For Better ePRO Data, Empower Your Participants

What does the term “source” bring to mind for you? Paper files? A clinic’s EMR? Fair enough. Those are the typical formats of source data in clinical trials. But when you think about it, those records are a few removes from the true source: the patient.

Granted, most trials depend on a host of instruments and analyzers. No patient can self-report their own hemoglobin levels. But there are measures, such as quality of life, whose source really is the patient’s own experience. And for an industry whose raison d’être is enhancing (and sometimes saving) lives, we have a hard time obtaining those measures.

That’s not to say that patient-reported outcomes are a rarity in clinical trials. In fact they’re common. But so are obstacles to collecting them. Even today, with several ePRO solutions on offer, too many trials rely on patients to complete paper diaries. But paper records are prone loss or damage. Also, it’s virtually impossible to tell whether a patient made daily diary entries as instructed, or retrospectively wrote responses just prior to a study visit, raising data quality concerns. (Here’s a great analysis of “parking lot syndrome”.)

“Mochaccino with a side of ePRO” has to become the new normal for trials

ePRO is a big improvement on paper, but it doesn’t integrate seamlessly into a patient’s day to day life. Nearly all trials today using an electronic system for PROs provision dedicated devices to patients for this purpose. Patients need to be trained on how to use this device, recall that training at the relevant time, and make a habit of keeping the device on their person to stay current with reporting tasks. These systems also require patients to remember passwords and other access credentials. A step as apparently simple as downloading an app can be fraught with challenges: the patient must remember their app store login, locate the download area, have sufficient memory on their phone to house and run the app, ensure the app installs successfully, and ensure it remains installed, running, and updated.

All of the above examples are potential points of failure that can compromise the quality of real world data and increase trial costs. These myriad tasks and responsibilities unrelated to the data itself can place a significant burden on a volunteer patient, particularly one who is very sick.

OpenClinica Participate eliminates potential points of failure by:

  • providing an system that can be used on the patient’s own device(s),
  • eliminating the need to patient’s to remember login credentials, and
  • removing the complexities associated with apps.

This helps place the patient at the center of the research. And perhaps best of all, OpenClinica Participate places the patient reported data into the master EDC database in real-time with zero additional effort.

The advantages of this approach aren’t just theoretical. OpenClinica and its partners have realized their benefits in more than 20 studies since the launch of OpenClinica Participate about a year and a half ago. In this post and future ones in this series, I’d like to share some short and informal case studies. I call this one:

On time, nearly every time

S-cubed, an innovative pharmaceutical consultancy and contract service company, based in the UK and Denmark, recently supported a study assessing a medication to protect against a virus associated with the common cold. In the study, subjects were asked to self-report symptoms at multiple time points per day over several days. On most days, self-reports were to be submitted in the morning, in the afternoon, and at night. To help drive compliance with this rigorous self-reporting schedule, study managers wished to engage their subjects and ensure the data capture method was convenient. To do so, they tapped into the ability of OpenClinica Participate to present clear, attractive eCRFs to subjects on their own mobile devices (smartphone, tablet, or laptop). S-cubed data managers established rules that fixed the date of all future study events based on the protocol events schedule and each subject’s date of enrollment. OpenClinica Participate automatically sent text messages and emails to each subject prior to a scheduled event (and at the end of the time window if the diary was not completed), directing them to the relevant data capture form.

The data collection process involved no offline component. Subjects always provided their reports on a connected device, without regard to the specificity of device or location, etc. Consequently, fine-grained metadata regarding the date and time of eCRF completion was available. This metadata provided compelling evidence that the experience afforded to patients by OpenClinica Participate drives widespread data entry and timelines.

Of the 92 subjects who completed at least one of the ePRO forms associated with the study, thus signaling intent to participate, 89 (97%) completed all forms required in the morning, afternoon and evening over multiple consecutive days, when timely reporting was most critical, Reasons for non-completion were sometimes outside of OpenClinica Participate’s control.

Of the all “3x daily” forms completed, the vast majority were completed in real-time, with approximately 93% being completed within 1- 2 hours of the scheduled timepoints.

