Network with OpenClinica at Mobile in Clinical Trials and DPharm

Busy Q4 2016 events program getting underway

This fall sees a busy events calendar for OpenClinica. In the run up to OC16 which starts on 3 October, OpenClinica is participating in some important events for the CRO community from September 19 – 21. Some may have registered already, but if you haven’t quite decided yet, these events are truly noteworthy.

They are essential for keeping you up-to-date and in the loop on the increasingly pivotal role of digital and cloud-based technology on clinical trials and the general advancement of life sciences.

These events are being held back-to-back in the same location, so if you’re attending one, then it’s worth getting more out of your time in Boston by making time to be at both.

The Conference Forum’s 3rd Annual Mobile in Clinical Trials

September 19, 2016 – The Fairmont Copley Plaza, Boston, MA

The program is led by Daniel Karlin, MD, Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer, Inc. The 2016 program is packed with the latest thinking, insight and updates into what’s real and proven in the application of mobile technology to advance clinical research.

Ben Baumann, OpenClinica COO is featured in panel discussion with other experts in various aspects of mobile in clinical trials, including wearables, IoT, BYOD, endpoints, validation and barriers, and research on messaging to engage patients. Moderated by Daniel Karlin, this session starts at 8.45AM: How are we Using Mobile in Clinical Trials Today? What are the Current Barriers?

6th annual DPharm: Disruptive Innovations to Advance Clinical Trials

September 20 – 21, 2016 – The Fairmont Copley Plaza, Boston, MA

The organizers are dedicated to presenting the annual event that the life science industry can rely on for the latest thinking in clinical trials for 21st century drug development.

Originally conceived as an industry forum on thinking radically differently about the way clinical trials are performed, the conference brings together disruptive thinkers and change makers eager to discuss current solutions in clinical development, propose innovative changes, and commit to testing and sharing the results in order to transform drug development and the industry.

Ben Baumann will be in attendance at DPharm.

Meet OpenClinica at Mobile in Clinical Trials and DPharm

We invite anyone planning to attend either event to track down Ben and introduce themselves, network with him and have a one-to-one informal chat. It’s good to talk… Hope to see you there!

Look who’s talking at OC16

The OC16 conference will shortly get underway in Boston on Monday, October 3rd 2016 at the Harvard Medical School. The line-up across the two-day program is made up of noteworthy experts and practitioners in the field of EDC, who will be sharing their knowledge and experience with the OpenClinica community. Here are just a few of the great speakers who will be taking part:

Morgan Hess-Holtz

Based at the Gorgas Memorial Institute for Health Studies, Panama, Morgan Hess-Holtz will be leading an informative breakout session discussing the use of OpenClinica in a prospective, multi-center cohort study in Latin America, on Monday 3rd October at 10:00 – 11:00am.

Lindsay Stevens

Lindsay Stevens will be leading two sessions at OC16, a Community Datamart breakout on Monday 3rd October, 11:00 – 11:55am, and a look at Tablet Data Collection with ODK Collect at 4:15 – 5:10pm.

Lindsay holds a Bachelor of Science from Macquarie University and joined the Kirby Institute, University of New South Wales, Australia in 2013. He provides data systems development and support to the VHCRP, with extensive experience of programming languages and EDC platforms. Systems developed include OpenClinica studies, OpenClinica reporting systems, and offline ODK collect surveys.

Patrick Murphy

Patrick Murphy holds a BS in Chemical Engineering from Northwestern University, and is Senior Director of Data Management at RTI-HS. He has personally led the 21 CFR Part 11 validation of many clinical database systems, including Clintrial and OpenClinica, and has provided on-site data management support to observational studies and clinical trials globally.

Patrick will be discussing Lessons Learned: Naming Conventions, Rules, and Data Cleaning in Grids on Monday 3rd October from 2:00 – 2:55pm.

Jacob Rousseau

Jacob Rousseau, Senior Clinical Developer at the Netherlands Cancer Institute is an OpenClinica developer/administrator, and contributes to the maintenance of the openclinica.nl website. Jacob will be revealing the secrets behind Streamling OpenClinica Data Uploads on Monday 3rd October, 3:15 – 4:10pm

Brittany Couture

Brittany Couture is a Research Assistant at Brigham and Women’s Hospital in the US presenting to us on Monday 3rd October, 3:15 – 4:10pm. The topic of her session is MySafeCare and the use of OpenClinica and other open source software to provide hospitalized patients and their families with a quick, electronic, and real time way to submit safety concerns to appropriate hospital staff.

