest company in the world, and bellwether of the technology industry, Apple’s announcements are immediately recounted, opined, lionized, and criticized all across the Internet—sometimes with very limited real information on the new product itself. Of course, it helps to have their unmatched track record in actually delivering the next big thing.

ResearchKit has grabbed such attention. Maybe not as much as The Watch, but amongst the minority of us who pay attention to such things. And the reactions have been typically polarized—it’s either an “ethics quagmire” or “Apple fixing the world.”

But reality rarely presents an either-or proposition. I’ve written before on the need to use technology in simple, scalable ways to engage more participants in research and capture more data. Every form of engaging with patients and conducting research is fraught with potential for bias, bad data, and ethical dilemmas. Properly controlling these factors is difficult, and the current handling of these factors lead many to conclude that clinical research is overly “bloated and highly controlled”. There’s truth to that, but the fundamental need for good controls is real. As technology enables us to engage in new ways, how we implement such controls is likely to transform, perhaps unrecognizably so.

I don’t think Apple—or anybody—has these problems fully solved yet. And I expect we’re going to a see a vigorous debate in coming years between #bigdata and #cleandata that I hope will lead us to more of both. But ResearchKit, or at least the announcement thereof, is a game changer. Whether or not ResearchKit in its present form becomes a widely adopted platform, the impact was felt overnight: “11,000 iPhone owners signed up for a heart health study using Apple’s newly-announced ResearchKit in the first 24 hours… To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country”. ResearchKit builds on momentum towards patient-centricity established in the last five years within pharma, NIH, online patient communities, mHealth, and health care, and uses Apple’s consumer clout to bring it to the attention of the average person on the street.

So let’s break down what we know about ResearchKit. Since this is a blog about OpenClinica, we’ll also share early thoughts on how we see OpenClinica, ResearchKit, and OpenClinica Participate fitting together.

It’s Open Source. Great move! We’ll learn more about what this means when the code is released next month.

The technical paper indicates it is a front-end software framework for research, and that they expect it to expand over time as modules are contributed by researchers. Through use of both platforms’ APIs, OpenClinica could serve as a powerful backend and ‘brain’ to ResearchKit.

It’s not clear if data goes through Apple’s servers on its way to a final destination. I also haven’t seen anything from Apple mentioning if it will be portable to other non-iOS platforms (which represent 80% of mobile device market share), though its open source nature would suggest that will be possible.

Surveys. Analogous in many ways to the forms module in OpenClinica Participate, it is a pre-built user interface for question and answer surveys. As somebody who’s worked in this realm for years, I know that this can mean a lot of things. What specific features are supported, how flexible is it, how easy is the build process? Perhaps most important, can it be ported to other mobile app platforms, or to the web?

Informed Consent. The need for fundamental ethical controls for for research conduct and data use are just as important in the virtual world as they are in the brick-and-mortar realm, and Informed Consent is a cornerstone. I’m glad to see ResearchKit taking this on; I don’t expect they have it 100% figured out, but their work with Sage Bionetworks, who has released an open toolkit on Participant Centered Consent, is a great sign.

Active Tasks. Maybe the most exciting component, here’s where ResearchKit takes advantage of the powerful sensors and hardware in the device and provides a way to build interactive tests and activities. In this way, I expect ResearchKit will be a great complementary/alternative frontend to OpenClinica Participate when specialized tests tied to specific, highly-calibrated devices are required.

In general, the promise is big: that technology will lower barriers in a way that leads to fundamental advances in our understanding of human health and breakthrough treatments. That we’ll go from data collected once every three months to once every second, and we’ll encounter–and solve–problems of selection bias, identity management, privacy, and more along the way. And that, according to John Wilbanks at Sage, “there’s coming a day when you’re not going to have an excuse to have a tiny cohort just because you chose not the use digital technologies to engage people.”

Let’s get social about code!

The move to Github is a powerful one, and one that we know will foster a strong, active community.

github2When we started building OpenClinica more than eight years ago we wanted to build a community around it and one has really emerged. I’ve personally been able to interact with hundreds of users over the years and I’ve learned a lot from them. People have been pushing the boundaries; starting their own user groups (all over the world!) and building cool tools and add-ons for OpenClinica. The only downside is that I don’t think there has been enough visibility into what other people have been building – but why? Perhaps the right tools for sharing weren’t in place.