97% form completion rate

93% on-time rate for “3x daily” forms

“Bring your own device” may not be the final frontier in ensuring patient convenience. Passive monitoring by nearly invisible devices is already a reality. But the principle will never change: let technology do the work, so people can live their lives.

 

My Resolution for 2017

The traditional month for making resolutions is over, but since the first day of the year, I’ve been hard at work on mine. I shared it with my team members early in January, and now I want to make it public.

My resolution for 2017 is to make life easier.

Not necessarily for me–though I’d take it–but for clients and collaborators of OpenClinica. The pace of clinical research will only accelerate, so eclinical software (and its users) will need to keep up or get left behind. While we can always make improvements in processing power and data storage, the big gains will come from empowering our users to do more in less time and to rapidly make smart decisions. In the world of electronic data capture, that means giving data managers powerful tools to get studies started, to seamlessly integrate randomization, EDC, and ePRO, and to gain insight into their queried and missing forms.

As a team, we’ve adopted “making the complex easy” as our theme for 2017. As you’ll see in the posts below, we’re poised to do just that. We have new clients that will challenge us to break new ground. We have new team members bringing that rare combination of domain expertise and raw passion. And we have a growing appreciation of the role ePRO will play in identifying therapies that aren’t only efficacious, but effective. So if my life doesn’t get any easier this year, it’s still bound to be exciting.

Our newest clients represent the future of research and care

New client relationships are exciting in any business. But they don’t get much more gratifying than the ones we’ve been fortunate to make. Looking back over the last six months of new client relationships, I’ve been struck with the emergence of some inspiring trends. A focus on personalized medicine. The willingness to take on looming problems in population health. The application of advanced computing and “big data” to challenges old and new. It’s been a potent reminder of the impact that our work here at OpenClinica makes possible.

Here is just a sample of the new partners that are energizing us:

The biotechnologists at miR Diagnostics specialize in the development of prognostic testing in cancer treatment. Their mission is to provide people diagnosed with cancer a deeper understanding their disease, and to help them make the safest, most informed treatment decisions possible. Using state of the art research, miR Diagnostics has developed cutting-edge, prognostic cancer testing systems that provide insight into tumor progression previously impossible to ascertain.

With Tools4Patient, too, medicine is personal. Tools4Patient develops companion diagnostics which contribute to the design of new treatment paradigms to improve outcomes and enhance quality of life for patients. Their first commercialized tool, Placebell, increases the sensitivity and power of clinical research results through improved Individual Placebo Response characterization.

From microbial pathogenesis to gene therapy, The Research Institute at Nationwide Children’s is claiming new frontiers on behalf of children from around the world. Add to that incredible mission a suite of stunning computational resources, and we knew we needed to work together.

Mercy Research, a centralized, multi-faceted research group within the Mercy health system, conducts more than 700 clinical studies at any given time. They’ve developed more than 40 innovating products and are now building one of the foremost teams for healthcare analytics. Suffice it to say, we’re proud to play our role in this enormous enterprise.

Malaria is responsible for more childhood mortality than any other single infectious agent. At Sanaria, through collaborations with renowned institutions like University of Tübingen, Germany, research is taking on a big aim: eradication through vaccination.  

Biolux Research develops technologies that enhance clinical outcomes and dramatically reduce treatment timelines in dentistry, implantology and orthodontics in a safe, effective and non-invasive approach. Learn how they’ve already succeeded with OrthoPulse®.

Again, these are only examples. In the space of a blog post, I can’t do justice to these missions, those of the new clients I didn’t mention, and the many we’ve been helping to advance for years. But I will be reporting our progress in making all these ventures like these as successful as they can be.

 

New eCRFs (Colleague Revelation Forms)

OpenClinica has welcomed several new team members over the last few months. We’ve collected some eCRFs (Collegue Revelation Forms) to introduce them!

Name: Paul Bowen
Title: Product Owner
Responsibility: I bridge the gap between our stakeholders and our engineering team to ensure that we build the features into OpenClinica that are needed most.
Background: Prior to joining OpenClinica, I spent ten years at Quintiles/Outcome Sciences developing an EDC platform for late phase studies. I also spent one year at Clinical Ink working on a patient engagement app.
What I love about research: I like being a part of something that is making people’s lives better in a significant way.
What I love about technology: Technology provides us with many new options to improve the way we do research. Working to figure out the best solutions is a fun part of this job.
What I love outside of work: When the weather is nice, my girlfriend and I like taking long walks with our dog. When it’s not as nice, we like watching sci-fi TV and movies.