Ready to register?

Click here to visitRegister-Button the OC16 Conference Page to see the full program and reserve your space now.

OC16 Program Announced!

There is not long to go now until OC16 kicks off at the Harvard Medical School New Research Building in Boston on Monday, October 3. We’re very pleased to be able to announce our full program and speakers.

At OC16 we’ll be hearing from more than 17 speakers from across the world, and you’ll have some not-to-be-missed opportunities. These include:

  • Meeting and networking with your peers in the community
  • Participating in discussions about the future of clinical data
  • Discovering innovation and finding out what’s next for OpenClinica

Day 1 highlights

The event will kick off on day one with an opening plenary from OpenClinica co-founder Cal Collins, followed by a panel discussion from our new Advisory Group. This session will be a great opportunity to hear about OpenClinica’s development and its influence on the future of clinical data.

After this, 12 sessions will run over the course of the day, split into two streams giving you a wide variety of topics to choose from. We’ll finish in the evening with a cocktail reception at The Isabella Stewart Gardner Museum, also known as Fenway Court. The evening event will showcase various technology demonstrations as you unwind with the rest of the community.

Day 2 highlights

Day two lets you get hands-on and feature a series of workshops led by fellow users, giving you a chance to develop best practice, expand your knowledge and learn from your peers. There will be morning and afternoon workshops offered.

Super User Training

If you’re in Boston for OC16 get more out of your time here! In conjunction with our annual conference, we will be offering our user training following the event, October 5th-7th. In this course you will learn how to use OpenClinica from the perspectives of all user roles, both site-level and study level. OpenClinica Super User training is great for people responsible for building studies, and training/supporting other users. To register, visit our Super User Training page.

Ready to register?

Click here to visitRegister-Button the OC16 Conference Page to see the full program and reserve your space now.

 

OC16: Call for Abstracts!

OC16 is coming to you this fall at the Harvard Medical School New Research Building–save the date!

Monday, Oct 3rd: Sessions & Demos
Tuesday, Oct 4th: Workshops
Wed-Fri, Oct 5th -7th: Optional OpenClinica Super User Training

The 2016 OpenClinica Global Conference is a unique opportunity to meet with and learn from OpenClinica users around the globe while discussing OpenClinica’s impact on the future of clinical data. Join us for a high-impact event in the heart of Boston’s medical research area to collaborate, integrate, and participate at all levels with the OpenClinica community.

The two-day conference will showcase new developments with OpenClinica’s architecture, preset case studies, illustrate exciting new modules, and much more.

Are there integration, strategies, or techniques you’d like to share? Connect with the community and illustrate your work at OC16!

Submission deadline is July 15, get your abstract in now! For more, visit OC16 conference page.

SocialMedia-OC16-FB

Disintermediation

“An approximate answer to the right problem is worth a good deal more than an exact answer to an approximate problem.” – John Tukey

Biopharma, governments, and the healthcare industry as a whole are grappling with what really provides healthcare value, and how to evaluate and measure it. Though not a new problem, it’s one that is now front-and-center as established models for healthcare research and evaluation are proving too slow, costly, and restrictive for today’s needs.

At the same time, easy-to-use mobile computing is everywhere in our day-to-day lives, providing the pipeline to ever more comprehensive and accessible data about our world.

How are these two things related? The relative lack of mobile technology in health research illuminates the limitations of research designs and data gathering methods from the 1970s that are still relied on today.

In field after field for the past 30 years, Internet technology has shown it can radically democratize and commoditize information, through automation and scaling with low-to-zero marginal costs. There’s a fancy term for this: disintermediation. Many in the healthcare and clinical research fields are looking toward general-purpose consumer mobile technology to disintermediate themselves from the data they seek. Direct engagement with patients using a mobile-centric, real-time approach is a big part of the way forward. This disintermediation aims for greater efficiency and improved accuracy in research. In some cases, entirely new ways of looking at problems may result from the ability to passively collect continuous data streams – the Parkinson’s mPower study is a great early example.