Github lets you fork, pull request and merge! Not only that, but you’ll get credit on your Github profile for pull requests that get merged. It’s like the social networking of code contributing. We really want to lower the barriers to solid contributions. In the past two months we’ve gotten five pull requests and two are in the process of being merged and will be in the next release (3.4). Of course, we’re really excited about this and look forward to more contributions. We really want this process to be simple, transparent and fun. Let us know what you think!

You can find us on Github here:

And for more info on our road map, you can check here:



New: OpenClinica Extensions Site


ExtensionsA number of people in the OpenClinica community have extended the OpenClinica platform in many useful ways—adding new features, building translations, CRFs, and other productivity enhancing tools. Sharing these extensions with others in the community can help make them the best they can be, by giving them greater adoption, generating useful feedback, and attracting additional collaborators.

In an attempt to make it easier to develop, share, and use these works, we have created the OpenClinica Extensions Site—a central place for people to make their project visible to others, while facilitating adoption and collaboration. The Extensions Site currently lists a number OpenClinica Extensions and we look forward to more new projects as they are added.

– Krikor Krumlian

Synchronizing OpenClinica Instances: Another Option for Using OpenClinica in Disconnected Settings

While tablet software maker Mi-Co is showcasing an integration of their Mi-Forms tablet-based forms software with OpenClinica that can be used in “offline” settings, elsewhere within the OpenClinica community, Raymond Omollo and Michael Ochieng have developed a separate option for using OpenClinica in settings without internet connectivity. Their method synchronizes multiple locally deployed instances of OpenClinica with a central OpenClinica database. Michael and Raymond recently presented their work at the OC13 conference. You can access their presentation slides here to see how they address key issues such as synchronization, back-ups, encryption, and user training.

Synchronization Flow Chart
Synchronization Flow Chart

While working for Drugs for Neglected Diseases initiative (DNDi), Michael and Raymond devised this approach for a WHO study of Buruli ulcers in West Africa (Ghana and Benin). The study, which is ongoing as of the date of this post, is a randomized controlled trial comparing the efficacy of 8 weeks treatment with clarithromycin and rifampicin versus streptomycin and rifampicin. It involves 430 subjects across 5 sites. The participating sites have limited or unstable internet connectivity, so a solution is needed that provided timely, auditable, and quality data entry given this constraint. A positive byproduct is enhancing the capacity of these disconnected sites to utilize EDC.

As they say, necessity is the mother of invention. And open source makes it easier for people to believe that what is necessary can in fact be accomplished. Kudos to Raymond and Michael for devising a solution that works for them. Perhaps it may work for others as well.  If you’d like to access the source code and documentation for their work, you can download these from the OpenClinica Tools and Tips page (scroll to bottom).  You can reach Raymond and Michael on the OpenClinica Developers mailing list:

– Ben Bauman

More About DNDi

Headquarted in Geneva, DNDi is a global organization that develops safe, effective, and affordable treatments for neglected diseases. The neglected diseases that DNDi tackles afflict many of the world’s poorest people (Malaria, Leishmaniasis, Chagas disease, Sleeping Sickness, Paediatric HIV, Filaria). DNDi’s goal to develop 11 to 13 new treatments by 2018. More at

Webinar: Tablet-based Offline EDC for OpenClinica – July 24

Offline Data Capture for OpenClinica – Demo of Mi-Forms Tablet Integration with OpenClinica

Date: July 24, 2013
Time: 2:00PM – 3:00PM EST

Attend this webinar to see, first hand, the use of tablets in offline, disconnected settings to capture and verify CRF data, and transmit them back into OpenClinica. See how the Mi-Forms/OpenClinica integration allows for easy design, deployment and verification of data at the point of capture.

RegisterButtonAt this webinar you’ll discover how to:

  • Enable multi-site offline data capture
  • Reduce query rates & speed trial completion
  • Cut clinical trial costs with mobile data capture

Ben Baumann, OpenClinica COO
Chris DiPierro, Mi-Co Director of Software Development
Gautham Pandiyan, Mi-Co VP of Sales & Marketing