Name:
 Bryan Farrow
Title: eClinical Catalyst
Responsibility: I’m the link between the data management community and OpenClinica. It’s my job to distribute news about our products and services to data managers who’ve been looking for solutions to industry-wide problems like integration and ease of use. Just as importantly, I bring unmet challenges back to our incredible team of developers and customer success professionals so that we can find a solution.
Background: Prior to joining OpenClinica, I spent five years at DrugDev, learning how just how much technology can affect the duration, cost and experience of running a trial. Prior to that, I was responsible for physician and patient communications at Boston Children’s Hospital.
What I love about research: The journey and the destination. Asking questions, devising ways to get an answer, and analyzing evidence are thrilling. With clinical research, we get to do all that with the aim of improving lives.
What I love about technology: For me, technology comes down to problem-solving. If you’re curious and persistent, you can always find a better way. And it’s so gratifying when you do.
What I love outside of work: My family above all. I love being a father to my two kids and a partner to my incredible wife. But when I need some “me time”, I usually reach for a book or journal dealing with philosophy. That was my major in college, and I’m still enamored with the power of logic and the gravity of big ethical and political questions.

Name: Brittany Stark
Title: Project Manager
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent 4 years in the Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center, working with phase 0-IV clinical trials in oncology. During this time, I gained experience as a Clinical Research Coordinator, Regulatory Affairs Specialist and later Clinical Trials Staff Educator. Prior to this, I spent over 4 years working in academia at the University of Kentucky (in a Human Behavioral Pharmacology and Clinical Psychology Lab) and later at the University of Maine (teaching SPSS as part of a Research Methods and Designs Course Lab).
What I love about research: The potential to advance our understanding of the world we live in and change lives for the better.

Name: Chris White
Title: Customer Success Team Lead
Responsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.
Background: Prior to joining OpenClinica, I spent two years in the consulting industry working with many different types of software. Prior to that, I spent 14 years creating positive customer experiences with two successful start-ups, helping to build their client focused operations.
What I love about research: There is still part of me that is the seven-year-old Calvin (from Calvin and Hobbes), always asking questions, wanting to know and understand the wide world around me.

 

 

What prevents you from doing (more) ePRO?

Patient-reported outcomes give us insights that no clinical assessment, imaging study and lab report can. For subjective measures, such as mood or energy level, there’s often no other source. But common methods of collecting PRO, from paper diaries to provisioned devices, pose real barriers. We want to know which ones you’ve faced. Tell us by completing the form below. We have more to say on the topic, but we want to start with your experiences!

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

When it comes to your assessing your trial technology, your data managers, study coordinators, Investigators and senior leaders are all study subjects.

In the previous post, I described the difference between efficacy and effectiveness, an increasingly important concept in clinical research and healthcare. After stressing the importance of effectiveness research to health policy planning and patient decision-making, I summarized seven criteria for identifying effectiveness studies. Finally, I asked whether these criteria could be re-purposed beyond a medical intervention to inform how we measure the effectiveness of software systems used to conduct clinical trials.

Is it possible to assess clinical trial software through the lens of effectiveness, as opposed to just efficacy?

I believe that it’s not only possible, but crucial. Why? We all want to reduce the time and cost it takes to deliver safe, effective drugs to those that need them. But if we don’t scrutinize our tools for doing so, we risk letting the status quo impede our progress. When lives are on the line, we can’t afford to let any inefficiency stand.

In this post, I adapt the criteria for effectiveness studies in clinical research into a methodology for evaluating the effectiveness of clinical research software. I limit the scope of adaptation to electronic data capture (EDC) systems, but I suspect that a similar methodology could be developed for CTMS, IVR, eTMF and other complementary technologies. If I open a field of inquiry, or even just broaden one that exists, I’ll consider it time well spent.

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 2 of 2)

Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)

Are you measuring all the relevant outcomes of your clinical trial technology?