There’s no question population health and observational research are being transformed by the ability to use mobile technology on a wide scale: A flood of low cost wireless sensors coming to market opens possibilities for ubiquitous, passive data collection. We have an unprecedented ability to engage and capture near-real time, in some cases, continuous data at a very low burden to the participant. Online communities are empowering patients by bringing together people who share a common disease burden and providing them with the chance to interact, share knowledge, and compare experiences like never before. This often includes raising the visibility of research participation opportunities. 

The needs of interventional research are changing too. An increased emphasis by payers and providers on effectiveness requires understanding how patients and therapies work in the real world. With the ubiquity of smartphones, we can collect patient-reported measures in a far more meaningful and timely way than with paper diaries or dedicated hand-held devices, allowing us to develop the evidence needed for a value-based market. Even in pivotal randomized registration trials, we can introduce changes to help better engage and retain patients, shorten timelines with adaptive designs that rely on real-time data, and do so in a way that improves these studies’ ability to demonstrate safety and efficacy.

We’re still in the early days of this patient-centric era. Most mHealth and virtual trial systems are bespoke platforms with purpose-built apps. These custom built solutions can be coded exactly to the needs of a given project. But building custom solutions sacrifices reusability and inhibits the ability to start the next project fast with out-of-the box, proven technology.

At OpenClinica, we are working to achieve both. We aim to combine the rigor and exactness of RCTs with a big data/population based approach that yields richer answers about how the real world works. The best way to do that is with a platform that creates a unified experience based on reusable, but customizable components. Our nearly 10 years of work in electronic data capture has taught us a lot about how to ensure data integrity and enable our customers to implement research protocols without writing code. At the same time, we’ve built a user experience for study participants that from the ground up is designed around simplicity, mobile-friendliness, and, ease-of-use. We’ve focused on components that solve problems in a generalizable way and just work, while also providing the means to tailor the user experience and features to meet the unique needs of each study.

Every day is an exciting challenge as we and our customers learn more about the patients we both serve.  Just a few months after the launch of OpenClinica Participate, we have started, or will soon begin, connecting patients in a daily diary study on nutrition, a behavioral health risk screening study, a hospital safety outcomes project, a long-term maternal & child health cohort, and two surgical device studies, including one involving photos captured directly from mobile devices. We’re rapidly making refinements to their user experience and adding features that help improve the speed, convenience, and quality of the research. With these new approaches comes changes at every level: research design; privacy, ethics, and consent; data validity; regulatory compliance; and analytical models. But the potential payoff is great – we now have new abilities to ask big, important research questions that have been impossible to answer in the past.

 

Reducing friction in patient engagement: an (unconventional) case study

Participate_SCDM_SurveyOur quest for frictionless, electronic patient reported outcomes (ePRO) data capture has us looking for novel ways to engage patients and streamline process. I’d like to share a fun and interesting example of this work, in which we used Participate (the OpenClinica ePRO solution) to engage study subjects at the recent SCDM annual conference.

Our goal at the SCDM conference was to get as many attendees to try OpenClinica Participate as possible. With the vast array of vendors, eye candy, and giveaways, it’s a big challenge to cut through the noise and offer a simple, fun way to engage an audience. The same holds true when engaging patients. With the enormous number of daily distractions, ensuring that your patients can quickly access, fill out and submit well-constructed, simple forms is key to compliance and ultimately, better data.

I built the form, shown here, in OpenClinica and enabled access to it via a custom URL, a new feature in our latest release.

Attendees filled out the form, sprinkled with fun health habit questions, then captured information to allow us to draw their names to win Fitbits and other giveaways. We were able to use this data and update our graphs to give the participant a view of how they stacked up with their peers—cool!

Imagine if patients could view a visual representation of the study they are enrolled in – see the parallels and possibilities?

Graphs_SCDM

Who says ePRO and patient engagement can’t be fun?

HTML Tips to Enhance Your eCRF

In some cases, the display of your OpenClinica eCRF may not be exactly what you had in mind. You may want to highlight key words or phrases, create a bullet point list, or insert a URL or image. Using HTML tags, you can make some simple manipulations to change the look and feel of your case report forms and make them more inviting for data entry.

Using HTML tags to enhance your eCRF

The HTML tags described in this document can be used in the following columns in the CRF Excel template:

  • Items Tab: LEFT_ITEM_TEXT
  • Items Tab: RIGHT_ITEM_TEXT
  • Items Tab: HEADER
  • Items Tab: SUBHEADER
  • Sections Tab: INSTRUCTIONS

What are HTML tags?

HTML, or Hyper Text Markup Language, is a markup language that is commonly used for web page development. HTML is written using “tags” that surround text or elements. These tags typically come in pairs, with a start tag and an end tag:

<start tag>Text to format</end tag>

To insert an HTML tag, simply surround the text you want to format with the desired tag. Below are the HTML tags that work in OpenClinica:

Table

You can download this HTML Tags Knowledge Article to help you to get started.

Inserting URLs and Images

HTML also allows you to insert a URL or Image into your CRF, which may be used to provide users with additional information or references.

Insert a URL

A URL may be inserted into a CRF in order to provide a link to further instructions or protocol information. To insert a URL into your CRF, use the following format:

Inserting images - using HTML tags to optimize your eCRF

Simply replace the areas highlighted in yellow with (a) your URL (inside the quotation marks) and (b) the hyperlinked text that you want to display to the user.

The following example will prompt the user to “Click Here!” and will open the OpenClinica website in a new browser tab:

<a href=”https://www.openclinica.com” target=”_blank”>Click Here!</a>

Inserting an image - using HTML tags to optimize your eCRF

Insert an Image

Similarly, HTML can be used to insert an image into your CRF. You might consider using an image to display a pain scale (or other reference image), or even to display your company’s logo.

Inserting an image - using HTML tags in OpenClinica

To insert an image into your CRF, use the following format:

<img src=”images/ImageName”>

Again, simply replace the highlighted text with your image name. You can use PNG, JPG, or GIF image extensions. You can control the height and width of the image using the following format:

<img src=”images/ImageName” width=“n” height=“n”>

The highlighted n corresponds to the desired width and height of the image in pixels.

The following example will insert an image (image1.png) with a width of 300 and a height of 150:

<img src=”images/image1.png” width=”300″ height=”150″>

You can download this Images & URLs Example CRF to help you practice.

The examples included in the above CRF Excel template will insert an image that already exists in the images directory of your OpenClinica application. To insert a custom image, community users will need to place the image in the following directory of the OpenClinica application:

tomcatwebappsOpenClinicaimages

OpenClinica Enterprise customers can request an image be placed on the application server by reaching out to the OpenClinica Enterprise Support team via the Issue Tracker.

Have you used HTML in your CRFs? Let us know if you have any other suggestions or tips!


IMPORTANT NOTES:

 The RESPONSE_OPTIONS_TEXT field is not included in the list above, as HTML tags are currently not supported for response options.

 The QUESTION_NUMBER field will display the text properly, but has been known to cause issues when extracting data. Therefore, HTML should not be used in this column.

Calculating ROI for ePRO

I recently delivered a webinar titled “Getting Started with eCOA/ePRO,” in which roughly a third of attendees polled cited expense as the number one reason that has prevented them from adopting an ePRO solution. So what does ePRO really cost? Is it worth it? Here I strive to provide a basic, high-level framework for thinking about the return on investment ROI of eCOA vs. paper.

Let’s start by taking a look at the costs that are unique to each approach.

Paper

In a traditional paper based model, you are incurring costs that stem from printing, mailing, data entry, and data cleaning. These are all expenses than can be estimated with a fair degree of accuracy, with the cost of data entry being the most significant of these. To estimate the cost of data entry, see how long it takes to key in a subject completed paper casebook, multiply this by your cost of labor (don’t forget to include overhead!).

ePRO

The cost side for ePRO is similarly straightforward, but the expense elements are different. You’re either building an ePRO system (which will almost carry a highly unpredictable cost) of buying one (much more predictable cost). Assuming you’re buying, here are the costs you may expect to incur:

· License
· Hosting
· Training and support
· Professional services (e.g. study configuration)
· Devices

You should evaluate whether your study and selected ePRO system will allow for patients to use their own devices, or if you will need to provision devices (or some mix thereof). The cost of provisioning devices, especially for a global study can be significant—in addition to the costs of the devices themselves, you will need to consider the costs of data plans, and logistics associated with supporting the devices. I’m a big fan of BYOD (bring your own device) but, depending on the study, it may not be feasible to utilize while maintaining scientific validity of data collected.