For pure pathogen-killing power, it’s hard to beat a surgeon’s hand scrub. Ask any clinician, and she’ll tell you how thoroughly chlorhexidine disinfects skin. If she’s a microbiologist, she’ll even explain to you the biocide’s mechanism of action–provided you’re still listening. But how would the practice fare, say, as a method of cold and flu prevention on a college campus? Your skepticism here would seem justified. After all, it’s hard to sterilize a cough in the dining hall.

Efficacy and effectiveness. It’s unfortunate their phonetics are so close, because while the terms do refer to relative locations along a continuum, they’re the furthest thing from synonyms, as the ever accumulating literature on the topic will attest.

In this post and the one that follows, I’d like to offer some clarity on efficacy vs. effectiveness and illustrate the value that each type of analysis offers. If nothing else, what emerges should provide an introduction to the concepts for those new to clinical research. But I have a more speculative aim, too. I’d like propose standards for assessing trial technology through each of these lenses. Why? Because while we’ve been asking whether a particular technology does what it’s explicitly designed to do, as we should and must, we may have forgotten to ask a critical follow-up question: Does it improve the pace and reliability of our research?

Continue reading Is Your Clinical Trial Software Effective, or Just Efficacious? (Part 1 of 2)

Introducing OpenClinica v4

The OC16 Conference (Oct 3-4 in Boston) is two weeks away and I’m thrilled to be there to introduce the all-new OpenClinica.

The OpenClinica project started 11 years ago with two goals in mind: use the web to help clinical researchers get better, faster data, and champion an open technology model that gives users the power to extend and customize it to their needs.

These goals remain our main focus and are as important as ever. Achieving them improves quality, gets new discoveries to patients faster, improves patient satisfaction, and reduces costs. But clinical trials keep getting more complex, expensive, and harder. Better technology is a must, and it’s time for OpenClinica to evolve.

Here’s a quick preview of what we’ll be showing at OC16. It has two main components:

1. OpenClinica 4 is a self-service e-source, patient engagement, and EDC platform with low cost of entry, rapid startup, optimized workflows, and massive scalability. It is designed to save time, work great in mobile environments, and encourage better collaboration. Picture:

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  • Working with your colleagues in real time on protocol design, in a visual, drag-and-drop way. When ready, its one-click to deploy to test, training, and production environments,
  • A fast, mobile-friendly, flexible forms engine with real-time edit checks, powerful expression logic, and advanced multimedia capabilities
  • Quickly, seamlessly, and securely inviting other users. Have them trained and working productively with the system in a self-service, fully automated way, and
  • Smart & customizable reports, dashboards, and queues that help you work better.

2. The OpenClinica 4 Toolkit is an open, modular environment for building health and research apps that guarantees high-integrity, trustworthy data and adherence to rigorous standards of quality. Developers in healthcare need to be able to easily build mobile & web-based health apps with powerful data collection, workflow, messaging, and visualization capabilities. A junior developer or a healthcare professional with some web programming background will be able to set up a development environment in 5-10 minutes, get a free developer key, and build a ‘hello world’ module in under 30. The toolkit, with a smart mix of modern web & mobile tools, the right amount of domain-specific intelligence, and guaranteed data integrity & security, can unlock immense productivity and innovation. The fundamental features OpenClinica is already built around– trustworthy data provenance, flexible data models, secure REST APIs, and high quality–are a great basis for such a toolkit.

Some key parts of the OpenClinica 4 technology have already been in use for over a year now in OpenClinica Participate. OpenClinica LLC’s engineers have been hard at work on the first four components of OC v4:  the protocol designer, the new form engine, a multi-tenant cloud architecture with single sign on, and self-service training. We will be putting these into use in trials early next year. Other components, like customizable dashboards, workflows, and improved reporting, and the toolkit will soon follow.

Over the past several months, 25 dedicated members of the OpenClinica community, with expertise in clinical trials, EDC, ePRO, data management, and community-based development, have worked in five advisory groups – EDC, Study Startup, eSource, API, and Community – providing strategic direction and ideas to shape the new OpenClinica.

Want to find out more? OC16’s opening panel will have a member of each advisory group sharing their view on where OpenClinica is going, and throughout the day we’ll have live demos, discussion, and training on OpenClinica 4. Come join us at OC16!