Once you’ve mapped out your costs of each route, you can begin to weigh these against the benefits of going eCOA.

cropped-istock_000037068804.jpg

Paper vs. eCOA

When you boil it down, people employ ePRO/eCOA to maximize data quality, increase productivity, and/or enable new capabilities that help answer their research questions. ePRO is e-source, so you don’t have worry about administering a paper data entry process. Depending on the study, the cost savings from this alone might justify ePRO.

There are some additional benefits ePRO offers over paper that may be harder to quantify, but nonetheless  very real. For example, there are clear data quality benefits to ePRO. The electronic system can ensure a minimum standard of data quality through edit checks and enforced data structures. ePRO data will always be cleaner than the same data captured on paper.

Benefits and Motivations for eCOA

 

The use of an ePRO system also allows you to know for sure when the data were recorded. For instance, patients can be reminded automatically when their diaries are overdue, and you now only have much stronger assurances that data were collected at the appropriate time (vs paper), you can also more easily monitor the study progress.

Bypassing manual data entry and having the system provide notifications to subjects to ensure data are captured in a timely way might allow for faster and better in-study decision making and even may accelerate study closeout. Also, an increasing amount of evidence exists that mobile-based messaging and communication strategies help increase patient engagement and treatment adherence. And of course, not having to deal with a stack of paper during a site visit might allow the clinician’s interaction with the patient to be higher quality.

Quantifying the benefits of all of these things can be tough, but start with those which are most quantifiable and see if those items alone these alone provide a compelling ROI (from my experience they often do).  Then the less tangible benefits become gravy to the ROI argument.  When modeling costs over time and a pay-back period, keep in mind that ePRO will typically carry a higher upfront cost than paper, with the cost saving benefits realized downstream over time. With today’s technologies, even most smaller studies should be able to realize a positive payback.

Naturally, there may be additional ROI factors to consider which are specific to your situation. If you have particular thoughts, questions, or experiences on this topic I encourage you to add a comment to this post.

OC15 in Review

Two weeks ago, members of the OpenClinica community converged on the Lloyd Hotel in Amsterdam for the 2015 OpenClinica Global Conference. The event was highlighted by a keynote from John Wilbanks, who inspired us with a great talk on how mobile technology and open source can help break new ground in understanding disease. Smartphone-based engagement tools, used in real world settings, can enable greater participation in research, cut costs, and make new research designs and insights possible. It’s not just theoretical, as his company, Sage BioNetworks, is walking the walk by open-sourcing its e-consent toolkit and working with Apple on studies using ResearchKit.

Our community demonstrated it is also a powerful driver of innovation. Through innovative applications, by integrating with other powerful tools, or augmenting the OpenClinica core with custom built extensions, OpenClinica is playing a role in patient engagement, big data, and translational science. TraIT shared its work integrating OpenClinica into a Translational Molecular Medicine infrastructure (ppt), Aachen University presented its integration of medical imaging applications, and University of Cambridge’s RDCIT team unveiled its integration sophisticated pedigree and phenotyping capabilities to support clinical genomics research (pdf). We got to take deep dives into powerful GUIs for data import, client libraries for OC’s web services API, and data marts/reporting. That’s just a few. Many of these efforts are open source and are being shared freely–a phenomenon unique in the field of clinical research.

https://twitter.com/RRittberg/status/604983558562820096/photo/1

https://twitter.com/benbaumann/status/604925177584087040/photo/1

We have become a community that rapidly disseminates ideas and code while holding each other to rigorous standards of quality. We are building on a shared foundation of strong data provenance, audit trails, privacy protections, and GCP compliance. OC15 was a reminder of how openly and effectively our community collaborates, and how great we are at welcoming new participants. I left OC15 inspired and motivated by the participants’ passion and creativity.